Market Newsdesk

MINNEAPOLIS, April 03, 2025 (GLOBE NEWSWIRE) — Northern Technologies International Corporation (NASDAQ: NTIC) today announced that it expects to release its fiscal 2025 second-quarter financial results on Thursday, April 10, 2025, before the market opens. A copy of the news release will be available on the Investor Relations section of NTIC’s webpage (www.ntic.com).

In conjunction with NTIC’s release of its financial and operating results, investors, analysts, and other interested parties are invited to participate in a conference call with management on Thursday, April 10, 2025, at 9:00 a.m. Eastern Time.

Patrick Lynch, President and CEO, and Matt Wolsfeld, CFO, will review NTIC’s fiscal 2025 second-quarter financial results and outlook, which will be followed by a question-and-answer session.

Details for the conference call are as follows.

CONFERENCE CALL CONFIRMATION:

NTIC Fiscal 2025 Second-Quarter Earnings Conference Call and Webcast

April 10, 2025, at 9:00 A.M. ET (8:00 A.M. CT, 7:00 A.M. MT, 6:00 A.M. PT)

Live Call Participants Registration URL:

https://register-conf.media-server.com/register/BI0367281b6c4e4339964df49370573727

To join the live call and ask a question, a participant must register using the URL above. Once registered, the participant will receive a dial-in number and unique PIN number to access the call.

URL EVENTS & PRESENTATIONS WEBPAGE:

The audio-only webcast can be accessed at the following link: https://edge.media-server.com/mmc/p/2p6jpccv. A link to the webcast is also available on the Investor Relations section of NTIC’s webpage. Participants are advised to go to the website at least 15 minutes early to register, download and install any necessary audio software. For those unable to participate in the live webcast, a replay of the webcast will be archived and accessible for approximately one year on the Investor Relations section of NTIC’s webpage.

About Northern Technologies International Corporation

Northern Technologies International Corporation develops and markets proprietary, environmentally beneficial products and services in over 65 countries either directly or via a network of subsidiaries, joint ventures, independent distributors and agents. NTIC’s primary business is corrosion prevention marketed mainly under the ZERUST® brand. NTIC has been selling its proprietary ZERUST® rust and corrosion inhibiting products and services to the automotive, electronics, electrical, mechanical, military and retail consumer markets for almost 50 years and more recently has also targeted and expanded into the oil and gas industry. NTIC offers worldwide on-site technical consulting for rust and corrosion prevention issues. NTIC’s technical service consultants work directly with the end users of NTIC’s products to analyze their specific needs and develop systems to meet their technical requirements. NTIC also markets and sells a portfolio of bio-based and biodegradable polymer resin compounds and finished products marketed under the Natur-Tec® brand.

Investor and Media Contact:
Matthew Wolsfeld, CFO
(763) 225-6600

ROCKAWAY, N.J., April 03, 2025 (GLOBE NEWSWIRE) — electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine and wellness company, has been recognized by the Financial Times as one of “The Americas’ Fastest Growing Companies 2025.” Debuting at number 125, electroCore joins 300 other companies dominating in their respective sectors.

This is the sixth annual list that the Financial Times published, ranking companies based on the highest compound annual revenue growth between the years 2020 and 2023. The healthcare & life sciences sector represented 10% of the of the fastest-growing companies. electroCore ranked 16 out of the other 29 healthcare & life sciences companies making the publication, including BeiGene, Hims & Hers Health and Progyny.

“electroCore delivers substantial value to our customers, offering a drug-free method for addressing pain, reducing stress, and improving sleep,” stated Joshua Lev, CFO of electroCore. “The ranking by the Financial Times reflects this value, as well as the hard work of our team to commercialize our innovative technology.”

The Americas’ Fastest Growing Companies 2025 list was announced on April 2, 2025, and can be currently viewed on the Financial Times website.

About electroCore, Inc.

electroCore, Inc. is a commercial stage bioelectronic medicine and wellness company dedicated to improving health through its non-invasive vagus nerve stimulation (“nVNS”) technology platform. Our focus is the commercialization of medical devices for the management and treatment of certain medical conditions and consumer product offerings utilizing nVNS to promote general wellbeing and human performance in the United States and select overseas markets.

For more information, visit www.electrocore.com.

Forward-Looking Statements

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize electroCore’s products, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the SEC available at www.sec.gov.

Contact

ECOR Investor Relations
(973) 302-9253
[email protected]

SINGAPORE, April 03, 2025 (GLOBE NEWSWIRE) — MoneyHero Limited (Nasdaq: MNY) (“MoneyHero” or the “Company”), a leading personal finance aggregation and comparison platform, as well as a digital insurance brokerage provider in Greater Southeast Asia, today announced that it will release its fourth quarter and full year 2024 results on Tuesday, April 29, 2025 before market opens and will hold a related conference call to discuss the results at 8:00 a.m. EDT the same day.

Investors and other interested parties may listen to the call by clicking on the registration link for the webcast or audio conference at:

Webcast: https://edge.media-server.com/mmc/p/g36exn6g/
Conference call: https://register-conf.media-server.com/register/BI63a8f286c9b74092aff58fc8eb219749

The webcast replay will be available on the Investor Relations website for 12 months following the event.

About MoneyHero Group

MoneyHero Limited
(NASDAQ: MNY) is a market leader in the online personal finance and digital insurance aggregation and comparison sector in Greater Southeast Asia. The Company operates in Singapore, Hong Kong, Taiwan and the Philippines. Its brand portfolio includes B2C platforms MoneyHero, SingSaver, Money101, Moneymax and Seedly, as well as the B2B platform Creatory. The Company also retains an equity stake in Malaysian fintech company, Jirnexu Pte. Ltd., parent company of Jirnexu Sdn. Bhd., the operator of RinggitPlus, Malaysia’s largest operating B2C platform. MoneyHero had over 270 commercial partner relationships as at September 30, 2024, and had approximately 7.4 million Monthly Unique Users across its platform for the three months ended September 30, 2024. The Company’s backers include Peter Thiel—co-founder of PayPal, Palantir Technologies, and the Founders Fund—and Hong Kong businessman, Richard Li, the founder and chairman of Pacific Century Group. To learn more about MoneyHero and how the innovative fintech company is driving APAC’s digital economy, please visit www.MoneyHeroGroup.com.

For inquiries, please contact:

Investor Relations:

MoneyHero IR Team
[email protected]

Media Relations:

MoneyHero PR Team
[email protected]

— Novel, locally administered gene therapy designed to boost cellular production of

anti-inflammatory protein IL-1Ra in the knee —

— Initial topline results from two-part, randomized, double-blind, active-controlled study

expected late 2026 —

BRISBANE, Calif., April 03, 2025 (GLOBE NEWSWIRE) — Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced the first patient has been dosed in the Phase 2 ASCEND study of PCRX-201 (enekinragene inzadenovec) for the treatment of osteoarthritis, or OA, of the knee. PCRX-201 features an innovative design based on the company’s proprietary high-capacity adenovirus, or HCAd, gene therapy vector platform. It is injected locally into the knee joint to boost cellular production of interleukin-1 receptor antagonist (IL-1Ra), and block interleukin-1 pathway activation to improve chronic inflammation, pain, and function. PCRX-201’s unique design also features an inducible promoter to mimic the body’s natural response to inflammation by “turning on” the expression of IL-1Ra when inflammation is present in the joint and turning off expression once inflammation is quelled.

“We are excited to advance PCRX-201 into Phase 2 clinical development as it marks an important milestone on our 5×30 path to growth and value creation, as well as our transition into an innovative biopharmaceutical organization,” said Frank D. Lee, chief executive officer of Pacira. “There is a significant need for innovation in the treatment of OA of the knee, as current therapies are based on decades-old mechanisms and only provide up to three to six months of relief. In our large Phase 1 study, a single intra-articular injection of PCRX-201 was well tolerated and demonstrated unprecedented pain relief and durability across all levels of OA severity for at least two years. PCRX-201 has the potential to address the underlying chronic inflammatory processes that contribute to OA joint degeneration over time, with local administration that is contained in the joint – delivering medicine where it matters.”

Study Design

The two-part, multicenter ASCEND study will involve approximately 135 patients, 45 to 80 years old with painful OA of the knee at a Kellgren-Lawrence (K-L) Grade of 2, 3 or 4. Subjects will be randomly assigned to a treatment dose group and stratified by K-L Grade, a semiquantitative method for evaluating the severity of OA on a scale of 0-4.

ASCEND will evaluate two doses of PCRX-201, Dose A is 1.4 x 10¹⁰ genome copies (GC) and Dose B is 1.4 x 10¹¹ GC. Patients will be randomized 1:1:1 to Dose A, Dose B or saline. All cohorts will receive concurrent pretreatment with an intraarticular corticosteroid (methylprednisolone 40 mg), a technique common in gene therapy dosing to improve tolerability and gene transfer.

Part A of the study will randomize approximately 45 patients and Part B will randomize approximately 90 patients. The drug product used in Part B of the study will be manufactured using the company’s newly developed, suspension-based batch manufacturing process intended for commercial scale-up. Pacira expects to report topline results from Part A of the study before the end of 2026.

For both Parts A and B of the study, the primary endpoint is the number and percent of treatment-emergent adverse events, adverse events of special interest, and serious adverse events for PCRX-201 plus steroid pretreatment versus saline plus steroid pretreatment from Week 1 through Week 52. The study’s secondary and exploratory endpoints include efficacy assessments such as changes in pain and physical function from baseline at Weeks 38 and 52. Efficacy will be measured using the Numerical Rating Scale (NRS); the Western Ontario and McMaster Universities Index (WOMAC), and the Knee Injury and Osteoarthritis Outcome Score (KOOS). Biomarkers, including structural endpoints, as well as immunogenicity and biodistribution will also be evaluated and all subjects will be followed for 5 years.

About PCRX-201

Pacira’s novel product candidate PCRX-201 (enekinragene inzadenovec), features an innovative design based on the company’s proprietary high-capacity adenovirus vector platform. It is currently being studied in the fundamental, underlying chronic inflammatory processes that contribute to “wear and tear” over time in osteoarthritis of the knee, a condition that affects more than 14 million individuals in the U.S. today.

In November 2024, Pacira reported promising data from a large Phase 1 study in which PCRX-201 provided sustained improvements in knee pain, stiffness, and function through two years following local administration, with a well-tolerated safety profile. These data were presented at the American College of Rheumatology’s annual ACR Convergence meeting at the American College of Rheumatology meeting. PCRX-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency. RMAT and ATMP are regulatory programs designed to expedite the development and review processes for promising therapies targeting a significant unmet need with preliminary clinical evidence indicating that the therapy has the potential to offer a major advantage over existing treatments. PCRX-201 is the first gene therapy to achieve these clinical results and earn these regulatory designations in osteoarthritis of the knee – a testament to its promise and potential.

About the High-capacity Adenovirus Vector Platform

In February 2025, in support of the company’s ‘5×30’ growth strategy, Pacira acquired GQ Bio Therapeutics and its novel high-capacity adenovirus (HCAd) vector gene therapy vector platform. This platform solves many of the challenges in the field of gene therapy that have prevented its utilization in treating common diseases, such as osteoarthritis.

Key features include:

• The HCAd vector is much more efficient at delivering genes into cells compared to many other gene therapies that rely on adenovirus associated virus, or AAV, vectors. As a result, the desired effect can be achieved with much smaller doses.
• The vector used in the HCAd platform can carry up to 30,000 base pairs of DNA, which enables gene therapy with multiple or larger genes compared to AAV vectors.
• Genetic medicines based on the HCAd platform can be administered locally and have the potential for redosing at therapeutically appropriate intervals.
• Lower dose levels and efficient delivery of genes into cells means that thousands of doses can be produced in a single batch. As a result, therapies built on the HCAd platform are expected to have a commercially attractive and viable cost of goods profile.

Beyond PCRX-201 and other product candidates in preclinical development, the company has identified numerous well-validated cytokines that could also be the basis for locally administered genetic therapies using the HCAd platform.

About Pacira

Pacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL^® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA^® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera_®º, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The Company is also advancing the development of PCRX-201, a novel, locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. To learn more about Pacira, visit www.pacira.com.

Forward-Looking Statements

Any statements in this press release about Pacira’s future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may,” “will,” “would,” “could,” “can” and similar expressions, constitute forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to: the settlement described herein, ‘5×30’, our growth and business strategy; our future outlook, our intellectual property and patent terms, our growth and future operating results and trends, our strategy, plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio, development programs, development of products, strategic alliances and other statements that are not historical facts. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We cannot assure you that our estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: the failure to realize the anticipated benefits and synergies from the acquisition of GQ Bio Therapeutics GmbH; risks associated with acquisitions, such as the risk that the acquired businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; our manufacturing and supply chain, global and U.S. economic conditions (including inflation and rising interest rates), and our business, including our revenues, financial condition, cash flow and results of operations; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL, ZILRETTA and iovera°; the rate and degree of market acceptance of EXPAREL, ZILRETTA and iovera°; the size and growth of the potential markets for EXPAREL, ZILRETTA and iovera° and our ability to serve those markets; our plans to expand the use of EXPAREL, ZILRETTA and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL, ZILRETTA and iovera°; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of U.S. Food and Drug Administration supplemental New Drug Applications and premarket notification 510(k)s; the related timing and success of European Medicines Agency Marketing Authorization Applications; our plans to evaluate, develop and pursue additional product candidates utilizing our proprietary multivesicular liposome (“pMVL”) drug delivery technology; the approval of the commercialization of our products in other jurisdictions; clinical trials in support of an existing or potential pMVL-based product; our commercialization and marketing capabilities; our ability to successfully complete capital projects; the outcome of any litigation; the recoverability of our deferred tax assets; assumptions associated with contingent consideration payments; assumptions used for estimated future cash flows associated with determining the fair value of the Company; the anticipated funding or benefits of our share repurchase program; and factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the Securities and Exchange Commission (the “SEC”). In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. Except as required by applicable law, we undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, and readers should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these statements. These factors include the matters discussed and referenced in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the SEC.

Investor Contact:
Susan Mesco, (973) 451-4030
[email protected]
Media Contact:
Sara Marino, (973) 370-5430
[email protected]

KANSAS CITY, Kan., April 03, 2025 (GLOBE NEWSWIRE) — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, announced that it held a Pre-NDA meeting with the U.S. Food and Drug Administration (FDA) yesterday to discuss the submission of a new drug application (NDA) for its lead Phase 3 asset CTx-1301 (dexmethylphenidate HCl) for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD).

“Our meeting with the FDA yesterday was very productive, and we remain on track for an NDA filing of CTx-1301 in mid-2025. We truly appreciate the FDA personnel who have been involved with the regulatory review of CTx-1301 to date. These interactions have been essential in helping us generate data to demonstrate the consistency and therapeutic benefit of our product. This important milestone is validation of our mission to bring to market the first, true, once-daily stimulant medication to treat ADHD over the entire active day,” said Cingulate Chairman and CEO Shane J Schaffer.

Last month Cingulate released Phase 3 safety data for CTx-1301, as well as the results from a food effect study with healthy adults, using a single 50-mg dose of CTx-1301, Cingulate’s highest dosage. A review of the results found that the safety profile of CTx-1301 has remained consistent over the course of nine clinical trials. A final analysis that combines both adult and pediatric safety and efficacy data will be prepared and included in the NDA submission.      

About Attention Deficit/Hyperactivity Disorder (ADHD)

ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC, just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65–90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined.

About CTx-1301

Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. While stimulants are the gold standard of ADHD treatment due to their efficacy and safety, the long-standing challenge continues to be providing patients with an entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off.

About Precision Timed Release™ (PTR™) Platform Technology

Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here.

About Cingulate Inc.

Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com.

Forward-Looking Statements 

This press release contains “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. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on March 27, 2025, and our other filings with the SEC. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Investor & Public Relations:

Thomas Dalton
Vice President, Investor & Public Relations, Cingulate
[email protected]
(913) 942-2301

Matt Kreps
Darrow Associates
[email protected]
(214) 597-8200

• On track to announce primary endpoint result from ORIGIN 3 trial this quarter (2Q 2025)
• U.S. FDA BLA submission for accelerated approval planned for 2H 2025

BRISBANE, Calif., April 03, 2025 (GLOBE NEWSWIRE) — Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced that it has completed full enrollment in the pivotal ORIGIN Phase 3 trial of atacicept in patients with IgA Nephropathy (IgAN).

“We are grateful for the IgAN community’s strong interest in the clinical development of atacicept that helped drive us towards completing full enrollment in the ORIGIN 3 trial with a total of 431 participants. Complete enrollment represents another key milestone on the path to potential approval of the first B cell modulator targeting both BAFF and APRIL for IgAN,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics. “We anticipate the 36-week primary efficacy endpoint data from the trial this quarter, which supports our planned Biologics License Application for an accelerated approval to the U.S. FDA in the second half of 2025. ORIGIN 3 follows the positive long-term results from the ORIGIN Phase 2b trial that demonstrated sustained and substantial reductions in Gd-IgA1, hematuria and proteinuria, and showed stabilized kidney function through 96 weeks, positioning atacicept as a potential best-in-class IgAN therapy. Pending the submission and thorough FDA review of the BLA, we would look forward to a potential PDUFA date and commercial launch in 2026.”

The ORIGIN 3 trial (NCT04716231) is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trial evaluating the safety and efficacy of atacicept in patients with IgAN who have persistent proteinuria and remain at high risk of disease progression. Participants are randomized 1:1 to at-home self-administered once-weekly subcutaneous injections of atacicept 150 mg or placebo for a 104-week double-blind period, followed by a 52-week open-label extension.

The primary efficacy endpoint is the change in proteinuria as evaluated by urine protein to creatinine ratio (UPCR) through 36 weeks in an interim analysis of at least 200 participants. The key secondary efficacy endpoint is change in kidney function as measured by estimated glomerular filtration rate (eGFR) through 104 weeks in the full study population.

For more information about the ORIGIN 3 clinical trial, please visit http://www.clinicaltrials.gov.

In addition, the Company is currently conducting the ORIGIN Extend trial, which provides extended access to atacicept for participants from the ORIGIN Phase 2b or Phase 3 trials until commercial availability in their region, and captures longer-term safety and efficacy data.

About Atacicept

Atacicept is an investigational recombinant fusion protein that contains the soluble transmembrane activator and calcium-modulating cyclophilin ligand interactor (TACI) receptor that binds to the cytokines B-cell activating factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL). These cytokines are members of the tumor necrosis factor family that promote B-cell survival and autoantibody production associated with certain autoimmune diseases, including IgAN and lupus nephritis.

The Phase 2b ORIGIN clinical trial of atacicept in IgAN met its primary and key secondary endpoints, with statistically significant and clinically meaningful proteinuria reductions and stabilization of eGFR versus placebo through 36 weeks. The safety profile during the randomized period was comparable between atacicept and placebo. Through 96 weeks, atacicept demonstrated further reductions in Gd-IgA1, hematuria, and proteinuria, as well as stabilization of eGFR reflecting a profile consistent with that of the general population without IgAN.

Atacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN, which reflects the FDA’s determination that, based on an assessment of data from the Phase 2b ORIGIN clinical trial, atacicept may demonstrate substantial improvement on a clinically significant endpoint over available therapies for patients with IgAN. Vera believes atacicept is positioned for best-in-class potential, targeting B cells to reduce autoantibodies and having been administered to more than 1,500 patients in clinical studies across different indications.

About Vera

Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunological diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fusion protein self-administered as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A PRoliferation-Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgAN, also known as Berger’s disease, and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also developing MAU868, a monoclonal antibody designed to neutralize infection with BK virus (BKV), a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. Vera retains all global developmental and commercial rights to atacicept and MAU868. Vera also holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B cell mediated diseases. For more information, please visit www.veratx.com

Forward-looking Statements

Statements contained in this press release regarding matters, events or results that may occur in the future are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, Vera’s plans to receive and report primary endpoint results in the Phase 3 ORIGIN 3 trial, to submit a Biologics License Application to the FDA, to potentially receive a PDUFA date, and potentially receive FDA approval for atacicept in IgAN and launch it commercially. Because such statements are subject to risk and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate,” “believe,” “may,” “on track,” “plan,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Vera’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks related to the regulatory approval process, results of earlier clinical trials may not be obtained in later clinical trials, preliminary results may not be predictive of topline results, risks and uncertainties associated with Vera’s business in general, the impact of macroeconomic and geopolitical events, and the other risks described in Vera’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Vera undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

For more information, please contact:

Investor Contact:

Joyce Allaire
LifeSci Advisors
212-915-2569
[email protected]

Media Contact:

Madelin Hawtin
LifeSci Communications
[email protected]

Company positions for long-term growth in medical device markets

Salt Lake City, UT, April 03, 2025 (GLOBE NEWSWIRE) — SINTX Technologies, Inc. (NASDAQ: SINT), an advanced ceramics company focused on medical device applications, today announced changes to its Board of Directors. The updates reflect the Company’s ongoing strategic transformation into a focused medical technology business.

Key changes include the retirement of longtime Chairman Dr. B. Sonny Bal, the appointment of President and CEO Eric Olson as Chairman of the Board, and the addition of five new directors with decades of industry expertise spanning orthopedics, spine, interventional pain, cardiovascular, medical device business development and global commercialization.

“These changes represent an exciting inflection point for SINTX,” said Eric Olson. “Our new Board brings a strong blend of industry leadership, commercial acumen, and strategic insight, all of which will be essential as we execute on our transformation and create long-term value for shareholders.”

Retirement of Dr. Sonny Bal

Dr. Bal has served as a Board Member since 2012, as Executive Chairman since 2014, and as President and CEO from 2015 to 2024. During his tenure, he helped establish SINTX as a biomaterials pioneer in silicon nitride and guided the company through its early evolution in orthopedic and spinal applications.

Appointment of Eric Olson as Chairman of the Board 

Mr. Olson has assumed the role of Board Chairman in addition to his ongoing duties as President and CEO. He previously served as CEO of Amedica Corporation, the predecessor to SINTX, and has played a key role in the company’s repositioning into the medical device space.

Appointment of Jay Moyes as Lead Independent Director 

Mr. Moyes served as CFO of Amedica from 2013 to 2014 and was a Board Member during the Company’s 2014 initial public offering and initial listing on the Nasdaq Capital Market. He also held the position of CFO for Myriad Genetics, CareDx and Sera Prognostics. He brings extensive experience in capital markets, corporate governance, and strategic finance, and has been a board member of multiple private and publicly traded life science companies. Mr. Moyes currently serves on the board of directors of Puma Biotechnology and BioCardia.

Appointment of New Directors

Chris Lyons brings more than 35 years of experience in the musculoskeletal and spine markets, with a strong focus on business development, M&A, and strategic growth. He spent 15 years at Smith & Nephew in senior commercial roles before joining Medtronic Spine and Biologics, where he led global business development for over a decade. At Medtronic, he managed acquisitions, investments, and partnerships worldwide. In 2018, he founded Southern Metrics Consulting, advising emerging medtech companies on commercialization and successful exits.

Robert (Bob) Mitchell has over three decades of executive leadership experience in global medical device organizations. At Cook Medical, he led five business units, including interventional radiology and endovascular therapies. He previously served as Vice President of Worldwide Sales at Align Technology (Invisalign) before becoming CEO of Millimed Holdings in Denmark. He also held leadership roles as COO of AngioDynamics and CEO of Nellix (acquired by Endologix). Currently, he Chairs Convi’s HR and Governance Committee, is Chairman of LifeSeal Vascular and Amecath, and an advisor to TVM Capital Healthcare in Dubai. His expertise spans operational leadership, commercialization, and strategic investments.

Mark Anderson is a seasoned executive with over 35 years in the medical device industry, primarily with Boston Scientific, a leading medical device company. His experience crossed four divisions Cardiology, Watchman, Endoscopy, and Corporate Contracts. Additionally, he managed the #1 customer for Boston Scientific (HCA Healthcare) for nearly 9 years. Mr. Anderson is recognized for building high-performing teams, expanding global markets, and scaling businesses with a strong commercial and clinical focus.

Gregg Honigblum has been a long-time supporter of SINTX and its predecessor, Amedica. As a former board member and early financial backer, Mr. Honigblum helped raise over $100 million in private funding for the company across multiple rounds. He currently serves as SINTX’s Chief Strategy Officer and has led recent financing efforts, including a successful ATM and PIPE transaction. His background includes investment banking, founding and scaling of medtech companies and extensive experience in capital formation and business strategy.

“We are fortunate to welcome such a strong group of individuals to our Board,” said Olson. “Their expertise will be instrumental in executing our strategic vision and delivering results for our patients, partners, and shareholders.”

For more information, please visit www.sintx.com

About SINTX Technologies, Inc.

Located in Salt Lake City, Utah, SINTX Technologies is an advanced ceramics company that develops and commercializes materials, components, and technologies for medical applications. SINTX is a global leader in the research, development, and manufacturing of silicon nitride, and its products have been implanted in humans since 2008. Over the past several years, SINTX has utilized strategic acquisitions and alliances to enter into new markets. For more information on SINTX Technologies or its materials platform, visit www.sintx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”) that are subject to a number of risks and uncertainties. Forward-looking statements can be identified by words such as: “anticipate,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding our ability to create long-term value for shareholders.

Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, difficulty in commercializing ceramic technologies and development of new product opportunities. A discussion of other risks and uncertainties that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements can be found in SINTX’s Risk Factors disclosure in its Annual Report on Form 10-K, filed with the SEC on March 19, 2025, and in SINTX’s other filings with the SEC. SINTX undertakes no obligation to publicly revise or update the forward-looking statements to reflect events or circumstances that arise after the date of this report, except as required by law.

Business and Media Inquiries for SINTX:

SINTX Technologies
801.839.3502
[email protected]

CAMBRIDGE, Mass., April 03, 2025 (GLOBE NEWSWIRE) — Akebia Therapeutics^®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the European Commission (EC) to approve XOANACYL^® (Ferric Citrate as Coordination Complex) for the treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease (CKD).

Averoa, a renal-focused biopharmaceutical company, licensed the rights to develop and commercialize ferric citrate from Akebia in the European Economic Area and certain countries in Europe and the Middle East. Averoa recently announced the positive opinion from CHMP here: https://averoa-pharma.org/wp-content/uploads/2025/04/20250402-AVA1014-Positive-opinion-EN-VF-2.04.2025.pdf.

“We congratulate our partner Averoa on a positive step toward securing EMA approval for XOANACYL, and we will continue to support their efforts to deliver a treatment for complications of kidney disease to patients in Europe,” said John P. Butler, Chief Executive Officer of Akebia.

The EC will review the CHMP recommendation, and a final decision is expected in approximately two months.

About Akebia Therapeutics

Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release.

Forward-Looking Statements

Statements in this press release regarding Akebia Therapeutics, Inc.’s (“Akebia’s”) strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding: Akebia’s statements regarding Averoa’s ability to secure EMA approval for XOANACYL; Akebia’s plans to support efforts to deliver a treatment for complications of kidney disease to patients in Europe; and Akebia’s expectations on the timing of a final decision from the EC. The terms “intend,” “believe,” “plan,” “goal,” “potential,” “anticipate, “estimate,” “expect,” “future,” “will,” “continue,” derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: decisions made by health authorities, such as the FDA and the EMA, with respect to regulatory filings and other interactions; the results of preclinical and clinical research; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; and early termination of any of Akebia’s collaborations. Other risks and uncertainties include those identified under the heading “Risk Factors” in Akebia’s Annual Report on Form 10-K for the year ended December 31, 2024, and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release.

Akebia Therapeutics^® is a registered trademark of Akebia Therapeutics, Inc. 

Akebia Therapeutics Contact

Mercedes Carrasco
[email protected]

Brera Holdings Executive Chairman Daniel McClory (left) and Juve Stabia President Andrea Langella (right) prior to kick-off at Juve Stabia

Dublin, Ireland and Castellammare di Stabia, Italy, April 03, 2025 (GLOBE NEWSWIRE) — Brera Holdings PLC (“Brera Holdings” or the “Company”) (Nasdaq: BREA), an Ireland-based, international holding company focused on expanding its global portfolio of men’s and women’s sports clubs through a multi-club ownership (“MCO”) approach, has released a new video presentation highlighting its strategic partnership with Italian football club Juve Stabia srl, “The Second Team of Naples,” and currently 6th in the Italy Serie B table following last weekend’s thrilling 2–1 victory over Cesena.

The video presentation features Chris Gardner, Brera board director and the real-life inspiration behind Will Smith who starred in the film The Pursuit of Happyness, who shares a heartfelt message about the partnership and his deep personal connection to Italy.

“This is not just about football. This is about culture, about passion, and about dreams,” said Gardner. “Italy has always held a very special place in my heart — the people, the energy, the sense of purpose. I believe in Brera Holdings and what we’re building here with Juve Stabia. This is going to be something the world is going to be watching.”

Also appearing in the video is Andrea Langella, President of Juve Stabia and shareholder, who speaks about the pride of the Castellammare di Stabia community, the team’s recent success, and the future under this new international ownership.

“We are honored to partner with Brera Holdings — a company that shares our values and our vision for the future,” said Langella. “Together, we aim to elevate Juve Stabia to new heights, not just in the standings, but in global recognition.”

Daniel McClory, Executive Chairman of Brera Holdings, explains how this partnership is part of a broader strategic effort to build on professionalized management, financial transparency, and global investor access with stand-out clubs such as Juve Stabia.

“By integrating Juve Stabia into Brera Holdings’ NASDAQ-listed MCO portfolio, we are bringing financial sophistication, governance, and international visibility to one of Italy’s most passionate football markets, the 3.5 million population area of soccer-rich Naples,” said McClory. “This is about more than capital — it’s about unlocking potential through global standards and long-term vision.”

The video — titled “Una città, un club e i nostri tifosi”, produced by Juve Stabia’s in-house filmmaker Eduardo Filtro — captures the essence of the city, the club, and its devoted fans. Through intimate storytelling and powerful visuals, the film celebrates the beginning of a new era for Juve Stabia — one rooted in tradition and elevated by innovation.

This partnership represents a key step in Brera’s long-term strategy to build a diverse, global MCO platform rooted in strong local identities and backed by world-class financial infrastructure. As a NASDAQ-traded company, Brera Holdings is uniquely positioned to provide its clubs with access to capital markets, investor confidence, and professionalized reporting — a significant step forward for Juve Stabia as it aspires to reach the top tiers of Italian and European football.

To view the full video presentation, visit: https://www.youtube.com/watch?v=_NFJGiCqdVM.

ABOUT BRERA HOLDINGS PLC

Brera Holdings PLC (Nasdaq: BREA) is dedicated to expanding its social impact football business by developing a global portfolio of emerging football and sports clubs. Building on the legacy of Brera FC, which it acquired in 2022, the Company aims to create opportunities for tournament prizes, sponsorships, and professional consulting services. Brera FC, recognized as “The Third Team of Milan,” has been crafting an alternative football legacy since its founding in 2000. The club also organizes the FENIX Trophy, a nonprofessional pan-European tournament acknowledged by UEFA. This tournament, which has been referred to as “the Champions League for Amateurs” by BBC Sport, has garnered significant media coverage, including from ESPN.

In its efforts to broaden its reach, Brera expanded into Africa in March 2023 by establishing Brera Tchumene FC in Mozambique, which quickly rose to the First Division after winning its post-season tournament. In April 2023, the Company acquired a 90% stake in the North Macedonian first-division team Fudbalski Klub Akademija Pandev, now known as Brera Strumica FC. Additionally, in June 2023, Brera made a strategic investment in Manchester United PLC, realizing a 74% gain. The Company has further diversified its portfolio by acquiring a majority stake in UYBA Volley, an Italian women’s professional volleyball team, in July 2023, assuming control of Bayanzurkh Sporting Ilch FC, a Mongolian National Premier League team, which became Brera Ilch FC, in September 2023, and establishing a joint stock company for the North Macedonian women’s football club Tiverija Strumica, now known as Brera Tiverija FC, a wholly-owned subsidiary of Brera Strumica FC, in June 2024.

On December 31, 2024, Brera signed of an agreement to acquire majority ownership of SS Juve Stabia srl, an Italian Serie B football club known as “The Second Team of Naples,” which will be conducted in a multi-step process, and marks a significant expansion of the Company’s MCO model. As of February 12, 2025, Brera holds a 38.46% equity ownership interest in Juve Stabia. With a strategic emphasis on bottom-up value creation, innovation-driven growth, and socially impactful outcomes, Brera Holdings has established itself as a forward-thinking leader in the global sports industry. For more information, visit www.breraholdings.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the Company’s ability to grow its business and other statements that are not historical facts, including statements which may be accompanied by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Actual results could differ materially from those described in these forward-looking statements due to a number of factors, including without limitation, the Company’s ability to continue as a going concern, the popularity and/or competitive success of the Company’s acquired football and other sports teams, the Company’s ability to attract players and staff for acquired clubs, unsuccessful acquisitions or other strategic transactions, the possibility of a decline in the popularity of football or other sports, the Company’s ability to expand its fanbase, sponsors and commercial partners, general economic conditions, and other risk factors detailed in the Company’s filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake any responsibility to update such forward-looking statements except in accordance with applicable law.

Company Contact Information:

Dan McClory, Executive Chairman, Brera Holdings PLC
Email: [email protected]

Attachment

• Brera Holdings Executive Chairman Daniel McClory (left) and Juve Stabia President Andrea Langella (right) prior to kick-off at Juve Stabia

COOTAMUNDRA, Australia, April 03, 2025 (GLOBE NEWSWIRE) — Australian Oilseeds Holdings Limited, a Cayman Islands exempted company (the “Company”) (NASDAQ: COOT) today announced Good Earth Oils (GEO) premium quality canola oil has successfully entered the JD.com supply chain and is now available for purchase on JD.com’s self-operated platform.

“This milestone marks another significant advancement for GEO’s presence in the Chinese market,” said Gary Seaton, Chief Executive Officer. “By joining JD.com’s self-operated platform, GEO enhances its visibility and credibility among Chinese consumers, offering them access to healthy, natural, and high-quality Australian canola oil. With a focus on quality, transparency, and sustainability, GEO is poised to become a trusted name in households across China.”

The successful integration into JD.com was made possible through the dedicated efforts of Shanghai Maiwei Trading Co., Ltd. and Shenzhen Maiwei Trading Co., Ltd. Their strategic coordination and unwavering commitment ensured that GEO canola oil met the rigorous standards required by JD’s platform.

In addition to JD.com, GEO’s online presence is expanding through sales channels on other leading e-commerce platforms in China such as Tmall Supermarket and Douyin (TikTok China). Maiwei is also actively developing large-scale offline private domain sales networks to further strengthen GEO’s market reach and brand recognition. This collaboration underscores the shared vision between Good Earth Oils and its partners in China to bring the best of Australian agriculture to the world, paving the way for further expansion across e-commerce and retail channels in China.

About Australian Oilseeds Investments Pty Ltd. Australian Oilseeds Investments Pty Ltd. is an Australian proprietary company that, directly and indirectly through its subsidiaries, is focused on the manufacture and sale of sustainable oilseeds (e.g., seeds grown primarily for the production of edible oils) and is committed to working with all suppliers in the food supply chain to eliminate chemicals from the production and manufacturing systems to supply quality products to customers globally. The Company engages in the business of processing, manufacture and sale of non-GMO oilseeds and organic and non-organic food-grade oils, for the rapidly growing oilseeds market, through sourcing materials from suppliers focused on reducing the use of chemicals in consumables in order to supply healthier food ingredients, vegetable oils, proteins and other products to customers globally. Over the past 20 years, the Company’s cold pressing oil plant has grown to become the largest in Australia, pressing strictly GMO-free conventional and organic oilseeds.

Contact

Australian Oilseeds Holdings Limited
126-142 Cowcumbla Street
Cootamundra New South Wales 2590
Attn: Amarjeet Singh, CFO
Email: [email protected]

Investor Relations Contact

Reed Anderson
(646) 277-1260
[email protected]