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 (FSD). However, clinical evidence supporting the approval is limited, and thus, 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., looks into the event and the consequences it has for Sarepta Therapeutics Inc 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. BMRN, and Translarna –from PTC Therapeutics, Inc. PTCT.

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

• While FSD is a clinical problem, eteplirsen is designed to save the lives of many people succumbing to DMD in their mid-twenties.
• 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 maintains a Buy rating and $45.00 price target on shares of Sarepta and a Neutral rating on shares of PTC Therapeutics. BioMarinis not rated.