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Oncology M&A – Merck’s $6.7B Terns bid
Merck agreed to acquire Terns Pharmaceuticals in a $6.7 billion all-cash deal, paying $53 per share to bolster its oncology pipeline. The centerpiece is TERN-701, an oral BCR::ABL tyrosine kinase...
Ocular drug development – Kodiak’s Phase 3 progress
Kodiak’s tarcocimab tedromer (Zenkuda) delivered positive top-line results in the Phase 3 Glow2 trial for diabetic retinopathy, triggering plans for an accelerated, multi-indication BLA...
Obesity pipeline – Wave’s disappointing early efficacy
Wave Life Sciences’ obesity program faced renewed investor pressure after early clinical readouts from its first-in-human Inlight trial showed limited weight impact. The company reported a small...
Diabetes drug competition – triple incretin outperformance
Novo Nordisk and United Biotechnology’s China-developed triple incretin UBT-251 beat semaglutide in a Phase 2 trial, escalating competition in the global GLP-1 obesity and diabetes market. The...
Women’s health oncology – FDA ovarian cancer approval
The FDA approved Corcept Therapeutics’ Lifyorli (relacorilant) in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal...
Drug platform deal – Novartis buys allergy biotech
Novartis agreed to acquire Excellergy for up to $2 billion, adding Exl-111—an effector cell response inhibitor targeting IgE—to its allergy pipeline. Exl-111 is in Phase 3 development and is...
Biotech funding – Pinnacle’s $89M Series B
Pinnacle Medicines raised an $89 million Series B to accelerate development of its oral peptide programs, bringing total disclosed funding to $134 million. The round was co-led by LAV and Foresite...
Diagnostics and regulation – CE-IVDR test certification
Invivoscribe obtained CE-IVDR certification for its IdentiClone Dx IGH assay, a B-cell clonality test detecting immunoglobulin heavy chain (IGH) gene rearrangements in suspected...
Regulatory approvals – rare disease (Hunter syndrome)
The FDA granted accelerated approval to Denali Therapeutics’ Hunter syndrome treatment Avlayah (tividenofusp alfa), marking a notable shift in the rare-disease review environment after multiple...
Regulatory approvals – ovarian cancer (Corcept)
The FDA approved Corcept Therapeutics’ Lifyorli (relacorilant) for ovarian cancer months ahead of schedule in combination with nab-paclitaxel. The approval covers adults with platinum-resistant...
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...