Zevra Therapeutics, Inc. (ZVRA) PT Raised to $20 at H.C. Wainwright

H.C. Wainwright analyst Oren Livnat raised the price target on Zevra Therapeutics, Inc. (NASDAQ: ZVRA) to $20.00 (from $18.00) while maintaining a Buy rating.

The analyst commented: "The FDA approved Zevra’s arimoclomol (brand name Miplyffa) to Niemann-Pick disease type C (NPC) on September 20. This follows the positive 11-5 AdCom vote, and came a day ahead of the August 21 PDUFA. Arimoclomol is the first-ever approved therapy for NPC, and we believe its approval will be greeted with enthusiasm in the highly-concentrated NPC community, both within the existing Expanded Access Program (EAP) population (~70 U.S. patients) on arimoclomol, and in the broader community of ~350 actively-treated U.S. NPC patients. We view this as a transformative event for Zevra, as we project peak arimoclomol sales of ~$250M (vs. Zevra’s current <$20M revenue base), and that is just U.S., not yet including any value for ex-US where there are ~250 patients in EAPs. Further this approval should also net Zevra a rare pediatric disease priority review voucher (PRV) worth at least $100M, with the most recent PRV sale we’re aware of near $160M; perhaps reflecting increasing scarcity value given the PRV program still set to sunset at the end of this month. Our arimoclomol projections are above consensus. We believe the Street underestimates the EAP “install base” conversion to paid therapy, as well as the patients likely warehoused by treating physicians—including physicians experienced with the product—who haven’t been able to get into the EAP. Further, we note that the launch has the benefit of Zevra already having orphan-disease commercial infrastructure in place, including market access and hub-services and Olpruva reps in the field calling on overlapping centers of excellence treating genetic and metabolic disorders. We expect the product to be commercially available by December. We incrementally further de-risk our ZVRA valuation, and raise our price target to $20 from $18. Reiterate Buy."

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