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Gene therapy – First-in-class hearing loss approval with voucher economics
Regeneron won FDA approval for Otarmeni (lunsotogene parvec), an AAV-mediated gene therapy for a rare inherited form of hearing loss caused by otoferlin variants. The decision makes the therapy...
Clinical/regulatory – Aneurysmal SAH program hits CRL despite prior trial support
Grace Therapeutics received a US FDA complete response letter for its GTx-104 NDA for aneurysmal subarachnoid hemorrhage, delaying the company’s push to update the standard of care. The FDA cited...
Cell therapy licensing – UCB buys Neurona as neurology dealmaking stays hot
UCB agreed to acquire Neurona Therapeutics for up to $1.15 billion, with $650 million paid upfront and the remainder tied to milestones. The deal targets epilepsy through Neurona’s lead asset...
Oncology diagnostics – Myriad plans broader precise MRD deployment after AACR readouts
Myriad Genetics signaled a broadened rollout of its precise MRD strategy in breast cancer following AACR readouts. The company is exploring wider adoption of its ultrasensitive ctDNA testing to...
Biotech financing – Ray Therapeutics closes Series B for retinal gene therapy
Ray Therapeutics raised $125 million in a Series B financing to advance retinal gene therapy programs, including its lead optogenetic asset RTx-015 for retinitis pigmentosa. The funding is set to...
Trial/AI diagnostics – Mechanosensing platform predicts breast cancer susceptibility
City of Hope and UC Berkeley disclosed an AI-enabled, microfluidic mechanosensing platform designed to stratify breast cancer risk at the single-cell level. In eBioMedicine, the team reported that...
Capital markets – Lucid Diagnostics prices $18M stock offering
Lucid Diagnostics priced an underwritten registered direct offering of 18 million shares at $1.00 per share, raising expected gross proceeds of $18 million. The financing is anchored by a $15...
Investment/VC – Kurma Partners closes €215M fund for therapeutic bets
Kurma Partners closed a €215 million fund, its fourth and largest, targeting investments in “disruptive therapeutic solutions.” The venture capital firm framed the new vehicle around expanding its...
EU approvals after FDA setback
Europe’s regulators moved forward on Sanofi’s multiple sclerosis program after the U.S. FDA rejected the company’s BTK inhibitor strategy. The EMA’s CHMP recommended approval for Cenrifki...
Phase III readout countdown and leadership refresh
Inventiva accelerated boardroom change and signaled continuity as it targets a Phase III readout for lanifibranor in MASH. The French biotech named new executives across finance, legal, and people...
FDA approval via national priority vouchers
Regeneron won the first FDA approval under the agency’s national priority voucher framework with Otarmeni, an AAV-mediated gene therapy for a rare inherited hearing loss. The therapy is cleared...
Revenue and label momentum for multiple sclerosis economics
Sanofi’s Dupixent partner Regeneron secured U.S. clearance for a pediatric chronic spontaneous urticaria label expansion, while Sanofi’s broader financial picture remained supported by earnings...
Cancer cell therapy M&A escalates in 2026
UCB moved quickly into epilepsy-focused cell therapy dealmaking by acquiring Neurona Therapeutics for up to $1.15 billion. The Belgian pharma’s purchase adds Neurona’s NRTX-1001, an epilepsy lead...
CAR-T and next-gen cell therapy enters wider solid tumor targeting
A new CAR-T design aimed at avoiding continuous activation showed early signals against multiple solid tumor types. Researchers at the University of Pennsylvania presented first-in-human Phase I...
C-suite, corporate actions, and product pipeline risk: CRL hits GTx-104
Grace Therapeutics faced a regulatory setback for its aneurysmal subarachnoid hemorrhage program despite earlier positive trial results. The FDA issued a complete response letter (CRL) for the...
Capital markets: Inventors and startups pursue new funding routes
Ray Therapeutics raised new growth capital to push a retinal gene therapy into later-stage clinical development. The company closed a $125 million Series B financing to support late-stage trials...
Foundational imaging and AI tooling for diagnosis
Researchers at City of Hope and UC Berkeley reported a microfluidic AI platform that ties mechanical properties of single breast epithelial cells to cancer susceptibility. The mechano-node-pore...
Biopharma policy and regulatory disclosure pressure
An unnamed pharma company asked regulators to change how the FDA publicly discloses complete response letters. The citizen petition targets the FDA’s July 2025 policy to release CRLs, arguing the...
FDA gene therapy approval (hearing loss) under National Priority Voucher program
The FDA approved Regeneron’s Otarmeni (lunsotogene parvec), the first gene therapy cleared under the agency’s National Priority Voucher program. The treatment is authorized for hearing loss due to...
EU regulatory greenlight after U.S. FDA rejection: Sanofi’s tolebrutinib (nrSPMS)
Sanofi’s tolebrutinib (branded Cenrifki) cleared another step for multiple sclerosis in Europe after the FDA had issued a complete response letter in the U.S. for treatment of non-relapsing...