FDA & Clinical Trials
Solventum’s $725M Acera Bet Gets a New FDA Clearance
Solventum (NYSE: SOLV) has a new FDA clearance that ties its first major acquisition to its long-established negative pressure business. The company said Monday that the U.S. Food and Drug Administration granted 510(k) clearance for its Restrata synthetic wound matrix to be used together with its V.A.C. negative pressure wound therapy system. On paper, it’s…
Vanda’s VQW-765 Misses Primary Endpoint in Phase 3 Anxiety Trial
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced that its Phase 3 study of VQW-765 in adults with social anxiety disorder failed to meet its primary endpoint. The company has placed the development program on hold while it analyzes the complete dataset. The randomized, double-blind and placebo-controlled Study 3201 enrolled 546 adults between the ages of 18…
Edesa Receives FDA Clearance for Phase 2 EB06 Vitiligo Study
Edesa Biotech Inc. (Nasdaq: EDSA) has received U.S. Food and Drug Administration clearance for the Investigational New Drug application supporting its Phase 2 study of EB06 in moderate-to-severe nonsegmental vitiligo. The October 15 clearance allows the Toronto-based biotechnology company to expand the ongoing study into the United States. Patient recruitment is already underway in Canada,…
At-Home Lasix ONYU Adds Four Days Out of Hospital in Trial
Heart failure patients sent home early with a wearable diuretic pump spent about four more days alive and out of the hospital over the next month than patients who stayed in for standard IV treatment. That’s the main finding of SUBCUT HF II, a randomized U.K. trial now published in the Journal of the American…
Verastem Reports VS-7375 Cancer Data and Prices $250M Offering
Verastem Oncology (Nasdaq: VSTM) reported initial Phase 1/2 response data for VS-7375 across several KRAS G12D-mutated cancers and priced a $250 million underwritten offering to fund further clinical development. VS-7375 is an investigational oral drug designed to inhibit both the active and inactive states of KRAS G12D, a mutation found in pancreatic, colorectal, lung and…
Entrada Reports Early ENTR-601-45 Data in Duchenne Muscular Dystrophy
Entrada Therapeutics Inc. (Nasdaq: TRDA) reported initial Phase 1/2 results for ENTR-601-45, an investigational genetic medicine being developed for people with Duchenne muscular dystrophy who are amenable to exon 45 skipping. The October 14 results came from the first cohort of the ELEVATE-45-201 study. Eight ambulatory participants between four and 20 years old were randomized…
Tegoprazan Hits Phase 3 Heartburn Goals in Reflux Disease
Why It Matters Heartburn that never fully goes away is one of the most common complaints in gastroenterology. A newer kind of acid blocker just put its detailed Phase 3 numbers on the table. Braintree Laboratories, part of privately held Sebela Pharmaceuticals, said on October 11 that full results from its TRIUMpH-NERD trial of tegoprazan…
Sycume Shrinks Eye Bulging in Long-Standing Thyroid Eye Disease
Innovent Biologics (HKEX: 01801) says its thyroid eye disease drug works in a group of patients that doctors have rarely been able to treat with medicine at all. In a release dated October 8, 2026, the Suzhou-based company reported that a Phase 3 trial of Sycume (teprotumumab N01, research code IBI311) met its primary endpoint…
Cullinan Doses First Patient in Potentially Registrational AML Trial
Cullinan Therapeutics Inc. (Nasdaq: CGEM) has dosed the first patient in a potentially registrational Phase 2 study of CLN-049 for relapsed or refractory acute myeloid leukemia. The October 8 milestone moves the investigational T-cell engager into a study intended to determine whether its results could support a future regulatory application. The trial is enrolling patients…
Hemostemix Secures Bahamas Approval for VesCell Phase 1 Study
Hemostemix Inc. (TSXV: HEM; OTCQB: HMTXF; FSE: 2VF0) has received regulatory and ethics approval in The Bahamas for a commercial Phase 1 study of its investigational VesCell cell therapy. The company announced on October 7 that the National Longevity and Regenerative Therapy Board, known as the LARTA Board, granted full approval for the study. The…
