Harmony Biosciences Receives FDA Approval for Wakix in Pediatric Patients
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Feb 17 2026
0mins
Should l Buy HRMY?
Harmony Biosciences' stock (HRMY) fell by 15.03% and hit a 20-day low amid broader market gains, with the Nasdaq-100 up 0.77% and the S&P 500 up 0.49%.
The company announced that its Wakix tablets received FDA approval for treating narcolepsy in pediatric patients aged 6 and older, marking a significant expansion into the pediatric market. This approval is expected to enhance Harmony's competitiveness in the pediatric neurological disorder market and reflects strong market confidence, as indicated by 8 out of 11 analysts rating the stock as 'Buy' or higher, with an average price target suggesting a potential upside of approximately 30%.
This FDA approval not only opens new market opportunities for Harmony but also positions Wakix as a unique treatment option for both pediatric and adult narcolepsy patients, potentially driving broader market acceptance and future growth.
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Analyst Views on HRMY
Wall Street analysts forecast HRMY stock price to rise
6 Analyst Rating
5 Buy
0 Hold
1 Sell
Moderate Buy
Current: 28.790
Low
32.00
Averages
43.83
High
55.00
Current: 28.790
Low
32.00
Averages
43.83
High
55.00
About HRMY
Harmony Biosciences Holdings, Inc. is a pharmaceutical company. It is focused on developing and commercializing therapies for patients living with rare neurological diseases as well as patients living with other neurological diseases who have unmet medical needs. Its product, WAKIX (pitolisant), is a first-in-class molecule with a novel mechanism of action designed to enhance histamine signaling in the brain by binding to H3 receptors. WAKIX was developed for the treatment of excessive daytime sleepiness (EDS) in pediatric patients, six years and older, with narcolepsy. HBS-102, an investigational compound, which is a melanin-concentrating hormone receptor 1 (MCHR1) antagonist. ZYN002 is an investigational drug product in development for the potential treatment of behavioral symptoms associated with Fragile X syndrome (FXS) and 22q11.2 deletion syndrome (22q). It also focused on the rare epilepsy franchise in its expanding late-stage pipeline of CNS assets: EPX-100 and EPX-200.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Wall Street Analysts Adjust Ratings
- Analyst Rating Updates: Top Wall Street analysts have adjusted their ratings on several companies, reflecting the latest market perspectives on these stocks, which could influence investor decisions and market trends.
- Overview of Rating Changes: While specific upgrades and downgrades are not detailed, the overall rating changes may lead to short-term volatility in related stocks, prompting investors to stay alert.
- Expected Market Reaction: Analyst rating adjustments typically attract market attention, potentially affecting investor confidence and trading volumes, thereby impacting stock prices.
- Impact on Investor Decisions: Investors considering buying CAVA stock should pay attention to analysts' views to make more informed investment decisions, even though specific recommendations are not provided in this article.
See More
Harmony Biosciences Q4 2025 Earnings Highlights
- Significant Revenue Growth: In Q4 2025, Harmony Biosciences reported net product revenue of $243.8 million, a 21% increase from $201.3 million in the same quarter last year, indicating strong demand in the narcolepsy market and sustained profitability.
- Sustained Patient Growth: CEO Jeffrey Dayno highlighted that the fourth quarter saw an average addition of over 400 patients, marking the first time in franchise history, showcasing WAKIX's unique competitive advantage and future growth potential.
- Robust Cash Flow: As of the end of Q4, the company had $882.5 million in cash, cash equivalents, and investments, ensuring funding for future R&D and market expansion, thereby enhancing financial flexibility within the industry.
- Optimistic Outlook: Management reiterated guidance for WAKIX net revenue of $1 billion to $1.04 billion in 2026, reflecting strong confidence in the narcolepsy market and the brand's blockbuster potential.
See More
Harmony Biosciences Q4 Earnings Analysis
- Earnings Performance: Harmony Biosciences reported a Q4 Non-GAAP EPS of $0.57, missing expectations by $0.50, indicating profitability challenges that could negatively impact investor confidence.
- Revenue Growth: The company achieved Q4 revenue of $243.78 million, a 21.1% year-over-year increase, beating market expectations by $3.46 million, suggesting sustained product demand that may lay a foundation for future performance.
- Patient Growth: The average number of patients on WAKIX increased by approximately 400 to around 8,500 in Q4, marking the third consecutive quarter of over 400 new patients, demonstrating the product's market acceptance and growth potential.
- Future Guidance: Harmony reiterated its 2026 net revenue guidance for WAKIX at $1.0 to $1.04 billion, and despite the current earnings miss, the company's confidence in future revenues may attract long-term investor interest.
See More
Harmony Biosciences Reports $868.5 Million Revenue for 2025, Guidance for 2026 Exceeds $1 Billion
- Significant Revenue Growth: Harmony Biosciences reported net product revenue of $868.5 million for 2025, reflecting a 22% year-over-year increase, driven by sustained demand for WAKIX among approximately 80,000 diagnosed narcolepsy patients, reinforcing the company's profitability and market position in the biotech sector.
- Optimistic Future Outlook: The company reiterated its 2026 WAKIX net revenue guidance of $1.0 to $1.04 billion, indicating a trajectory towards blockbuster status, showcasing the strong market potential and ongoing momentum of the Pitolisant franchise.
- Increased R&D Investment: Research and development expenses reached $49.9 million in Q4 2025, a 44% increase, demonstrating the company's commitment to advancing new drug development and expanding its product pipeline, particularly in the field of central nervous system disorders.
- Market Expansion Strategy: Harmony plans to broaden the indications for Pitolisant into larger CNS conditions, which is expected to provide new revenue growth drivers in the future, especially in the management of fatigue, thereby enhancing its competitive edge in the market.
See More
Harmony Biosciences Downgraded, Shares Drop 10%
- Rating Downgrade Impact: Deutsche Bank and Truist downgraded Harmony Biosciences from buy to hold, resulting in a ~10% drop in stock price during Monday trading, reflecting market concerns about the company's future performance.
- Intellectual Property Case Risk: Analysts highlighted that Harmony's main drug, Wakix (pitolisant), faces an intellectual property case with AET Pharma, with indications that the judge may be siding against Harmony; if exclusivity is lost, generics could enter the market as early as this year instead of 2030.
- Market Outlook Uncertainty: Truist's analyst noted that the judge's initial comments following the trial do not bode well for HRMY, increasing uncertainty around the durability of the Wakix franchise, which could impact the company's overall valuation.
- Single Value Driver: As Wakix remains the sole value driver for Harmony, concerns about its future prompted the downgrade, indicating a lack of confidence in the company's profitability moving forward.
See More
Harmony Biosciences to Announce Q4 Earnings on February 24
- Earnings Announcement Date: Harmony Biosciences Holdings, Inc. is set to release its Q4 2023 earnings on February 24 before market open, with a consensus EPS estimate of $1.07, reflecting a slight decline of 0.9% year-over-year, indicating potential challenges in profitability.
- Revenue Growth Expectations: The revenue estimate for the quarter stands at $240.32 million, representing a robust year-over-year growth of 19.4%, suggesting strong market demand and sales performance that could lay the groundwork for future growth.
- Historical Performance Review: Over the past two years, Harmony Biosciences has exceeded EPS estimates 75% of the time and revenue estimates 63% of the time, indicating a relatively stable financial performance that enhances investor confidence.
- Expectation Revision Dynamics: In the last three months, EPS estimates have seen two upward revisions and one downward revision, while revenue estimates have experienced seven upward revisions with no downward adjustments, reflecting analysts' optimistic outlook on the company's future performance, which may influence stock price movements.
See More
Wall Street Analysts Adjust Ratings
- Analyst Rating Updates: Top Wall Street analysts have adjusted their ratings on several companies, reflecting the latest market perspectives on these stocks, which could influence investor decisions and market trends.
- Overview of Rating Changes: While specific upgrades and downgrades are not detailed, the overall rating changes may lead to short-term volatility in related stocks, prompting investors to stay alert.
- Expected Market Reaction: Analyst rating adjustments typically attract market attention, potentially affecting investor confidence and trading volumes, thereby impacting stock prices.
- Impact on Investor Decisions: Investors considering buying CAVA stock should pay attention to analysts' views to make more informed investment decisions, even though specific recommendations are not provided in this article.
See More
Harmony Biosciences Q4 2025 Earnings Highlights
- Significant Revenue Growth: In Q4 2025, Harmony Biosciences reported net product revenue of $243.8 million, a 21% increase from $201.3 million in the same quarter last year, indicating strong demand in the narcolepsy market and sustained profitability.
- Sustained Patient Growth: CEO Jeffrey Dayno highlighted that the fourth quarter saw an average addition of over 400 patients, marking the first time in franchise history, showcasing WAKIX's unique competitive advantage and future growth potential.
- Robust Cash Flow: As of the end of Q4, the company had $882.5 million in cash, cash equivalents, and investments, ensuring funding for future R&D and market expansion, thereby enhancing financial flexibility within the industry.
- Optimistic Outlook: Management reiterated guidance for WAKIX net revenue of $1 billion to $1.04 billion in 2026, reflecting strong confidence in the narcolepsy market and the brand's blockbuster potential.
See More
Harmony Biosciences Q4 Earnings Analysis
- Earnings Performance: Harmony Biosciences reported a Q4 Non-GAAP EPS of $0.57, missing expectations by $0.50, indicating profitability challenges that could negatively impact investor confidence.
- Revenue Growth: The company achieved Q4 revenue of $243.78 million, a 21.1% year-over-year increase, beating market expectations by $3.46 million, suggesting sustained product demand that may lay a foundation for future performance.
- Patient Growth: The average number of patients on WAKIX increased by approximately 400 to around 8,500 in Q4, marking the third consecutive quarter of over 400 new patients, demonstrating the product's market acceptance and growth potential.
- Future Guidance: Harmony reiterated its 2026 net revenue guidance for WAKIX at $1.0 to $1.04 billion, and despite the current earnings miss, the company's confidence in future revenues may attract long-term investor interest.
See More
Harmony Biosciences Reports $868.5 Million Revenue for 2025, Guidance for 2026 Exceeds $1 Billion
- Significant Revenue Growth: Harmony Biosciences reported net product revenue of $868.5 million for 2025, reflecting a 22% year-over-year increase, driven by sustained demand for WAKIX among approximately 80,000 diagnosed narcolepsy patients, reinforcing the company's profitability and market position in the biotech sector.
- Optimistic Future Outlook: The company reiterated its 2026 WAKIX net revenue guidance of $1.0 to $1.04 billion, indicating a trajectory towards blockbuster status, showcasing the strong market potential and ongoing momentum of the Pitolisant franchise.
- Increased R&D Investment: Research and development expenses reached $49.9 million in Q4 2025, a 44% increase, demonstrating the company's commitment to advancing new drug development and expanding its product pipeline, particularly in the field of central nervous system disorders.
- Market Expansion Strategy: Harmony plans to broaden the indications for Pitolisant into larger CNS conditions, which is expected to provide new revenue growth drivers in the future, especially in the management of fatigue, thereby enhancing its competitive edge in the market.
See More
Harmony Biosciences Downgraded, Shares Drop 10%
- Rating Downgrade Impact: Deutsche Bank and Truist downgraded Harmony Biosciences from buy to hold, resulting in a ~10% drop in stock price during Monday trading, reflecting market concerns about the company's future performance.
- Intellectual Property Case Risk: Analysts highlighted that Harmony's main drug, Wakix (pitolisant), faces an intellectual property case with AET Pharma, with indications that the judge may be siding against Harmony; if exclusivity is lost, generics could enter the market as early as this year instead of 2030.
- Market Outlook Uncertainty: Truist's analyst noted that the judge's initial comments following the trial do not bode well for HRMY, increasing uncertainty around the durability of the Wakix franchise, which could impact the company's overall valuation.
- Single Value Driver: As Wakix remains the sole value driver for Harmony, concerns about its future prompted the downgrade, indicating a lack of confidence in the company's profitability moving forward.
See More
Harmony Biosciences to Announce Q4 Earnings on February 24
- Earnings Announcement Date: Harmony Biosciences Holdings, Inc. is set to release its Q4 2023 earnings on February 24 before market open, with a consensus EPS estimate of $1.07, reflecting a slight decline of 0.9% year-over-year, indicating potential challenges in profitability.
- Revenue Growth Expectations: The revenue estimate for the quarter stands at $240.32 million, representing a robust year-over-year growth of 19.4%, suggesting strong market demand and sales performance that could lay the groundwork for future growth.
- Historical Performance Review: Over the past two years, Harmony Biosciences has exceeded EPS estimates 75% of the time and revenue estimates 63% of the time, indicating a relatively stable financial performance that enhances investor confidence.
- Expectation Revision Dynamics: In the last three months, EPS estimates have seen two upward revisions and one downward revision, while revenue estimates have experienced seven upward revisions with no downward adjustments, reflecting analysts' optimistic outlook on the company's future performance, which may influence stock price movements.
See More
