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NEWS #PharmaBuzz
04 Mar 2026
// PHARMIWEB
https://www.pharmiweb.com/press-release/2026-03-04/harmony-biosciences-to-participate-in-upcoming-investor-conferences
24 Feb 2026
// PHARMIWEB
https://www.pharmiweb.com/press-release/2026-02-24/harmony-biosciences-reports-strong-2025-financial-results-and-reiterates-2026-net-revenue-guidance-o
17 Feb 2026
// BUSINESSWIRE
https://www.businesswire.com/news/home/20260217839280/en/Harmony-Biosciences-Receives-U.S.-Food-and-Drug-Administration-Approval-for-WAKIX-pitolisant-for-the-Treatment-of-Cataplexy-in-Pediatric-Narcolepsy
10 Feb 2026
// BUSINESSWIRE
https://www.businesswire.com/news/home/20260210287847/en/Harmony-Biosciences-to-Report-Fourth-Quarter-and-Full-Year-2025-Financial-Results-on-February-24-2026
12 Jan 2026
// PHARMIWEB
https://www.pharmiweb.com/press-release/2026-01-12/harmony-biosciences-guides-to-over-1-billion-in-wakix-revenue-in-2026-advancing-robust-late-stage
07 Jan 2026
// PHARMIWEB
https://www.pharmiweb.com/press-release/2026-01-07/harmony-biosciences-to-present-at-the-44th-annual-jp-morgan-healthcare-conference-1
Drugs in Development
Details:
The collaboration aims to advance the clinical development of HBS-301 for narcolepsy.
Lead Product(s): HBS-301
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Recipient: Beacon Biosignals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration December 16, 2025
Beacon Biosignals Partners Harmony Biosciences to Advance Clinical Endpoints in Hypersomnia
Details : The collaboration aims to advance the clinical development of HBS-301 for narcolepsy.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Undisclosed
December 16, 2025
Details:
BP1.15205, a miscellaneous product targeting the Orexin 2 receptor, shows promise in treating narcolepsy.
Lead Product(s): BP1.15205
Therapeutic Area: Sleep Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Bioprojet Pharma
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 19, 2025
Lead Product(s) : BP1.15205
Therapeutic Area : Sleep
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Bioprojet Pharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Harmony Biosciences Begins First Human Study of Orexin 2 Agonist for Hypersomnolence
Details : BP1.15205, a miscellaneous product targeting the Orexin 2 receptor, shows promise in treating narcolepsy.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 19, 2025
Details:
Pitolisant HCl is a small molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Prader-Willi Syndrome.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 21, 2025
Lead Product(s) : Pitolisant Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of Pitolisant in Participants With Prader-Willi Syndrome
Details : Pitolisant HCl is a small molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Prader-Willi Syndrome.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 21, 2025
Details:
HBS-201 (Pitolisant HCl) is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Narcolepsy.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Brand Name: HBS-201
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 04, 2025
Lead Product(s) : Pitolisant Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of HBS-201 (Pitolisant Delayed-release)
Details : HBS-201 (Pitolisant HCl) is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Narcolepsy.
Product Name : HBS-201
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 04, 2025
Details:
ZYN002 is a Controlled Substance drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Cannabidiol,Midazolam,Omeprazole,Losartan Potassium,Dextromethorphan,Caffeine,Repaglinide,Bupropion Hydrochloride
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Controlled Substance
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 16, 2025
Lead Product(s) : Cannabidiol, Midazolam, Omeprazole, Losartan Potassium, Dextromethorphan
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Drug Interaction Study of ZYN002 Transdermal Gel and Probe Substrates
Details : ZYN002 is a Controlled Substance drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
April 16, 2025
Details:
ZYN002 is the first-and-only pharmaceutically manufactured synthetic cannabidiol devoid of THC and formulated for the treatment of Fragile X Syndrome.
Lead Product(s): Cannabidiol
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Controlled Substance
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 08, 2025
Lead Product(s) : Cannabidiol
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Harmony Shows Promising ZYN002 Data in Fragile X Syndrome Extension
Details : ZYN002 is the first-and-only pharmaceutically manufactured synthetic cannabidiol devoid of THC and formulated for the treatment of Fragile X Syndrome.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
April 08, 2025
Details:
Wakix (pitolisant) is an oral H3 receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of idiopathic hypersomnia.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Brand Name: Wakix
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 19, 2025
Lead Product(s) : Pitolisant Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Harmony Provides Update on the Status of the sNDA for Pitolisant in Idiopathic Hypersomnia
Details : Wakix (pitolisant) is an oral H3 receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of idiopathic hypersomnia.
Product Name : Wakix
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 19, 2025
Details:
Wakix (pitolisant) is an oral H3 receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of narcolepsy in pediatric patients 6 years of age and older.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Sleep Brand Name: Wakix
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 24, 2024
Lead Product(s) : Pitolisant Hydrochloride
Therapeutic Area : Sleep
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
HARMONY BIOSCIENCES Receives FDA Approval for WAKIX® in Pediatric Narcolepsy
Details : Wakix (pitolisant) is an oral H3 receptor antagonist/inverse agonist, small molecule drug. It is being evaluated for the treatment of narcolepsy in pediatric patients 6 years of age and older.
Product Name : Wakix
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 24, 2024
Details:
The acquisition enhances Harmony's strategy by adding a rare epilepsy franchise, including EPX-100, a potent oral 5HT2 agonist, to its innovative CNS pipeline.
Lead Product(s): Clemizole hydrochloride
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Recipient: Epygenix Therapeutics
Deal Size: $680.0 million Upfront Cash: $35.0 million
Deal Type: Acquisition April 30, 2024
Lead Product(s) : Clemizole hydrochloride
Therapeutic Area : Neurology
Highest Development Status : Phase II
Recipient : Epygenix Therapeutics
Deal Size : $680.0 million
Deal Type : Acquisition
Harmony Biosciences Acquires Epygenix, Adding Epilepsy Franchise to Pipeline
Details : The acquisition enhances Harmony's strategy by adding a rare epilepsy franchise, including EPX-100, a potent oral 5HT2 agonist, to its innovative CNS pipeline.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : $35.0 million
April 30, 2024
Details:
Pitolisant is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Prader-Willi Syndrome.
Lead Product(s): Pitolisant Hydrochloride
Therapeutic Area: Genetic Disease Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 16, 2024
Lead Product(s) : Pitolisant Hydrochloride
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of Pitolisant in Patients With Prader-Willi Syndrome
Details : Pitolisant is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Prader-Willi Syndrome.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 16, 2024
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
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