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

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

Collaboration leverages DualityBio's proprietary DUPAC payload platform and early global clinical development capabilities, with Genentech assuming further clinical development and global commercialization DUPAC, one of the DualityBio's four proprietary ADC technology platforms, comprises multiple payloads with novel mechanism of action designed to address resistance to the payload classes underlying currently approved ADCs DualityBio to receive a US$45 million upfront payment, more than US$1

Designation supports the global development of RTX-117 and may provide potential future access to a transferable Priority Review Voucher, subject to approval and applicable requirements Aug. 26, 2026 -- ReviR Therapeutics, a clinical-stage biotechnology company advancing small-molecule therapies through the integration of artificial intelligence and RNA biology, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to RTX-117, the

NBI-1117567 is an investigational oral, muscarinic M1 preferring (M1/M4) selective agonist discovered by Nxera and advancing through clinical development under a multi-program collaboration with Neurocrine Nxera to receive a US$10 million milestone payment upon IND Acceptance, as part of the overall milestone package Nxera retains development and commercialization rights to the M1 receptor agonist for all indications in Japan 26 August 2026 – Nxera Pharma Co., Ltd. (“Nxera” or “the Company”; TS