Sarepta Therapeutics Shares Crumble After Regulators Request More Work to Be Done

Sarepta Therapeutics saw its share price dip on Thursday after regulators requested more work be done before approval of final-phase testing for a treatment for Duchenne muscular dystrophy.

Analysts generally viewed the action of the U.S. Food and Drug Administration as a minor delay.

SVB Leerink analyst Joseph Schwartz has maintained an outperform rating on SRPT stock and said”As the DMD gene therapy race continues to heat up, we believe investors will likely view today’s news as a noticeable but recoverable stumble for SRPT’s horse.”

According to Schwartz, the “clinical profile” of the Sarepta treatment is likely to be preferred over the Pfizer treatment.

Pfizer is also developing gene transfer therapy for the treatment of Duchenne muscular dystrophy, or DMD.
RBC analyst Brian Abrahams expects a delay of no more than six weeks and said that FDA requests like this are “easily addressable.” Abrahams also rates SRPT stock as “outperform.”

Raymond James analyst Chris Caso wrote in a note that the delay would be slight but thinks Pfizer could be first to start Phase 3. He says both companies likely will start Phase 3 trials before year-end. Caso as well has an “outperform” rating on the stock.

Last week Sarepta announced that the FDA’s Office of Tissues and Advanced Therapies requested more potency assays. The FDA wants the assays before allowing the company to give doses of its treatment to participants in Phase 3 tests.

Sarepta said it has several existing assays and data that it believes could fill the agency’s request. but needs to confer further with the agency.

“We look forward to working with (the FDA) to potentially satisfy their requests and to obtain clarity on the timing of the commencement of our commercial supply study,” Sarepta Chief Executive Doug Ingram said in the company’s release.

Disclaimer: We have no position in Sarepta Therapeutics Inc. (NASDAQ: SRPT) and have not been compensated for this article.