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En Carta’s point‑of‑care Lyme test gets FDA breakthrough designation
En Carta Diagnostics received FDA Breakthrough Device Designation for EC Pocket Lyme, a rapid molecular point‑of‑care assay that detects Borrelia DNA from skin interstitial fluid using a...
DeepMind’s AlphaGenome debuts — community presses for validation
DeepMind published AlphaGenome in Nature, an AI model that predicts regulatory activity from long stretches of noncoding DNA up to one million base pairs and scores variant effects across...
Cellares raises $257M to scale cell therapy manufacturing ahead of IPO
Cellares closed a $257 million Series D to accelerate commercial roll‑out of its automated cell therapy manufacturing services and to prep for a planned 2027 IPO. The funding will expand global...
Summit’s PD‑1xVEGF bispecific accepted — FDA sets November decision date
The FDA accepted Summit Therapeutics’ BLA/MAA for ivonescimab, a PD‑1/VEGF bispecific antibody for non‑small cell lung cancer, and set a PDUFA decision date in November. Summit reported the filing...
FDA pauses Regenxbio gene trials: tumor found in child
The U.S. Food and Drug Administration placed clinical holds on Regenxbio’s gene‑therapy programs after a pediatric trial participant was diagnosed with a brain tumor. Regenxbio confirmed the holds...
Lilly inks up-to-$1.12B recombinase pact with Seamless
Eli Lilly struck an exclusive research-and-license agreement with Seamless Therapeutics worth up to $1.12 billion to apply Seamless’s programmable recombinase platform to genetic hearing‑loss...
Repertoire adds Lilly to partner roster — blockbuster autoimmune pact
Repertoire Immune Medicines expanded its pharma partnerships by signing Eli Lilly to a collaboration focused on tolerizing vaccines for autoimmune diseases, in a deal that could be worth up to...
Moderna and Merck report 49% drop in melanoma recurrence with mRNA combo
Interim five‑year data from a randomized Phase II trial show that combining Moderna’s personalized neoantigen mRNA candidate (mRNA‑4157/intismeran autogene) with pembrolizumab reduced melanoma...
Summit secures FDA date for PD‑1/VEGF bispecific
The FDA accepted Summit Therapeutics’ marketing application for ivonescimab, a PD‑1/VEGF bispecific antibody, and set a PDUFA decision date in November. Summit said regulators acknowledged its...
Tenpoint wins FDA approval for presbyopia drop — raises $235M to launch
Tenpoint Therapeutics received FDA approval for its topical presbyopia eye drop and simultaneously closed financing of approximately $235 million in combined debt and equity to support...
Thermo Fisher raises guide after strong Q4 — sees mid‑single‑digit growth for 2026
Thermo Fisher Scientific reported stronger‑than‑expected Q4 results and updated guidance for 2026, forecasting roughly 4–6% revenue growth as life sciences and bioprocessing demand remains...
Oxford Nanopore reverses phase‑out plan — P2 Solo supported through 2030
After customer backlash, Oxford Nanopore extended support for its PromethION 2 Solo (P2 Solo) sequencer through the end of 2030. The company will stop selling the P2 Solo later this year but will...
CMS opens Round 3 of IRA drug negotiations — 15 medicines named, Part B included
The Centers for Medicare & Medicaid Services published the list of 15 drugs selected for the third round of Inflation Reduction Act price negotiations, marking the first time Medicare Part B...
Cellares raises $257M as it scales automated cell‑therapy manufacturing
Cellares closed a $257 million Series D financing to expand its automated cell‑therapy manufacturing facilities and accelerate a planned commercial launch ahead of a targeted 2027 IPO. The funding...
FDA halts Regenxbio gene trials: brain tumor sparks holds
The U.S. Food and Drug Administration placed clinical holds on multiple Regenxbio gene‑therapy studies after the detection of a brain tumor in a pediatric trial participant. Regenxbio told...
FDA lifts partial hold on Intellia CRISPR trial – one study resumes
The FDA lifted a clinical hold on one of Intellia’s Phase 3 trials of its CRISPR/Cas9 candidate nexiguran ziclumeran (nex‑z), allowing the Magnitude‑2 study for ATTR‑PN (polyneuropathy) to restart...
Lilly inks $1.12B recombinase pact with Seamless – hearing loss push
Eli Lilly struck a research and licensing agreement with Seamless Therapeutics worth up to $1.12 billion to apply Seamless’s programmable recombinase gene‑editing platform to genetic forms of...
CMS names 15 drugs for round‑three price talks: Part B drugs included
The Centers for Medicare & Medicaid Services announced 15 medicines for Round 3 of Inflation Reduction Act price negotiations, marking the first time Part B (physician‑administered) drugs are...
Roche’s GLP‑1/GIP CT‑388 posts competitive Phase‑2 weight loss
Roche reported Phase‑2 data showing its dual GLP‑1/GIP agonist CT‑388 produced approximately 22.5% placebo‑adjusted weight loss at 48 weeks, prompting the company to move the candidate toward...
Tenpoint eye drop cleared: presbyopia approval paired with $235M raise
Tenpoint Therapeutics secured FDA approval for its presbyopia eye drop and announced $235 million in combined debt and equity to support commercialization. The company positioned the product as a...