Amylyx reported that avexitide met the FDA-agreed primary endpoint in the 78-participant Phase III LUCIDITY trial for post-bariatric hypoglycemia following Roux-en-Y gastric bypass. Once-daily subcutaneous avexitide reduced the composite rate of Level 2 and…
AstraZeneca disclosed three divergent Phase III lung-cancer outcomes on the same day. In SAFFRON, osimertinib plus savolitinib met progression-free-survival and overall-survival endpoints versus platinum chemotherapy after osimertinib progression in biomarker-selected EGFR-mutant, MET-driven non-small cell…
The FDA granted accelerated approval to Bristol Myers Squibb’s iberdomide (Zenbexus), the company’s first approved CELMoD, in combination with daratumumab and hyaluronidase-fihj and dexamethasone, for multiple myeloma patients who have received at least one…
Shattuck Labs reported Phase 1 healthy-volunteer results for SL-325, a monoclonal antibody that blocks the TL1A receptor DR3. The company observed 3.7% anti-drug-antibody incidence and complete blockade of TL1A binding to DR3 for more…
Graviton BioScience said the FDA cleared an investigational new drug application for a capsule formulation of GV101, an oral selective ROCK2 inhibitor, enabling a planned randomized Phase II study in Friedreich’s ataxia. The study…
Sionna Therapeutics reported that adding the NBD1 stabilizer SION-719 to Trikafta for 14 days did not achieve the Phase IIa trial’s key activity endpoint. Mean placebo-adjusted sweat chloride change was −1.0 mmol/L with p=0.7….
AbCellera reported that a single 600 mg subcutaneous dose of ABCL635, an antibody antagonist of the neurokinin-3 receptor, met both Phase 2 primary endpoints in moderate-to-severe menopausal vasomotor symptoms. At week four, participants had…
Silence Therapeutics reported that divesiran met the randomized Phase 2 SANRECO primary endpoint in phlebotomy-dependent polycythemia vera (PV). Clinical response occurred in 88% of divesiran-treated patients versus 19% with placebo, with activity preserved at…
Tenax Therapeutics reported that the 241-patient Phase 3 LEVEL study of oral levosimendan, TNX-103, did not improve six-minute walk distance or the key Kansas City Cardiomyopathy Questionnaire symptom endpoint in pulmonary hypertension associated with…
FDA issued a Complete Response Letter for ITM’s 177Lu-edotreotide NDA in gastroenteropancreatic neuroendocrine tumors. ITM said the letter cited chemistry, manufacturing and controls and third-party commercial-facility inspection items, without identifying clinical, nonclinical, or safety…
