Market Newsdesk

COLMAR, Pa., April 22, 2025 (GLOBE NEWSWIRE) — Dorman Products, Inc. (NASDAQ:DORM) is announcing the release of 353 new automotive repair solutions this month for its Light Duty business segment. More than one hundred of the new products are either aftermarket exclusives or Dorman^® OE FIX^® innovations with upgraded features and repair convenience. The April releases join a growing Dorman catalog of over 138,000 SKUs, offering millions of new sales opportunities for aftermarket parts distributors, retailers and repair shops, and more accessible solutions for vehicle owners.

This month’s releases include four OE FIX steering knuckles that are the newest additions to Dorman’s comprehensive line of aftermarket steering and suspension components. The knuckles feature a patent-pending proprietary coating that helps prevent the formation of corrosion between the surfaces of the knuckle and wheel hub bearing, a common problem that can lead to seizing and a difficult repair on certain Ford, Toyota and Lexus trucks and SUVs.

“These new knuckles are the latest example of how we are constantly striving to offer customers the quality, performance and coverage they need. The Dorman steering and suspension line offers a broad and deep range of products, covering the most popular cars and trucks on the road. That means technicians can count on seamless, predictable repairs to help ensure the same smooth ride and steering feel that customers expect,” said Mike DiGregorio, Vice President–Product Innovation.

Additional first-to-the-aftermarket highlights for April include:

• A battery main fuse for select Chevrolet and GMC trucks, designed to match the performance of an original equipment fuse.
• An exterior cargo door handle, also for specified Chevrolet and GMC trucks, engineered to replace a factory handle that is malfunctioning or broken from fatigue. The handle is designed to match the performance and the appearance of the original equipment handle.
• A power running board motor for certain Ford F-150 trucks equipped with motorized running boards. The new motor has undergone rigorous cycle testing for reliable service life and is designed to replace a factory unit that has burned out from normal wear.

Find Dorman products near you using the search tool or take the Dorman Virtual Tour to learn more about the company, including history, culture and more.

Contacts

Marketing: Steve Gisondi, Vice President of Marketing, [email protected]  

Investor Relations: Alex Whitelam, Vice President, Investor Relations, [email protected]

Visit our website at www.dormanproducts.com. The Investor Relations section of the website contains a significant amount of information about Dorman, including financial and other information for investors. Dorman encourages investors to visit its website periodically to view new and updated information.

About Dorman

Dorman gives professionals, enthusiasts and owners greater freedom to fix motor vehicles. For over 100 years, we have been driving new solutions, releasing tens of thousands of aftermarket replacement products engineered to save time and money and increase convenience and reliability.

Founded and headquartered in the United States, we are a pioneering global organization offering an always-evolving catalog of products, covering cars, trucks and specialty vehicles, from chassis to body, from underhood to undercarriage, and from hardware to complex electronics.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “should,” “likely,” “probably,” “anticipates,” “expects,” “intends,” “plans,” “projects,” “believes,” “views,” “estimates,” and similar expressions are used to identify these forward-looking statements. Such forward-looking statements are based on current expectations that involve known and unknown risks, uncertainties, and other factors (many of which are outside of our control) that may cause actual events to be materially different from those expressed or implied by such forward-looking statements. For additional information concerning factors that could cause actual results to differ materially from the information contained in this press release, please see Dorman’s prior press releases and filings with the U.S. Securities and Exchange Commission (“SEC”), including Dorman’s most recent annual report on Form 10-K and its subsequent SEC filings. Dorman is under no obligation to (and expressly disclaims any such obligation to) update any of the information in this press release if any forward-looking statement later turns out to be inaccurate whether as a result of new information, future events or otherwise.

NEW YORK, April 22, 2025 (GLOBE NEWSWIRE) — Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it will participate in four upcoming investor conferences in May:

• The Citizens 2025 Life Sciences Conference
  The Company will present on Wednesday, May 7, 2025, at 1:30 p.m. ET in New York, NY

• BofA Securities 2025 Health Care Conference
  The Company will present on Tuesday, May 13, 2025, at 3:00 p.m. PT in Las Vegas, NV

• 2025 RBC Capital Markets Global Healthcare Conference
  The Company will present on Tuesday, May 20, 2025, at 3:05 p.m. ET in New York, NY

• Mizuho Neuro & Ophthalmology Summit 2025
  The Company will participate in investor meetings on Wednesday, May 21, 2025, in New York, NY

Live webcasts of the presentations at the Citizens, BofA, and RBC conferences can be accessed on the “Webcasts & Presentations” page of the “Investors” section of the Company’s website at axsome.com. Replays of the webcasts will be available for approximately 30 days following each event.

About Axsome Therapeutics

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X.

Forward Looking Statements

Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s Sunosi^®, Auvelity^®, and Symbravo^® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of Sunosi, Auvelity, and Symbravo and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Investors:

Mark Jacobson
Chief Operating Officer
(212) 332-3243
[email protected]

Media:

Darren Opland
Director, Corporate Communications
(929) 837-1065
[email protected]

PETACH TIKVA, Israel, April 22, 2025 (GLOBE NEWSWIRE) — PolyPid Ltd. (Nasdaq: PYPD), (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that the Company’s management will participate in a fireside chat at The Citizens Life Sciences Conference taking place in New York, NY, from May 7-8, 2025.

The PolyPid management team will participate in one-on-one investor meetings during this event. Investors interested in meeting with PolyPid around the conference should contact their Citizens JMP representative.

About PolyPid

PolyPid Ltd. (Nasdaq: PYPD) is a late-stage biopharma company aiming to improve surgical outcomes. Through locally administered, controlled, prolonged-release therapeutics, PolyPid’s proprietary PLEX (Polymer-Lipid Encapsulation matriX) technology pairs with Active Pharmaceutical Ingredients (APIs), enabling precise delivery of drugs at optimal release rates over durations ranging from several days to months. PolyPid’s lead product candidate D-PLEX₁₀₀ is in Phase 3 clinical trial for the prevention of abdominal colorectal surgical site infections. In addition, the Company is currently in preclinical stages to test the efficacy of OncoPLEX for the treatment of solid tumors, beginning with glioblastoma.

For additional Company information, please visit http://www.polypid.com and follow us on Twitter and LinkedIn.

Contacts:

PolyPid Ltd. 
Ori Warshavsky
COO – US
908-858-5995
[email protected]

Investors:

Brian Ritchie
LifeSci Advisors
212-915-2578
[email protected]

TORONTO, April 22, 2025 (GLOBE NEWSWIRE) — Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FRA: 0K91) (“Quantum BioPharma” or the “Company”), is pleased to announce the appointment of Kevin Malone as an advisor to the Board of Directors. Mr. Malone brings a vast wealth of successful stock trading experience, especially in manipulated companies, from his years of wealth management.

About Mr. Kevin Malone

Mr. Malone is a 2nd generation financial advisor with over 40 years of family experience in wealth management. This combined with his deep entrepreneurial background he launched Malone Wealth in 2021. Mr. Malone focuses deeply on pattern recognition skills and data research to differentiate himself from other financial advisors.

His investment philosophy is based on rigorous research, disciplined risk management, and a long-term approach that seeks to maximize returns while minimizing risk. His Firm identifies undervalued assets and sectors while tactically rebalancing investments to unseen macro conditions.

Kevin has grown his following in communities fighting market corruption in recent years and wants to continue that fight forever. Kevin also started a charitable fund that he plans on using to get personal finance and financial literacy implemented into the US Public Education System. He believes Americans were always at a disadvantage when it comes to finance because they were never taught it. This is unacceptable to him, and he believes everyone should have the right to learn personal finance for free.

Zeeshan Saeed, CEO of Quantum BioPharma said, “We are thrilled and honored to welcome Kevin Malone as an advisor. His wealth of experience, especially in naked short squeeze strategies, will be an incredible addition to our team of experts fighting the banks and investors engaged in this type of stock trading activity and manipulation”.

Mr. Malone says, ”I’ve seen firsthand how naked short selling and the unlimited liquidity privileges granted to market makers can devastate my clients’ investments. In 2021, when multiple brokerages removed the buy button on GameStop, I witnessed millions of dollars in client nest eggs and retirements vanish—simply because Wall Street got caught cheating. That moment changed everything for me. I committed to becoming a fiduciary who actively fights against market corruption. When I learned about Quantum’s mission and their work to cure MS, I immediately knew I wanted to be part of their fight. This is the kind of battle worth joining,”.

About Quantum BioPharma Ltd.

Quantum BioPharma (NASDAQ: QNTM) is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc. (“Lucid”), Quantum BioPharma is focused on the research and development of its lead compound, Lucid-MS. Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. Quantum BioPharma invented unbuzzd™ and spun out its OTC version to a company, Celly Nutrition Corp. (“Celly Nutrition”), led by industry veterans. Quantum BioPharma retains ownership of 25.71% (as of June 30, 2024) of Celly Nutrition at www.unbuzzd.com. The agreement with Celly Nutrition also includes royalty payments of 7% of sales from unbuzzd™ until payments to Quantum BioPharma total $250 million. Once $250 million is reached, the royalty drops to 3% in perpetuity. Quantum BioPharma retains 100% of the rights to develop similar products or alternative formulations specifically for pharmaceutical and medical uses. Quantum BioPharma maintains a portfolio of strategic investments through its wholly owned subsidiary, FSD Strategic Investments Inc., which represents loans secured by residential or commercial property. For more information visit www.quantumbiopharma.com.

For more information on Quantum BioPharma, please visit www.quantumbiopharma.com.

Forward Looking Information

This press release contains certain “forward-looking statements” within the meaning of applicable Canadian securities law. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always, identified by words or phrases such as “believes”, “anticipates”, “expects”, “is expected”, “scheduled”, “estimates”, “pending”, “intends”, “plans”, “forecasts”, “targets”, or “hopes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “will”, “should” “might”, “will be taken”, or “occur” and similar expressions) are not statements of historical fact and may be forward-looking statements. The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding: the Company’s focus on the research and development of Lucid-MS to prevent and reverse myelin degradation; the Company’s Lucid-21-302 clinical development program in multiple sclerosis advancing towards human phase-2 efficacy trials; Lucid-21-302 having an initial indication in multiple sclerosis; the Company’s intention to retain 100% of the rights to develop products for pharmaceutical and medical uses; the Company’s intention to maintain a portfolio of strategic investments through FSD Strategic Investments Inc.; Enterprise and Empire playing a key role in assisting the Company to enhance its market awareness and foster productive, continuing dialogues with shareholders and other market participants; Enterprise being engaged by the Company for an indefinite period; the Agencies working with the Company to develop and implement a comprehensive public relations strategy designed to increase the Company’s visibility throughout the investment community; the Company’s approach to treatments in brain disorders and alcohol health representing a tremendous revenue potential; Empire being engaged for a period of three months; the Agencies assisting the Company with its public relations strategy; rekvry™ fulfills an unmet need in healthcare settings, reducing the costs and burden on healthcare resources and staff; the Company continuing to execute on key growth initiatives and raise awareness for unbuzzd™ with a 360-degree marketing approach; the Company expects the RTD formulation to be available in Q1 2025; and LUCID-21-302 having a potentially expedited pathway to market.

Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Company’s assessment of market conditions, its ability to gain market share, and its potential competitive edge are accurate; the Company will have the ability to carry out its plans with respect to its new innovation and offerings, including its ability to conduct research and development of Lucid-MS; the Company’s Lucid-21-302 clinical development program in multiple sclerosis will advance towards human phase-2 efficacy trials; Lucid-21-302 having an initial indication in multiple sclerosis; the Company will retain 100% of the rights to develop similar product or alternative formulations specifically for pharmaceutical and medical uses; the Company will seek new business opportunities; the Company will increase efficiency in its processes and partnerships; the Company will have the ability to carry out its other goals and objectives the Company’s intention to maintain a portfolio of strategic investments through FSD Strategic Investments Inc.; Enterprise and Empire will play a key role in assisting the Company to enhance its market awareness and foster productive, continuing dialogues with shareholders and other market participants; Enterprise will be engaged by the Company for an indefinite period after; the Agencies will work with the Company to develop and implement a comprehensive public relations strategy designed to increase the Company’s visibility throughout the investment community; the Company’s approach to treatments in brain disorders and alcohol health will have a tremendous revenue potential; Enterprise will be assisting the Company with its public relations strategy; rekvry™ will fulfill an unmet need in healthcare settings, reducing the costs and burden on healthcare resources and staff; the Company will continue to execute on key growth initiatives and raise awareness for unbuzzd™ with a 360-degree marketing approach; the Company’s RTD formulation will be available in Q1 2025; and LUCID-21-302 will have a potentially expedited pathway to market.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the Company’s inability to retain 100% of the rights to develop products for pharmaceutical or medical uses; the Company’s inability to enhance its product development capabilities and/or maintain a portfolio of strategic investments; the Company’s Lucid-21-302 clinical development program in multiple sclerosis will not advance towards human phase-2 efficacy trials; Lucid-21-302 not having an initial indication in multiple sclerosis; the Company will not have the ability to carry out its other goals and objectives the Company’s intention to maintain a portfolio of strategic investments through FSD Strategic Investments Inc.; the Agencies will not play a key role in assisting the Company to enhance its market awareness and foster productive, continuing dialogues with shareholders and other market participants; Enterprise will not be engaged by the Company for an indefinite period; the Agencies will not work with the Company to develop and implement a comprehensive public relations strategy designed to increase the Company’s visibility throughout the investment community; the Company’s approach to treatments in brain disorders and alcohol health will not have a tremendous revenue potential; Empire will not be engaged for the period of three months; the Agencies will not be assisting the Company with its public relations strategy; rekvry™ will not fulfill an unmet need in healthcare settings or reduce the costs and burden on healthcare resources and staff; the Company will not continue to execute on key growth initiatives and raise awareness for unbuzzd™ with a 360-degree marketing approach; the Company’s RTD formulation will not be available in Q1 2025; LUCID-21-302 will not have a potentially expedited pathway to market; and the risks discussed in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2023, final short form base shelf prospectus dated December 22, 2023 and registration statement on Form F-3 containing a base shelf prospectus, each under the heading “Risk Factors”. These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Readers are cautioned that the foregoing list is not exhaustive. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events, or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.

The reader is urged to refer to additional information relating to Quantum BioPharma, including its annual information form, can be located on the SEDAR+ website at www.sedarplus.ca and on the EDGAR section of the United States Securities and Exchange Commission’s website at
www.sec.gov
for a more complete discussion of such risk factors and their potential effects.

Contacts:

Quantum BioPharma Ltd.

Zeeshan Saeed, Founder, CEO and Executive Co-Chairman of the Board
Email: [email protected]  
Telephone: (833) 571-1811

Investor Relations

Investor Relations: [email protected]  
General Inquiries: [email protected]   

MARYSVILLE, Ohio, April 22, 2025 (GLOBE NEWSWIRE) — To help increase the creation of community gardens and green spaces in underserved areas, The Scotts Miracle-Gro Foundation has joined Keep America Beautiful’s 2025 Martin Luther King Corridor Community Grants initiative.

The program awards grants to support projects that address inner-city heat islands in underserved communities through the planting of trees, shrubs, ground cover and grass. Grants will also be awarded for community gardens and orchards that mitigate food insecurity. The goal is to convert brown spaces, significantly hotter due to lack of vegetation, into green spaces with environmental, health and safety benefits.

“People want greener, healthier and more beautiful communities, but in underserved areas, resources often are scarce,” said Jennifer Lawson, president and CEO of Keep America Beautiful. “This is why the MLK Corridor Community Grants are so important. They are a vehicle to bring communities and people together, creating special bonds grounded in the creation and enjoyment of natural landscapes.”

Brian Herrington, president of The Scotts Miracle-Gro Foundation, added, “Earth Day is an ideal time to shine a light on the important role green spaces play in our lives. Beyond reducing heat islands and addressing food insecurity, they are a catalyst for environmental and wellness benefits, from helping clean the air to fostering positive social interactions. Earth Day serves as our reminder to support green spaces in communities year round.”

Grant applications were open to Keep America Beautiful affiliates, nonprofits, local governments and other community organizations. Grant winners will be notified by the end of April 2025. The Scotts Miracle-Gro Foundation is contributing $200,000 to be awarded through 2026.

To learn how communities and individuals can do their part to create greener neighborhoods, The Scotts Miracle-Gro Foundation encourages people to join in Keep America Beautiful’s Greatest American Cleanup.

About The Scotts Miracle-Gro Foundation

The mission of The Scotts Miracle-Gro Foundation is to inspire, connect and cultivate a community of purpose. The Foundation is deeply rooted in helping create healthier communities, empower the next generation, and preserve our planet. The Foundation is a 501(c)(3) organization that funds non-profit entities that support its core initiatives in the form of grants, endowments and multi-year capital gifts. For more information, visit www.scottsmiraclegrofoundation.org.

About Keep America Beautiful

A leading national nonprofit, Keep America Beautiful inspires and educates people to take action every day to improve and beautify their community environment. We envision a country in which every community is a clean, green, and beautiful place to live. For more information about Keep America Beautiful, visit www.kab.org

For media inquiries:

Tom Matthews
Chief Communications Officer
[email protected]
937-844-3864

Leslie McClain
Vice President, Communications
[email protected]

BOSTON and SAN DIEGO, April 22, 2025 (GLOBE NEWSWIRE) — Rapport Therapeutics, Inc. (Nasdaq: RAPP) (“Rapport” or the “Company”), a clinical-stage biotechnology company dedicated to the discovery and development of small molecule precision medicines for patients with neurological or psychiatric disorders, today announced that management plans to participate in three upcoming investor conferences.

Jones Trading Virtual CNS Symposium – fireside chat on Tuesday, April 29, 2025, from 11:00-11:25am ET.

Citizens JMP 2025 Life Sciences Conference (New York City) – fireside chat on Thursday, May 8, 2025, from 1:30-1:55pm ET.

Mizuho Neuro & Ophthalmology Summit 2025 (New York City) – investor meetings on Wednesday, May 21, 2025.

Interested parties may access the live and archived webcasts of the Jones Trading and Citizens JMP fireside chats under the “Investors” section of the company’s website at: https://investors.rapportrx.com.

About Rapport Therapeutics

Rapport Therapeutics is a clinical-stage biotechnology company dedicated to discovering and developing small molecule precision medicines for patients with neurological or psychiatric disorders. The Company’s founders have made pioneering discoveries related to the function of receptor associated proteins (RAPs) in the brain. Their findings form the basis of Rapport’s RAP technology platform, which enables a differentiated approach to generate precision small molecule product candidates with the potential to overcome many limitations of conventional neurology drug discovery. Rapport’s precision neuroscience pipeline includes the Company’s lead investigational drug, RAP-219, designed to achieve neuroanatomical specificity through its selective targeting of a RAP expressed in only discrete regions of the brain. The Company is currently pursuing RAP-219 as a potential treatment for refractory focal epilepsy, bipolar mania and diabetic peripheral neuropathic pain. Additional preclinical and late-stage discovery stage programs are also underway, including targeting chronic pain and hearing disorders.

Contact

Julie DiCarlo
Head of Communications & IR
Rapport Therapeutics
[email protected]

Source: https://www.rapportrx.com/
        

LONDON, April 22, 2025 (GLOBE NEWSWIRE) — Autolus Therapeutics plc (Nasdaq: AUTL), an early commercial stage biopharmaceutical company developing, manufacturing and delivering next-generation programmed T cell therapies, today announces that it will release its first quarter 2025 financial results and operational highlights before open of US markets on Thursday, May 8, 2025.

Management will host a conference call and webcast at 8:30 am EDT/13:30 pm BST to discuss the company’s financial results and provide a general business update. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call.

A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website.

About Autolus Therapeutics plc

Autolus Therapeutics plc (Nasdaq: AUTL) is an early commercial stage biopharmaceutical company developing, manufacturing and delivering next-generation T cell therapies for the treatment of cancer and autoimmune disease. Using a broad suite of proprietary and modular T cell programming technologies, Autolus is engineering precisely targeted, controlled and highly active T cell therapies that are designed to better recognize target cells, break down their defense mechanisms and eliminate these cells. Autolus has an FDA approved product, AUCATZYL, and a pipeline of product candidates in development for the treatment of hematological malignancies, solid tumors and autoimmune diseases. For more information, please visit www.autolus.com

Contact:  

Amanda Cray 
+1 617-967-0207 
[email protected] 

Olivia Manser 
+44 7780 471 568 
[email protected] 

– Initiation of Upcoming Phase 1a/1b Clinical Trial Expected in the Second Quarter of 2025 –

WAYNE, Pa, April 22, 2025 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a Phase 1a/1b clinical trial of ATI-052, a potential best-in-class bispecific anti-TSLP/IL-4R monoclonal antibody.

“Therapeutic innovation is at the core of the important work we do at Aclaris, and bispecific antibodies represent a groundbreaking innovation in immunotherapy that we believe will evolve the therapeutic armamentarium in a variety of settings,” said Dr. Hugh Davis, Aclaris’ President and Chief Operating Officer. “Key to our license agreement with Biosion, Inc. were the rights to ATI-052, a potential best-in-class investigational bispecific antibody that exhibits a high binding affinity to, and dual blockade of, both the TSLP ligand and the IL-4 receptor, and as such inhibits a key central proinflammatory pathway. Developing bispecific antibodies for immuno-inflammatory disorders is of significant interest to Aclaris, and the clearance of the ATI-052 IND by the FDA is an important milestone in that regard.”

The randomized, blinded, placebo-controlled, Phase 1a/1b clinical trial will evaluate single and multiple ascending doses of ATI-052 followed by a proof-of-concept portion in an undisclosed indication. The Company expects to initiate the trial in the second quarter of 2025.

Bispecific antibodies are engineered to have two distinct binding domains that can bind to two targets simultaneously. This dual binding and pathway inhibition potentially enhances efficacy over traditional monoclonal antibodies, with broad applications for the potential treatment of many immune-modulated diseases.

About Investigational New Drug Applications (INDs)

An IND application is a request submitted to the FDA seeking permission to test a new drug in humans. The application includes detailed information about the investigational drug, its composition, pharmacology and toxicology data from preclinical studies, proposed clinical trial protocols, and information on manufacturing and quality control. Organizations can initiate a clinical trial in the U.S. only with IND clearance from the FDA.

About ATI-052

ATI-052 is an investigational, potential best-in-class anti-TSLP/IL-4R bispecific monoclonal antibody being developed to treat certain immuno-inflammatory diseases. ATI-052 targets thymic stromal lymphopoietin (TSLP) and interleukin-4 receptor (IL-4R) that blocks both the upstream TSLP receptor signal transduction and downstream IL-4R activation which inhibits both IL-4 and IL-13 signaling, thereby inhibiting this central proinflammatory pathway and potentially offering enhanced efficacy through dual pathway inhibition. ATI-052 utilizes the same TSLP antigen-binding fragment (Fab) region as bosakitug (ATI-045), Aclaris’ investigational anti-TSLP monoclonal antibody, but is engineered to bind more tightly to the neonatal Fc receptor (FcRn), potentially extending its half-life. ATI-052 has the potential to treat a variety of atopic, immunologic and respiratory diseases. Aclaris has the exclusive worldwide rights to ATI-052, excluding Greater China.

About Aclaris Therapeutics, Inc.

Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of product candidates powered by a robust R&D engine. For additional information, please visit www.aclaristx.com and follow Aclaris on X (formerly Twitter) at @AclarisTx and on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include expectations regarding its development plans for ATI-052, including the anticipated design and timing for its Phase 1a/1b trial of ATI-052, the potential for ATI-052 to be a best-in-class anti-TSLP/IL-4R bispecific monoclonal antibody and the therapeutic potential of ATI-052. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris’ reliance on third parties over which it may not always have full control, Aclaris’ ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the macroeconomic environment and other risks and uncertainties that are described in the Risk Factors section of Aclaris’ Annual Report on Form 10-K for the year ended December 31, 2024, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “SEC Filings” page of the “Investors” section of Aclaris’ website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

Aclaris Therapeutics Contact:

Will Roberts

Senior Vice President
Corporate Communications and Investor Relations
(484) 329-2125
[email protected]

FALLS CHURCH, Va., April 22, 2025 (GLOBE NEWSWIRE) — Northrop Grumman Corporation (NYSE: NOC) has released its first quarter 2025 financial results. A copy of the earnings release has been furnished in the company’s Form 8-K filing and is also available on the company’s investor relations website at http://investor.northropgrumman.com.

As previously announced, Northrop Grumman will webcast its earnings conference call at 9:30 a.m. Eastern time today. A live audio broadcast of the conference call will be available on http://investor.northropgrumman.com.

Northrop Grumman is a leading global aerospace and defense technology company. Our pioneering solutions equip our customers with the capabilities they need to connect and protect the world, and push the boundaries of human exploration across the universe. Driven by a shared purpose to solve our customers’ toughest problems, our employees define possible every day.

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Todd Ernst (Investors)
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