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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...
Precision oncology regulatory reach in Japan
Japan’s Ministry of Health approved Haihe Biopharma and Taiho Oncology’s risovalisib for PIK3CA-mutant advanced or recurrent ovarian clear cell carcinoma, pairing it with companion diagnostic...
Precision medicine assays and EU diagnostics standards
Invivoscribe secured CE-IVDR certification for its IdentiClone Dx IGH assay, a test designed to detect immunoglobulin heavy chain (IGH) gene rearrangements in patients with suspected B-cell...
Clinical trial updates in kidney disease drug development
Maze Therapeutics reported clinically meaningful Phase 2 top-line results for MZE829, an oral APOL1 inhibitor being tested in patients with broad APOL1-mediated kidney disease. The company said...
CDx- and data-driven oncology AI partnerships
Tempus AI and Daiichi Sankyo partnered to develop proof-of-concept multimodal AI models intended to improve oncology ADC development by increasing the probability of success through better patient...
Oral peptide platforms add new institutional firepower
Pinnacle Medicines, an oral peptide startup, raised $89 million in a Series B backed by U.S. and China investors, following OrbiMed’s involvement. The round brings Pinnacle’s total fundraising to...
Regulatory and trial strategy disruption at Innate Pharma
Innate Pharma discontinued its Phase 1/2 NK cell engager IPH6501 in B-cell non-Hodgkin lymphoma as part of a strategic pipeline refocus. The company ended the dose-escalation portion previously...
Beam data update for gene editing in AATD
Beam Therapeutics reported positive progress in its Phase 1/2 base editing program BEAM-302 for alpha-1 antitrypsin deficiency (AATD), saying the treatment restored protective protein production...
U.S. manufacturing scale-up for complex biologics
UCB selected Gwinnett County, Georgia, for its new U.S. biologics manufacturing facility, a planned 460,000-square-foot campus designed to produce complex biologics 24/7 for the U.S. market. UCB...
Merck’s CML dealmaking – Terns acquisition
Merck agreed to acquire Terns Pharmaceuticals in an all-cash $6.7 billion transaction, valuing the company at $53 per share and positioning Merck to bolster its hematology-oncology pipeline. The...
FDA approvals – early wins in ovarian cancer and Hunter syndrome
The FDA approved Corcept Therapeutics’ Lifyorli (relacorilant) ahead of schedule for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. The agency...