H.C. Wainwright Reiterates Buy Rating on Harmony Biosciences Holdings Inc. (HRMY)

H.C. Wainwright analyst Patrick Trucchio reiterated a Buy rating and $75.00 price target on Harmony Biosciences Holdings Inc. (NASDAQ: HRMY).

The analyst commented: "Harmony Biosciences received an FDA Refusal to File (RTF) letter on February 19 for its supplemental new drug application (sNDA) for pitolisant in idiopathic hypersomnia (IH); however, we believe the long-term strategy remains intact with pitolisant high-dose (HD). Moreover, Harmony reaffirmed its 2025 revenue guidance of $820–$860M, which compares to our $870M estimate and the $859M FactSet consensus, underscoring continued confidence in its core WAKIX (pitolisant) franchise, in our view. Thus, while the RTF is a setback, admittedly, our valuation remains underpinned by the pitolisant HD formulation, which Harmony sees as the primary value driver in IH. With a Phase 3 trial for pitolisant HD expected to start in 4Q25 and a PDUFA (FDA action) date target in 2028 (implying an NDA filing in the 2Q27-1Q28 timeframe), we continue to view the long-term opportunity favorably. With HRMY shares down approximately 8% intraday (vs. XBI up 1%), we believe the sell-off tied to the RTF on pitolisant has created a compelling entry point; we reiterate our Buy rating and $75 price target on HRMY."

For an analyst ratings summary and ratings history on Harmony Biosciences Holdings Inc. click here. For more ratings news on Harmony Biosciences Holdings Inc. click here.

Shares of Harmony Biosciences Holdings Inc. closed at $35.32 yesterday.

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