Collegium Pharmaceutical (COLL) FDA Approvals

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.

Poster Presentation - October 22,2025

• Drug: Jornay PM
• Announced Date: October 22, 2025
• Indication: for the treatment of attention deficit hyperactivity disorder

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.

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.

Collegium Pharmaceutical FDA Events - Frequently Asked Questions

Has Collegium Pharmaceutical received FDA approval?

As of now, Collegium Pharmaceutical (COLL) has not received any FDA approvals for its therapy in the last two years.

What drugs has Collegium Pharmaceutical submitted to the FDA?

In the past two years, Collegium Pharmaceutical (COLL) has reported FDA regulatory activity for Jornay PM.

What is the most recent FDA event for Collegium Pharmaceutical?

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."

What conditions do Collegium Pharmaceutical's current drugs treat?

Currently, Collegium Pharmaceutical has one therapy (Jornay PM) targeting the following condition: for the treatment of attention deficit hyperactivity disorder.