Get the Daily Brief
Latest Biotech News
RNA epigenetic therapy moves into Phase 2 for sarcoma
Storm Therapeutics closed a $56 million Series C to drive STC-15 into Phase 2 testing across selected sarcoma indications. The RNA-modifying enzyme inhibitor targets METTL3, aiming to disrupt...
FDA priority review advances next B7-H3 ADC in small-cell lung cancer
The FDA accepted and granted priority review to Daiichi Sankyo and Merck’s ifinatamab deruxtecan for advanced extensive-stage small-cell lung cancer. The drug is a B7-H3-directed antibody-drug...
Roche restarts Elevidys Phase 3 to seek revised European approval path
Roche will run a new global Phase 3 trial for Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys as it seeks a path to approval in Europe. This follows a negative European...
Foundation Medicine to buy Saga Diagnostics’ MRD platform for up to $595M
Roche subsidiary Foundation Medicine agreed to acquire Saga Diagnostics for up to $595 million to expand its cancer molecular residual disease (MRD) testing portfolio. The deal adds Saga’s...
Revolution Medicines delivers RAS inhibitor advance in metastatic pancreatic cancer
Revolution Medicines priced major concurrent offerings totaling $2 billion shortly after releasing top-line Phase 3 results for daraxonrasib (RMC-6236) in metastatic pancreatic ductal...
Gene therapy rights reshuffle as MeiraGTx buys back failed J&J eye asset
MeiraGTx and Johnson & Johnson completed a buyback arrangement in which J&J handed back rights to the failed eye disease gene therapy bota-vec (botaretigene sparoparvovec) for $25 million upfront....
Biotech financing scale-up continues with Terremoto’s $108M Series C
Terremoto Biosciences raised $108 million in a Series C to advance small-molecule drug programs targeting AKT. The company said funding supports first-in-human testing for its next-generation...
Cell and gene therapy economics spotlight as iPSC manufacturing cuts NK COGS up to 95%
A new cost analysis highlights that manufacturing natural killer cell therapies using induced pluripotent stem cells (iPSCs) can reduce cost of goods sold dramatically versus traditional...
Obesity drug development – cardiovascular and liver safety data
Eli Lilly’s oral obesity drug Foundayo (orforglipron) cleared key cardiovascular safety scrutiny in the Phase 3 Achieve-4 trial in adults with type 2 diabetes and obesity or overweight at...
Malaria diagnostics – FDA approval for blood-donor risk screening
Grifols won US FDA approval for a nucleic-acid-based assay to screen blood donors for malaria risk. The Procleix Plasmodium Assay is automated on the Procleix Panther system and detects ribosomal...
Cancer therapeutics – FDA priority review for B7-H3 ADC in small-cell lung cancer
The US FDA granted priority review to Daiichi Sankyo and Merck’s B7-H3-directed antibody-drug conjugate ifinatamab deruxtecan. The decision applies to the BLA for patients with advanced...
Pancreatic cancer – Phase 3 success and capital market response
Revolution Medicines’ Phase 3 RAS inhibitor daraxonrasib delivered a major clinical signal in metastatic pancreatic ductal adenocarcinoma, with top-line results tied to longer survival versus...
Sarcoma precision oncology – STC-15 enters Phase 2 with fresh funding
Storm Therapeutics closed a $56 million Series C to drive STC-15 into Phase 2 evaluation across sarcoma indications. The RNA epigenetics program targets METTL3, an enzyme involved in mRNA...
Diagnostics and MRD – Roche to acquire Saga Diagnostics’ Pathlight platform
Roche, via its subsidiary Foundation Medicine, agreed to acquire Saga Diagnostics in a deal valued at up to $595 million, expanding Foundation’s molecular residual disease (MRD) footprint. The...
Digital health – CMS rolls out Medicare app ‘App Store’ to distribute vetted digital health tools
CMS is launching a Medicare-focused digital health ecosystem that functions like an “App Store,” aiming to make patient data more portable across a curated set of digital health apps. The program...
Gene editing and antiviral platforms – FDA guidance and policy shifts on gene therapies
The FDA issued draft guidance on assessing the safety of gene-edited products, focusing on next-generation sequencing-based approaches and bioinformatics methods to characterize risks such as...
Immunology startup launch – Bain capital seeds Beeline Medicines with BMS-licensed assets
Bain Capital Life Sciences officially launched Beeline Medicines as a new immunology-focused biotech, built around five Bristol Myers Squibb programs originally licensed for development. The...
Biotech capital markets – benchmark-setting IPO and obesity pipeline funding
Kailera Therapeutics priced a $625 million IPO, positioning the obesity-focused developer among the largest biotech offerings in the past several years. The company said it will use proceeds to...
Obesity and diabetes therapeutics: Foundayo clears heart safety hurdle; FDA seeks liver-risk data
Eli Lilly said its oral GLP-1 receptor agonist Foundayo (orforglipron) met the primary goal of a cardiovascular outcomes safety test in people with diabetes and obesity, showing no greater risk of...
FDA regulatory posture on peptides: agency moves toward advisory review and potential easing
The FDA is moving toward reconsidering restrictions on compounded “popular peptides,” setting up advisory panel review sessions as the agency evaluates whether a handful of peptide products should...