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Sarepta plummets after a third death in its muscular dystrophy program for investigational gene therapies, prompts FDA action and intensifies safety scrutiny.

Kostas Biliouris, BMO Capital Markets biotech analyst, joins CNBC's 'Squawk on the Street' to discuss the latest details on Sarepta after the company declined the FDA's request to halt shipments of its gene therapy.

Sarepta Therapeutics has plunged to new lows below $13, down over 35% in recent trading, after rejecting the FDA's request to voluntarily halt all shipments of Elevidys following a third death tied to the gene therapy. Just days after our previous analyses highlighted the company's apparent undervaluation following its restructuring, its defiant stance has now triggered fresh investor concerns, validating the regulatory risks associated with biotech stocks.

The ground shook for Sarepta Therapeutics, Inc. SRPT last week as the U.S. Food and Drug Administration (FDA), alarmed by a third patient death tied to its gene therapy platform, pulled a rare move: requesting a voluntary halt to Elevidys shipments. The company's response?

Shares of Sarepta Therapeutics plunged more than 30% on Friday after Food and Drug Administration Commissioner Marty Makary said the agency is considering whether the company's gene therapy should stay on the market. Sarepta has reported three patient deaths related to its gene therapies.

The Food and Drug Administration (FDA) on Tuesday said it is investigating the risk of acute liver failure with serious outcomes, including hospitalization and death, following Sarepta Therapeutics, Inc.'s SRPT Elevidys treatment and evaluating the need for further regulatory action.