- Expected to enroll approximately 4,600 participants with obesity or overweight across two pivotal trials (AURORA-1 and AURORA-2) in the U.S., Europe, and Canada. - Global Phase III clinical program to investigate efficacy and safety of three maintenance doses (20 mg, 40 mg, and 60 mg) over 72 weeks in participants with obesity or overweight without type 2 diabetes (AURORA-1) and with type 2 diabetes (AURORA-2). - Topline data from the AURORA Phase III clinical program are expected in the thir

Sept. 1, 2026 -- Pyrotech Therapeutics ("Pyrotech" or the "Company"), a clinical-stage biopharmaceutical company pioneering innate immune modulation and pyroptosis-targeted therapies, announced that the first healthy volunteer has been dosed in the Phase 1 clinical study of PTT-121, its novel gasdermin D (GSDMD) inhibitor. This marks a pivotal milestone for PTT-121 as the world's first selective GSDMD inhibitor to advance into human clinical testing, breaking the previous characterization of GSD

New single-arm, open-label data extend the body of evidence supporting consistent clinical benefit and safety with Camzyos, adding to the longest-running clinical development experience for a cardiac myosin inhibitor (CMI) in symptomatic oHCM Additional presentations at ESC Congress build upon the established effectiveness and safety pro Camzyos in real-world settings Bristol Myers Squibb (NYSE: BMY) today presented results from the EXPLORER-LTE cohort of the MAVA-LTE study (NCT03723655) in a l

Phase 2 GenePHIT trial successfully randomized and completed enrollment of one of the largest gene therapy trials conducted in heart failure to date, with more than 170 participants randomized across 64 sites in 12 countries1 Baseline characteristics demonstrate successful enrollment of a well-characterized population of patients with non-ischemic heart failure with reduced ejection fraction (HFrEF) Initial efficacy and safety outcomes from GenePHIT are expected in the first half of 2027 AskBio

- Plozasiran reduced triglycerides (TG) by 79% and 81% versus placebo in SHASTA-3 and SHASTA-4 across the broad sHTG population - - More than 90% of plozasiran-treated patients achieved triglycerides below thresholds for AP risk, 500 mg/dL at Month 12, and more than half achieved triglycerides below 150 mg/dL - - Plozasiran reduced cumulative acute pancreatitis (AP) events by 78% versus placebo in patients with TG above 500 mg/dL, with or without a prior history of AP - - Greater absolute benefi

-Data presented in a late-breaking presentation at the European Society of Cardiology (ESC) Congress 2026- -Phase 1a clinical data for CTX310® continued to demonstrate robust, dose-dependent reductions in circulating ANGPTL3 with a mean reduction from baseline of 79% (maximum 89%), a mean reduction in triglycerides (TG) of 48% (maximum 78%), and a mean reduction of low-density lipoprotein (LDL) of 53% (maximum 84%) at the highest dose- -CTX310 was well tolerated with no treatment-related serious

These are heady days for PharmaEssentia, a biotech that got its start 23 years ago in Taiwan, went public 10 years later and now is deepening the foothold of its first commercial product Besremi. “There’s a lot of electricity in the air in the organization right now,” Samuel Lin, PharmaEssentia’s Head of U.S. Global Operations, said in an interview with Fierce. “Sometimes you have to stop and pinch yourself a little bit.” The excitement ramped up on Monday as the FDA signed off on a key label

MIMRYLO™ is the First and Only Hepcidin Mimetic Peptide Therapy Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera, Offering a Novel Mechanism to Maintain Hematocrit Control, Meaningfully Reduce Phlebotomy Burden, and Improve Fatigue Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Response During Weeks 20-32 FDA Approval Triggers $275M in Milestones, 14%-29% Royalties, with Up to an Additional $875M in Potential Future Milestones Investo

MIMRYLO, a First-in-Class Medicine with a Unique Mechanism of Action, is Approved for the Treatment of Erythrocytosis in Adults with Polycythemia Vera (PV) MIMRYLO Has Been Shown to Maintain Hematocrit Control, the Primary Treatment Goal in PV, as Well as Reduce Phlebotomy Burden and Improve Fatigue Approval Supported by Phase 3 VERIFY Results Showing 76.9% of Patients Achieved Clinical Response During Weeks 20-32 Takeda (TSE:4502/NYSE:TAK) announced U.S. Food and Drug Administration (FDA) appr

Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today announced the peer-reviewed publication of mature Phase 1b results from the fully enrolled C-800-01 cohort evaluating botensilimab (BOT), a multifunctional Fc-enhanced anti–CTLA-4 antibody, plus balstilimab (BAL), an anti–PD-1 antibody, in 123 heavily pre-treated patients with microsatellite-stable (MSS) metastatic colorectal cancer (mCRC) without active liver metastases. The manuscript, titled "Extended Follow-Up of Bote