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Large-cap acquisitions to expand oncology portfolios
GSK agreed to acquire Nuvalent for $10.6 billion, adding near-commercial and clinical-stage targeted programs for NSCLC. The deal brings zidesamtinib (NVL-520) and eladalkib (NVL-655), both...
Gene therapy in the clinic: early safety signals for XLRS
A Chinese research team reported safety and feasibility of a subretinal AAV8 gene therapy delivering a codon-optimized RS1 transgene for pediatric X-linked retinoschisis (XLRS), with results...
Non-viral gene delivery funding and trial push
SonoThera raised $125 million to advance its ultrasound-based, microbubble-mediated non-viral gene delivery platform into clinical development. The financing is intended to propel lead programs in...
Diagnostics and regulatory expansion in molecular testing
OraSure Technologies received FDA 510(k) clearance for an at-home urine sample collection kit for sexually transmitted infection (STI) testing on Roche systems. The Colli-Pee kit supports...
Biotech IPO momentum: new public listings and record-setting deals
Kardigan filed for a Nasdaq IPO targeting net proceeds around $320 million, as the cardio-focused company prepares Phase 2b/3 and Phase 2 studies across genetic dilated cardiomyopathy and calcific...
Hearing loss program reshuffling at Sensorion
Sensorion ended development of its OTOF-related hearing loss gene therapy program, citing a strategic review that found the development environment had “notably changed.” The decision follows...
HIV long-acting oral regimen clears key Phase 3 milestones
Merck and Gilead reported that a combination of Merck’s islatravir and Gilead’s lenacapavir met primary efficacy endpoints in two Phase 3 trials evaluating a weekly oral HIV regimen for people who...
Molecular glue deals expand: Alzecure and Orionis double down with Lilly and Novartis
Lilly agreed to receive $10 million upfront plus milestones and royalties in a licensing and collaboration deal with AlzeCure for gamma-secretase modulator ACD680, bringing Lilly deeper into...
Manufacturing and quality systems: EU GMP changes drive process integrity testing
A new industry analysis highlights how revised EU manufacturing guidelines are pushing drug developers toward stronger in-process assurance for sterile filtration. The focus is on PUPSIT (pre-use...
GSK acquisition expands late-stage lung cancer portfolio
GSK agreed to acquire Nuvalent for $10.6 billion, adding two near-commercial non-small cell lung cancer (NSCLC) programs to its pipeline and positioning the company for potential approvals later...
Massive biotech IPO delivers IPO-era momentum for oncology
Parabilis Medicines priced a $670 million upsized initial public offering on Nasdaq, extending what has become a steady run of large biopharma debuts in 2026. The company offered 3.5 million...
Guardant Health wins FDA nod for HER2 liquid biopsy companion diagnostic
Guardant Health announced FDA approval of its Guardant360 CDx assay as a companion diagnostic for Boehringer Ingelheim’s Hernexeos (zongertinib) in adults with HER2-mutant advanced NSCLC. The...
Takeda’s oral TYK2 inhibitor scores another head-to-head psoriasis win
Takeda reported that zasocitinib, its oral TYK2 inhibitor for plaque psoriasis, beat Bristol Myers Squibb’s Sotyktu in a head-to-head Phase 3 study. The company said zasocitinib induced complete...
SonoThera raises for ultrasound-aided non-viral gene delivery to clinic
SonoThera raised $125 million to push its ultrasound-based, non-viral gene delivery platform into clinical development. The funding follows the company’s focus on two lead programs—Duchenne...
AI tools enter cardiovascular and neuroscience pipelines through new biotech spending and cloud adoption
Sofinnova Partners partnered with Amazon Web Services to deliver an AI platform (“Sofia”) to life science investors’ portfolio companies, adding “founder-facing” tools for competitive analysis,...
Caribou shows off-the-shelf CAR-T efficacy versus autologous in lymphoma
Caribou Biosciences reported median progression-free survival of 17.1 months for its off-the-shelf CAR-T cell therapy candidate, adding evidence that the “universal” approach can match efficacy...
Sanofi halts Phase 3 CIDP trial after interim futility reads
Sanofi stopped its Phase 3 MOBILIZE trial of riliprubart in chronic inflammatory demyelinating polyneuropathy (CIDP) after an independent monitoring board concluded the study was unlikely to...
US health policy uncertainty pressures pharma investment plans in Germany
Pfizer CEO Albert Bourla is reportedly reconsidering parts of the company’s planned German investments after Germany’s proposed healthcare reforms raised concerns about predictability for drug...
Immuno-oncology tech meets in vivo tools through new trispecific reagent
Bio X Cell launched a ready-to-use, anti-mouse trispecific antibody targeting PD-L1 × TIGIT × LAG3 in a murine IgG2a format for standard mouse models. The catalog product is designed to support...
Acquisition: GSK buys Nuvalent for lung cancer programs
GSK agreed to acquire Nuvalent in a roughly $10.6 billion deal, adding two late-stage precision oncology drugs under FDA review for non-small cell lung cancer. The assets are led by zidesamtinib...