fda-and-biotech News

XOMA Stock Plunges 25% on Partner's Failed Drug Trial
FDA & Biotech
1mo ago

XOMA Stock Plunges 25% on Partner's Failed Drug Trial

Rezolute's clinical trial failure for diabetes drug ersodetug erases a potential key royalty stream for XOMA, highlighting the risks of its biotech financing model.

Rezolute Bio Shares Collapse 88% After Lead Drug Fails Pivotal Trial
FDA & Biotech
1mo ago

Rezolute Bio Shares Collapse 88% After Lead Drug Fails Pivotal Trial

The biotech company's ersodetug for congenital hyperinsulinism did not show a statistically significant benefit over placebo, jeopardizing its future.

Rhythm Pharma Hits Record High on Prader-Willi Syndrome Drug Data
FDA & Biotech
1mo ago

Rhythm Pharma Hits Record High on Prader-Willi Syndrome Drug Data

Stock surges after a study showed its drug setmelanotide reduced hunger and BMI, paving the way for a pivotal Phase 3 trial for the rare genetic disease.

Sanofi Gains on China Approval for Two Rare Disease Drugs
FDA & Biotech
2mo ago

Sanofi Gains on China Approval for Two Rare Disease Drugs

The French drugmaker's shares edged higher after securing market access for its hemophilia and blood-clotting treatments, expanding its footprint in a key growth market.

GRI Bio Sinks Despite Positive Lung Disease Trial Data
FDA & Biotech
2mo ago

GRI Bio Sinks Despite Positive Lung Disease Trial Data

Investors weigh promising safety and efficacy signals from the company's Phase 2a idiopathic pulmonary fibrosis study against underlying financial realities.

Pfizer Oncology Drug Tukysa Shows Promise in Breast Cancer Trial
FDA & Biotech
2mo ago

Pfizer Oncology Drug Tukysa Shows Promise in Breast Cancer Trial

Positive Phase 3 data for the Seagen-acquired drug offers a key pipeline victory as the pharmaceutical giant navigates its post-COVID strategy.

Fulcrum Therapeutics Stock Slides on $175M Offering
FDA & Biotech
2mo ago

Fulcrum Therapeutics Stock Slides on $175M Offering

Capital raise comes just months after the failure of its lead drug candidate, fueling a strategic pivot to its sickle cell disease program.

Pfizer Shares Fall as FDA Widens Covid Vaccine Safety Probe
FDA & Biotech
2mo ago

Pfizer Shares Fall as FDA Widens Covid Vaccine Safety Probe

Regulators are now investigating deaths potentially linked to vaccines across all adult age groups, increasing pressure on the pharmaceutical giant.