fda-and-biotech News

Sarepta Stock Plunges as Elevidys Sales Fall Short
FDA & Biotech
3w ago

Sarepta Stock Plunges as Elevidys Sales Fall Short

Shares tumbled nearly 12% after initial revenue from the company's cornerstone gene therapy for Duchenne muscular dystrophy disappointed investors.

Sarepta Tumbles 11% as Cautious Outlook Wipes Out Revenue Beat
FDA & Biotech
3w ago

Sarepta Tumbles 11% as Cautious Outlook Wipes Out Revenue Beat

Drugmaker surpasses Q4 estimates but withholds detailed 2026 forecast for its key gene therapy ELEVIDYS, citing deferred treatments and sparking investor concern.

Day One Biopharma Stock Soars on Strong Ojemda Sales Outlook
FDA & Biotech
3w ago

Day One Biopharma Stock Soars on Strong Ojemda Sales Outlook

Shares jumped over 18% after the company signaled strong initial sales for its newly approved pediatric brain tumor drug, Ojemda, boosting investor confidence.

Autolus Surges on Strong 2026 Revenue Forecast
FDA & Biotech
3w ago

Autolus Surges on Strong 2026 Revenue Forecast

Company signals confidence in its lead cancer therapy, obe-cel, ahead of a potential FDA approval later this year, causing shares to jump.

Lyra Therapeutics Halts Drug Development, Shares Plummet
FDA & Biotech
3w ago

Lyra Therapeutics Halts Drug Development, Shares Plummet

Company to slash workforce and seek strategic alternatives after suspending its lead sinusitis treatment, LYR-210, citing need to preserve capital.

Krystal Biotech Surges on Strong VYJUVEK Sales and Ambitious Pipeline
FDA & Biotech
3w ago

Krystal Biotech Surges on Strong VYJUVEK Sales and Ambitious Pipeline

Shares jumped after the company beat Q4 revenue estimates for its rare disease drug and outlined a plan to have four marketed medicines by 2030 at the J.P. Morgan Healthcare Conference.

Axogen Surges to 52-Week High on Strong Q4 Revenue Beat
FDA & Biotech
3w ago

Axogen Surges to 52-Week High on Strong Q4 Revenue Beat

The nerve repair specialist reported a 21.3% jump in preliminary Q4 revenue, capitalizing on the recent landmark FDA approval of its Avance nerve graft.

Ionis Doubles Olezarsen Peak Sales Forecast to Over $2 Billion
FDA & Biotech
3w ago

Ionis Doubles Olezarsen Peak Sales Forecast to Over $2 Billion

Shares hold near 52-week highs as investors weigh blockbuster potential for its sHTG drug against a staggering 200% run-up over the last year.