fda-and-biotech News

Ionis Hits 52-Week High as Hepatitis B Drug Succeeds in Phase 3
FDA & Biotech
1mo ago

Ionis Hits 52-Week High as Hepatitis B Drug Succeeds in Phase 3

Shares surge after the GSK-partnered drug, bepirovirsen, demonstrates a functional cure, paving the way for regulatory filings in early 2026.

Merck Challenges Rivals with Keytruda Combo in Lung Cancer Trial
FDA & Biotech
1mo ago

Merck Challenges Rivals with Keytruda Combo in Lung Cancer Trial

Initiates Phase 3 study for oral KRAS inhibitor calderasib, aiming to secure a first-line, chemo-free therapy in a lucrative cancer market.

Zymeworks Hits 52-Week High on 'Unprecedented' Cancer Drug Results
FDA & Biotech
1mo ago

Zymeworks Hits 52-Week High on 'Unprecedented' Cancer Drug Results

Phase 3 data shows its zanidatamab therapy extends survival past two years in stomach cancer, prompting partner Jazz Pharma to ready FDA submission.

Eli Lilly Bets on Oral Obesity Drug in $1.3B Nimbus Pact
FDA & Biotech
1mo ago

Eli Lilly Bets on Oral Obesity Drug in $1.3B Nimbus Pact

Deal reinforces Lilly's strategy to dominate the next wave of metabolic disease therapies, expanding its pipeline beyond injectable treatments.

Instil Bio Stock Collapses After Halting New Cancer Drug Program
FDA & Biotech
1mo ago

Instil Bio Stock Collapses After Halting New Cancer Drug Program

Shares plummeted nearly 50% after the company's subsidiary ended development of its AXN-2510 asset, marking another major pipeline setback for the biotech firm.

Lilly Bets Big on Oral Obesity Drug in New $1.3B Nimbus Pact
FDA & Biotech
1mo ago

Lilly Bets Big on Oral Obesity Drug in New $1.3B Nimbus Pact

The deal aims to crack the next frontier in weight-loss treatment, expanding Lilly's arsenal beyond its blockbuster injectable drugs Zepbound and Mounjaro.

Bright Minds Stock Soars 23% on Positive Epilepsy Drug Trial Data
FDA & Biotech
1mo ago

Bright Minds Stock Soars 23% on Positive Epilepsy Drug Trial Data

Phase 2 study shows significant seizure reduction in rare epilepsy syndromes, setting the stage for pivotal trials and hitting a new 52-week high.

Alumis Stock More Than Doubles on Positive Psoriasis Drug Trial Results
FDA & Biotech
1mo ago

Alumis Stock More Than Doubles on Positive Psoriasis Drug Trial Results

The biotech's oral drug, envudeucitinib, demonstrated high rates of skin clearance in Phase 3 studies, positioning it as a potential best-in-class competitor to established treatments.