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Why Is Sarepta Therapeutics (SPRT) Stock Down 20% Today?
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Shares of Sarepta Therapeutics (SRPT - Free Report) fell nearly 20% in early morning trading Thursday after new reports suggested that the Food and Drug Administration may force the company to offer its Duchenne muscular dystrophy (DMD) drug to patients at cost.
The rumors are swirling based on an FDA press release that detailed plans for the regulatory body to streamline its expanded access program. This process, often called “compassionate use,” allows doctors to individually request access to investigational drugs for their patients.
“The FDA has a long history of supporting patient access to investigational treatments and we hope the information released today will help health care professionals, patients, and industry to more easily navigate the expanded access process and help patients who qualify to gain access to potentially life-saving investigational treatments,” the agency said.
While the new process could allow Sarepta to offer its eteplirsen drug to patients with DMD without first receiving FDA approval, another caveat of the compassionate use program is that drug makers must only charge patients enough to recoup manufacturing costs.
It is important to note that Sarepta and eteplirsen were not mentioned specifically in the FDA’s statement. However, it appears that investors are connecting the dots between today’s announcement and the agency’s decision to delay its ruling on eteplirsen last week.
Sarepta has been fighting an uphill battle against the FDA to get eteplirsen approved. The agency has already turned down the drug twice this year, but last week’s delay caused some to regain hope that the FDA might still approve the DMD drug.
Duchenne muscular dystrophy, which currently has not approved treatments, is a rare degenerative disorder that causes weakness in the arms and legs and eventually death. DMD affects about one in 3,600 boys.
FDA approval is necessary for Sarepta, as the compassionate use program will probably not be economically feasible for the company in the long-term.
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Why Is Sarepta Therapeutics (SPRT) Stock Down 20% Today?
Shares of Sarepta Therapeutics (SRPT - Free Report) fell nearly 20% in early morning trading Thursday after new reports suggested that the Food and Drug Administration may force the company to offer its Duchenne muscular dystrophy (DMD) drug to patients at cost.
The rumors are swirling based on an FDA press release that detailed plans for the regulatory body to streamline its expanded access program. This process, often called “compassionate use,” allows doctors to individually request access to investigational drugs for their patients.
“The FDA has a long history of supporting patient access to investigational treatments and we hope the information released today will help health care professionals, patients, and industry to more easily navigate the expanded access process and help patients who qualify to gain access to potentially life-saving investigational treatments,” the agency said.
While the new process could allow Sarepta to offer its eteplirsen drug to patients with DMD without first receiving FDA approval, another caveat of the compassionate use program is that drug makers must only charge patients enough to recoup manufacturing costs.
It is important to note that Sarepta and eteplirsen were not mentioned specifically in the FDA’s statement. However, it appears that investors are connecting the dots between today’s announcement and the agency’s decision to delay its ruling on eteplirsen last week.
Sarepta has been fighting an uphill battle against the FDA to get eteplirsen approved. The agency has already turned down the drug twice this year, but last week’s delay caused some to regain hope that the FDA might still approve the DMD drug.
Duchenne muscular dystrophy, which currently has not approved treatments, is a rare degenerative disorder that causes weakness in the arms and legs and eventually death. DMD affects about one in 3,600 boys.
FDA approval is necessary for Sarepta, as the compassionate use program will probably not be economically feasible for the company in the long-term.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>