Sarepta's (SRPT) New Timeline Might be Unrealistic, Says Deutsche Bank

Deutsche Bank maintained a Hold rating on Sarepta Therapeutic (NASDAQ: SRPT) and reduced its price target to $24.00 (from $35.00). Earlier Sarepta announced the FDA requires additional data as part of the NDA submission for Eteplirsen, which will delay its NDA filing for Etepliersen to mid-2015. Analyst Robyn Karnauskas said the company's timeline was aggressive and potentially unrealistic.

"Today, the company seemed surprised with the FDA’s addl requirements published in the minutes from a meeting in Sept. We note that these minutes nor the minutes from April have been made public, so we cannot fully judge their contents. When asked what changed from the Apr. meeting to now, they co could only point to the clinical site inspection in May and the release of 144 wk data. There was no indication in the minutes of any safety issues in the 144 wk data. Mgmt suggested this could be a cause of the addl requests. They also indicated that they had no idea that the FDA was going to express such serious concerns regarding the robustness of dystrophin measurement data. We question the potential disconnect between the co and the FDA," said Karnauskas.

"In the minutes, the FDA requested 3 mth data on 12-24 newly exposed pts. We note that this trial has likely not yet started enrolling (to begin next mth). The co believes that the trial enrollment will go swiftly and they will have the necessary data by 1Q15. They further est it will take another Q to prepare the data for submission in the NDA by mid-2015. We see this timeline as aggressive and potentially unrealistic," continued the analyst.

"The co noted that they will likely have more contact w/ the FDA over the next few months to determine what else may be needed for a complete NDA submission. With a filing estimated for mid-2015, we seriously question why at this point the co would not know everything that is needed to successfully complete the application. As of now the co needs to incld 3 mth data from 12-24 new pts, 168 wk biopsies (the co says that 8/12 pts will participate), patientlevel natural history, MRI data from a non-SRPT trial, all avail. data from ongoing trials, and add’l data from later time points & from newly enrolled pts," she added.

For an analyst ratings summary and ratings history on Sarepta Therapeutic click here. For more ratings news on Sarepta Therapeutic click here.

Shares of Sarepta Therapeutic closed at $23.56 yesterday.

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