Gold prices edge higher with focus on Ukraine-Russia, Jackson Hole
On Thursday, Mizuho (NYSE:MFG) Securities maintained an Outperform rating on Harmony Biosciences Holdings Inc. (NASDAQ:HRMY), but reduced the stock’s price target from $52.00 to $42.00. The revision follows a setback for the company as the U.S. Food and Drug Administration (FDA) issued a Refusal to File letter regarding Harmony (JO:HARJ)’s Wakix treatment for idiopathic hypersomnia (IH). The news has impacted the stock, which is currently trading at $35.32, having declined nearly 10% over the past week according to InvestingPro data.
The decision to adjust the price target is based on several key changes to Mizuho’s model. These include the removal of the Wakix IH opportunity, which had previously assumed a 40% probability of success. Additionally, the launch timeline for pitolisant-HD in IH has been moved up to better align with Harmony’s projected timeline. The model also now incorporates for the first time the preannounced fourth-quarter 2024 revenue and initial 2025 revenue guidance for Wakix. Despite these challenges, InvestingPro data shows the company maintains excellent financial health with strong profitability metrics, including a 78.7% gross margin and solid cash flows that exceed debt obligations.
Despite the FDA’s refusal to file letter being a setback to the bullish case for Harmony Biosciences, Mizuho analysts anticipate that the upcoming fourth-quarter 2024 results, which are expected next week, could offer some insight into the company’s future. Furthermore, the potential for positive Phase 3 data for ZYN-002 in Fragile X Syndrome (FXS) is seen as a potential catalyst for the stock.
The new price target implies a 19% upside potential for Harmony Biosciences stock, which is why Mizuho continues to recommend the stock with an Outperform rating. The firm’s analysts are looking ahead to the next developments that could influence the company’s trajectory and investor sentiment.
In other recent news, Harmony Biosciences has received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for their drug pitolisant, intended for treating excessive daytime sleepiness in adults with idiopathic hypersomnia. Despite this regulatory setback, the company maintains its 2025 revenue guidance of $820-$860 million. Deutsche Bank (ETR:DBKGn) has initiated coverage on Harmony Biosciences with a Buy rating and a $55 price target, highlighting the company’s successful commercial track record with its narcolepsy treatment, Wakix. H.C. Wainwright also reaffirmed a Buy rating, maintaining a $75 price target, and noted Harmony’s recent pre-announcement of its 2024 preliminary net revenue. The company expects fourth-quarter 2024 net product revenues of about $201 million and full-year revenues of roughly $714 million. Harmony anticipates initiating a Phase 3 trial for a higher-dose formulation of pitolisant in the fourth quarter of 2025. Additionally, Harmony is set to release top-line data from a Phase 3 trial evaluating ZYN002, a cannabidiol gel, in Fragile X syndrome by the third quarter of 2025. The company is also planning a Phase 3 trial for pitolisant-HD in narcolepsy and idiopathic hypersomnia in the fourth quarter of 2025.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.