Sarepta TherapeuticsNASDAQ: SRPT

Previously, Sarepta's gene therapy treatment Elevidys was approved for only a limited number of Duchenne muscular dystrophy patients. Regulators, however, have expanded that range, and it can now be used to treat patients who are 4 and older.

Sarepta Therapeutics' most important medicine now looks even more promising. The biotech's financial results are improving substantially.

Sarepta Therapeutics (SRPT) witnessed a jump in share price last session on above-average trading volume. The latest trend in earnings estimate revisions for the stock suggests that there could be more strength down the road.

Sarepta Therapeutics excels in rare disease therapies using RNA, gene editing, and gene therapies, with significant revenue growth driven by ELEVIDYS gene therapy approval. Despite missing the primary endpoint, ELEVIDYS hit key secondary endpoints, leading to FDA approval for all DMD patients ages 4 and older. Now with a label that covers roughly 80% of the DMD population, Sarepta is positioned for explosive growth in the DMD market.

Douglas Ingram, Sarepta CEO, joins 'Fast Money' to talk FDA approval of Elevidys and its impact on the company's stock.

Sarepta Therapeutics Inc (NASDAQ:SRPT) shares soared almost 35% after the US Food and Drug Administration (FDA) approved the expanded use of its gene therapy Elevidys for patients with Duchenne muscular dystrophy (DMD). DMD is a rare genetic condition which causes weakness and the wasting away of the body's muscles, with symptoms including trouble walking and running, falling frequently, fatigue and learning disabilities or difficulties.

Sarepta Therapeutics (NASDAQ: SRPT ) stock jumped about 30% overnight after the Food and Drug Administration (FDA) approved one of its gene therapies for children with Duchenne muscular dystrophy (DMD). Peter Marks, director of the Center for Biologics Evaluation and Research, overruled three research teams and his top lieutenants in making the decision.

Sarepta Therapeutics (SRPT) shares soared in premarket trading Friday, a day after the Food and Drug Administration (FDA) allowed expanded use of the biotech's treatment for a rare muscle disease in children, which especially affects boys.

Sarepeta Therapeutics Inc.'s stock soared 38% in premarket trade Friday, after the biotech said the U.S. regulator has approved an expanded indication of its treatment for the rare muscle disorder Duchenne muscular dystrophy.