Harmony Biosciences Announces Encouraging Outcomes for Pitolisant GR; Aims to Submit NDA in Early 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 24 2025
0mins
Should l Buy HRMY?
Source: NASDAQ.COM
Bioequivalence Study Results: Harmony Biosciences announced that its pitolisant gastro-resistant formulation is bioequivalent to the marketed pitolisant tablet, with both containing 17.8 mg of the active ingredient.
Dosing Optimization Findings: A dosing-optimization study indicated that all patients could begin treatment at the therapeutic dose of 17.8 mg without the need for dose titration.
Future Plans for Drug Application: The company plans to submit a new drug application for the pitolisant GR formulation in early 2026, aiming for a PDUFA date in the first quarter of 2027.
Market Response: Following the announcement, Harmony Biosciences shares saw a slight increase of 0.32% in pre-market trading, reaching $34.42.
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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: 35.850
Low
32.00
Averages
43.83
High
55.00
Current: 35.850
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 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 CFO Sells Shares Amid Strong Earnings
- Executive Sell-off: Sandip Kapadia, CFO of Harmony Biosciences, sold 20,961 shares on January 15, 2026, for approximately $752,800, fully exiting direct equity ownership, which may indicate a cautious outlook on the company's future.
- Strong Earnings Report: The company reported its highest net income since Q3 2022 in Q3 2025, highlighting robust performance in the rare neurological disease treatment market, with expectations to exceed $1 billion in revenue from its WAKIX product by the end of 2026.
- Future Outlook: Harmony Biosciences anticipates sufficient revenue to sustain operations into 2040, bolstered by several medications advancing to later stages of development, showcasing its long-term potential in the biopharmaceutical sector.
- Investment Appeal: With a strong financial performance and a projected 10% growth in 2025, HRMY presents itself as an attractive biomedical investment option, drawing significant investor interest.
See More
Harmony Biosciences: Future Prospects and Challenges Ahead
- Patent Protection Extension: Harmony Biosciences' primary drug, Wakix, is set to lose patent exclusivity in 2030, but the development of Pitolisant GR could extend its patent protection into the 2040s, enhancing its competitive position in the narcolepsy market.
- Clinical Trial Progress: Pitolisant HD is currently in phase 3 trials aimed at treating sleep inertia in patients with idiopathic hypersomnia, with topline data expected in 2027, and positive results could pave the way for FDA approval in 2028.
- New Drug Pipeline: Harmony is also developing BP1.15205 and EPX-100, targeting various sleep/wake disorders and showing promise in treating Dravet and Lennox-Gastaut syndromes, with key data anticipated in 2024 that could influence future FDA decisions.
- Investor Confidence Issues: Despite Harmony's strong financial performance, lingering doubts from a 2023 short-seller report have negatively impacted investor sentiment, leading to poor stock performance; however, its relatively attractive valuation offers a margin of safety for potential investors.
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 CFO Sells Shares Amid Strong Earnings
- Executive Sell-off: Sandip Kapadia, CFO of Harmony Biosciences, sold 20,961 shares on January 15, 2026, for approximately $752,800, fully exiting direct equity ownership, which may indicate a cautious outlook on the company's future.
- Strong Earnings Report: The company reported its highest net income since Q3 2022 in Q3 2025, highlighting robust performance in the rare neurological disease treatment market, with expectations to exceed $1 billion in revenue from its WAKIX product by the end of 2026.
- Future Outlook: Harmony Biosciences anticipates sufficient revenue to sustain operations into 2040, bolstered by several medications advancing to later stages of development, showcasing its long-term potential in the biopharmaceutical sector.
- Investment Appeal: With a strong financial performance and a projected 10% growth in 2025, HRMY presents itself as an attractive biomedical investment option, drawing significant investor interest.
See More
Harmony Biosciences: Future Prospects and Challenges Ahead
- Patent Protection Extension: Harmony Biosciences' primary drug, Wakix, is set to lose patent exclusivity in 2030, but the development of Pitolisant GR could extend its patent protection into the 2040s, enhancing its competitive position in the narcolepsy market.
- Clinical Trial Progress: Pitolisant HD is currently in phase 3 trials aimed at treating sleep inertia in patients with idiopathic hypersomnia, with topline data expected in 2027, and positive results could pave the way for FDA approval in 2028.
- New Drug Pipeline: Harmony is also developing BP1.15205 and EPX-100, targeting various sleep/wake disorders and showing promise in treating Dravet and Lennox-Gastaut syndromes, with key data anticipated in 2024 that could influence future FDA decisions.
- Investor Confidence Issues: Despite Harmony's strong financial performance, lingering doubts from a 2023 short-seller report have negatively impacted investor sentiment, leading to poor stock performance; however, its relatively attractive valuation offers a margin of safety for potential investors.
See More
