Latest Biotech News

Revolution Medicines reported interim success in its Phase 3 RASolute 302 trial, with daraxonrasib nearly doubling survival versus standard chemotherapy in previously treated metastatic pancreatic...

After Revolution Medicines declared its daraxonrasib Phase 3 readout as meeting overall survival and progression-free survival endpoints, Wall Street analysts characterized the result as...

Allogene Therapeutics posted early Phase 3 Alpha3 data suggesting its off-the-shelf CAR-T cemacabtagene ansegedleucel (cema-cel) can drive minimal residual disease (MRD) negativity in first-line...

Allogene’s Phase 3 trial results continued to support the company’s “off-the-shelf” CAR-T strategy in large B-cell lymphoma. In an early analysis after 45 days of treatment, the company reported...

Spyre Therapeutics reported its first major Phase 2 results for SPY001 in ulcerative colitis, setting the company up to compete against newer integrin-pathway approaches entering the clinic. In...

Spyre doubled down on its SPY001 Phase 2 messaging, describing the α4β7-targeted program as capable of outperforming current standards in ulcerative colitis. The company said the latest readout...

The FDA escalated pressure on clinical-development sponsors to report results from registered studies, citing a compliance review that found results were missing for 30% of registered clinical...

The FDA is nearing a decision on leadership for its Center for Biologics Evaluation and Research (CBER), with sources telling Endpoints News that the agency is narrowing its search for a new...

Regeneron entered radiopharmaceuticals through a collaboration with Telix Pharmaceuticals, targeting next-generation radiopharmaceutical therapies and diagnostics across solid tumors. Under the...

Click Therapeutics cut more than a quarter of its workforce shortly after raising Series D funding, according to reporting from Endpoints News. The digital therapeutics startup disclosed a $50...

Revolution Medicines said daraxonrasib, its KRAS-targeted drug for metastatic pancreatic cancer, met early goals in a Phase 3 checkpoint and the company ended the study early after survival...

Allogene Therapeutics reported early clinical data showing its cema-cel “off-the-shelf” CAR-T therapy eliminated detectable lymphoma cells at rates exceeding standard care in an interim readout of...

BioNTech disclosed positive Phase 2 results for trastuzumab pamirtecan (BNT323), setting the stage for an FDA filing as the company looks to compete in HER2-positive oncology where antibody-drug...

GSK said it plans to start five Phase 3 studies for a gynecological cancer antibody-drug conjugate licensed from Hansoh Pharma after early promising data. The company’s decision expands the trial...

Sidewinder Therapeutics raised $137 million in a Series B to advance a pipeline of bispecific antibody-drug conjugates aimed at improving tumor targeting and safety. The round was co-led by...

Neomorph raised an additional $100 million in funding to advance molecular glue programs, expanding resources for discovery and translation of degradation-oriented therapeutics. The company’s...

AbbVie agreed to license ex-China rights to two Haisco Pharmaceutical pain compounds in a transaction structured around a $30 million upfront payment for the candidates. The licensing arrangement...

Vivatides Therapeutics closed an oversubscribed $54 million Series A to advance extrahepatic RNA therapeutics, focusing on improvements to delivery technologies and preclinical optimization. The...

Seaport Therapeutics and Hemab Therapeutics moved toward public markets as the biotech IPO window shows signs of reopening, each filing for IPO plans to fund clinical and pipeline work. Seaport...

Spyre Therapeutics reported early Phase 2 data for SPY001 in ulcerative colitis, meeting the study’s primary goal and supporting further development as the company aims to compete with entrenched...