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Obesity drug pipeline steps forward in Phase 3 with Boehringer’s survodutide
Boehringer Ingelheim reported Phase 3 topline results for survodutide, its dual-acting obesity drug that targets GLP-1 and glucagon. In the Synchronize-1 trial of 725 participants, the company...
Precision oncology diagnostics: CareDx to acquire Naveris for NavDx and HPV MRD access
CareDx agreed to buy Naveris in a deal valued at up to $260 million, including $160 million upfront and as much as $100 million tied to revenue milestones. The acquisition is designed to expand...
M&A dealmaking heats up in KRAS and immunology: AbbVie options Kestrel for pan-RAS inhibitor
AbbVie signed an agreement to acquire Kestrel Therapeutics under an option structure valued at up to $1.45 billion, contingent on milestones tied to Kestrel’s oral pan-KRAS inhibitor KST-6051. The...
Clinical trial shift toward earlier evidence in solid tumor KRAS targeting: Erasca reports new data
Erasca reported preliminary clinical updates for ERAS-0015, its pan-RAS-targeting therapy, after a period of volatility tied to patient-reported and competitive readouts in the RAS space. The...
Immunology in the clinic: Coultreon launches Phase 1 SIK3 inhibitor package after $125 million Series A
Coultreon Biopharma (rebranded from an Onco3R Therapeutics spinout) raised a $125 million Series A to advance COL-5671, an oral SIK3 inhibitor designed for autoimmune indications. The round was...
Gene editing commercial benchmark: Intellia’s lonvo-z reaches Phase 3 endpoint in hereditary angioedema
Intellia reported Phase 3 success for lonvo-z (lonvoguran ziclumeran) in hereditary angioedema, positioning the treatment toward regulatory filing for an in vivo CRISPR approach. The company said...
Automation and agentic AI for clinical trial operations: Suvoda expands RTSM with agentic AI
Suvoda launched an updated randomization and clinical trial supply management (RTSM) system that incorporates agentic AI, aiming to compress trial startup timelines and reduce manual configuration...
Regulatory and market access in diabetes care: Health Canada approves first semaglutide generic for Ozempic
Health Canada approved the first generic version of Novo Nordisk’s Ozempic, clearing Dr. Reddy’s Laboratories’ semaglutide injection submission. The decision follows a review that Health Canada...
Immunology drug pipeline funding
Coultreon Biopharma, formerly Onco3R Therapeutics (now rebranded), raised a $125 million Series A led by Sofinnova Investments to advance COL-5671, an oral small-molecule inhibitor of...
CAR-T modality shift toward in vivo generation
The CAR-T field is increasingly shifting toward in vivo approaches, according to industry reporting that points to growing momentum behind therapies that aim to generate CAR-T cells inside the...
FDA real-time clinical trial data review pilot
The FDA announced a pilot program to access and review clinical trial data in real time as it flows from sponsors, marking a step toward more continuous oversight rather than post-hoc data...
KRAS inhibitor dealmaking and acquisition rights
AbbVie agreed to an exclusive option to acquire Kestrel Therapeutics for up to $1.45 billion, tied to milestones for Kestrel’s oral pan-KRAS inhibitor KST-6051. The deal comes as Kestrel disclosed...
M&A in precision oncology diagnostics
CareDx said it entered a definitive agreement to acquire Naveris for up to $260 million, combining CareDx’s precision oncology testing footprint with Naveris’ liquid biopsy capabilities in...
Obesity therapeutics: Phase 3 efficacy for Boehringer dual-acting agent
Boehringer Ingelheim reported success for its dual-acting obesity shot survodutide in a Phase 3 trial, reporting up to 17% weight loss among participants who stayed on treatment through the...
Clinical disruption and regulatory action: FDA proposes withdrawing Tavneos
The FDA proposed withdrawing Amgen’s Tavneos (avacopan) NDA, alleging “untrue statements” were included in the approval application. The proposed action targets the approval of the C5aR antagonist...
KRAS/precision oncology pipeline: investigational pan-RAS molecular glue hits early signal, stock reacts
Erasca’s shares fell sharply after the company reported Phase 1 dose-escalation results for ERAS-0015, a pan-RAS molecular glue in RAS-mutant solid tumors including non-small-cell lung cancer and...
Public markets and pipeline: Intellia in vivo CRISPR Phase 3 success and FDA filing path
Intellia’s in vivo CRISPR therapy lonvo-z (lonvoguran ziclumeran) achieved major efficacy in the Phase 3 HAELO study for hereditary angioedema, cutting swelling attack rates by 87% versus placebo...
Funding and platform: Nervonik raises Series B for peripheral nerve stimulation
Nervonik raised $52.5 million in a Series B round to support development and commercialization planning for its peripheral nerve stimulation (PNS) system aimed at chronic pain and other...
Regulatory: FDA real-time trial review + pilot AI safety monitoring
The FDA announced it will begin a pilot effort to let reviewers access clinical trial data in real time as it flows in. The initiative is intended to accelerate benefit-risk assessment during...
UK clinical trials overhaul: Combined Review to shorten timelines
The UK implemented the biggest overhaul of clinical trials rules in about 20 years, with new regulations taking effect April 28. The update aims to reduce approval timelines and introduces a...