Collegium Pharmaceutical's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Collegium Pharmaceutical (COLL).
Over the past two years, Collegium Pharmaceutical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Jornay. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Jornay PM FDA Regulatory Events
Jornay PM is a drug developed by Collegium Pharmaceutical for the following indication: for the treatment of attention deficit hyperactivity disorder.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Jornay PM
- Announced Date:
- October 22, 2025
- Indication:
- for the treatment of attention deficit hyperactivity disorder
Announcement
Collegium Pharmaceutical, Inc announced it will have poster presentations highlighting real-world data from its differentiated neuropsychiatry product, Jornay PM, (methylphenidate HCl), a central nervous system (CNS) stimulant for the treatment of attention deficit hyperactivity disorder (ADHD) in people 6 years of age and older at the American Academy of Child & Adolescent Psychiatry (AACAP) and Neuroscience Education Institute (NEI) conferences.
AI Summary
Collegium Pharmaceutical will present real-world data on its ADHD product Jornay PM at two conferences. One poster will appear at the American Academy of Child & Adolescent Psychiatry in Chicago (Oct 20–25). The other will be shown at the Neuroscience Education Institute Fall Congress in Colorado Springs (Nov 6–9).
The AACAP poster explores optimal dosing of methylphenidate in adolescents and adults in real-world psychiatric settings. The NEI poster examines how patients use and respond to Jornay PM outside clinical trials.
Thomas Smith, M.D., said these findings during ADHD Awareness Month highlight Collegium’s commitment to improving care. Researchers will share insights on dosing and patient response to this unique nighttime ADHD stimulant.
The AACAP poster will be shown Oct 22, 4–6 p.m. CDT at the Hyatt Regency, and the NEI poster will be presented Nov 7, 4–5 p.m. MST at Broadmoor West.
Read Announcement
Collegium Pharmaceutical FDA Events - Frequently Asked Questions
As of now, Collegium Pharmaceutical (COLL) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Collegium Pharmaceutical (COLL) has reported FDA regulatory activity for Jornay PM.
The most recent FDA-related event for Collegium Pharmaceutical occurred on October 22, 2025, involving Jornay PM. The update was categorized as "Poster Presentation," with the company reporting: "Collegium Pharmaceutical, Inc announced it will have poster presentations highlighting real-world data from its differentiated neuropsychiatry product, Jornay PM, (methylphenidate HCl), a central nervous system (CNS) stimulant for the treatment of attention deficit hyperactivity disorder (ADHD) in people 6 years of age and older at the American Academy of Child & Adolescent Psychiatry (AACAP) and Neuroscience Education Institute (NEI) conferences."
Currently, Collegium Pharmaceutical has one therapy (Jornay PM) targeting the following condition: for the treatment of attention deficit hyperactivity disorder.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:COLL) was last updated on 10/23/2025 by MarketBeat.com Staff
