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Multiple myeloma accelerated approval
Bristol Myers Squibb’s next multiple myeloma pill iberdomide—marketed as Zenbexus—won FDA accelerated approval for patients whose disease has returned or progressed after treatment. The agency’s...
Cancer drug pricing and cost-effectiveness review
AstraZeneca’s newly approved hypertension drug Baxfendy failed an effectiveness-versus-price cost-effectiveness screen from the Institute for Clinical and Economic Review (ICER). In a draft...
AI to reduce clinical trial monitoring costs
Tufts Center for the Study of Drug Development (CSDD) released an analysis suggesting an agentic AI clinical monitoring system can materially improve oncology trial economics. The report modeled...
FDA device pathway for blood-based lung cancer screening
Freenome won FDA breakthrough device designation for its blood-based SimpleScreen lung cancer screening assay. The designation applies to adults ages 50 to 80 with at least a 20 pack-year smoking...
Gene therapy bankruptcy auction and asset transfer
PTC Therapeutics won a bankruptcy auction bid of $211 million for a Sangamo gene therapy program targeting Fabry disease. The deal centers on ST-920, a one-time AAV gene therapy that is described...
CAR-T company transitions and profitability milestone
Legend Biotech reported its first profitable quarter, with adjusted net income of $63 million in the second quarter, driven by demand for Carvykti. The company also detailed a leadership shift:...
AI-driven biotech capital raise for menopause antibody
AbCellera launched an underwritten public offering aimed at raising about $200 million to advance its menopause antibody program. The company’s plan includes common shares and pre-funded warrants,...
Oncology trial set-back and pipeline reprioritization
PDS Biotechnology halted work on a phase 3 head and neck cancer therapy and redirected resources toward a colorectal contender in phase 2 development for metastatic disease. The decision...
New rare disease therapy enters phase III with large Series B
Vaderis Therapeutics closed an oversubscribed Series B financing of $152 million and launched HEROIC, a global phase III trial for hereditary hemorrhagic telangiectasia (HHT). The company is...
FDA approved oral contraception alternative in device/diagnostics stream
Geneseeq received China’s NMPA approval for its NTRK fusion detection kit, PanTRKare, as a companion diagnostic for Vcare PharmaTech’s TRK inhibitor Velmarto. The sequencing-based assay is...
Lung cancer – Phase 3 readout for exon 20 EGFR inhibitor sets up major FDA race
Taiho Oncology and Cullinan Therapeutics said zipalertinib has cleared a registrational Phase 3 endpoint in frontline EGFR exon 20 insertion lung cancer, using an early data check to halt...
Neurodegeneration – CAR-T regimens move toward α-synuclein targeting in Parkinson’s
A preclinical study reported a first CAR-Treg concept aimed at a pathogenic form of α-synuclein in Parkinson’s disease. In two mouse models, engineered regulatory T cells recognizing α-synuclein...
Genie therapy – Sangamo Fabry assets auction accelerates PTC and Lilly entry
PTC Therapeutics and Eli Lilly are preparing to buy pieces of Sangamo Therapeutics’ Fabry disease gene therapy business via a bankruptcy auction, with Deal terms reported as up to $264 million for...
Oncology – Intranasal NEO100 shows Phase 2a endpoint hit in IDH1-mutant glioma
NeOnc Technologies reported Phase 2a results for intranasal NEO100 in recurrent IDH1-mutant high-grade glioma, saying the study met its primary endpoint for six-month progression-free survival....
Rare disease antibodies – AbCellera raises $200M to fund ABCL635 and ABCL365 programs
AbCellera Biologics launched an underwritten public offering aimed at raising $200 million through a mix of common shares and pre-funded warrants. The financing is designed to fund continued...
Regulatory devices – FDA grants Breakthrough Device designation to Freenome’s SimpleScreen lung test
Freenome said the FDA has issued Breakthrough Device designation for its blood-based SimpleScreen lung cancer screening assay. The designation applies to adults ages 50 to 80 with at least a 20...
Capital markets – Epicrispr secures $90M Series C to advance gene-silencing therapy into pivotal trials
Epicrispr Biotechnologies announced an oversubscribed $90 million Series C round to advance EPI-321, its lead epigenetic gene-silencing therapy for facioscapulohumeral muscular dystrophy. The...
Biotech funding and innovation – Khartis Therapeutics emerges with $95M for oral TED IGF-1R inhibitor
Khartis Therapeutics officially emerged from stealth with a $50 million Series B that brought its total funding to $95 million, led by Forge Life Science Partners with Longwood Fund and Lilly Asia...
Clinical pipeline and drug safety – Neurocrine’s Vykat XR faces expert concerns tied to reported deaths and severe events
Experts in Prader-Willi syndrome have issued safety alerts for Neurocrine Biosciences’ Vykat XR, citing deaths and severe adverse events reported to the FDA’s adverse event monitoring systems. The...
Molecular glue and gene editing finance – Sangamo bankruptcy auction also brings Lilly purchase of technology stake
Sangamo’s bankruptcy proceedings are driving deal-making across the Fabry space, with PTC’s winning bid for the program and Eli Lilly receiving a technology purchase for $50 million. The reported...