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Biomea Fusion Announces First Patient Dosed in Phase I Study of BMF-650 a Next-Generation Oral GLP-1 Receptor Agonist
Globenewswire· 2025-10-27 12:00
SAN CARLOS, Calif., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. (“Biomea,” “Biomea Fusion” or the “Company”) (Nasdaq: BMEA), a clinical-stage diabetes and obesity medicines company, today announced that the first patient has been dosed in a Phase I clinical trial of BMF-650, the Company’s investigational, next-generation oral small molecule glucagon-like peptide-1 (“GLP-1”) receptor agonist (“RA”). BMF-650 is an orally administered, next-generation small molecule GLP-1 RA being developed by Biomea ...
Amarin Issues Statement Supporting FDA’s Action to Revise Labeling for Fenofibrate Drugs Reinforcing a Lack of Cardiovascular Benefit
Globenewswire· 2025-10-27 12:00
DUBLIN and BRIDGEWATER, N.J., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a company committed to advancing the science of cardiovascular care worldwide, today issued the following statement in response to the recent action taken by the U.S. Food and Drug Administration (FDA) to update the labeling for fenofibrate drugs in association with cardiovascular care: We applaud the FDA’s decision to revise the labeling of fenofibrates (fibrates). The updated labeling now includes a clear ...
AlphaTON (Nasdaq:ATON) and Cyncado Therapeutics: Preclinical Mesothelioma Data Show Direct A2B Tumor Activity; TT-4 Achieved >90% Tumor Growth Inhibition; First-Patient Dosing on Track for Q1 2026
Globenewswire· 2025-10-27 12:00
Post-conference recap highlights direct anti-tumor effects in epithelial and non-epithelioid mesothelioma models, >90% tumor growth inhibition in vivo when TT-4 was combined with anti-PD-1, and superior monotherapy activity versus anti-PD-1 alone, reduced tumor PD-L1 correlated with decreased pCREBDover, DE, Oct. 27, 2025 (GLOBE NEWSWIRE) -- AlphaTON Capital Corp (Nasdaq: ATON) and its wholly owned oncology-focused subsidiary Tarus Therapeutics, LLC, operating as Cyncado Therapeutics (Cyncado), today issued ...
Amneal Launches Brekiya® – the First and Only DHE Autoinjector for Adults with Migraine With or Without Aura and Cluster Headaches
Globenewswire· 2025-10-27 12:00
Brekiya® autoinjector, a new specialty therapy from Amneal, is now available for prescription exclusively through Walgreens Specialty Pharmacy and Sterling Specialty Pharmacy BRIDGEWATER, N.J., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the U.S. commercial launch of Brekiya® (dihydroergotamine mesylate) injection, the first and only ready-to-use dihydroergotamine (DHE) autoinjector approved for the acute treatment of migraine wit ...
Artelo Biosciences Names Veteran Life Sciences Executive Mark Spring, CPA, as Chief Financial Officer
Globenewswire· 2025-10-27 12:00
SOLANA BEACH, Calif., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, dermatological, or neurological conditions, today announced the appointment of Mark Spring, CPA, as Chief Financial Officer, effective November 1, 2025. Mr. Spring had been serving as a financial consultant to the Company since December 2024. The appointment strengthen ...
Revolution Medicines’ RAS(ON) Multi-Selective Inhibitor Daraxonrasib Granted U.S. FDA Orphan Drug Designation in Pancreatic Cancer
Globenewswire· 2025-10-27 12:00
REDWOOD CITY, Calif., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to daraxonrasib, the company’s RAS(ON) multi-selective inhibitor, for the treatment of pancreatic cancer. “We are gratified the FDA has granted Orphan Drug Designation to daraxonrasib for the treatment o ...
Icotrokinra maintains standout combination of therapeutic benefit and a favorable safety profile in once-daily pill through 28 weeks in ulcerative colitis
Prnewswire· 2025-10-27 11:30
Accessibility StatementSkip Navigation Building on 12-week findings, icotrokinra demonstrated clinically meaningful outcomes at Week 28 with 31.7% of patients achieving clinical remission and 38.1% showing endoscopic improvement versus placebo in the Phase 2b ANTHEM-UC study Results support Phase 3 clinical development of icotrokinra, a first-in-class targeted oral peptide that precisely blocks the IL-23 receptor, in both moderately to severely active ulcerative colitis and Crohn's disease PHOENIX, Oct. 27, ...
TREMFYA® (guselkumab), the first and only IL-23 inhibitor with a fully subcutaneous treatment regimen, demonstrates durable remission in Crohn's disease at two years
Prnewswire· 2025-10-27 11:30
Accessibility StatementSkip Navigation Clinical remission rates were over 85% for both TREMFYA maintenance doses at 96 weeks in both the Phase 3 GRAVITI and GALAXI studies At Week 96 (as observed)*:    TREMFYA 100 mg q8w TREMFYA 200 mg q4w | Clinical remission | | | | --- | --- | --- | | | 92.0% | 93.4% | | GRAVITI | 86.7% | 87.1% | | GALAXI 2, 3 (pooled) | | | | Endoscopic response | 65.0% | 65.1% | | GRAVITI | 73.6% | 70.7% | | GALAXI 2, 3 (pooled) | | | | Endoscopic remission | 41.5% | 46.0% | | GR ...
Nutriband Co-Founder Gareth Sheridan Returns as CEO
Globenewswire· 2025-10-27 11:00
ORLANDO, Fla., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW) has announced that Company founder, Gareth Sheridan has returned as Company CEO. During the period of August 10 until October 27 , Co-Founder and Chairman, Serguei Melnik had taken over the responsibilities of CEO. Mr Sheridan has returned to the position of CEO effective immediately and will guide the company through the final 2025 framework towards the target NDA filing in 2026 for AVERSA Fentanyl. AVERSA FENTANYL ...
Aquestive Therapeutics to Report Third Quarter 2025 Financial Results and Recent Business Highlights on November 5 and Host Conference Call on November 6 at 8:00 a.m. ET
Globenewswire· 2025-10-27 11:00
WARREN, N.J., Oct. 27, 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 delivery technologies, today announced that it will report results for the third quarter ended September 30, 2025 and provide an update on recent developments in its business after market close on Wednesday, November 5, 2025. Management will host a conference c ...