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Regulatory setback for Grace Therapeutics’ GTx-104 NDA
Grace Therapeutics said the FDA issued a complete response letter (CRL) for its GTx-104 NDA for aneurysmal subarachnoid hemorrhage, delaying the company’s efforts to update the standard of care....
Sanofi MS turnaround and opposition to FDA clearance
In parallel coverage of Sanofi’s MS regulatory pathway, reporting emphasized that tolebrutinib’s U.S. rejection contrasted with Europe’s momentum. After the FDA returned a complete response...
Securing large financing: Ray Therapeutics’ retinal gene therapy Series B
Ray Therapeutics closed a $125 million Series B financing to advance RTx-015, its optogenetic retinal gene therapy in patients with retinitis pigmentosa. The company said the round funds...
Biomedical VC and growth capital: Kurma closes €215M fund
Kurma Partners announced it has closed its fourth and largest venture fund, raising €215 million, aimed at backing disruptive therapeutic solutions. The fund’s size and track record were...
Oncology diagnostics: Myriad expands MRD approach after AACR readouts
Myriad Genetics is planning a broader Precise MRD launch in breast cancer following AACR readouts. The company’s focus is an ultrasensitive circulating tumor DNA test intended to quantify risk of...
AI-driven clinical trial design: synthetic control arms spotlighted
A Qureight-anchored innovation spotlight highlighted how synthetic control arms—external-data-generated comparators—are being used to reduce dependence on placebo groups. The approach uses...
Cell biology platform: plasma proteomics for Parkinson’s disease classification
Researchers presented a plasma proteomics approach designed to classify Parkinson’s disease using molecular signatures derived from blood. The work, attributed to Minster and Jafri and published...
New FDA approval and generics: regional radiopharma shifts
Novartis’ Pluvicto radioligand therapy faces an EU setback risk after the company withdrew an application to expand the label into earlier prostate cancer treatment, despite having U.S. and UK...
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...