Latest Biotech News

Tenax Therapeutics’ TNX-103 failed to hit the primary efficacy goal in a Phase 3 trial for heart failure associated with pulmonary hypertension (PH-HFpEF), triggering an early investor retreat. In...

Sionna Therapeutics’ Phase 2 cystic fibrosis program for SION-719 failed to improve outcomes when added to Vertex’s Trikafta, prompting Sionna to stop advancing the add-on approach. The company...

Silence Therapeutics reported Phase 2 success for divesiran, positioning the company to move the gene-silencing therapy toward Phase 3 in polycythemia vera (PV). Silence said the treatment met the...

Silence Therapeutics said divesiran stabilized red blood cell levels in a Phase 2 PV trial, a result the company believes could position it against major upcoming options. In the 48-patient study,...

Jazz Pharmaceuticals agreed to acquire Actio Biosciences for $820 million upfront, with additional milestone payments of up to $500 million tied to performance for its ultra-rare epilepsy drug....

Sobi will pay $75 million upfront to Innate Pharma for rights to market lacutamab, agreeing to a total deal value of $580 million ahead of a planned Phase 3 push. The transaction gives Sobi market...

CSPC Pharmaceutical Group announced FDA IND approval for SYS-6037, its mpox mRNA vaccine injection co-developed with the Institute of Microbiology of the Chinese Academy of Sciences. The clearance...

WuXi AppTec won a preliminary injunction in the 1260H case after a judge ruled that the U.S. Department of Defense’s designation of the company as a “Chinese military company” was likely arbitrary...

BioNTech’s former chief strategy officer Ryan Richardson’s team secured $25 million in seed funding for a virtual cancer surveillance startup. The company’s focus is aimed at using ongoing, remote...

Novo Nordisk and Amazon Web Services struck an AI drug discovery pact that includes AWS as Novo’s preferred cloud and AI partner and the creation of a London innovation hub for joint...

STAT+ reports that China is tightening oversight of clinical trials, even as U.S. stakeholders seek ways to match China’s historically faster pace. A key focus is on investigator-initiated trials...

STAT+ highlights growing safety concerns for radiopharmaceutical developers as more programs move into clinical trials. While the targeting premise remains that isotopes can deliver radiation more...

A Nature Communications study led by Zhou, Su, Liang and colleagues examines whether molecular residual disease (MRD) signals after surgery can guide care in early-stage, resected non-small cell...

Arpeggio Biosciences is disbanding after leadership concluded its Nrf2 small-molecule degrader program for non-small cell lung cancer could not separate efficacy from off-target liability. In an...

Eli Lilly shares rose after the company reported second-quarter results that beat analyst expectations, driven by continued revenue momentum from tirzepatide marketed as Zepbound for obesity and...

aTyr Pharma laid off 60% of its workforce as it conserves resources for a second shot at Phase 3 success in a lung disease program. The report indicates the company is taking cost-reduction steps...

Two debuting biotechs used IPOs to put fresh capital behind late-stage ambitions and targeted discovery programs. Latigo Biotherapeutics raised $346 million for a pipeline that includes a...

Braveheart Bio priced a large biotech IPO tied to a clinical-stage heart drug, positioning the company to build momentum ahead of key development milestones. The report says the Braveheart Bio...

An article focused on regulatory operations argues that submission readiness depends on more than compiling scientific evidence into an eCTD. It stresses that regulators can only evaluate what is...

A real-world study of nearly 5,000 men with metastatic hormone-sensitive prostate cancer suggests a specific prostate-specific antigen (PSA) milestone may better correlate with survival than...