tiprankstipranks
Ratings

Harmony Biosciences: Buy Rating Affirmed Despite FDA Setback, Strong Growth Potential in Pitolisant Franchise and Pipeline Opportunities

Harmony Biosciences: Buy Rating Affirmed Despite FDA Setback, Strong Growth Potential in Pitolisant Franchise and Pipeline Opportunities

Analyst Patrick Trucchio from H.C. Wainwright reiterated a Buy rating on Harmony Biosciences Holdings (HRMYResearch Report) and keeping the price target at $75.00.

Discover the Best Stocks and Maximize Your Portfolio:

Patrick Trucchio has given his Buy rating due to a combination of factors including Harmony Biosciences’ strong long-term strategy and its focus on the pitolisant franchise, specifically the high-dose (HD) formulation, which is viewed as a primary value driver for idiopathic hypersomnia (IH). Despite a recent setback with the FDA’s refusal to file a supplemental new drug application for pitolisant in IH, Trucchio maintains confidence in the company’s strategic direction, particularly with the anticipated Phase 3 trial for pitolisant HD expected to start in late 2025.
Harmony’s reaffirmation of its 2025 revenue guidance and the potential for significant growth through pipeline opportunities such as ZYN002 in Fragile X syndrome and EPX100 in epilepsy further solidify Trucchio’s positive outlook. While acknowledging potential risks, including clinical and commercialization challenges, the analyst employs a discounted cash flow and sum-of-the-parts valuation approach, leading to a calculated firm value of approximately $4.2 billion and a price target of $75, making the current market conditions an attractive entry point for investors.

In another report released today, Needham also maintained a Buy rating on the stock with a $50.00 price target.

1