MIRAMAR, Fla., May 15, 2025 (GLOBE NEWSWIRE) -- HCW Biologics Inc. (the “Company” or “HCW Biologics”) (NASDAQ: HCWB), a clinical-stage biopharmaceutical company focused on discovering and developing novel immunotherapies to lengthen health span by disrupting the link between inflammation and age-related diseases, today reported financial results and recent business highlights for its first quarter ended March 31, 2025.
On May 15, 2025, the Company closed... Read more
European Patent Office largely dismisses opposition filed by BioNTech SE, Pfizer Inc., and others in December 2023 challenging validity of EP 4 023 755 B1 and maintains the patent subject to amendments to specific patent claims A hearing on infringement of EP 4 023 755 B1 which will also include EP 3 708 668 B1, the validity of which was confirmed in amended form in March 2025, is scheduled for July 1, 2025, before the Regional Court Düsseldorf, Germany TUBINGEN,... Read more
Conference Call Today at 4:30 p.m. ET SEATTLE / May 15, 2025 / Business Wire / Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the first quarter ended March 31, 2025, which include: Net loss for the first quarter of 2025 was $33.5 million, or $0.58 per share, compared to a net loss of $37.2 million, or $0.63 per share for the first quarter of 2024.
At March 31, 2025, we had $52.4 million of cash... Read more
SAN DIEGO / May 15, 2025 / Business Wire / Contineum Therapeutics, Inc. (NASDAQ: CTNM) (Contineum or the Company), a clinical-stage biopharmaceutical company pioneering differentiated therapies for the treatment of neuroscience, inflammation and immunology (NI&I) indications, today announced that management is scheduled to present at the 2025 RBC Capital Markets Global Healthcare Conference on Tuesday, May 20th at 8:30 a.m. ET. An audio webcast of the presentation can... Read more
PDUFA target action date of January 13, 2026
If approved, FILSPARI would be the first and only FDA-approved treatment for FSGS, a rare kidney condition and a leading cause of kidney failure SAN DIEGO / May 15, 2025 / Business Wire / Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for traditional approval of FILSPARI (sparsentan) for the treatment of focal... Read more
90% of Pediatric Participants on CRENESSITY versus 21% on Placebo Achieved ≥1 Threshold for Androstenedione Reduction or Glucocorticoid Reduction
Observed Rates of Select Reproductive Hormone Normalization in Adult Males Taking CRENESSITY with Substantial Glucocorticoid Dose Reductions
Findings Presented at the 2025 American Association of Clinical Endocrinology Annual Meeting SAN DIEGO, May 15, 2025 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX)... Read more
Duchenne (SGT-003): Participant dosing ongoing in the Phase 1/2 INSPIRE DUCHENNE trial; Solid on track to discuss accelerated pathways with U.S. FDA later in 2025
FA (SGT-212): Dosing of first participant anticipated in the second half of 2025
CPVT (SGT-501): FDA IND on track for submission first half of 2025
Cash: Company ended first quarter 2025 with $306.9 million in cash, cash equivalents, investments and available-for-sale securities; Solid has... Read more
New Analysis Shows Treatment with Investigational Paltusotine Resulted in Rapid and Durable IGF-1 Control in Surgically Naïve Acromegaly Patients
Additional Research Includes Acromegaly Symptom Burden and Standard-of-Care Discontinuation Rates SAN DIEGO, May 15, 2025 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced it will present two abstracts at the American Association of Clinical Endocrinology (AACE) Annual Meeting... Read more
Enrollment Completion for Ongoing Registrational PROSERA Phase 3 Study in PAH Expected in Early June; New Patient Screening Closed
Topline Results Announcement from PROSERA Phase 3 Expected in February 2026
To Date, Blinded Baseline Characteristics Align with Intended Study Population
First Site Activations for Planned Registrational Phase 3 SERANATA Study in PH-ILD Expected in the Fourth Quarter of 2025
Cash, cash equivalents and marketable... Read more
Clinical programs on track, with two major milestones later this year, and cash position, CHF 131 million as of March 31, 2025, expected to provide funding well into 2027
IND filing and initial clinical data on first targeted Radio-DARPin therapy program, MP0712, expected in 2025; strategic partnership with Orano Med expanded from four to ten programs
Data from dosing cohort 8 in Phase 1/2a trial of MP0533 demonstrate increased rates and depth of responses; study protocol... Read more
Announced Global Collaboration with Novo Nordisk to Develop Oral Small Molecules for Metabolic Diseases with Over $2.2 Billion in Potential Milestone Payments
On Track to Select a Next-Generation Oral Small Molecule PTH1R Agonist to Accelerate Toward the Clinic Later in 2025
Expect to Initiate Phase 1 Trial for SEP-631, MRGPRX2 NAM Program for Mast Cell Diseases, in Third Quarter of 2025
Ended First Quarter 2025 with $398.2 Million in Cash, Cash Equivalents and Marketable... Read more
RP-A601 was generally well-tolerated at a dose of 8.0E13 GC/kg with no dose-limiting toxicities in all three patients with up to 12 months follow-up
RP-A601 promoted increased protein expression and desmosomal localization of Plakophilin-2 (PKP2), Desmocollin-2, and Cadherin-2 in all three patients
Improvement or stabilization observed in arrhythmia burden, heart function, and quality of life in all patients
No further dose escalation planned
Investor webinar to be... Read more
Zynyz® (retifanlimab-dlwr), a PD-1 inhibitor, is now approved for the treatment of advanced squamous cell carcinoma of the anal canal (SCAC) in combination with chemotherapy and as a monotherapy
Patients with SCAC treated with Zynyz achieved a statistically significant improvement in progression-free survival and improvement in overall survival WILMINGTON, Del. / May 15, 2025 / Business Wire / Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration... Read more
Topline CATT1 Phase 3 data is expected in 2H 2026
Protocol amendment shortens trial duration from 12 to 6 months, expediting time to topline data HIGH POINT, N.C., May 15, 2025 (GLOBE NEWSWIRE) -- vTv Therapeutics Inc. (Nasdaq: VTVT), a late-stage biopharmaceutical company with an innovative clinical portfolio of small molecules and lead program in diabetes, today announced that screening has been reinitiated in the Company’s CATT1 Phase 3 trial investigating c... Read more
CHICAGO / May 15, 2025 / Business Wire / MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that an abstract about the efficacy data from the Phase 2 THIO-101 clinical trial was accepted for poster presentation at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO), taking place May 30 to June 3, 2025, in Chicago, Illinois. The poster... Read more
Presenting new data in the most mature readout to date, with 60% more patients and reported median and 2-year overall survival. LEXINGTON, Mass. / May 15, 2025 / Business Wire / Agenus Inc. (“Agenus” or the Company”) (NASDAQ: AGEN), a leader in immuno-oncology, today announced new data from its ongoing Phase 1 trial evaluating botensilimab and balstilimab (BOT/BAL) in patients with microsatellite stable (MSS) metastatic colorectal cancer (mCRC) at the 2025 European... Read more
Mike Heffernan appointed as Chairman of the Board
Topline data from Phase 2 LOTUS trial of AVTX-009 for the treatment of hidradenitis suppurativa expected in 2026
Cash on hand of approximately $125 million as of March 31, 2025 expected to provide runway into 2027, with optionality to extend into 2028 WAYNE, Pa., May 12, 2025 (GLOBE NEWSWIRE) -- Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company focused on the treatment of immune dy... Read more
Term sheet with Universal Capital, LLC to fund HOPE Therapeutics clinic acquisition strategy
Funding tied to already-announced acquisitions, with additional tranches contemplated for further growth, subject to standard due diligence
Together with previously announced term sheet with a strategic investor, HOPE funding of $10.3 million is planned in the near term MIAMI, May 15, 2025 /PRNewswire/ -- HOPE Therapeutics™, Inc. ("HOPE"), a multi-site clinical... Read more
Halifax, Nova Scotia--(Newsfile Corp. - May 15, 2025) - Sona Nanotech Inc. (CSE: SONA) (OTCQB: SNANF) (the "Company", "Sona") is pleased to announce the successful completion of bacterial endotoxin testing ("BET") on Sona's uniquely biocompatible gold nanorods using the Limulus Amebocyte Lysate ("LAL") method at a leading global provider of laboratory testing and expert advisory services for MedTech and pharmaceutical companies based in the US.
Sona Nanotech CEO, David... Read more
Arcutis convened the Genital Psoriasis Wellness Consortium, a multidisciplinary group of clinicians who are experts in their fields
Publication includes 14 consensus statements aimed at improving diagnosis, treatment, outcomes, and shared decision-making
Genital involvement occurs in approximately two-thirds of the nine million individuals with plaque psoriasis WESTLAKE VILLAGE, Calif., May 15, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq:... Read more
TORONTO, May 15, 2025 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is thrilled to formally announce the launch of the Phenesafe AI platform, an AI technology stack specifically designed to derive novel substituted phenethylamine molecules for patent and... Read more
Statistically significant safety and efficacy data from 0.25 mg and 0.50 mg cohorts to be presented
Presentation scheduled for Thursday, May 15, 2025, at 11:36 a.m. PT PITTSBURGH, May 15, 2025 (GLOBE NEWSWIRE) -- Lipella Pharmaceuticals Inc. (Nasdaq: LIPO) (“Lipella,” “we,” “our,” or the “Company”), a clinical-stage biotechnology company focused on developing therapies for diseases with significant unmet needs, today announced that topline data from... Read more
First ASXL1 Pediatric Acute Myeloid Leukemia (AML) Patient Dosed at MD Anderson Cancer Center: Program Supported by Rare Pediatric Disease Designation (RPDD) NEW YORK, May 15, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that the first pediatric AML patient... Read more
Positive interim 2-week safety and biomarker results from its ongoing Phase 2a study evaluating GRI-0621 for the treatment of Idiopathic Pulmonary Fibrosis (“IPF”)
Continued momentum with completed patient enrollment for the 6-week interim analysis (n=24) and over two-thirds enrollment completed for the overall trial
Cash runway expected to fund operations through Q3 2025 LA JOLLA, CA, May 15, 2025 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI... Read more
Company’s PlaCCine® technology platform demonstrates better durability and other advantages compared to mRNA vaccines
Results further validate PlaCCine as a novel vaccine platform with potential applications in COVID-19 and other infectious diseases with epidemic implications LAWRENCEVILLE, N.J., May 15, 2025 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company focused on developing non-viral DNA-mediated immunotherapies and evaluating an adaptation... Read more
Novel combination achieves 60.8% response rate and 90.2% disease control rate in first-line non-small cell lung cancer (1L NSCLC)
Notably, ~92% of all evaluable patients have PD-L1 TPS <50%, including 43% with PD-L1 below 1 (TPS <1%), who represent an area of high unmet need
Data demonstrates significant improvement in response rates compared to historical controls, and safety continues to be favourable
Multi-centre INSIGHT-003 is evaluating the same immunot... Read more
Despite growing recognition of long COVID as a serious condition, diagnosed patients have no approved treatment options, with many suffering from debilitating fatigue and brain fog
Evidence suggests sustained inflammation plays a central role in the pathogenesis of long COVID, particularly in the associated cognitive dysfunction and other neurological symptoms1
Bezisterim targets key underlying mechanisms of neuroinflammation, and has demonstrated the potential to reduce... Read more
NEW YORK, May 15, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced the publication of a new study in the Journal of ‘Clinical Nuclear Medicine’ demonstrating that intranasal administration of foralumab significantly dampened... Read more
Obtained written alignment from the FDA on key elements of TSHA-102 pivotal Part B trial design and next steps on enabling study initiation
The FDA advised the Company to submit pivotal Part B trial protocol and associated statistical analysis plan as an amendment to the IND application, eliminating the need for formal end-of-phase meeting and potentially expediting study initiation and registration; IND amendment submission expected in Q2 2025
High dose and low dose... Read more
Antimicrobial resistance is recognized as one of the top global public health threats, and Telomir-Ag2 strengthens Telomir's pipeline with a differentiated candidate designed to address this urgent and expanding crisis MIAMI, FL / ACCESS Newswire / May 15, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO), or Telomir, a leader in age-reversal science, today announced the identification of Telomir-Ag2 as a novel drug candidate for the treatment of bacterial infections,... Read more
UTRECHT, The Netherlands and CAMBRIDGE, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (“Merus”, “the Company”, “we”, or “our”), an oncology company developing innovative, full-length multispecific antibodies and antibody drug conjugates (Biclonics®, Triclonics® and ADClonics®), today announced publication on the mechanism of action of petosemtamab, a bispecific antibody targeting Epidermal Growth Factor Receptor (EGFR) and Leucine-Rich... Read more
SAN DIEGO, May 15, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX) (the Company), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced that it will host a virtual research and development (R&D) day on Thursday, May 22, 2025, from 10:00 to 11:30 AM ET. To register, click here.
The event will feature key opinion leaders (KOLs) Fred Hayden, MD, FACP (University of Virginia... Read more
SOUTH SAN FRANCISCO, Calif., May 15, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced that it has received approval from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), to initiate dosing in the 10,000-participant portion of its ongoing Phase 2b clinical trial evaluating its oral pill COVID-19 vaccine... Read more
REDWOOD CITY, Calif., May 15, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced poster presentations from its VYKATTM XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, clinical development program for the treatment of hyperphagia associated PWS at the Pediatric Endocrine Society (PES) Meeting 2025, which is... Read more
Completed last subject, last visit in the chronic cohort, data readout targeted for early June 2025 Vancouver, British Columbia--(Newsfile Corp. - May 15, 2025) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF), a clinical-stage biotechnology company dedicated to developing neuro-reparative therapeutics, today reported its financial and operational results for the first quarter ended March 31, 2025.
"We continue to make important progress in the clinical development... Read more
Received approval by U.S. Food and Drug Administration (FDA) for ZEVASKYN™ (prademagenezamikeracel), the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB)
U.S. launch of ZEVASKYN underway with activation of first qualified treatment center (QTC)
Entered into sales agreement for priority review voucher (PRV) for $155 million CLEVELAND,... Read more
PONTE VEDRA, Fla. / May 15, 2025 / Business Wire / Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today announced manufacturing and supply chain milestones for its lead drug candidate, tecarfarin, a novel oral vitamin K antagonist (VKA) anticoagulant that is designed to address unmet needs in anticoagulation therapy.
Cadrenal completed the technical transfer and manufacturing of its... Read more
Clinical data builds with CR in testicular cancer, enrollment in Phase 2 gastric trial, and new data in PD-1–resistant tumors Near-term capital transactions poised to bolster liquidity NEW YORK, May 15, 2025 (GLOBE NEWSWIRE) -- MiNK Therapeutics, Inc. (NASDAQ: INKT), a clinical-stage biopharmaceutical company pioneering the development of allogeneic, off-the-shelf invariant natural killer T (iNKT) cell therapies, today announced its financial results for the... Read more
LAUSANNE, Switzerland, May 15, 2025 /PRNewswire/ -- ADC Therapeutics SA (NYSE: ADCT), a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs), today announced participation in two upcoming investor conferences:
RBC Capital Markets Global Healthcare ConferenceDate: May 21, 2025Presentation Time: 10:30-10:55 a.m. ETFormat: Fireside ChatSpeaker: Ameet Mallik, Chief Executive OfficerTo register for the webcast, click here.
Jefferies Global... Read more
PEMGARDA™ (pemivibart) net product revenue of $11.3 million reported for Q1 2025, influenced by planned transition (Jan/Feb) from a contracted to an internalized sales force
PEMGARDA revenue re-acceleration observed in Q2 2025 to date
Invivyd continues to target near-term profitability (1H 2025) with existing cash and cash equivalents, anticipated growth of net product revenue, and continued reduction of operating expenses
Since Emergency Use Authorization (EUA)... Read more
LEXINGTON, Mass., May 15, 2025 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (Nasdaq: VYGR), a biotechnology company dedicated to leveraging genetics to treat neurological diseases, today announced the first peer-reviewed publication of data demonstrating the ability of alkaline phosphatase (ALPL) to transport a novel AAV capsid across the blood-brain barrier (BBB). The article, titled “Highly conserved brain vascular receptor ALPL mediates transport of engineered AAV... Read more
Two subtype specific cohorts with ~15 patients each added to the ongoing RESET-Myositis™ trial
RMAT designation granted for rese-cel in myositis, which is a disabling, multi-system autoimmune disease affecting approximately 80,000 U.S. patients with no approved treatments other than monthly IVIg
Multiple Phase 1/2 disease cohorts fully enrolled across the RESET™ clinical development program; 44 patients enrolled and 23 patients dosed as of May 9,... Read more
DUBLIN, May 15, 2025 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today announced the acceptance of a Pharmaceutical Pipeline Presentation at the American Society of Clinical Psychopharmacology Annual Meeting (ASCP) in Arizona, United States from May 27 – 30, where Professor Michael E. Thase, MD, Professor of Psychiatry,... Read more
NEW YORK / May 15, 2025 / Business Wire / OS Therapies (NYSE-A: OSTX) (“OS Therapies” or “the Company”), a clinical-stage immunotherapy and Antibody Drug Conjugate (ADC) biopharmaceutical company, today announced the launch of OS Animal Health, Inc., a wholly owned subsidiary focused on commercializing OST-HER2 for the treatment of canine osteosarcoma. OST-HER2 market opportunity in canine osteosarcoma exceeds $150 million
Recent data in prevention of amputation... Read more
First Patient Enrolled in Multi-Dose Phase 1b/2 Trial of Bel-sar in Non-Muscle-Invasive Bladder Cancer (NMIBC); Initial Data at 3 Months Expected by Year-End 2025
Strengthened Leadership Team with the Appointment of Tony Gibney as Chief Financial and Business Officer BOSTON, May 15, 2025 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function,... Read more
$3 Million Lead Order from Strategic Investors Supports Bold Transformation VANCOUVER, British Columbia, May 15, 2025 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (TSX-V: RKV) (FSE: 7JO) (“Rakovina” or the “Company”), a biopharmaceutical company advancing innovative cancer therapies through artificial intelligence (AI)-powered drug discovery, today announces a strategic financing of approximately $4 million (the “Offering”) consisting of concurrent private... Read more
BOSTON, May 15, 2025 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (“Aura”) (Nasdaq: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, today announced the launch of an underwritten public offering of shares of its common stock and accompanying warrants to purchase shares of its common stock and, to certain investors, pre-funded warrants to purchase shares of common stock and accompanying warrants... Read more
MISSISSAUGA, Ontario / May 15, 2025 / Business Wire / Covalon Technologies Ltd. (the "Company" or "Covalon") (TSXV: COV; OTCQX: CVALF), an advanced medical technologies company, is pleased to announce the promotion of Ms. Kim Crooks to the position of Chief Operating Officer (COO), effective immediately. In addition to her new role, Ms. Crooks has been appointed to Covalon's Board of Directors.
Ms. Crooks rejoined Covalon in early 2024 as Senior Vice President – Operations,... Read more
SAN FRANCISCO, CALIFORNIA, May 15, 2025 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary TriKE® natural killer (NK) cell engager platform, today announced the appointment of Andrew Ritter to its Board of Directors. Mr. Ritter will be replacing current board member Dr. Rajesh Shrotriya, who is resigning from his position.
“We... Read more
Accelerating Expansion Across Human and Veterinary Health Through Innovation and Strategic Collaboration BRUSSELS, May 15, 2025 (GLOBE NEWSWIRE) -- Anbio Biotechnology, a global leader in in-vitro diagnostic (IVD) technologies, is pleased to announce its participation in three major international exhibitions this May: EuroMedLab 2025 in Brussels, AVA Conference 2025 in Sydney, and the 47th ACMTT 2025 in Bangkok. These events reflect Anbio’s strategic commitment to... Read more
