Core Viewpoint - Harmony Biosciences received a Refusal to File (RTF) letter from the FDA for pitolisant for excessive daytime sleepiness (EDS) in adult patients with idiopathic hypersomnia (IH), but the company's 2025 net revenue guidance remains unchanged at $820 million to $860 million [1]. Group 1: Company Developments - The CEO of Harmony Biosciences expressed disappointment over the RTF letter but reaffirmed the long-term strategy for pitolisant in IH, with plans to initiate a Phase 3 registrational trial in Q4 2025 and a target PDUFA date in 2028 [2]. - Despite the primary outcome for EDS not reaching statistical significance in the Phase 3 INTUNE Study, open-label phase data indicated that patients experienced improvements on the Epworth Sleepiness Scale that were five times greater than clinically meaningful levels [2]. - Most patients in the long-term extension study achieved normal wakefulness levels and maintained this response beyond one year [3]. Group 2: Financial Performance - In January, Harmony reported preliminary net product revenue for Q4 of approximately $201 million, up from $168.4 million year-over-year, exceeding the consensus estimate of $198.6 million [4]. - The average number of patients on Wakix increased by approximately 300 sequentially to around 7,100 for the quarter ended December 31, 2024 [4]. Group 3: Market Reaction - Following the news, HRMY stock declined by 6.50% to $36.55 [5].

Investors with an interest in Medical - Biomedical and Genetics stocks have likely encountered both Harmony Biosciences Holdings, Inc. (HRMY) and BeiGene, Ltd. (ONC) . But which of these two stocks is more attractive to value investors? We'll need to take a closer look to find out. The best way to find great value stocks is to pair a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system. The Zacks Rank is a proven strategy that targets companies with positive earnings e ...

Investors seek growth stocks to capitalize on above-average growth in financials that help these securities grab the market's attention and produce exceptional returns. But finding a great growth stock is not easy at all.In addition to volatility, these stocks carry above-average risk by their very nature. Also, one could end up losing from a stock whose growth story is actually over or nearing its end.However, the task of finding cutting-edge growth stocks is made easy with the help of the Zacks Growth Sty ...

Shares of Harmony Biosciences Holdings, Inc. (HRMY) have gained 13.5% over the past four weeks to close the last trading session at $39.54, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $51 indicates a potential upside of 29%.The average comprises 10 short-term price targets ranging from a low of $28 to a high of $75, with a standard deviation of $13.58. While the lowest estim ...

Core Insights - Harmony Biosciences Holdings, Inc. (HRMY) is currently viewed as a better value opportunity compared to Repligen (RGEN) for investors interested in Medical - Biomedical and Genetics stocks [1] Valuation Metrics - HRMY has a forward P/E ratio of 12.06, significantly lower than RGEN's forward P/E of 99.13 [5] - HRMY's PEG ratio stands at 0.51, indicating a favorable valuation relative to its expected earnings growth, while RGEN's PEG ratio is much higher at 4.76 [5] - HRMY's P/B ratio is 3.71, compared to RGEN's P/B of 4.70, suggesting HRMY is more attractively priced relative to its book value [6] Zacks Rank and Style Scores - HRMY holds a Zacks Rank of 1 (Strong Buy), indicating a positive earnings outlook, while RGEN has a Zacks Rank of 3 (Hold) [3] - Based on the Style Scores system, HRMY has a Value grade of A, whereas RGEN has a Value grade of D, further supporting HRMY as the preferred choice for value investors [6]

If you like what you have just read and want to receive at least 4 exclusive stock tips every week focused on Pharma, Biotech and Healthcare, then join me at my marketplace channel, Haggerston BioHealth . Invest alongside the model portfolio or simply access the investment bank-grade financial models and research. I hope to see you there.Harmony Biosciences Holdings, Inc. (NASDAQ: HRMY ) is a Pennsylvania based, commercial stage pharmaceutical company that it is best known for marketing and selling Wakix (p ...

Core Viewpoint - Harmony Biosciences Holdings, Inc. (HRMY) is experiencing solid improvement in earnings estimates, which may lead to continued short-term price momentum and an improving earnings outlook [1][2]. Estimate Revisions - The upward trend in earnings estimate revisions indicates growing analyst optimism regarding Harmony Biosciences' earnings prospects, which is expected to positively impact its stock price [2]. - For the current quarter, the earnings estimate is $0.73 per share, reflecting a +62.22% change from the previous year [4]. - The Zacks Consensus Estimate for the current quarter has increased by 5.49% over the last 30 days, with one estimate moving higher and no negative revisions [4]. - For the full year, the earnings estimate stands at $2.43 per share, representing a +14.08% change from the previous year [5]. - The consensus estimate for the current year has increased by 15.8%, with one estimate moving higher and no negative revisions [5]. Zacks Rank - The positive estimate revisions have led Harmony Biosciences to achieve a Zacks Rank 1 (Strong Buy), indicating strong potential for outperformance [6]. - Stocks with Zacks Rank 1 (Strong Buy) and 2 (Buy) have historically outperformed the S&P 500 [6]. Stock Performance - Harmony Biosciences shares have increased by 8.3% over the past four weeks, suggesting investor confidence in its earnings growth prospects [7].

Group 1 - Harmony Biosciences Holdings, Inc. (HRMY) shares have increased by 8.3% over the past four weeks, closing at $36.42, with a mean price target of $50.80 indicating a potential upside of 39.5% [1] - The mean estimate consists of 10 short-term price targets with a standard deviation of $13.43, where the lowest estimate is $28 (23.1% decline) and the highest is $75 (105.9% increase) [2] - Analysts show strong agreement in revising earnings estimates higher, with the Zacks Consensus Estimate for the current year increasing by 15.8% over the last 30 days [9][10] Group 2 - HRMY holds a Zacks Rank 1 (Strong Buy), placing it in the top 5% of over 4,000 ranked stocks based on earnings estimates [11] - The clustering of price targets with a low standard deviation suggests a high degree of agreement among analysts regarding the stock's price movement [7] - While price targets may not be reliable indicators of actual price movements, they can provide a directional guide for potential stock performance [12]

Investors interested in stocks from the Medical - Biomedical and Genetics sector have probably already heard of Harmony Biosciences Holdings, Inc. (HRMY) and Repligen (RGEN) . But which of these two companies is the best option for those looking for undervalued stocks? Let's take a closer look.The best way to find great value stocks is to pair a strong Zacks Rank with an impressive grade in the Value category of our Style Scores system. The Zacks Rank is a proven strategy that targets companies with positiv ...

Company Participation in Industry Events - Harmony Biosciences Holdings Inc will participate in the 43rd Annual J P Morgan Healthcare Conference in San Francisco CA on January 15 2025 [1] - Jeffrey M Dayno MD President and Chief Executive Officer is scheduled to present at the conference at 11:15 am PT 2:15 pm ET [1] - A webcast of the fireside chat will be available on the investor page of Harmony's website [1] Company Overview - Harmony Biosciences is a pharmaceutical company focused on developing and commercializing innovative therapies for patients with rare neurological diseases [2] - The company is driven by novel science visionary thinking and a commitment to addressing unmet medical needs [2] - Established by Paragon Biosciences LLC in 2017 and headquartered in Plymouth Meeting PA [2] - The company aims to create a better future through therapeutic innovations culture and community programs [2] Contact Information - Investor contact Brennan Doyle can be reached at 484-539-9700 or via email [3] - Media contact Cate McCanless can be reached at 202-641-6086 or via email [3]