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Press releases published on May 5, 2025
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
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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 …
Ichnos Glenmark Innovation (IGI) Receives U.S. FDA Fast Track Designation for ISB 2001 for Relapsed/Refractory Multiple Myeloma
GlobeNewswire
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May 5, 2025
NEW YORK, May 05, 2025 (GLOBE NEWSWIRE) -- IGI, Inc., a global, fully integrated clinical-stage biotechnology company focused on developing multispecifics™ in oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track …
Microbix’s Clot-Buster Drug Project Advances
GlobeNewswire
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May 5, 2025
MISSISSAUGA, Ontario, May 05, 2025 (GLOBE NEWSWIRE) -- Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, announces that its funding and commercialization partner, Sequel Pharma, LLC (“ …
IRADIMED CORPORATION Announces First Quarter 2025 Financial Results
GlobeNewswire
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May 5, 2025
Announces Regular Quarterly Cash Dividend of $0.17 Per Share Reaffirms Full Year 2025 Revenue and Earnings Guidance Reports record revenue of $19.5 million for the first quarter of 2025, an increase of $1.9 million or 11%, compared to the same period in …
Aquestive Therapeutics to Participate in Citizens Life Sciences Conference
GlobeNewswire
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May 5, 2025
WARREN, N.J., May 05, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and …
Aptose Provides Clinical Update for the Tuspetinib-based Triple Drug Frontline Therapy in Newly Diagnosed AML Patients from the Phase 1/2 TUSCANY Trial
GlobeNewswire
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May 5, 2025
Aptose is developing TUS+VEN+AZA as a one-of-a-kind safe and mutation agnostic frontline triple drug therapy for newly diagnosed AML patients First two dose cohorts of TUS+VEN+AZA triplet demonstrate safety, complete remissions, and MRD negativity across …