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Merck-Terns M&A signals next-gen oncology push
Merck & Co. agreed to acquire Terns Pharmaceuticals in an all-cash $6.7 billion deal, positioning TERN-701 as a potential differentiated option for chronic myeloid leukemia. The transaction,...
FDA clears Denali’s brain-penetrating Hunter syndrome therapy
The FDA approved Denali Therapeutics’ Avlayah (tividenofusp alfa) for Hunter syndrome, marking a notable rare-disease decision after heightened scrutiny of the category. The approval came via...
Denali and Corcept add early FDA wins for oncology and rare disease
The FDA issued separate early approvals for Denali’s Avlayah and Corcept Therapeutics’ Lifyorli, reinforcing momentum for programs that can win accelerated or shortened review timelines. Corcept’s...
Kodiak’s Zenkuda delivers Phase 3 win and ramps accelerated BLA plan
Kodiak Sciences’ tarcocimab tedromer, now branded Zenkuda, produced a positive Phase 3 outcome in the Glow2 trial for diabetic retinopathy, beating a sham procedure and triggering a near-term...
Maze’s APOL1 inhibitor posts Phase 2 kidney results amid investor pullback
Maze Therapeutics disclosed positive topline Phase 2 data for MZE829, an oral dual-mechanism APOL1 inhibitor, in patients with APOL1-mediated kidney disease. In the Horizon study, Maze reported a...
UCB commits $2B for US biologics manufacturing hub in Georgia
UCB selected Gwinnett County, Georgia, as the site for its new U.S. biologics manufacturing facility, projecting a $2 billion investment for a 460,000-square-foot campus. The site is designed to...
Novartis buys Excellergy for next-gen anti-IgE allergy therapy
Novartis agreed to buy Excellergy for up to $2 billion, seeking a next-generation anti-IgE program that could succeed or extend beyond Xolair. Exl-111, Excellergy’s lead IgE antibody, is in Phase...
FDA moves on brain-shuttle rare disease and diagnostics, plus EU device clearance
Regulatory actions in this cycle also spanned approvals and device changes that affect clinical workflows. The FDA approved Denali’s Hunter syndrome therapy, while it also granted an early...
Pinnacle Medicines closes $89M Series B for oral peptide pipeline
Pinnacle Medicines raised $89 million in a Series B financing to advance its oral peptide drug programs, increasing total funding to $134 million. The round was co-led by LAV and Foresite Capital...
Neion Bio emerges from stealth with egg-based biologics co-development deal
Neion Bio exited stealth and signed its first co-development and supply agreement with a major global pharmaceutical company, establishing near-term commercial momentum for its egg-based...
Regulatory approvals – rare disease
The FDA approved Denali Therapeutics’ Avlayah (tividenofusp alfa) for Hunter syndrome, giving a new option for a rare neurological disorder after prior agency scrutiny of rare disease programs....
Gene therapy – FDA rare immune approval
FDA cleared Rocket Pharma’s gene therapy for severe leukocyte adhesion deficiency type 1 (LAD-1), marketed as Kresladi, after a prior 2024 rejection linked to manufacturing concerns. The one-time...
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...