Rhythm Pharmaceuticals Announces Additional Positive Data from Phase 3 TRANSCEND trial of Setmelanotide in Patients with Acquired Hypothalamic Obesity

18.8% placebo-adjusted difference in BMI reduction achieved in all patients (N=142) at 52 weeks, including 12 Japanese patients and 10 supplemental patients with acquired hypothalamic obesity —

— March 20, 2026 PDUFA goal date for sNDA for setmelanotide in acquired hypothalamic obesity —

BOSTON, March 01, 2026 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced additional positive data from its global Phase 3 TRANSCEND trial of setmelanotide in patients with acquired hypothalamic obesity (HO). This new data set includes 12 patients from a Japanese cohort and 10 supplemental patients who were enrolled in addition to the primary 120-patient pivotal cohort.

Highlights from these 52-week data include:

  • -18.8% placebo-adjusted difference1 in BMI reduction (N=142);
  • Primary endpoint of mean BMI reduction of -16.4% from baseline for all patients on setmelanotide therapy (n=94) compared with +2.4% BMI change for patients on placebo (n=48) at 52 weeks (95% CI; p<0.0001); and
  • Among patients aged 12 and older (n=98), the setmelanotide group (n=66) showed an average weekly reduction of 2.5 points in the weekly average most hunger score, compared with a 1.3‑point reduction in the placebo group (n=32) (p=0.0015).

“Building off our strong pivotal data, these efficacy data further support setmelanotide’s potential to become the first therapy approved for patients living with the hunger, reduced energy expenditure, accelerated weight gain, and obesity of acquired hypothalamic obesity,” said David Meeker, M.D., Chairman, Chief Executive Officer and President of Rhythm. “We look forward to continuing our positive dialogue with regulators, and we are well prepared to bring setmelanotide to patients with acquired HO, pending U.S. Food and Drug Administration (FDA) approval.”

Rhythm previously announced the TRANSCEND trial met its primary and key secondary endpoints when it disclosed topline data from the pre-specified 120-patient pivotal cohort in April 2025. The Company’s supplemental New Drug Application (sNDA) is under review by the U.S. Food and Drug Administration (FDA) with a PDUFA goal date of March 20, 2026. Rhythm will submit the final data package to the FDA on March 2, 2026 ahead of the previously agreed upon submission date for the supplemental data.  

The European Medicines Agency (EMA) is reviewing Rhythm’s Type II variation submission to the Marketing Authorization Application (MAA) for setmelanotide for the same indication. The Company anticipates the Committee for Medicinal Products for Human Use (CHMP) would issue an opinion to the European Commission (EC) in the second quarter of 2026 with potential marketing authorization in the second half of 2026. The Company will also submit the full data package to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and plans to seek marketing authorization for setmelanotide to treat acquired hypothalamic obesity there, as well.

About Acquired Hypothalamic Obesity

Acquired hypothalamic obesity is a rare disease characterized by accelerated and sustained weight gain caused by an injury to the hypothalamus. Hypothalamic injury may lead to decreased alpha-melanocyte-stimulating hormone (α-MSH) production and impairment of MC4R pathway signaling. The MC4R pathway is responsible for regulating energy balance and body weight. Acquired hypothalamic obesity most frequently follows the growth or treatment of craniopharyngioma, astrocytoma or other hypothalamic-pituitary tumors. Additional causes of injury may include traumatic brain injury, stroke or inflammation. Due to impairment of the MC4R pathway, patients experience accelerated and sustained weight gain, often accompanied by hyperphagia and/or decreased energy expenditure. Acquired hypothalamic obesity can occur as early as six months following hypothalamic injury. Rhythm estimates 10,000 patients living with acquired HO in the United States, approximately 10,000 patients in Europe and between 5,000 to 8,000 people living with acquired hypothalamic obesity in Japan.

About Rhythm Pharmaceuticals

Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE® (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the U.S. Food and Drug Administration (FDA) to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. Both the European Commission (EC) and the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as investigational MC4R agonists bivamelagon and RM-718, and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.

Setmelanotide Indication

In the United States, setmelanotide is indicated to reduce excess body weight and maintain weight reduction long term in adult and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency as determined by an FDA-approved test demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

In the European Union and the United Kingdom, setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. In the European Union and the United Kingdom, setmelanotide should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.

Limitations of Use

Setmelanotide is not indicated for the treatment of patients with the following conditions as setmelanotide would not be expected to be effective:

  • Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign
  • Other types of obesity not related to BBS or POMC, PCSK1, or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity

Contraindication

Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.

WARNINGS AND PRECAUTIONS

Disturbance in Sexual Arousal: Spontaneous penile erections in males and sexual adverse reactions in females have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression, suicidal ideation and depressed mood have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.

Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation, darkening of pre-existing nevi, development of new melanocytic nevi and increase in size of existing melanocytic nevi have occurred. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.

Risk of Serious Adverse Reactions Due to Benzyl Alcohol Preservative in Neonates and Low Birth Weight Infants: IMCIVREE is not approved for use in neonates or infants. Serious and fatal adverse reactions including “gasping syndrome” can occur in neonates and low birth weight infants treated with benzyl alcohol preserved drugs.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥20%) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection.

USE IN SPECIFIC POPULATIONS

Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See section 4.8 of the Summary of Product Characteristics for information on reporting suspected adverse reactions in Europe.

Please see the full Prescribing Information for additional Important Safety Information.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our pivotal Phase 3 TRANSCEND study evaluating setmelanotide for the treatment of acquired hypothalamic obesity, including the additional data set of 12 patients from a Japanese cohort and 10 supplemental patients enrolled in addition to the primary 120-patient pivotal cohort; the potential for setmelanotide to treat hypothalamic obesity; the safety, efficacy, potential benefits of, and clinical design or progress of any of our products or product candidates at any dosage or in any indication; our expectations surrounding potential regulatory submissions, progress, or approvals and timing thereof for any of our product candidates, including the sNDA to the FDA and the PDUFA goal date of March 20, 2026, including the submission of the final data package to the FDA, the Type II variation request to the EMA and the anticipated decision by the CHMP to issue an opinion to EC and potential marketing authorization in the second half of 2026; as well as the Company’s engagement with PMDA and plans to seek authorization for setmelanotide to treat acquired hypothalamic obesity in Japan; the estimated market size and addressable population for our drug products, including setmelanotide for the treatment of hypothalamic obesity in the United States, the EU and Japan; and presentation of the full data from the TRANSCEND study at an upcoming medical meeting; including the content, date and timing of any of the foregoing. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. Such statements are subject to numerous risks, uncertainties and other important factors, including those discussed under the caption “Risk Factors” in Rhythm’s Annual Report on Form 10-K for the year ended December 31, 2025, and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.

Corporate Contact:

David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
857-264-4280
[email protected]

Media Contact:

Layne Cosgrove
Real Chemistry
(410) 916-1035
[email protected]

1 ANCOVA model with unequal variance to account for possible unequal residual variances was used to estimate the difference between treatment groups. Rubin’s Rule was used to provide the overall estimates of differences in least square (LS) means, corresponding CI and p-value.



Public Storage and Welltower Announce Strategic Data Science Partnership to Advance Application of AI in Real Estate Investing

Public Storage and Welltower Announce Strategic Data Science Partnership to Advance Application of AI in Real Estate Investing

FRISCO, Texas & TOLEDO, Ohio–(BUSINESS WIRE)–
Public Storage (NYSE: PSA) and Welltower (NYSE: WELL) today announced a strategic data science partnership bringing together Welltower’s industry-leading data science-driven capital allocation expertise and Public Storage’s scaled operational, pricing, and customer analytics capabilities.

Welltower’s industry-leading data science platform – the company’s umbrella term encompassing machine learning, deep learning, and AI – was formed in 2016 and has since been led by a multidisciplinary team of Ph.D. computer scientists, engineers, statisticians, and mathematicians. This data science-driven capital allocation engine is designed to dynamically direct capital to the highest risk-adjusted return opportunities across acquisitions, developments, dispositions and lending. While Welltower’s platform has historically been focused on capital allocation, Public Storage has developed best-in-class operational data science capabilities as part of its transformation, including revenue management, customer behavior modeling, demand forecasting, and operating efficiency analytics, which are core drivers of net operating income growth and margin expansion.

As part of the partnership, Public Storage will license bespoke models from Welltower to deploy capital with greater velocity and precision on granular acquisitions to ultimately achieve stronger risk-adjusted returns. These capabilities build upon Public Storage’s Value Creation Engine and support its PS4.0TM strategy to compound per share value. Additionally, over time, Public Storage will share its proven operational data science capabilities to further drive Welltower’s operating performance and analytics-driven decision-making across the Welltower Business System.

As the largest companies in their respective sectors with decades of history, each company owns an unparalleled repository of proprietary data that is neither accessible nor replicable by competitors, third party data providers, or large language model (LLM) interfaces, creating a durable asymmetric information advantage. Welltower, the world’s largest publicly traded real estate company, has utilized its data science platform to successfully scale an unscalable business, as evidenced by over $80 billion of capital allocation activity in recent years. In an industry defined by lengthy transaction timelines of 5-9 months, Welltower has compressed the process to mere weeks, using advanced mathematical models and high performance compute. In turn, the company has substantially reduced latency in the system and dramatically increased “velocity to market.” The models that Public Storage will license from Welltower use various supervised and unsupervised learning to focus on micro-markets with the greatest return and growth potential.

“Both Welltower and Public Storage have built differentiated data science capabilities that create a durable competitive advantage,” said Tom Boyle, Public Storage’s incoming Chief Executive Officer. “By integrating Welltower’s data science-driven capital allocation capabilities into our PS4.0 platform, we expect to further sharpen how we deploy capital and accelerate value creation. Over time, our operational analytics capabilities will help enhance Welltower’s operating platform, as well.”

Welltower’s CEO, Shankh Mitra, said, “While real estate is the world’s largest asset class, it has historically been characterized as a local, ‘gut-feel’ industry that has proven to be one of the most unscalable businesses. While some have attempted to scale the business through service models, we believe that the only way to truly scale this business is through the data generated by the assets.” He continued, “We are delighted to announce this partnership with Public Storage, a truly iconic company. Harnessing the power of Welltower’s data science platform, Public Storage will be deploying quantitative models for the real world – a world of science and math, not language and images – trained on decades of actual, proprietary performance data. This will significantly accelerate capital allocation decisions, demonstrating a tangible, real-world application of AI.”

About Public Storage

Public Storage, a member of the S&P 500, is a REIT that primarily acquires, develops, owns, and operates self-storage facilities. At December 31, 2025, we: (i) owned and/or operated 3,533 self-storage facilities located in 40 states with approximately 258 million net rentable square feet in the United States and (ii) owned a 35% common equity interest in Shurgard Self Storage Limited (Euronext Brussels: SHUR), which owned 332 self-storage facilities located in seven Western European countries with approximately 18 million net rentable square feet operated under the Shurgard® brand. Our headquarters are located in Frisco, Texas.

About Welltower

Welltower Inc. (NYSE: WELL), an S&P 500 company, is positioned at the center of the silver economy, focusing on rental housing for aging seniors across the United States, United Kingdom, and Canada. Our portfolio of 2,000+ seniors and wellness housing communities are positioned at the intersection of housing and hospitality, creating vibrant communities for mature renters and older adults. We believe our real estate portfolio is unmatched, located in highly attractive micromarkets with stunning built environments. Yet, we are an unusual real estate organization as we view ourselves as an operating company in a real estate wrapper, driven by highly-aligned partnerships and an unconventional culture. Through our disciplined approach to capital allocation powered by our Data Science platform and superior operating results driven by the Welltower Business System – our end-to-end operating platform – we aspire to deliver long-term compounding of per share growth for our existing investors, our North Star.

More information is available at www.welltower.com. We routinely post important information on our website at www.welltower.com in the “Investors” section, including corporate and investor presentations and financial information. We intend to use our website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD. Such disclosures will be included on our website under the heading “Investors”. Accordingly, investors should monitor such portion of our website in addition to following our press releases, public conference calls and filings with the Securities and Exchange Commission. The information on our website is not incorporated by reference in this press release and our web address is included as an inactive textual reference only.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements relating to Welltower’s and Public Storage’s data science capabilities and partnership, the strategies for and expected results of the partnership, including with respect to capital allocation decisions, speed of capital deployment, realization of investment returns, and acceleration of shareholder value creation, and all other statements other than statements of historical fact. Such statements are based on each company’s beliefs and assumptions made based on information currently available to management of that company and may be identified by the use of the words “outlook,” “guidance,” “expects,” “believes,” “anticipates,” “should,” “estimates,” and similar expressions. These forward-looking statements involve known and unknown risks and uncertainties, which may cause each company’s actual results and performance to be materially different from those expressed or implied in the forward-looking statements. Risks and uncertainties that may impact future results and performance include, but are not limited to Welltower’s and Public Storage’s ability effectively and securely to develop the data science tools underlying the partnership and to leverage each company’s respective data for the partnership’s intended purposes, as well as those risks and uncertainties described in Part 1, Item 1A, “Risk Factors” in Welltower’s most recent Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission (the “SEC”) on February 12, 2026, Public Storage’s most recent Annual Report on Form 10-K for the year ended December 31, 2025 filed with the SEC on February 12, 2026, and in each company’s respective other filings with the SEC. These forward-looking statements speak only as of the date of this press release or as of the dates indicated in the statements. All of the forward-looking statements, including those in this press release, are qualified in their entirety by this cautionary statement. Welltower and Public Storage expressly disclaim any obligation to update publicly or otherwise revise any forward-looking statements, whether as a result of new information, new estimates, or other factors, events or circumstances after the date of these forward-looking statements, except when expressly required by law. Given these risks and uncertainties, you should not rely on any forward-looking statements in this press release, or which management of either company may make orally or in writing from time to time, neither as predictions of future events nor guarantees of future performance.

Joe Fisher

[email protected]

KEYWORDS: Texas Ohio United States North America

INDUSTRY KEYWORDS: Construction & Property Data Analytics Finance Artificial Intelligence Professional Services Technology REIT Fintech

MEDIA:

Septerna Announces Positive Phase 1 Data for SEP-631, an Oral MRGPRX2 NAM for the Treatment of Mast Cell-Driven Diseases, and Outlines Initial Phase 2 Development Strategy

SEP-631 Demonstrated Robust, Dose-Dependent Inhibition of Icatibant-Induced Skin Wheal Formation, with Complete Inhibition Observed at Doses as Low as 10 mg Once-Daily 

Well-Tolerated Across All Doses Studied with an Adverse Event Profile Comparable to Placebo; Pharmacokinetic Profile Supports Once-Daily Oral Dosing

Phase 2 Development Planned to Begin with Chronic Spontaneous Urticaria in the Second Half of 2026

Company to Host Conference Call and Webcast on Monday, March 2, 2026, at 8:00 a.m. ET

SOUTH SAN FRANCISCO, Calif., March 01, 2026 (GLOBE NEWSWIRE) — Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering oral small molecule GPCR-targeted medicines, today announced positive results from its Phase 1 clinical trial evaluating SEP-631, a potent and selective oral negative allosteric modulator (NAM) of Mas-related G protein-coupled receptor X2 (MRGPRX2). Based on these results, Septerna plans to advance SEP-631 into Phase 2 development for chronic spontaneous urticaria (CSU) and continue evaluation of additional mast cell-driven indications.

“These data mark an important milestone for the SEP-631 program and more broadly for our Native Complex Platform®, which enables new approaches to GPCR drug discovery by reconstituting functional GPCR complexes outside of cells,” said Jae Kim, M.D., chief medical officer of Septerna. “Importantly, the robust inhibition of icatibant-induced wheal formation observed is consistent with the differentiated insurmountable NAM mechanism we characterized preclinically and provides clinical proof-of-mechanism for the MRGPRX2 pathway. Overall, we believe the strength and consistency of these results position SEP-631 as a potentially differentiated oral treatment for patients living with mast cell-driven diseases. With a clear path into Phase 2 development in chronic spontaneous urticaria, we are focused on translating this early validation into meaningful outcomes for patients and exploring additional high-need indications where MRGPRX2 biology is implicated.”

Phase 1 Results

SEP-631 was evaluated in a randomized, double-blind, placebo-controlled Phase 1 trial in healthy volunteers, including single-ascending dose, multiple-ascending dose and food-effect cohorts. The study assessed safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) activity.

SEP-631 was well-tolerated across all doses studied:

  • Adverse event profile comparable to placebo
  • No severe or serious adverse events
  • No clinically meaningful laboratory or ECG abnormalities

SEP-631 demonstrated a PK profile supportive of convenient once-daily oral dosing, including:

  • Half-life of approximately 24 hours
  • No clinically meaningful effect of food on exposure, supporting dosing without food restrictions

Pharmacodynamic activity was assessed using icatibant-induced skin wheal formation, an established skin test used to measure mast cell activation and target engagement, as a translational model of MRGPRX2-mediated mast cell activation. Use of short-wave infrared imaging technology enabled accurate and precise measurement of the skin test wheals. SEP-631 produced robust suppression of wheal formation across evaluated dose levels, with complete inhibition observed at doses as low as 10 mg once daily following the 10 µg/mL icatibant challenge. Following the 100 µg/mL icatibant challenge, inhibition was dose-dependent, with progressively greater suppression observed at increasing SEP-631 doses with near to complete inhibition achieved at 90 and 200 mg once daily. These findings are consistent with the insurmountable NAM mechanism of SEP-631 observed preclinically and support potent target engagement and functional blockade of MRGPRX2 signaling in humans, providing clinical proof-of-mechanism.

Phase 2 Development Strategy

Septerna plans to initiate a Phase 2b clinical trial of SEP-631 in chronic spontaneous urticaria (CSU) in the second half of this year, following the completion of ongoing long-term toxicology studies.

The planned Phase 2b study will be a randomized, double-blind, placebo-controlled, global trial evaluating once-daily oral SEP-631 in adult patients with moderate-to-severe CSU who remain symptomatic despite treatment with second-generation antihistamines. Following the CSU study initiation, the company also plans to pursue an open-label study in chronic inducible urticaria (CIndU), specifically in patients with symptomatic dermatographism.

Beyond urticaria, Septerna is evaluating additional mast cell-driven diseases with high unmet medical need and evidence of MRGPRX2 expression, and has initially prioritized atopic dermatitis, interstitial cystitis, migraine and asthma for further assessment.

Conference Call and Webcast Information

Septerna will host a conference call and webcast on Monday, March 2, 2026, at 8:00 a.m. ET to discuss the Phase 1 results and initial Phase 2 development strategy for SEP-631. The live webcast will be available in the investors section of the company’s website at www.septerna.com. A replay will be available shortly after the event and will be archived for at least 30 days.

About SEP-631

Septerna is developing SEP-631, a selective oral small molecule Mas-related G protein-coupled receptor X2 (MRGPRX2) negative allosteric modulator (NAM) for the treatment of patients with chronic spontaneous urticaria (CSU) and other mast-cell driven diseases. MRGPRX2 is known to play an important role in mast cell activation and degranulation which, in combination with other inflammatory mediators, lead to debilitating symptoms for patients. In a Phase 1 clinical trial, SEP-631 demonstrated favorable tolerability, once-daily pharmacokinetics and pharmacodynamic evidence of MRGPRX2 pathway inhibition. Septerna plans to advance SEP-631 into Phase 2 development in CSU and chronic inducible urticaria and is evaluating its potential in additional mast cell-driven indications, including atopic dermatitis, interstitial cystitis, migraine and asthma.

About Septerna

Septerna, Inc. is a clinical-stage biotechnology company with a world-class team of GPCR experts and drug developers advancing cutting-edge science to unlock the full potential of GPCR therapies for patients with significant unmet needs. The company’s proprietary Native Complex Platform® is designed to enable new approaches to GPCR drug discovery and has led to the development of a diverse pipeline of novel oral small molecule drug candidates. Septerna is advancing programs in endocrinology, immunology and inflammation, metabolic diseases and additional therapeutic areas, both independently and with partners. For more information, please visit www.septerna.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements about Septerna’s beliefs and expectations regarding: the continued advancement of SEP-631, including the plan to initiate a Phase 2b clinical study in CSU in the second half of 2026 subject to the successful completion of long-term preclinical toxicology studies; the role of MRGPRX2 in mast cell-driven diseases; the potential of SEP-631 to provide a convenient oral treatment option for patients with CSU and other mast cell-driven diseases; expectations regarding the anticipated once-daily dosing frequency of SEP-631; the ability of the SEP-631 Phase 1 safety and efficacy observations to successfully translate into clinical outcomes in patients; the potential of its proprietary Native Complex Platform®; the size and growth potential of the markets for its current and future product candidates; its expectations regarding strategic plans for its business, product candidates, and technology; and the scope of protection it is able to establish and maintain for intellectual property rights covering its Native Complex Platform® and its product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “objective,” “ongoing,” “plan,” “predict,” “project,” “potential,” “should,” or “would,” or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward looking statements contain these identifying words.

Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: Septerna’s product candidates successfully entering and advancing through clinical trials (including SEP-631) including uncertainties related to opening INDs and other regulatory approvals; risks related to clinical development outcomes including unexpected safety or efficacy findings; the results of preclinical studies including the long-term toxicology studies for SEP-631, or clinical studies not being predictive of future clinical outcomes; risks related to the timing of initiating clinical studies and future availability of clinical data; and the scope of protection Septerna is able to establish and maintain for intellectual property rights covering its Native Complex Platform® and its product candidates. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in Septerna’s Annual Report on Form 10-K for the year ended December 31, 2024, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Septerna’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Septerna explicitly disclaims any obligation to update any forward-looking statements subject to any obligations under applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Investor Contact:

Renee Leck, THRUST
[email protected]

Media Contact:

Carly Scaduto, THRUST
[email protected]



Upstream Bio Presents Additional Analyses from the Phase 2 VIBRANT Trial of Verekitug in Chronic Rhinosinusitis with Nasal Polyps at 2026 AAAAI Annual Meeting

– Primary endpoint of endoscopic nasal polyp score (NPS) showed reduction of –1.95 (p < 0.0001) in new analysis with adjustment for concomitant rescue therapy use


Secondary endpoints also provided strong efficacy data
in new analyses
, including reduction in nasal congestion score (NCS) by
-0.96 (p < 0.0001)

WALTHAM, Mass., March 01, 2026 (GLOBE NEWSWIRE) — Upstream Bio, Inc. (Nasdaq:UPB), a clinical-stage company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders, today presented additional data from the Phase 2 VIBRANT clinical trial evaluating verekitug in participants with chronic rhinosinusitis with nasal polyps (CRSwNP). The additional analyses incorporated a worst-observation carried-forward (WOCF) statistical approach to adjust for concomitant rescue therapy use, including nasal polyp surgery, systemic corticosteroids, or escalation of background treatments. The data support previously reported positive top-line results and were presented in a late-breaking poster session at the American Academy of Allergy Asthma & Immunology (AAAAI) 2026 Annual Meeting in Philadelphia.

Dosed 100 mg every 12 weeks, verekitug met the study’s primary endpoint using both the WOCF and primary (treatment policy) analyses, demonstrating an improved placebo-adjusted reduction in NPS of -1.95 (p < 0.0001) in the WOCF analysis as compared to a reduction of -1.77 (p < 0.0001) in the primary analysis at week 24.

The trial also showed a placebo-adjusted reduction in the patient-reported NCS, a key secondary endpoint, of -0.96 (p < 0.0001) in the WOCF analysis as compared to -0.77 (p = 0.0003) in the primary analysis.

As previously reported in the top-line results, verekitug reduced the need for surgery or systemic corticosteroids by 76% (p = 0.03) compared with placebo, and was generally well tolerated, demonstrating a favorable safety profile consistent with previous studies, with no SAEs observed.

“The strong results in clinical effect we saw in these additional analyses are an important validation of verekitug’s impact on endpoints that take into consideration the use of rescue medication, which was substantially reduced with verekitug treatment in VIBRANT. As this approach more closely aligns with that used in other recent studies of agents in CRSwNP, it also enhances our understanding of verekitug’s potential to add to the existing armamentarium for this serious disease. The presentation of these data continues to reinforce verekitug’s differentiated profile, comprising robust clinical activity with far less-frequent dosing, relative to currently available biologics as a potential treatment of CRSwNP,” said Aaron Deykin, MD, Chief Medical Officer and Head of Research & Development at Upstream Bio. “As we prepare to initiate our Phase 3 trials in CRSwNP and severe asthma, we believe that verekitug’s unique mechanism of action and differentiated product profile could position it to significantly advance the standard of care for people with serious respiratory diseases.”

“The magnitude of improvement observed with verekitug across both analytical approaches, along with the previously reported reduction in rescue interventions, suggests the potential for meaningful benefit for people living with chronic rhinosinusitis with nasal polyps,” said Joseph Han, MD, Professor in the Department of Otolaryngology & Head and Neck Surgery and the Chief for the Division of Allergy at Old Dominion University (Eastern Virginia Medical School), and principal investigator on the VIBRANT trial. “Additionally, the efficacy outcomes we observed in VIBRANT, combined with the every 12-week dosing interval, suggest that verekitug could represent a valuable new treatment option for people living with this challenging condition.”

VIBRANT (NCT06164704) was a Phase 2 global, randomized, double-blind, placebo-controlled, parallel group clinical trial that evaluated the efficacy and safety of verekitug over 24 weeks in 81 adults with CRSwNP.

Upstream Bio designed the VIBRANT trial using endpoints that, pending interactions with regulatory authorities, could produce data to support submissions for product approval. Planning activities for Phase 3 trials in CRSwNP and severe asthma have commenced, and the Company intends to initiate registrational trials in both indications, following planned regulatory interactions.

About CRSwNP

CRSwNP is a chronic inflammatory disease of the upper airway, marked by inflammation in the nose and sinuses and the presence of nasal polyps. CRSwNP has four main symptoms: runny nose or postnasal drip, nasal congestion, facial pressure and/or pain and loss of smell and/or taste. Despite available treatments such as corticosteroids, surgery and, more recently, biologics, the quality-of-life studies and post-surgical recurrence rates clearly show that many people with CRSwNP have uncontrolled symptoms that are impacting their daily life and current treatments are not meeting their needs. It is estimated that CRSwNP affects up to 4% of the general population, of whom 40% have uncontrolled disease.

Nasal polyps are associated with significant disease burden and debilitating symptoms; it is estimated that over 40% of people with severe asthma also have CRSwNP and that up to 70% of people with CRSwNP also have asthma, demonstrating a strong association between the two conditions.

About the Phase 2 VIBRANT Trial

The Phase 2 VIBRANT trial (NCT06164704) was a global, randomized, placebo-controlled, parallel group clinical trial, which was designed to assess the efficacy and safety of verekitug in adults with CRSwNP who were receiving concurrent intranasal corticosteroid therapy. Participants received either 100 mg of verekitug or placebo subcutaneously every 12 weeks for 24 weeks. The primary endpoint was change in endoscopic nasal polyp score at Week 24, a primary endpoint that has been used in several registrational trials for other biologic treatments for CRSwNP. Secondary endpoints included: nasal congestion score, sinus opacification, difficulty with sense of smell, total symptom score, percentage of participants requiring systemic corticosteroids or nasal polyp surgery, and time to first such interventions up to Week 24.

About Verekitug

Verekitug is a novel recombinant fully human immunoglobulin G1 (IgG1) monoclonal antibody that binds to the thymic stromal lymphopoietin (TSLP) receptor and inhibits proinflammatory signaling initiated by TSLP. It is the only known antagonist currently in clinical development that targets and inhibits the TSLP receptor.

TSLP is a cytokine that is a key driver of the inflammatory response in major allergic and inflammatory diseases, such as asthma, where disruption of TSLP signaling has been clinically validated as an effective therapeutic strategy. TSLP activation is one of the first events in the inflammatory cascade stimulated by allergens, viruses and other triggers, initiating the activation of downstream targets such as IL-4, IL-5, IL-13, IL-17 and IgE. Because TSLP is a target upstream in the inflammatory cascade, blocking the TSLP receptor presents an opportunity for a single treatment to impact the drivers of multiple pathological inflammatory processes across a broad set of diseases.

Verekitug has advanced into three separate global, placebo-controlled, randomized Phase 2 clinical trials including the recently completed positive VIBRANT trial (NCT06164704) in patients with CRSwNP and VALIANT trial (NCT06196879) in patients with severe asthma. The VENTURE trial (NCT06981078) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) is ongoing. Additionally, in May 2025, Upstream Bio initiated the VALOUR trial (NCT06966479), a long-term extension study in eligible participants with severe asthma who completed the VALIANT Phase 2 clinical trial.

About Upstream Bio

Upstream Bio is a clinical-stage biotechnology company developing treatments for inflammatory diseases, with an initial focus on severe respiratory disorders. The Company is developing verekitug, the only known antagonist currently in clinical development that targets the receptor for thymic stromal lymphopoietin (TSLP), a cytokine which is a clinically validated driver of inflammatory response positioned upstream of multiple signaling cascades that affect a variety of immune mediated diseases. The Company has evaluated this highly potent monoclonal antibody in separate Phase 2 trials for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), severe asthma, and an ongoing Phase 2 trial in chronic obstructive pulmonary disease (COPD). Upstream Bio’s team is committed to maximizing verekitug’s unique attributes to address the substantial unmet needs for patients underserved by today’s standard of care. To learn more, please visit www.upstreambio.com.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “continue,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “predict,” “project,” “seeks,” “should,” “target,” “will” and variations of these words or similar expressions. Any statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements include, without limitation, express or implied statements regarding: the global development of verekitug for the treatment of severe asthma, CRSwNP and COPD, including the initiation, timing, progress and results of ongoing and planned clinical trials; expectations for future discussions with regulatory authorities and the potential of the endpoints of the Company’s clinical trials to produce data that could support submissions for product approval; expectations regarding the differentiation, safety, efficacy, tolerability, and/or extended dosing interval of verekitug; and expectations for the size and growth potential of the market for verekitug in CRSwNP and the Company’s ability to serve that market. Any forward-looking statements in this press release are based on the Company’s current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or implied in the Company’s forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and uncertainties related to: Upstream Bio’s ability to advance verekitug through clinical development, and to obtain regulatory approval of and ultimately commercialize verekitug on the expected timeline, if at all; the initiation, timing, progress and results of clinical trials; Upstream Bio’s ability to fund its development activities and achieve development goals; Upstream Bio’s dependence on third parties to conduct clinical trials and manufacture verekitug, and commercialize verekitug, if approved; Upstream Bio’s ability to attract, hire and retain key personnel, and protect its intellectual property; Upstream Bio’s financial condition and need for substantial additional funds in order to complete development activities and commercialize verekitug, if approved; regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; Upstream Bio’s competitors and industry; and other risks and uncertainties described in greater detail under the caption “Risk Factors” in Upstream Bio’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as well as any subsequent filings with the SEC. Any forward-looking statements represent Upstream Bio’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Upstream Bio explicitly disclaims any obligation or undertaking to update any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based except to the extent required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Investor and Media Contact:

Meggan Buckwell
Director, Corporate Communications and Investor Relations
[email protected]



Celldex Presents Positive Data Demonstrating Barzolvolimab Retreatment Achieves Similar Profound Efficacy to First Exposure in Patients with Cold Urticaria (ColdU) and Symptomatic Dermographism (SD) Further Demonstrating First-in-Class and Best-in-Disease Barzolvolimab Profile at AAAAI 2026

– Late breaking Poster Presentation at AAAAI –

– Ability to retreat facilitates a real-world paradigm in which treatment for ColdU and SD may be intermittent with barzolvolimab –

HAMPTON, N.J., March 01, 2026 (GLOBE NEWSWIRE) — Celldex (NASDAQ:CLDX) presented new positive data from the Phase 2 ColdU and SD Open Label Extension (OLE), highlighting that retreatment with barzolvolimab leads to rapid improvement in urticaria control after symptom recurrence. Barzolvolimab is a humanized monoclonal antibody with a completely novel mechanism of action that uniquely targets the root cause of ColdU and SD—the mast cell. The data were shared today in a late breaking poster presentation at the 2026 American Academy of Allergy, Asthma & Immunology’s (AAAAI) Annual Meeting being held in Philadelphia, PA. The data were presented by Jonathan A. Bernstein, MD, trial investigator and Professor of Clinical Medicine in the Department of Internal Medicine at the University of Cincinnati College of Medicine.

“Patients and physicians need treatment options that provide durable, symptom-free complete response and the potential for flexibility that reflects real world treatment paradigms,” said Diane Young, MD, Senior Vice President and Chief Medical Officer of Celldex. “We previously presented data in chronic spontaneous urticaria showing that up to 41% of patients continued to experience a complete response seven months after receiving their final dose on study. The data presented today from our inducible urticaria study demonstrate that when disease symptoms do recur, patients can be retreated and, importantly, achieve the same high levels of complete response they experienced on initial treatment. We believe barzolvolimab’s unique mechanism of action, which targets the root cause of these forms of chronic urticaria—the mast cell, drives this effect and supports barzolvolimab’s profile as a best-in-class, best-in-disease potential treatment option for patients with chronic urticarias.”

In the main portion of the Phase 2 study, 193 patients with ColdU (n=96) or SD (n=97) received 150 mg Q4W, 300 mg Q8W barzolvolimab, or placebo for 20 weeks. Patients with disease recurrence during the main study follow-up period qualified for the OLE. 121 patients entered the OLE, 61 patients with ColdU and 60 patients with SD, and 116 patients completed treatment in the OLE. Patients treated with placebo in the main study entered the OLE faster than patients treated with barzolvolimab (median time of 56 days versus 105 days from last dose in main study).

Barzolvolimab re-treatment achieved similar profound efficacy to first exposure in patients with ColdU and SD.

  • With barzolvolimab re-treatment, 62% of patients with ColdU and 60% of patients with SD had a complete response at Week 20 in the OLE. These findings are consistent with the complete response rates in these patients to their initial treatment of 66% for ColdU and 49% for SD at Week 20 in the main study.
  • Among patients with ColdU who achieved a complete response in the main study (n = 22), in the OLE, 82% of these patients achieved a complete response again and 95% achieved complete or partial response at Week 20.
  • Among patients with SD who achieved a complete response in main study (n = 21), in the OLE, 86% of these patients achieved a complete response again and 100% achieved either a complete or partial response at Week 20.
  • Marked, rapid reduction in critical temperature and friction thresholds were observed upon re-treatment,
  • Barzolvolimab re-treatment resulted in clinically meaningful improvements in urticaria control, achieving a high rate of well controlled disease: up to 68% of patients with ColdU and 69% of patients with SD. 
  • Barzolvolimab was well tolerated with a safety profile consistent with prior studies,
  • The ability to re-treat facilitates a real-world paradigm in which treatment for CIndU may be intermittent.
  • A global Phase 3 trial (EMBARQ-ColdU and SD) (NCT07266402) designed to establish the efficacy and safety of barzolvolimab in adult patients with ColdU and SD who remain symptomatic despite H1 antihistamine treatment initiated in late 2025 and is enrolling patients.

About Chronic Inducible Urticaria (CIndU), Cold Urticaria (ColdU), Symptomatic Dermographism (SD)

CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them. ColdU symptoms include itching, burning wheals/hives and angioedema when skin is exposed to cold temperatures. SD symptoms include the development of wheals in response to stroking, scratching or rubbing of the skin. For these diseases, mast cell activation leading to release of soluble mediators is thought to be the driving mechanism leading to the wheals and other symptoms. There are currently no approved therapies for chronic inducible urticarias other than antihistamines and patients attempt to manage symptoms associated with their disease through avoidance of triggers.

About Barzolvolimab

Barzolvolimab is a humanized monoclonal antibody with a novel mechanism of action that targets mast cells by binding with high specificity to a unique part of the KIT receptor and potently inhibiting its activity. The KIT receptor is abundantly expressed by mast cells and critical for their function and survival. Mast cells are drivers of inflammatory responses such as hypersensitivity and allergic reactions and, in certain inflammatory diseases, such as chronic urticarias, mast cell activation plays a central role in the onset and progression of the disease. Based on data from robust, randomized, placebo controlled Phase 2 studies, barzolvolimab has significant potential as a first-in-class and best-in-disease treatment option for patients with chronic spontaneous urticaria (CSU), cold urticaria (ColdU) and symptomatic dermographism (SD). Barzolvolimab is currently being studied in Phase 3 studies in CSU and ColdU/SD and Phase 2 studies in prurigo nodularis (PN) and atopic dermatitis (AD), with additional indications planned for the future.

About Celldex

Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders.
Visit www.celldex.com.

Forward Looking Statement

This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159) and CDX-622, in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company’s programs to continue to develop; our ability to protect the Company’s intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company’s products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under “Risk Factors” in our annual report on Form 10-K and quarterly reports on Form 10-Q.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

Company Contact

Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
(508) 864-8337
[email protected]

Patrick Till
Meru Advisors
(484) 788-8560
[email protected]



SMR Deadline: BFA Law Urges NuScale Power Corporation Investors with Losses to Act Before April 20 Securities Fraud Class Action Deadline Amid 12% Stock Decline

A securities fraud class action has been filed against NuScale executives alleging misrepresentations about ENTRA1 leading to a 12.4% stock plunge.

NEW YORK, March 01, 2026 (GLOBE NEWSWIRE) — Leading securities law firm Bleichmar Fonti & Auld LLP announces that a class action lawsuit has been filed against NuScale Power Corporation (NYSE:SMR) and certain of the Company’s senior executives for securities fraud after a significant stock drop resulting from the potential violations of the federal securities laws.

If you invested in NuScale, you are encouraged to obtain additional information by visiting: https://www.bfalaw.com/cases/nuscale-class-action-lawsuit.

Key Details of the NuScale ($SMR) Class Action:

  • Lead Plaintiff Deadline: April 20, 2026
  • Alleged Misconduct: Misrepresenting the experience and capabilities of ENTRA1 and its role in developing and commercializing NuScale’s nuclear power modules
  • Largest Alleged Stock Decline: November 10, 2025 – 12.4% Stock Drop
  • Court: U.S. District Court for the District of Oregon
  • Action: Contact BFA Law to discuss your rights

Investors have until April 20, 2026 to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors in NuScale Class A common stock. The case is pending in the U.S. District Court for the District of Oregon and is captioned Truedson v. NuScale Power Corporation, et al., No. 3:26-cv-00328.

Why is NuScale Being Sued for Securities Fraud?

NuScale is a nuclear technology company. Its core technology is the NuScale Power Module (“NPM”), a small modular nuclear reactor (“SMR”) designed to generate energy within a broader power plant. Prior to the start of the Class Period, NuScale established a partnership with ENTRA1 Energy LLC. Under this agreement, ENTRA1 was responsible for constructing power generation facilities incorporating NuScale’s NPMs and managing the financing, development, and initial operations of the facilities utilizing the NPMs.

NuScale allegedly touted ENTRA1’s purported wide-ranging capabilities and deep experience developing power plants. According to NuScale, ENTRA1 is an “independent power plant development platform,” “led by an executive team of energy, infrastructure, and finance sector veterans,” with the type of experience that is “exactly what is required” to commercialize and deploy NuScale’s NPMs.

As alleged, in truth, ENTRA1 had never built, financed, or operated any significant project, let alone a project in the complex field of nuclear power generation. Moreover, in contrast to NuScale’s representations, ENTRA1 had been organized primarily to support the work of one individual, its principal Wadie Habboush, an investor and entrepreneur.

Why did NuScale’s Stock Drop?

On November 6, 2025, NuScale disclosed that its general and administrative expenses had increased from $17 million in the prior year period, to $519 million during 3Q 2025, due largely to NuScale’s payment of $495 million to ENTRA1 for its services. Also on November 6, 2025, under pressure from investment analysts, NuScale acknowledged that ENTRA1 did not have any significant experience building nuclear power projects and admitted that ENTRA1 would not actually be “out there building the power plants” but would serve “to coordinate projects, to bring in partners, to get deals and the partners they bring in that can execute.”

Following this news, analysts with Guggenheim Securities, LLC published a report stating that ENTRA1 is a “3-year old company that has never built, financed or operated anything” and had just “3 employees and 1 investor,” and stated a “more accurate description of ENTRA1 would be that it is an entity supporting the activities of a single individual, specifically Mr. Habboush.” This news caused the price of NuScale stock to drop $4.03 per share over two trading days, or more than 12.4%, from a closing price of $32.46 per share on November 6, 2025, to $28.43 per share on November 10, 2025.

Click here for more information:

https://www.bfalaw.com/cases/nuscale-class-action-lawsuit

.

What Can You Do?

If you invested in NuScale, you may have legal options and are encouraged to submit your information to the firm.

All representation is on a contingency fee basis; there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses.

Submit your information by visiting:


https://www.bfalaw.com/cases/nuscale-class-action-lawsuit

Or contact:
Adam McCall
[email protected]
212.789.3619

Why Bleichmar Fonti & Auld LLP?

BFA is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It has been named a top plaintiff law firm by Chambers USA, The Legal 500, and ISS SCAS, and its attorneys have been named “Elite Trial Lawyers” by the National Law Journal, “Litigation Stars” by Benchmark Litigation, among the top “500 Leading Plaintiff Financial Lawyers” by Lawdragon, “Titans of the Plaintiffs’ Bar” by Law360 and “SuperLawyers” by Thomson Reuters. Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.’s Board of Directors, as well as $420 million from Teva Pharmaceutical Ind. Ltd.

For more information about BFA and its attorneys, please visit https://www.bfalaw.com.


https://www.bfalaw.com/cases/nuscale-class-action-lawsuit

Attorney advertising. Past results do not guarantee future outcomes.



NIO Inc. Provides February 2026 Delivery Update

  • 20,797 vehicles were delivered in February 2026, increasing by 57.6% year-over-year
  • 47,979 vehicles were delivered year-to-date in 2026, increasing by 77.3% year-over-year
  • Cumulative deliveries reached 1,045,571 as of February 28, 2026  

SHANGHAI, March 01, 2026 (GLOBE NEWSWIRE) — NIO Inc. (NYSE: NIO; HKEX: 9866; SGX: NIO) (“NIO” or the “Company”), a pioneer and a leading company in the global smart electric vehicle market, today announced its February 2026 delivery results.

The Company delivered 20,797 vehicles in February 2026, representing an increase of 57.6% year-over-year. The deliveries consisted of 15,159 vehicles from the Company’s premium smart electric vehicle brand NIO, 2,981 vehicles from the Company’s family-oriented smart electric vehicle brand ONVO, and 2,657 vehicles from the Company’s small smart high-end electric car brand FIREFLY. Cumulative deliveries reached 1,045,571 as of February 28, 2026.

On February 6, 2026, NIO reached a historic milestone of completing 100 million cumulative battery swaps, demonstrating large-scale validation of its battery swapping model and further reinforcing battery swapping as a mainstream energy solution for electric vehicles in China. During the Chinese New Year holiday, daily battery swap volumes reached record highs for five consecutive days, reflecting both strong user reliance and NIO’s robust service capabilities. NIO’s comprehensive battery swapping and charging network ensures efficient, worry-free and seamless travel experiences for users.

About NIO Inc.

NIO Inc. is a pioneer and a leading company in the global smart electric vehicle market. Founded in November 2014, NIO aspires to shape a sustainable and brighter future with the mission of “Blue Sky Coming”. NIO envisions itself as a user enterprise where innovative technology meets experience excellence. NIO designs, develops, manufactures and sells smart electric vehicles, driving innovations in next-generation core technologies. NIO distinguishes itself through continuous technological breakthroughs and innovations, exceptional products and services, and a community for shared growth. NIO provides premium smart electric vehicles under the NIO brand, family-oriented smart electric vehicles through the ONVO brand, and small smart high-end electric cars with the FIREFLY brand.

Safe Harbor Statement

This press release contains statements that may constitute “forward-looking” statements pursuant to the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “aims,” “future,” “intends,” “plans,” “believes,” “estimates,” “likely to” and similar statements. NIO may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”), in its annual report to shareholders, in announcements, circulars or other publications made on the websites of each of The Stock Exchange of Hong Kong Limited (the “SEHK”) and the Singapore Exchange Securities Trading Limited (the “SGX-ST”), in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about NIO’s beliefs, plans and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: NIO’s strategies; NIO’s future business development, financial condition and results of operations; NIO’s ability to develop and manufacture vehicles of sufficient quality and appeal to customers on schedule and on a large scale; its ability to ensure and expand manufacturing capacities including establishing and maintaining partnerships with third parties; its ability to provide convenient and comprehensive power solutions to its customers; the viability, growth potential and prospects of the battery swapping, BaaS, and NIO Assisted and Intelligent Driving and its subscription services; its ability to improve the technologies or develop alternative technologies in meeting evolving market demand and industry development; NIO’s ability to satisfy the mandated safety standards relating to motor vehicles; its ability to secure supply of raw materials or other components used in its vehicles; its ability to secure sufficient reservations and sales of its vehicles; its ability to control costs associated with its operations; its ability to build its current and future brands; general economic and business conditions globally and in China and assumptions underlying or related to any of the foregoing. Further information regarding these and other risks is included in NIO’s filings with the SEC and the announcements and filings on the websites of each of the SEHK and SGX-ST. All information provided in this press release is as of the date of this press release, and NIO does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

For more information, please visit: http://ir.nio.com

Investor Relations

[email protected]

Media Relations

[email protected]



NVIDIA and Global Telecom Leaders Commit to Build 6G on Open and Secure AI-Native Platforms

News Summary:

  • Leading operators and infrastructure providers including Booz Allen, BT Group, Cisco, Deutsche Telekom, Ericsson, MITRE, Nokia, ODC, SK Telecom, SoftBank Corp. and T-Mobile will build on open and trusted software-defined wireless platforms.
  • The commitment complements NVIDIA’s ongoing collaborations with industry and governments across Europe, Japan, Korea, the U.K. and the U.S. to advance AI-native 6G innovation.

BARCELONA, Spain, March 01, 2026 (GLOBE NEWSWIRE) — Mobile World Congress—NVIDIA today announced a commitment — together with Booz Allen, BT Group, Cisco, Deutsche Telekom, Ericsson, MITRE, Nokia, OCUDU Ecosystem Foundation, ODC, SK Telecom, SoftBank Corp. and T-Mobile — to build the world’s next generation of wireless networks on AI-native, open, secure and trustworthy platforms.

The initiative represents a shared commitment to ensure 6G infrastructure — the foundation for the world’s future connectivity — is open, intelligent, resilient and accelerates innovation and safeguards global trust.

Beyond traditional connectivity, 6G wireless networks will become the fabric for physical AI, enabling billions of autonomous machines, vehicles, sensors and robots and significantly increasing demands for security and trust. Legacy wireless architectures were not designed to meet these requirements, creating challenges as networks increase in complexity.

To address this, NVIDIA is bringing the industry together to advance AI-native, software-defined wireless platforms built on open and trusted principles. By embedding AI across the radio access network (RAN), edge and core, 6G networks must enable secure integrated sensing and communications, intelligence and decision-making while supporting interoperability, supply-chain resilience and faster innovation.

“AI is redefining computing and driving the largest infrastructure buildout in human history — and telecommunications is next,” said Jensen Huang, founder and CEO of NVIDIA. “Together with a global coalition of industry leaders, NVIDIA is building AI-RAN to transform the world’s telecom networks into AI infrastructure everywhere.”

Uniting on Openness and Trust for the AI-Native, Software-Defined Era of Connectivity

6G will be AI-native and software-defined, enabling wireless networks to advance at the pace of innovation. 6G networks, built on AI-RAN architecture, will continuously evolve through software, enabling real-time intelligence and rapid advancement. This transformation opens the door for a diverse ecosystem of participants — from global operators and technology providers to startups, researchers and developers — all contributing through open and programmable platforms.

Allison Kirkby, chief executive of BT Group, said: “Connectivity is the backbone of economic growth, and with this collaboration, we’re helping lay the foundations for a future ecosystem that is intelligent, sustainable and secure. By building on open and trustworthy AI native platforms, we can simplify future technologies like 6G, ensuring they build upon the strengths of today’s 5G networks while still unlocking powerful new capabilities at scale.”

Tim Höttges, CEO of Deutsche Telekom AG, said: “Best network, best customer experience — that remains our promise. With an open, intelligent and trusted 6G infrastructure, we are laying the foundation for the era of physical AI and unlocking new value for our customers, for industry and for society.”

Arielle Roth, Assistant Secretary of Commerce for Communications and Information, and Administrator at the National Telecommunications and Information Administration, said: “America’s 6G leadership will be critical to our nation’s economic prosperity, national security and global competitiveness. Today’s announcement demonstrates that the United States and our allies and partners around the world are leading in this next-generation technology. We look forward to the next steps from this international industry coalition as they advance and implement their shared 6G vision.”

Jung Jai-hun, president and CEO of SK Telecom, said: “SKT is evolving telco infrastructure to serve as the foundation for the AI era, where connectivity serves as a platform for intelligence and innovation. Together, we can build open, trusted infrastructure that drives a global ecosystem of AI innovation.”

Hideyuki Tsukuda, executive vice president and chief technology officer of SoftBank Corp., said: “Al-native 6G will transform wireless networks into secure, software-defined infrastructure that supports the next wave of global innovation. SoftBank Corp. is driving this innovation with NVIDIA by advancing open and trusted platforms that enable interoperability, resilience and continuous evolution at scale.”

Srini Gopalan, CEO of T-Mobile, said: “We’re at a pivotal moment. In the U.S., we’ve laid the foundation with 5G Advanced and AI-native networks where intelligence lives inside the network. As 6G becomes the backbone of the AI era, telecom will serve as the nervous system of the digital economy, enabling autonomous systems and intelligent industries at scale and unlocking new value for customers and businesses alike. T-Mobile is proud to help define what’s next through deep ecosystem collaboration and sustained innovation.”

A Shared Vision for 6G: Open, Software-Defined, AI-Native

NVIDIA participates in global private and public initiatives to advance 6G innovation, contributing open source software, accessible platforms and joint research and development projects:

  • In the United States, NVIDIA has joined the FutureG Office-led OCUDU Initiative, aligning with government and industry partners to accelerate open, software-defined and AI-native 6G architectures.
  • NVIDIA is a founding member of the AI-RAN Alliance, which now has over 130 participating companies driving AI-RAN innovation.
  • NVIDIA, along with Booz Allen, Cisco, T-Mobile, MITRE and ODC, in October launched the AI-Native Wireless Networks (AI-WIN) project, an all-American AI-RAN stack to accelerate the path to 6G.
  • In Korea, NVIDIA is collaborating with an industry consortium to help shape intelligent, secure, programmable 6G networks from the ground up.
  • In the U.K., NVIDIA is collaborating with the Department for Science, Innovation and Technology to advance applied research, ecosystem development and trusted AI-native network design.
  • Across Europe and Japan, NVIDIA is actively engaged with public and industry programs aimed at strengthening open innovation, interoperability and trusted infrastructure.

Together, these collaborations represent a unified commitment — supported by like‑minded governments, operators and technology partners — to shape secure, intelligent and trusted global connectivity for the next generation of wireless technology.

About NVIDIA


NVIDIA
(NASDAQ: NVDA) is the world leader in AI and accelerated computing.

For further information, contact:

Kasia Johnston
Corporate Communications
NVIDIA Corporation
+1-415-813-8859
[email protected]

Certain statements in this press release including, but not limited to, statements as to: AI and telecommunications redefining computing and driving the largest infrastructure buildout in human history; Together with a global coalition of industry leaders, NVIDIA building AI-RAN to transform the world’s telecom networks into AI infrastructure everywhere; the benefits, impact, performance, and availability of NVIDIA’s products, services, and technologies; expectations with respect to NVIDIA’s third party arrangements, including with its collaborators and partners; expectations with respect to technology developments; and other statements that are not historical facts are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections based on management’s beliefs and assumptions and on information currently available to management and are subject to risks and uncertainties that could cause results to be materially different than expectations. Important factors that could cause actual results to differ materially include: global economic and political conditions; NVIDIA’s reliance on third parties to manufacture, assemble, package and test NVIDIA’s products; the impact of technological development and competition; development of new products and technologies or enhancements to NVIDIA’s existing product and technologies; market acceptance of NVIDIA’s products or NVIDIA’s partners’ products; design, manufacturing or software defects; changes in consumer preferences or demands; changes in industry standards and interfaces; unexpected loss of performance of NVIDIA’s products or technologies when integrated into systems; and changes in applicable laws and regulations, as well as other factors detailed from time to time in the most recent reports NVIDIA files with the Securities and Exchange Commission, or SEC, including, but not limited to, its annual report on Form 10-K and quarterly reports on Form 10-Q. Copies of reports filed with the SEC are posted on the company’s website and are available from NVIDIA without charge. These forward-looking statements are not guarantees of future performance and speak only as of the date hereof, and, except as required by law, NVIDIA disclaims any obligation to update these forward-looking statements to reflect future events or circumstances.

© 2026 NVIDIA Corporation. All rights reserved. NVIDIA and the NVIDIA logo are trademarks and/or registered trademarks of NVIDIA Corporation in the U.S. and other countries. Other company and product names may be trademarks of the respective companies with which they are associated. Features, pricing, availability and specifications are subject to change without notice.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/acfd4c33-2372-4abd-a20d-81205c419f1f



Li Auto Inc. February 2026 Delivery Update

BEIJING, China, March 01, 2026 (GLOBE NEWSWIRE) — Li Auto Inc. (“Li Auto” or the “Company”) (Nasdaq: LI; HKEX: 2015), a leader in China’s new energy vehicle market, today announced that it delivered 26,421 vehicles in February 2026. As of February 28, 2026, Li Auto’s cumulative deliveries reached 1,594,304.

Li Auto officially rolled out OTA update version 8.3 ahead of the Chinese Spring Festival, featuring comprehensive upgrades in three key areas: VLA Driver large model, smart cockpit and smart electric functionality. During the Spring Festival travel peak, the Company provided users with a stable and convenient energy replenishment experience through its nationwide network of more than 4,000 super charging stations. From February 14 to February 23, 2026, the Company powered over 1.45 million charging sessions, with total charging volume exceeding 42 million kWh. The Company plans to launch the all-new Li L9 in the second quarter.

As of February 28, 2026, the Company had 539 retail stores in 160 cities, 548 servicing centers and Li Auto-authorized servicing shops operating in 223 cities. The Company also had 4,054 super charging stations in operation equipped with 22,447 charging stalls in China.

About Li Auto Inc.

Li Auto Inc. is a leader in China’s new energy vehicle market. The Company designs, develops, manufactures, and sells premium smart electric vehicles. Its mission is: Be Proactive, Change the World (主动积极,改变世界). Through innovations in product, technology, and business model, the Company provides families with safe, convenient, and comfortable products and services. Li Auto is a pioneer in successfully commercializing extended-range electric vehicles in China. While firmly advancing along this technological route, it builds platforms for battery electric vehicles in parallel. The Company leverages technology to create value for users. It concentrates its in-house development efforts on proprietary range extension systems, innovative electric vehicle technologies, and smart vehicle solutions. The Company started volume production in November 2019. Its current model lineup includes a high-tech flagship family MPV, four Li L series extended-range electric SUVs, and two Li i series battery electric SUVs. The Company will continue to expand its product lineup to target a broader user base.

For more information, please visit: https://ir.lixiang.com.

Safe Harbor Statement

This press release contains statements that may constitute “forward-looking” statements pursuant to the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “aims,” “future,” “intends,” “plans,” “believes,” “estimates,” “targets,” “likely to,” “challenges,” and similar statements. Li Auto may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the “SEC”) and The Stock Exchange of Hong Kong Limited (the “HKEX”), in its annual report to shareholders, in press releases and other written materials, and in oral statements made by its officers, directors, or employees to third parties. Statements that are not historical facts, including statements about Li Auto’s beliefs, plans, and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: Li Auto’s strategies, future business development, and financial condition and results of operations; Li Auto’s limited operating history; risks associated with extended-range electric vehicles and high-power charging battery electric vehicles; Li Auto’s ability to develop, manufacture, and deliver vehicles of high quality and appeal to customers; Li Auto’s ability to generate positive cash flow and profits; product defects or any other failure of vehicles to perform as expected; Li Auto’s ability to compete successfully; Li Auto’s ability to build its brand and withstand negative publicity; cancellation of orders for Li Auto’s vehicles; Li Auto’s ability to develop new vehicles; and changes in consumer demand and government incentives, subsidies, or other favorable government policies. Further information regarding these and other risks is included in Li Auto’s filings with the SEC and the HKEX. All information provided in this press release is as of the date of this press release, and Li Auto does not undertake any obligation to update any forward-looking statement, except as required under applicable law.

For investor and media inquiries, please contact:

Li Auto Inc.
Investor Relations
Email: [email protected]

Christensen Advisory
Roger Hu
Tel: +86-10-5900-1548
Email: [email protected]



APEX Tech Acquisition Inc. Announces Closing of Initial Public Offering, Including Partial Exercise of Overallotment Option

New York, New York, Feb. 28, 2026 (GLOBE NEWSWIRE) — APEX Tech Acquisition Inc., a blank check company incorporated in the Cayman Islands as an exempted company (the “Company”), today announced the closing of its initial public offering of 11,197,131 units, including partial exercise of an over-allotment option, at $10.00 per unit for aggregate gross proceeds to the Company of $111,971,310. The units began trading on The New York Stock Exchange (“NYSE”) on February 26, 2026 under the ticker symbol “TRADU.” Each unit consists of one ordinary share and one right to receive one-fourth (1/4) of one ordinary share upon the consummation of an initial business combination. Once the securities comprising the units begin separate trading, the ordinary shares and the rights are expected to be traded on NYSE under the symbols “TRAD” and “TRADR,” respectively.

A.G.P./Alliance Global Partners acted as the sole book-running manager for the offering.

Venture Bridge Legal served as the U.S. counsel to the Company and Robinson & Cole LLP served as the U.S. counsel to the representative of the underwriters in this offering.

A registration statement on Form S-1 relating to the securities, as amended (File No. 333-291936) was previously filed with the Securities and Exchange Commission (“SEC”) and declared effective on February 25, 2026. This offering was made only by means of a prospectus forming part of the effective registration statement. Copies of the final prospectus may be obtained on the SEC’s website at http://www.sec.gov. Electronic copies of the prospectus may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. No securities regulatory authority has either approved or disapproved of the contents of this press release.

About APEX Tech Acquisition Inc.

The Company is a blank check company incorporated in the Cayman Islands as an exempted company with limited liability for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. The Company intends to conduct a search for target businesses without being limited to a particular industry.

Forward-Looking Statements

This press release contains statements that constitute “forward-looking statements,” including with respect to the initial public offering, the underwriters’ exercise of over-allotment option, the anticipated use of the net proceeds thereof and the Company’s search for an initial business combination. No assurance can be given that the offering discussed above will be completed on the terms described, or at all, or that the net proceeds of the offering will be used as indicated. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company’s registration statement and preliminary prospectus for the IPO filed with the SEC. Copies are available on the SEC’s website, www.sec.gov.The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Contact:

APEX Tech Acquisition Inc.
Attn: Shaoren Liu
E-mail: [email protected]