Harmony Biosciences Receives FDA Approval for Wakix Label Expansion
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
0mins
Should l Buy HRMY?
Source: seekingalpha
- Label Expansion: Harmony Biosciences announced that its sleep disorder therapy Wakix has received FDA approval for use in children aged six and older with narcolepsy, marking a strategic expansion into the pediatric market.
- Drug Background: Wakix (pitolisant) was initially approved by the FDA in 2019 for treating excessive daytime sleepiness in adults with narcolepsy and was further expanded in 2020 to include adults with cataplexy, indicating its broad therapeutic potential.
- Market Outlook: This approval not only opens the pediatric market for Harmony Biosciences but also has the potential to enhance the market value of pitolisant through the development of next-generation formulations, strengthening the company's position in a competitive pharmaceutical landscape.
- CEO's Vision: CEO Jeffrey Dayno remarked that the company is focused on further growing and expanding the value of pitolisant through additional indications and new formulations, reflecting a positive outlook on future market opportunities.
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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: 36.010
Low
32.00
Averages
43.83
High
55.00
Current: 36.010
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.
Harmony Biosciences Receives FDA Approval for Wakix Label Expansion
- Label Expansion: Harmony Biosciences announced that its sleep disorder therapy Wakix has received FDA approval for use in children aged six and older with narcolepsy, marking a strategic expansion into the pediatric market.
- Drug Background: Wakix (pitolisant) was initially approved by the FDA in 2019 for treating excessive daytime sleepiness in adults with narcolepsy and was further expanded in 2020 to include adults with cataplexy, indicating its broad therapeutic potential.
- Market Outlook: This approval not only opens the pediatric market for Harmony Biosciences but also has the potential to enhance the market value of pitolisant through the development of next-generation formulations, strengthening the company's position in a competitive pharmaceutical landscape.
- CEO's Vision: CEO Jeffrey Dayno remarked that the company is focused on further growing and expanding the value of pitolisant through additional indications and new formulations, reflecting a positive outlook on future market opportunities.
See More
Harmony Receives FDA Approval for Wakix in Pediatric Narcolepsy
- FDA Approval Milestone: Harmony Biosciences announced that its Wakix tablets have received FDA approval for treating narcolepsy in pediatric patients aged 6 and older, marking an expansion of the drug's application in the pediatric population and expected to significantly enhance the company's competitiveness in the pediatric neurological disorder market.
- Positive Market Reaction: Following the FDA approval announcement, Harmony's stock (HRMY) rose by 2% on Tuesday, reflecting investor optimism regarding the company's future growth potential, particularly in the unique pediatric narcolepsy treatment space.
- Analyst Ratings Optimistic: According to Koyfin data, 8 out of 11 analysts covering the stock rate it as 'Buy' or higher, indicating strong market confidence in Harmony's future performance, with an average price target of $46.73, suggesting a potential upside of approximately 30%.
- Unique Treatment Option: Wakix is now the first and only FDA-approved non-controlled substance treatment for both pediatric and adult narcolepsy patients with or without cataplexy, a significant distinction that enhances its clinical utility and may drive broader market acceptance.
See More
Harmony Biosciences CFO Executes Stock Sale
- Executive Stock Sale: Sandip Kapadia, CFO of Harmony Biosciences, sold 3,746 shares on January 26, 2026, for approximately $139,171, indicating his market activity, although this transaction is significantly below his recent median sale size of 13,494 shares.
- Holding Changes: Following this transaction, Kapadia's direct holdings decreased from over 127,000 shares in March 2023 to 24,521 shares, reflecting a potential decline in confidence regarding the company's future, yet he still retains shares valued at approximately $916,105.
- Strong Financial Performance: Harmony Biosciences has shown robust financial results in FY 2025, with expectations to exceed $1 billion in revenue from WAKIX alone by the end of 2026, highlighting the company's market potential and competitive edge in rare neurological disease treatments.
- Long-Term Growth Outlook: The company is also advancing other medications, which are projected to generate sufficient revenue to support operations well into 2040, particularly against the backdrop of a 10% expected growth in 2025, reinforcing its position in the biomedical sector.
See More
Harmony Biosciences CFO Sells Shares
- Executive Stock Sale: Sandip Kapadia, CFO of Harmony Biosciences, executed an open-market sale of 3,746 shares on January 26, 2026, totaling approximately $139,171, indicating confidence in the company's future prospects.
- Ownership Changes: Although Kapadia sold all his direct shares on January 15, his stock options and restricted stock units vested on January 24 and 25, allowing him to regain partial ownership, reflecting ongoing executive commitment to the company.
- Strong Financial Performance: Harmony Biosciences has shown robust performance in FY 2025, particularly in Q3 2025, where it achieved its highest net income since Q3 2022, underscoring its competitive position in the biopharmaceutical sector.
- Future Revenue Expectations: The company anticipates over $1 billion in revenue from WAKIX alone by the end of 2026, and with advancements in other drug developments, Harmony Biosciences is positioned to operate effectively into 2040.
See More
Harmony Biosciences CFO Fully Exits Equity Ownership
- Executive Sell-Off: Harmony Biosciences CFO Sandip Kapadia executed an open-market sale of 20,961 shares on January 15, 2026, totaling approximately $752,800, marking a complete exit from direct equity ownership and reflecting a trend of gradual divestment over the past year.
- Context of Divestment: This sale represents the final step in Kapadia's series of stock sales, which reduced his holdings from 72,948 shares to zero, potentially indicating a shift in confidence regarding the company's future prospects.
- Price Comparison: The weighted average sale price was $35.92 per share, slightly below the market close of $36.41 on January 15, 2026, suggesting that the market still holds a favorable view of the stock despite the executive's exit.
- Financial Outlook: Harmony Biosciences anticipates over $1 billion in revenue from WAKIX alone by the end of 2026, and with strong financial results and ongoing drug development, the company presents a promising investment opportunity in the biopharmaceutical sector.
See More
Harmony Biosciences CFO Fully Exits Equity Ownership
- Executive Share Sale: Harmony Biosciences CFO Sandip Kapadia executed an open-market sale of 20,961 shares on January 15, 2026, totaling approximately $752,800, fully exiting direct equity ownership, indicating a potential decline in confidence regarding the company's future prospects.
- Historical Trading Comparison: This sale reduced Kapadia's direct holdings from 72,948 shares to zero, reflecting a series of prior dispositions over the past year, which may suggest a reassessment of the company's outlook.
- Transaction Price Analysis: The weighted average sale price was $35.92 per share, slightly below the market close of $36.41 on January 15, 2026, indicating that the executive chose to exit at a near-peak market price, which could impact investor sentiment.
- Company Financial Outlook: Despite the executive's sell-off, Harmony Biosciences has shown strong performance in FY 2025, with expectations to exceed $1 billion in revenue from WAKIX alone by the end of 2026, highlighting the company's potential and long-term growth opportunities in the biopharmaceutical sector.
See More
Harmony Biosciences Receives FDA Approval for Wakix Label Expansion
- Label Expansion: Harmony Biosciences announced that its sleep disorder therapy Wakix has received FDA approval for use in children aged six and older with narcolepsy, marking a strategic expansion into the pediatric market.
- Drug Background: Wakix (pitolisant) was initially approved by the FDA in 2019 for treating excessive daytime sleepiness in adults with narcolepsy and was further expanded in 2020 to include adults with cataplexy, indicating its broad therapeutic potential.
- Market Outlook: This approval not only opens the pediatric market for Harmony Biosciences but also has the potential to enhance the market value of pitolisant through the development of next-generation formulations, strengthening the company's position in a competitive pharmaceutical landscape.
- CEO's Vision: CEO Jeffrey Dayno remarked that the company is focused on further growing and expanding the value of pitolisant through additional indications and new formulations, reflecting a positive outlook on future market opportunities.
See More
Harmony Receives FDA Approval for Wakix in Pediatric Narcolepsy
- FDA Approval Milestone: Harmony Biosciences announced that its Wakix tablets have received FDA approval for treating narcolepsy in pediatric patients aged 6 and older, marking an expansion of the drug's application in the pediatric population and expected to significantly enhance the company's competitiveness in the pediatric neurological disorder market.
- Positive Market Reaction: Following the FDA approval announcement, Harmony's stock (HRMY) rose by 2% on Tuesday, reflecting investor optimism regarding the company's future growth potential, particularly in the unique pediatric narcolepsy treatment space.
- Analyst Ratings Optimistic: According to Koyfin data, 8 out of 11 analysts covering the stock rate it as 'Buy' or higher, indicating strong market confidence in Harmony's future performance, with an average price target of $46.73, suggesting a potential upside of approximately 30%.
- Unique Treatment Option: Wakix is now the first and only FDA-approved non-controlled substance treatment for both pediatric and adult narcolepsy patients with or without cataplexy, a significant distinction that enhances its clinical utility and may drive broader market acceptance.
See More
Harmony Biosciences CFO Executes Stock Sale
- Executive Stock Sale: Sandip Kapadia, CFO of Harmony Biosciences, sold 3,746 shares on January 26, 2026, for approximately $139,171, indicating his market activity, although this transaction is significantly below his recent median sale size of 13,494 shares.
- Holding Changes: Following this transaction, Kapadia's direct holdings decreased from over 127,000 shares in March 2023 to 24,521 shares, reflecting a potential decline in confidence regarding the company's future, yet he still retains shares valued at approximately $916,105.
- Strong Financial Performance: Harmony Biosciences has shown robust financial results in FY 2025, with expectations to exceed $1 billion in revenue from WAKIX alone by the end of 2026, highlighting the company's market potential and competitive edge in rare neurological disease treatments.
- Long-Term Growth Outlook: The company is also advancing other medications, which are projected to generate sufficient revenue to support operations well into 2040, particularly against the backdrop of a 10% expected growth in 2025, reinforcing its position in the biomedical sector.
See More
Harmony Biosciences CFO Sells Shares
- Executive Stock Sale: Sandip Kapadia, CFO of Harmony Biosciences, executed an open-market sale of 3,746 shares on January 26, 2026, totaling approximately $139,171, indicating confidence in the company's future prospects.
- Ownership Changes: Although Kapadia sold all his direct shares on January 15, his stock options and restricted stock units vested on January 24 and 25, allowing him to regain partial ownership, reflecting ongoing executive commitment to the company.
- Strong Financial Performance: Harmony Biosciences has shown robust performance in FY 2025, particularly in Q3 2025, where it achieved its highest net income since Q3 2022, underscoring its competitive position in the biopharmaceutical sector.
- Future Revenue Expectations: The company anticipates over $1 billion in revenue from WAKIX alone by the end of 2026, and with advancements in other drug developments, Harmony Biosciences is positioned to operate effectively into 2040.
See More
Harmony Biosciences CFO Fully Exits Equity Ownership
- Executive Sell-Off: Harmony Biosciences CFO Sandip Kapadia executed an open-market sale of 20,961 shares on January 15, 2026, totaling approximately $752,800, marking a complete exit from direct equity ownership and reflecting a trend of gradual divestment over the past year.
- Context of Divestment: This sale represents the final step in Kapadia's series of stock sales, which reduced his holdings from 72,948 shares to zero, potentially indicating a shift in confidence regarding the company's future prospects.
- Price Comparison: The weighted average sale price was $35.92 per share, slightly below the market close of $36.41 on January 15, 2026, suggesting that the market still holds a favorable view of the stock despite the executive's exit.
- Financial Outlook: Harmony Biosciences anticipates over $1 billion in revenue from WAKIX alone by the end of 2026, and with strong financial results and ongoing drug development, the company presents a promising investment opportunity in the biopharmaceutical sector.
See More
Harmony Biosciences CFO Fully Exits Equity Ownership
- Executive Share Sale: Harmony Biosciences CFO Sandip Kapadia executed an open-market sale of 20,961 shares on January 15, 2026, totaling approximately $752,800, fully exiting direct equity ownership, indicating a potential decline in confidence regarding the company's future prospects.
- Historical Trading Comparison: This sale reduced Kapadia's direct holdings from 72,948 shares to zero, reflecting a series of prior dispositions over the past year, which may suggest a reassessment of the company's outlook.
- Transaction Price Analysis: The weighted average sale price was $35.92 per share, slightly below the market close of $36.41 on January 15, 2026, indicating that the executive chose to exit at a near-peak market price, which could impact investor sentiment.
- Company Financial Outlook: Despite the executive's sell-off, Harmony Biosciences has shown strong performance in FY 2025, with expectations to exceed $1 billion in revenue from WAKIX alone by the end of 2026, highlighting the company's potential and long-term growth opportunities in the biopharmaceutical sector.
See More
