Treating Female Sexual Dysfunction (And How To Invest In It)

On Tuesday, the FDA approved Flibanserin, a product developed by privately held Sprout Pharmaceuticals, as the first pharmacologic therapy for female sexual dysfunction. However, clinical evidence supporting the approval is limited, and the consent comes with a Black Box warning, REMS, and three additional studies.

In a report issued Wednesday, Roth Capital Partners analyst Debjit Chattopadhyay, Ph.D., looked into the event and the consequences it has for Sarepta Therapeutics Inc (NASDAQ: SRPT). The expert concludes that this move by the agency can be seen “as another sign of flexibility especially for first-in-class therapies,” which bodes well for eteplirsen (from Sarepta), drisapersen (from BioMarin Pharmaceutical Inc. (NASDAQ: BMRN)) and Translarna (from PTC Therapeutics, Inc. (NASDAQ: PTCT)).

The note highlights a few key points to take into account:

• While FSD is a clinical problem, eteplirsen is designed to save the lives of many people succumbing to DMD in their mid-20s.
• Several “ongoing studies clear an important bottleneck.”
• The re-scoring of Dystrophin eliminated “the second key bottle neck allowing NDA submission to proceed (…) Positive findings support the mechanism of action of eteplirsen.”
• The fourth biopsy analysis is being completed in the most robust way possible.
• Roth Capital expects NDA acceptance within the next few weeks, with no RTF given the interactions Sarepta has had with the FDA over the past three years.

The firm maintained a Buy rating and $45.00 price target on shares of Sarepta and a Neutral rating on shares of PTC Therapeutics. BioMarinis not rated.