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M&A – Merck buys Terns for CML asset
Merck agreed to acquire Terns Pharmaceuticals in an all-cash deal valued at about $6.7 billion, bringing the CML candidate TERN-701 into Merck’s oncology portfolio. The transaction is expected to...
Late-stage/clinical development – diabetic retinopathy (Kodiak)
Kodiak Sciences reported positive phase III Glow2 (tarcocimab tedromer), setting up an accelerated multi-indication BLA path for the newly branded Zenkuda in diabetic retinopathy. The topline...
Clinical development – oral peptide pipeline financing (Pinnacle)
Pinnacle Medicines raised $89 million in a series B to advance its oral peptide programs, including next steps across its chemistry and clinical pipeline. The round brings Pinnacle’s total capital...
Manufacturing expansion – UCB’s new U.S. biologics plant
UCB selected Gwinnett County, Georgia for a new 460,000-square-foot biologics manufacturing facility expected to cost around $2 billion. The site is designed to use a digital-first approach...
FDA approval – gene therapy (LAD-1)
The FDA approved Rocket Pharma’s gene therapy Kresladi for severe leukocyte adhesion deficiency type 1 (LAD-1), a highly ultra-rare disorder that exposes children to life-threatening infections....
Company funding – intracellular pan-cancer delivery (Idel)
Idel Therapeutics closed a €9 million seed round (about $10.4 million) to develop an intracellular delivery technology aimed at getting cytotoxic drugs into the cytosol of tumor cells. The company...
Diagnostics regulation – CE-IVDR for B-cell clonality testing (Invivoscribe)
Invivoscribe obtained CE-IVDR certification for its IdentiClone Dx IGH assay, a test intended to detect immunoglobulin heavy chain (IGH) gene rearrangements in patients with suspected B-cell...
Clinical development setbacks – Wave obesity trial disappoints
Wave Life Sciences’ obesity program hit investor disappointment after the company reported a roughly 1% body-weight reduction over six months in its Inlight phase I follow-up. Shares fell sharply...
FDA fast-tracks rare disease therapies
The FDA cleared Denali Therapeutics’ Hunter syndrome drug Avlayah (tividenofusp alfa) under an accelerated approval pathway, reversing recent scrutiny and rejection patterns for rare disease...
Merck’s $6.7B Terns acquisition reshapes CML strategy
Merck agreed to acquire Terns Pharmaceuticals in an all-cash $6.7 billion deal, valuing Terns at about $53 per share. The transaction centers on TERN-701, an oral allosteric BCR::ABL tyrosine...
Ocular biotech Kodiak’s Glow2 sets up accelerated BLA
Kodiak Sciences reported positive Phase 3 top-line results from Glow2 for tarcocimab tedromer in diabetic retinopathy, shifting investor expectations after prior setbacks. The company said the...
Wave Life Sciences stumbles after obesity Phase 1 readout
Wave Life Sciences disclosed Phase 1 data from its first-in-human Inlight trial of WVE-007, an INHBE GalNAc-siRNA candidate for obesity, and the market reacted sharply. Investors pulled back after...
APOL1 kidney disease bet faces choppy reaction
Maze Therapeutics disclosed topline Phase 2 results for MZE829, an oral APOL1 inhibitor targeting APOL1-mediated kidney disease and related patient subgroups. The company reported a clinically...
Novo–United Biotechnology triple incretin raises competitive heat in China
Novo Nordisk and United Biotechnology reported additional Phase 2 results for a China-developed next-generation triple incretin therapy, UBT-251. The companies said the regimen outperformed...
Pinnacle Medicines raises $89M for oral peptide pipeline
Pinnacle Medicines secured an $89 million Series B co-led by LAV and Foresite Capital to advance its oral peptide programs. The funding brings Pinnacle’s total capital raised to $134 million and...
Korea dealmaking points to active BD in platforms and oncology
Biotech deal activity in South Korea highlighted renewed momentum across platforms and oncology assets. Alteogen signed a potential $579 million license deal with Biogen, while Celltrion boosted...
Regulatory pushback: Novartis hit with data-sharing class action
Novartis faces a class-action lawsuit alleging it used tracking tools on consumer-facing branded drug websites to share sensitive patient information without consent. The complaint was filed in...
Cerebro-immune linkage found in anti-NMDA receptor encephalitis
Cold Spring Harbor Laboratory researchers reported a mechanistic link between cancer immune responses and autoimmune brain disease in Nature. Their findings focus on ectopic NMDAR expression in...
Rare disease approvals and FDA stance
The FDA granted accelerated approval to Denali Therapeutics’ Avlayah (tividenofusp alfa) for Hunter syndrome, a decision that Denali frames as a return to a rare-disease surrogate-endpoint pathway...
Big Pharma M&A to replenish oncology pipeline
Merck agreed to acquire Terns Pharmaceuticals in an all-cash $6.7 billion deal, aiming to bolster its oncology portfolio ahead of major patent expirations. Under the terms, Merck will pay $53 per...