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Regulatory approvals – gene therapy enters mainstream
The FDA approved Regeneron’s Otarmeni (lunsotogene parvec), a gene therapy for a rare inherited form of hearing loss linked to otoferlin variants. The approval marks the first gene therapy cleared...
EU greenlights after US rejection – MS drug polarity shift
Europe’s regulator moved to approve Sanofi’s tolebrutinib for a subset of multiple sclerosis patients after the FDA previously issued a complete response letter. The EMA’s CHMP recommended...
Biopharma M&A – big-ticket neuro deal
UCB agreed to acquire Neurona Therapeutics in a transaction valued at up to $1.15 billion, adding epilepsy-focused assets to its neuroscience pipeline. The deal includes $650 million upfront with...
Oncology clinical signals – AACR readouts reshape early RAS/ADC strategies
At AACR 2026, early clinical data surfaced across both targeted therapy and antibody-drug conjugate programs, including new activity signals for RAS-directed approaches and CLDN6-targeting ADCs....
Cell therapy – new gene-edited/T-cell designs for solid tumors
Early first-in-human data at AACR 2026 pointed to a novel CAR T architecture designed to reduce chronic activation stress in solid tumors. Perelman School of Medicine investigators presented Phase...
AI in clinical decision-making – evidence lag meets real-world deployment
A Nature Medicine paper argued that health-care AI tools are being deployed rapidly without clear evidence that they improve patient outcomes. The analysis focused on how many AI systems...
Psychedelics – FDA voucher acceleration for mental health candidates
The FDA moved to speed its review of psychedelic-derived medicines by issuing priority vouchers tied to three mental health programs. The agency’s move includes a voucher for Compass Pathways’...
Biotech financings – Ray Therapeutics funds retinal gene therapy push
Ray Therapeutics closed a $125 million Series B to advance retinal gene therapy for retinitis pigmentosa. The company said the financing will fund late-stage clinical development and commercial...
Regulatory and reimbursement pathway – faster Medicare coverage for devices
The FDA and CMS launched the RAPID coverage pathway to align regulatory authorization and Medicare national coverage timing for breakthrough medical devices. Under the program, CMS will issue a...
Venture and ecosystem – Kurma Partners targets disruptive therapeutics with €215M fund
Kurma Partners closed a €215 million fund, its fourth and largest, aimed at backing disruptive therapeutic solutions. The venture firm said the vehicle will support a mix of platform and...
Regulators – MS therapy approvals split across US and EU
Sanofi’s tolebrutinib (Cenrifki) avoided a repeat of its US rejection as the EMA’s CHMP recommended approval for patients with non-relapsing secondary progressive multiple sclerosis. The CHMP...
C-suite and execution – Inventiva reshuffles leadership ahead of MASH readout
Inventiva overhauled senior leadership as it heads toward a late-stage decision point for lanifibranor in metabolic dysfunction-associated steatohepatitis (MASH). The French biotech named...
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...