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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...
Oncology licensing and partnerships: AbbVie eyes pan-RAS via Kestrel option deal
AbbVie agreed to secure an exclusive option to acquire Kestrel Therapeutics for up to $1.45 billion tied to milestones for KST-6051, its oral pan-KRAS inhibitor in solid tumors. Kestrel disclosed...
FDA enforcement: proposed withdrawal of Amgen’s Tavneos
The FDA proposed withdrawing Amgen’s Tavneos (avacopan) after alleging “untrue statements” in the drug’s approval application. The agency’s Center for Drug Evaluation and Research put forward...
Clinical setback: Erasca’s pan-RAS molecular glue faces scrutiny after interim patient death
Erasca’s shares plunged after a phase I interim update for ERAS-0015, a pan-RAS molecular glue tested in RAS-mutant solid tumors including non-small-cell lung cancer and pancreatic ductal...
Big deal: CareDx to acquire Naveris to expand HPV liquid biopsy testing
CareDx agreed to acquire Naveris for up to $260 million in a deal designed to add HPV-driven cancer liquid biopsy testing to its portfolio. The transaction includes $160 million upfront in cash...
Gene editing breakthrough: Intellia’s lonvo-z hits primary endpoint in Phase 3
Intellia reported that its in vivo CRISPR therapy lonvoguran ziclumeran (lonvo-z) met the primary endpoint in the Phase 3 HAELO study for hereditary angioedema. The company said the treatment...
M&A: Sun Pharma to acquire Organon for $11.75B to build women’s health footprint
Sun Pharma agreed to acquire Organon & Co. for $11.75 billion in an all-cash transaction expected to close in early 2027. The acquisition adds Organon’s women’s health products, legacy brands, and...
FDA/biomarkers: Laguna Diagnostics gets Breakthrough Device for mRNA test to distinguish psychosis subtypes
Laguna Diagnostics’ blood-based mRNA Gene Biomarker test for schizophrenia and bipolar I disorder received FDA Breakthrough Device designation. The assay is designed to differentiate schizophrenia...
Immunology drug build-out: Coultreon raises $125M for oral SIK3 inhibitor after Galapagos acquisition
Coultreon Biopharma, formerly a Galapagos-linked asset platform focused on an oral immunology strategy, raised a $125 million Series A to advance its lead pill designed to selectively inhibit...
FDA moves to speed oncology and other trials with real-time data review
The FDA launched a pilot program to collect and review clinical trial data in real time, aiming to give reviewers earlier visibility into safety signals and other critical information as studies...
New KRAS G12D targeted therapy posts early human signals
A first-in-human trial testing setidegrasib against KRAS G12D–driven lung and pancreatic cancers reported early clinical success, published by an international consortium in the New England...