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Moderna + Merck mRNA‑antibody combo halves melanoma recurrence in interim readout
Interim phase II data from a personalized mRNA neoantigen therapy (intismeran autogene/mRNA‑4157) combined with pembrolizumab showed a roughly 49% reduction in melanoma recurrence and deaths...
Revita endoscopic procedure cuts post‑GLP‑1 weight regain ~70%
Six‑month results from the REMAIN‑1 randomized trial showed Fractyl Health’s Revita procedure reduced weight regain after GLP‑1 discontinuation by roughly 70% versus a sham procedure. The cohort...
Roche trims pipeline after futility finds; flags China diagnostic headwinds
Roche disclosed a program cut after a futility analysis ended a phase 2 fibrosis/inflammation program tied to a Kiniksa asset the company had acquired; Roche said no new safety signals appeared...
DNA‑protein crosslinks activate cGAS‑STING and drive progeroid disease
A Science paper showed that unrepaired DNA‑protein crosslinks (DPCs) accumulate in cells lacking the SPRTN protease, triggering micronuclei formation and activation of the cGAS‑STING innate immune...
FDA halts Regenxbio gene therapy trials — safety scare weeks before approval
The FDA placed Regenxbio’s gene therapy programs on clinical hold after a pediatric trial participant developed a brain tumor, prompting an immediate suspension of two trials and rattling a...
FDA designates NanoMosaic’s Tessie platform as advanced manufacturing tech
The FDA granted Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s Tessie gene therapy QC platform, giving the Waltham, Massachusetts firm prioritized regulatory interactions for...
Lilly inks up‑to‑$1.12B Seamless deal — recombinase editing enters big‑pharma orbit
Eli Lilly agreed to an exclusive research and licensing collaboration with Seamless Therapeutics to apply programmable recombinase gene editing to hearing‑loss targets, in a deal that could reach...
Repertoire lands Lilly collaboration — $1.9B autoimmune programs add Big Pharma backing
Repertoire Immune Medicines added Eli Lilly to its roster of major partners, securing an up‑front payment and potential milestones that push the alliance value toward roughly $1.9–1.92 billion....
FDA clears Tenpoint’s dual‑agent presbyopia drop — startup secures $235M push
Tenpoint Therapeutics won FDA approval for Yuvezzi, a first‑in‑class combination eye drop (carbachol + brimonidine) for presbyopia, and closed up to $235 million in financing to support...
DeepMind releases AlphaGenome — AI predicts noncoding DNA function at scale
DeepMind published AlphaGenome, a long‑sequence DNA model that predicts regulatory activity and variant effects across up to one million base pairs, tackling the functional interpretation of...
Fractyl’s Revita shows large cut in post‑GLP‑1 weight regain — six‑month trial readout
Fractyl Health reported six‑month REMAIN‑1 results showing that its endoscopic procedure Revita reduced weight regain after GLP‑1 discontinuation by ~70% versus sham in patients who stopped...
Cellares raises $257M to scale cell‑therapy manufacturing ahead of IPO
Cellares closed a $257 million Series D to accelerate commercial launches of its cell therapy manufacturing automation and to support an anticipated 2027 IPO bid. The company’s integrated robotics...
Eikon targets $273–274M IPO to fund oncology imaging and discovery platform
Eikon Therapeutics set terms for an IPO to raise roughly $273–274 million, citing proceeds to advance its high‑throughput single‑molecule imaging platform and oncology pipeline. The company’s...
Thermo Fisher projects 4–6% revenue growth in 2026 — life‑sciences demand steadies
Thermo Fisher issued guidance for 2026 revenue growth of 4–6% and reported Q4 2025 results that beat estimates, driven by life‑sciences solutions and bioprocess strength. The company posted...
FDA halts Regenxbio studies — tumor found in trial participant
The U.S. Food and Drug Administration placed clinical holds on Regenxbio’s gene therapy programs after investigators identified a brain tumor in a treated participant. The hold affects trials for...
FDA designates NanoMosaic as AMT: gene therapy QC platform gains fast-track access
The U.S. FDA granted Advanced Manufacturing Technology (AMT) designation to NanoMosaic’s Tessie platform for assessing gene therapy quality, enabling prioritized regulatory interactions for...
CMS names 15 drugs for round three negotiations — Part B biologics included
The Centers for Medicare & Medicaid Services released the slate of 15 medicines selected for the third round of Inflation Reduction Act price negotiations, marking the first time Part B...
Repertoire and Lilly expand autoimmune push — multibillion platform validation
Repertoire Immune Medicines signed a major collaboration with Eli Lilly to develop tolerizing therapies for autoimmune diseases, securing up-front and milestone payments that validate the...
Lilly backs recombinase editing — Seamless deal targets genetic hearing loss
Eli Lilly licensed Seamless Therapeutics’ recombinase gene editing platform in a collaboration worth up to roughly $1.12 billion to develop precision genetic medicines for hearing loss. The pact...
Tenpoint wins FDA approval for dual‑agent presbyopia drop — $235M financing closes
Tenpoint Therapeutics secured U.S. FDA approval for Yuvezzi, a dual‑agent eye drop combining carbachol and brimonidine for adult presbyopia, and concurrently closed up to $235 million in...