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Press releases published on May 5, 2025
Vaxart CEO Issues Letter to Stockholders Highlighting Company Progress
GlobeNewswire
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May 5, 2025
Urges Stockholders to Vote FOR Reverse Stock Split Proposal at Upcoming Annual Meeting as Recommended by Leading Independent Proxy Advisory Firms SOUTH SAN FRANCISCO, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today issued the …
Capricor Therapeutics Announces Completion of Mid-Cycle Review Meeting with FDA on Deramiocel for the Treatment of Duchenne Muscular Dystrophy Cardiomyopathy
GlobeNewswire
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May 5, 2025
-Company remains on track for PDUFA target action date of August 31, 2025- -Advisory committee meeting to be held in advance of target action date- SAN DIEGO, May 05, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company …
Scorpius Holdings Announces Corporate Update Including Cost Optimization Initiatives, Strategic Corporate Developments, and Potential Opportunities for Expansion into Southeast Asia
GlobeNewswire
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May 5, 2025
Operational Realignment Expected to Deliver Over $6 Million in Annual Cost Savings Company Exploring CDMO Expansion Opportunities in Southeast Asia San Antonio, TX , May 05, 2025 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (OTC: SCPX) (“Scorpius” or “the …
BioVie Unveils Corporate Advisory Board Featuring Neuralink Co-Founder, Former Executives from Mastercard and Apple, and High-Impact Industry Leaders to Advance BioVie Mission and Growth
GlobeNewswire
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May 5, 2025
The seven-member Board includes Cedars-Sinai brain health leader Dr. Zaldy Tan, Parkwood marketing powerhouse Justina Omokhua, and Neuralink visionary Tim Gardner Each Board member brings deep personal conviction and cross-sector expertise to unlock value …
Praxis Precision Medicines Highlights DEE Clinical Program Updates at Virtual Investor Event
GlobeNewswire
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May 5, 2025
BOSTON, May 05, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by …
UNITY Biotechnology Announces Complete 36-Week Results from the ASPIRE Phase 2b Study of UBX1325 in Diabetic Macular Edema and Provides Corporate Updates
GlobeNewswire
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May 5, 2025
UBX1325 demonstrated vision gains that were comparable and statistically non-inferior to aflibercept at week 36 in a difficult-to-treat DME patient population UBX1325 generally outperformed aflibercept in a pre-specified subgroup of patients entering the …
Rezolute Receives Breakthrough Therapy Designation from FDA for Ersodetug in the Treatment of Hypoglycemia Due to Tumor Hyperinsulinism
GlobeNewswire
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May 5, 2025
Registrational study in patients with tumor hyperinsulinism (HI) expected to commence mid-year Designation underscores need for therapies to treat severe hypoglycemia in the oncology setting REDWOOD CITY, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Rezolute, …
Exagen Inc. Reports Record Q1 2025 Revenue Driven by Growth in Average Selling Price and Testing Volume
GlobeNewswire
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May 5, 2025
CARLSBAD, Calif., May 05, 2025 (GLOBE NEWSWIRE) -- Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing solutions, today reported financial results for the quarter ended March 31, 2025, and recent corporate updates. Three Months Ended …
Immutep’s Efti in Combination with KEYTRUDA® (pembrolizumab) Drives Strong Overall Survival in Head and Neck Cancer with CPS <1
GlobeNewswire
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May 5, 2025
Complementary nature of these two immunotherapies leads to excellent 17.6-month median Overall Survival in head and neck cancer patients with PD-L1 CPS <1 Mature overall survival data builds on encouraging high response rates with multiple complete …
Chemomab Announces Presentation of Positive Nebokitug Phase 2 Clinical Data in Primary Sclerosing Cholangitis in Distinguished Plenary Session at DDW 2025
GlobeNewswire
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May 5, 2025
SPRING Trial Data Presented at Digestive Disease Week® 2025 Shows that Nebokitug at 15 and 48 Weeks of Treatment Is Well-Tolerated and Associated with Significant Improvements in Multiple Fibrotic and Inflammatory Biomarkers that Represent Slowing of …
Can-Fite Has Raised $175 Million in Total to Date for the Development of Namodenoson and Piclidenoson, Advancing into Pivotal Phase 3 Trials in Liver Cancer and Psoriasis
GlobeNewswire
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May 5, 2025
Ramat Gan, Israel, May 05, 2025 (GLOBE NEWSWIRE) -- Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small-molecule drugs for oncological and inflammatory diseases, today announced that …
Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI™ (ustekinumab-aekn) with Stelara® (ustekinumab)
GlobeNewswire
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May 5, 2025
The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentations matching the reference product, effective as of April 30, 2025 SELARSDI is approved for all indications …
Algernon Announces Warrant Extension
GlobeNewswire
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May 5, 2025
THIS NEWS RELEASE IS NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES FOR DISSEMINATION IN THE UNITED STATES VANCOUVER, British Columbia, May 05, 2025 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF) (the “Company …
Firefly Neuroscience Achieves Multi-Fold Database, IP Portfolio, and Commercial Footprint Expansion Through Acquisition of Evoke Neuroscience, Inc.
GlobeNewswire
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May 5, 2025
Builds upon Firefly’s recent acceptance into the NVIDIA Connect program Marks next major step toward building a proprietary foundation model of the human brain KENMORE, N.Y., May 05, 2025 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. (“Firefly,” or the “ …
Alterity Therapeutics Granted U.S. FDA Fast Track Designation for ATH434 to Treat Multiple System Atrophy
GlobeNewswire
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May 5, 2025
– Fast Track Designation highlights potential of ATH434 to address high unmet need for individuals with MSA – MELBOURNE, Australia and SAN FRANCISCO, May 05, 2025 (GLOBE NEWSWIRE) -- Alterity Therapeutics (ASX: ATH, NASDAQ: ATHE) (“Alterity” or “the …
Palvella Therapeutics to Ring the Nasdaq Opening Bell on May 12, 2025
GlobeNewswire
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May 5, 2025
WAYNE, Pa., May 05, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc. (Palvella or “the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from …
SEED Therapeutics Highlights Breakthrough Advances in Targeted Protein Degradation at AACR 2025
GlobeNewswire
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May 5, 2025
Novel RBM39 molecular glue achieves complete tumor regression in mechanism-based Ewing sarcoma models; IND filing expected mid-2025 Dual PROTAC strategy overcomes hook effect and enhances KRAS G12D degradation in collaboration with University of …
BioCryst Reports First Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire
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May 5, 2025
—Q1 2025 ORLADEYO net revenue of $134.2 million (+51 percent y-o-y)— —Full year 2025 ORLADEYO revenue guidance increased to $580 million to $600 million— —Company now expects to be profitable for full year 2025, a year ahead of schedule— —Company pays down …
Regeneration Biomedical to Present Updated Phase 1 Trial Data on Autologous Stem Cell Therapy Injected Directly into the Brain for Alzheimer’s Disease in Podium Presentation at the ISCT 2025 Scientific Annual Meeting
GlobeNewswire
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May 5, 2025
Abstract selected for a podium presentation and winner of the Host Region (US West) Award First-in-human data now includes five patients, with follow-up ranging from 23 weeks to over a year post-treatment Injections of Wnt-activated, autologous, expanded, …
Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI™ (ustekinumab-aekn) with Stelara® (ustekinumab)
GlobeNewswire
·
May 5, 2025
The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentations matching the reference product, effective as of April 30, 2025 SELARSDI is approved for all indications …