Get the Daily Brief
Latest Biotech News
Oncology clinical readouts (China immunotherapy bispecifics)
Akeso’s ivonescimab extended survival in squamous non-small cell lung cancer in a China-only Phase 3 program presented at ASCO. In Harmoni-6, the PD-1/VEGF bispecific plus chemotherapy reduced the...
Regulatory pathway / early-stage oncology signals (ADC)
AstraZeneca/az’s pipeline ADC candidate puxitatug samrotecan generated high response rates in B7-H4–selected endometrial cancer data shown at ASCO. In the Phase 1/2a BLUESTAR study (NCT05123482),...
Oncology clinical readouts (breast cancer)
Giredestrant, an oral selective estrogen receptor degrader (SERD), reduced recurrence risk across menopausal subgroups in ER+/HER2− early breast cancer in the lidERA Phase 3 trial results...
Regulatory / clinical development (CNS thyroid hormone prodrug)
Autobahn Therapeutics received FDA Fast Track designation for elunetirom (ABX-002) as adjunctive treatment for bipolar depression. The company said the designation is intended to increase the...
Biopharma dealmaking (onco antibodies with China partner)
Pfizer agreed to pay upfront and milestones totaling as much as $10.5 billion for a multi-asset oncology collaboration with Innovent Biologics. The deal sets Pfizer up for a 12-candidate antibody...
Biotech funding / digital health expansion
Signos raised $20 million to expand its glucose monitoring platform beyond diabetes into weight-loss applications. The company’s system pairs Dexcom’s over-the-counter CGM devices with an app that...
Protein design / AI infrastructure for biotech discovery
Chan Zuckerberg Initiative’s Biohub unveiled an AI-generated protein atlas, the ESM Atlas, expanding predicted protein structure coverage by more than a billion entries. Biohub said the database,...
Research instrumentation / lab technology (microplate readers)
BMG LABTECH highlighted how microplate readers and reporter assays support real-time microbiology workflows in pathogen studies at the University of Glasgow. In a discussion with microbiologist...
Daraxonrasib reshapes second-line metastatic pancreatic cancer
Revolution Medicines disclosed expanded Phase 3 results for daraxonrasib in patients with KRAS-mutant metastatic pancreatic cancer, reporting a median overall survival gain of 13.2 months across...
Akeso and Summit’s Harmoni-6 delivers OS win in first-line squamous NSCLC
Akeso and Summit Therapeutics’ ivonescimab posted a statistically significant overall survival improvement versus a PD-1 inhibitor plus chemotherapy in Harmoni-6, a Phase 3 trial run entirely in...
Autobahn’s elunetirom gets FDA Fast Track for bipolar depression
The FDA granted Fast Track status to elunetirom (ABX-002) as an adjunctive treatment for depressive episodes associated with bipolar I or bipolar II disorder in adults, according to a May 26...
FDA label expansion watch: Ionis’ Tryngolza olezarsen has PDUFA in June
A busy June at the FDA includes 11 upcoming PDUFA dates, with at least eight new products and three label expansions awaiting decisions, according to a regulatory calendar overview. One of the...
Revolution begins shipping daraxonrasib under FDA early access
Revolution Medicines began shipping daraxonrasib to physicians and patients under an FDA-authorized early access program, the company said during an event tied to ASCO. Daraxonrasib remains...
Pfizer and Innovent strike a $10.5B antibody-drug conjugate collaboration
Pfizer announced a multi-drug R&D collaboration with Innovent Biologics valued at $10.5 billion, targeting next-generation antibody-drug conjugates (ADCs) for targeted cancer therapies. The deal...
Giredestrant expands adjuvant SERD benefit across menopausal status
New data from the lidERA Phase 3 trial showed that adjuvant giredestrant, an investigational oral selective estrogen receptor degrader (SERD), cut recurrence risk across both premenopausal and...
B7-H4 ADC puxitatug samrotecan posts strong response in endometrial cancer
B7-H4-directed antibody-drug conjugate puxitatug samrotecan (AZD8205) delivered a 47.1% confirmed objective response rate in B7-H4-expressing recurrent or progressive endometrial cancer in the...
Allogene names Zachary Roberts as CEO succession
Allogene Therapeutics announced that Zachary Roberts, currently executive vice president of R&D and chief medical officer, will succeed David Chang as president and CEO on July 1, and will also...
Signos raises $20M to expand CGM use for weight loss
Signos raised $20 million to expand its glucose monitoring platform beyond diabetes by targeting weight loss, the company said. The approach combines an over-the-counter Dexcom CGM with an app...
ASCO late-stage oncology highlights
Revolution Medicines delivered what oncologists described as “landscape-changing” data for daraxonrasib at ASCO, extending survival in second-line metastatic pancreatic cancer with...
Immuno-oncology trial readout in NSCLC
Akeso and Summit’s ivonescimab extended survival in a China-based Phase 3 study in previously untreated squamous NSCLC, delivering a 34% risk reduction in death versus standard immunotherapy plus...