-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

AusperBio Therapeutics has raised $120 million in series C funds to advance its oligonucleotide therapy for chronic hepatitis B through phase 3 testing and hopefully on to commercialization. The Bay Area biotech's lead candidate, dubbed AHB-137, is an unconjugated antisense oligonucleotide (ASO) designed to suppress production of viral hepatitis B protein, inhibit viral DNA replication and promote immune reactivation. The therapy is currently undergoing a late-stage study in China. The series

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

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") announced that the Biomedical Advanced Research and Development Authority (BARDA) has exercised a $36.9 million procurement option, under Project BioShield funding, from its April 2026 contract with Shionogi Inc., a New Jersey-based subsidiary of Shionogi, to procure Fetroja® (cefiderocol) as a critical countermeasure against difficult-to-treat Gram-negative bacterial infections

First patient safely dosed in Phase 1 KOALA trial evaluating KMCAR™ T-cell therapy in patients with relapsed/refractory kappa-restricted multiple myeloma Patient was monitored after initial dose to assess response and side-effects, with the treatment seen as well tolerated, and second patient to be treated imminently The study is the first in-human trial for the novel KMCAR™ T-cell immunotherapy, which targets the Kappa Myeloma Antigen (KMA), a tumour-specific receptor found only on malignant pl

Summit Therapeutics and Akeso said Wednesday their bispecific PD-1/VEGF antibody ivonescimab (SMT112/AK112) scored yet another Chinese Phase III win, this time demonstrating an overall survival (OS) benefit in front-line advanced biliary tract cancer (BTC) — its first pivotal success beyond four positive non–small-cell lung cancer (NSCLC) readouts. "The breakthrough clinical value of ivonescimab is now expanding from lung cancer to a broader range of solid tumours," said Akeso CEO Michelle Xia.

The FDA has approved Takeda’s Mimrylo (rusfertide) for polycythemia vera, introducing a new mechanism of action to the nonmalignant rare blood cancer and handing CEO Julie Kim another major regulatory win since taking the helm. A form of myeloproliferative neoplasm, polycythemia vera (PV) causes the bone marrow to make too many red blood cells, which can result in life-threatening cardiovascular events, such as stroke and heart attack. Mimrylo offers a new approach to curtailing the overproduc