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…
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…
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….
China’s NMPA accepted Alebund Pharmaceuticals’ new drug application for AP301, a non-absorbed fiber-iron phosphate binder for hyperphosphatemia in maintenance-dialysis patients with chronic kidney disease. The filing is supported primarily by the 474-patient, 52-week RESPOND-1…
Scholar Rock will remove Catalent Indiana from the apitegromab biologics license application after FDA classified the site’s April inspection as Official Action Indicated. FDA review is proceeding with a second U.S. fill-finish facility, and…
The FDA approved Takeda’s Orzeyful (oveporexton), an oral orexin receptor 2 (OX2R)-selective agonist, for narcolepsy type 1 in adults. Takeda and multiple independent outlets describe it as the first medicine approved to address the…
The FDA approved Moderna’s mFLUSIVA (mRNA-1010), the first mRNA-based seasonal influenza vaccine authorized in the United States, for adults age 50 and older. The approval is split into two tiers: full approval for adults…
