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: "On January 13, Harmony pre-announced 2024 preliminary net revenue from its lead product WAKIX, (pitolisant), FDA-approved in type 1 and type 2 narcolepsy (NT1 and NT2), and provided revenue guidance for 2025 (Exhibit 1). Highlights: (1) in 4Q24, Harmony expects net product revenues of approximately $201M, in-line with our estimate and consensus, and FY2024 revenues of approximately $714M, in-line our $714M estimate and vs. the $712M consensus; (2) announced 2025 net product revenue guidance between $820M-$860M (vs. our $870M estimate and the $859M consensus), on-track to a potential blockbuster opportunity, in our view; (3) anticipates a decision by the FDA on the filing of the supplemental New Drug Application (NDA) submitted in 4Q24 for WAKIX in the treatment of idiopathic hypersomnia (IH), in 1Q25, with potential approval later in 2025, in our view; (4) expects additional preclinical data on BP1.15205, an OX2R agonist, at the SLEEP 2025 Annual Conference taking place on June 8-11 in Seattle, WA, which we believe has best-in-class potential for the treatment of narcolepsy and other sleep/wake disorders; (5) on-track to file an Investigational New Drug (IND) application for BP1.15205 in mid-2025, implying the potential initiation of first-in-human studies in 3Q25, if accepted; (6) expects top-line data from a pivotal Phase 3 trial evaluating ZYN002, cannabidiol gel, in Fragile X syndrome (FXS), in 3Q25; (7) expects a Phase 3 trial evaluating pitolisant-HD in narcolepsy and IH to initiate in 4Q25; and (8) initiated a Phase 3 study in Lennox-Gastaut syndrome (LGS) with EPX-100, clemizole hydrochloride, a 5HT2 agonist, in 4Q24. We reiterate our $75 price target and Buy rating and on HRMY shares."

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 $38.54 yesterday.

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