Sarepta Therapeutics (SRPT) may snag an accelerated approval for its muscular dystrophy gene remedy, analysts steered Wednesday as SRPT inventory rocketed.
The view comes after Sarepta mentioned late Tuesday the Meals and Drug Administration will not maintain an advisory committee assembly to debate its gene remedy, SRPT-9001. These conferences enable consultants to debate the deserves and dangers of some medication. Now, Sarepta is probably going on the trail to accelerated FDA approval of its gene remedy, Needham analyst Gil Blum mentioned in a be aware to shoppers.
“This flip of occasions clears out potential headwinds forward of the (approval) date, turning this into a real binary,” he mentioned. “Sarepta was buying and selling up premarket and we anticipate the identify to have a robust opening this morning.”
In morning buying and selling on right now’s inventory market, SRPT inventory surged 20.3% close to 147. The information despatched shares skyrocketing above a purchase level at 134.18 out of a flat base, in accordance with MarketSmith.com.
SRPT Inventory: No Deficiencies In Utility
Sarepta’s gene remedy goals to deal with Duchenne muscular dystrophy. Sufferers with this type of the muscle-wasting illness do not make sufficient dystrophin, a protein concerned in muscle power. Sarepta’s therapy inserts a shortened model of the gene that codes for the dystrophin protein.
Promisingly, Sarepta mentioned the FDA hasn’t famous any important security considerations, Blum mentioned. Additional, the company hasn’t discovered any deficiencies within the medical information submitted to assist approval.
“We view these developments positively and imagine they additional assist our bullish place on an accelerated approval for SRPT-9001,” Blum mentioned.
He saved his purchase ranking and 200 value goal on SRPT inventory.
Shares have a robust Relative Power Score of 94, in accordance with IBD Digital. This places Sarepta inventory within the high 6% of all shares on the subject of 12-month efficiency.
Comply with Allison Gatlin on Twitter at @IBD_AGatlin.
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