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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...
Rare disease regulator action – Denali accelerated approval and prior rejection context
FDA cleared Denali Therapeutics’ Avlayah (tividenofusp alfa) for Hunter syndrome under the accelerated approval pathway, a notable decision as the agency has recently rejected several rare disease...
Kidney disease pipeline – Maze Phase 2 AMKD readout
Maze Therapeutics reported positive topline Phase 2 data for MZE829, an oral dual-mechanism APOL1 inhibitor, in patients with broad APOL1-mediated kidney disease (AMKD). In the company’s Horizon...
Cell therapy pipeline decision – Innate ends NK cell engager study
Innate Pharma discontinued its Phase 1/2 study of IPH6501, a tetraspecific antibody-based NK cell engager being evaluated in B-cell non-Hodgkin lymphoma. The company said the program was halted as...
Gene editing advance – Beam base editing update for AATD
Beam Therapeutics provided updated evidence supporting its base editing program BEAM-302 in alpha-1 antitrypsin deficiency (AATD). In the ongoing Phase 1/2 study, Beam reported that patients...
Immunotherapy+data – Tempus and Daiichi Sankyo build AI models for ADC patient selection
Tempus AI partnered with Daiichi Sankyo to develop proof-of-concept AI models aimed at improving success rates for novel oncology antibody-drug conjugates (ADCs). Under the agreement, Daiichi...
Diagnostics + manufacturing systems – CE mark for Countable Labs single-molecule PCR
Countable Labs obtained a CE mark for its Countable 4 single-molecule PCR platform, extending access to European biopharma and contract manufacturing customers. The company described the...
CDMO + site expansion – Rentschler’s Milford manufacturing growth
Rentschler Biopharma highlighted progress and expansion at its U.S. Milford, Massachusetts facility, describing a transition into a new phase of multi-product growth. The company said it is...
Startup financing – Excalipoint seed for solid-tumor T-cell engagers
Excalipoint Therapeutics launched with an oversubscribed $68.7 million seed round to advance a portfolio of T-cell engagers for solid tumors. The financing positions the company among the larger...