Regeneron Pharmaceuticals on Thursday reported upbeat results from a Phase II study of the natriuretic peptide receptor 1 (NPR1)-blocking antibody baloncibart (REGN7544) in adults with postural orthostatic tachycardia syndrome (POTS), showing a notable reduction in the exaggerated heart rate response to standing with a single dose. The company plans to advance the therapy into late-stage testing next year. The PINNACLE trial randomly assigned 82 patients to a single subcutaneous dose of baloncib

Nine-month NHP durability and favorable GLP toxicology pro first-in-human phase 1/2 trial in 2027 Mammoth Biosciences, Inc., a biotechnology company harnessing its proprietary next-generation in vivo CRISPR gene editing platform to create potential one-time curative therapies, recently presented new preclinical data on its lead developmental candidate, MB-111, at the American Heart Association Scientific Sessions, held November 6–9 in Chicago. MB-111 is a potential first-in-class, single-dose

Addex Therapeutics’ neuropsychiatric-focused spinout has raised $105 million in series B funds to bankroll a planned phase 2 study of its schizophrenia treatment. Switzerland-based Addex originally launched Neurosterix in April 2024, armed with a $65 million series A led by funds affiliated with life sciences investment firm Perceptive Advisors. Neurosterix is helmed by CEO Fred Callori, who is also a managing director at Perceptive. In a Wednesday release, Addex didn’t identify the investors in

Following an earlier bacterial vaccine development collaboration, AstraZeneca has acquired partner Omniose for an undisclosed amount, with the biotech becoming a wholly-owned subsidiary of the UK drugmaker's infectious disease unit. "Omniose's bioconjugation platform represents a differentiated approach to engineering conjugate vaccines and strengthens our ability to develop novel vaccines against serious bacterial infections," said Benjamin Moutier, AstraZeneca's SVP of infectious disease. The

Hangzhou Eli Radiopharma concluded a series A round, raising nearly RMB 400 million ($60 million), to propel its oncology- and neurology-directed radiopharmaceutical assets into clinical development. "Moving our pipeline toward the clinic is a critical next step in translating our research into meaningful advances for patients," said Eli Radiopharma CEO and founder Feng Yu. "We remain focused on addressing unmet clinical needs and strengthening our R&D and clinical development capabilities." The

The proceeds will also fund the expansion of the company’s neurodegeneration programmes. Credit: H_Ko/Shutterstock.com. Delix Therapeutics has secured $100m in an oversubscribed Series C financing round to fund the development of zalsupindole (DLX001), an orally bioavailable neuroplastogen. The company will advance zalsupindole into Phase II development and finance a broader pipeline expansion. The drug is being designed to treat psychiatric and psychological disorders. In animal models, single

RMAT designation provides early and frequent FDA engagement to support planned pivotal development of Senza5 CART5 Therapy may be eligible for priority review and accelerated approval if applicable criteria are met Orphan Drug Designation, granted in July 2026, provides development incentives to support Senza5 CART5 in T-cell lymphoma Nov. 10, 2026 -- Vittoria Biotherapeutics, Inc. (“Vittoria” or the “Company”), a clinical-stage immunotherapy company developing engineered T-cell therapies, tod

The FDA has approved Merck KGaA's oral CSF-1R inhibitor Pimjetmi (pimicotinib) for adults with symptomatic tenosynovial giant cell tumour (TGCT) for whom surgical removal could cause worsening functional limitations or severe morbidity. The decision gives the German drugmaker another major market for the treatment, following approvals in China, Canada and Switzerland. TGCT is a rare, usually benign tumour arising from the synovium of joints, tendon sheaths and bursae. While it doesn't typically

Trial designed to improve outcomes through Signatera™-guided Treatment on MRD (TOMR), identifying high-risk patients for curative-intent treatment Natera, Inc. (Nasdaq:NTRA), a global leader in cell-free DNA and precision medicine, today announced that it has entered into a clinical collaboration agreement with Incyte (Nasdaq:INCY) for a new phase II study in colorectal cancer (CRC). The trial will evaluate INCA33890, Incyte’s investigational bispecific immunotherapy, in patients with stage 2/

Breakthrough Therapy designation granted based on FDA’s review of safety and efficacy data from the chronic cohort of the Phase 1b/2a CONNECT SCI study Phase 3 RESTORE registrational study enrolling participants, with site activation continuing in the United States and Canada Nov. 12, 2026 -- NervGen (NASDAQ: NGEN), a late-stage clinical biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic condition