Collegium Pharmaceutical (COLL) FDA Approvals $36.20 +0.22 (+0.61%) Closing price 06/30/2026 04:00 PM EasternExtended Trading$36.21 +0.01 (+0.03%) As of 06/30/2026 04:10 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Collegium Pharmaceutical's Drug in the FDA Approval ProcessThis 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 22,2025Poster Presentation Drug: Jornay PMAnnounced Date: October 22, 2025Indication: for the treatment of attention deficit hyperactivity disorderAnnouncementCollegium 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 SummaryCollegium 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 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. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events AC Immune FDA EventsAptevo Therapeutics FDA EventsHeartBeam FDA EventsCandel Therapeutics FDA EventsCogent Biosciences FDA EventsDesign Therapeutics FDA EventsMoleculin Biotech FDA EventsNovoCure FDA EventsSCYNEXIS FDA EventsSarepta Therapeutics FDA EventsStoke Therapeutics FDA EventsVistaGen Therapeutics FDA EventsADC Therapeutics FDA EventsArcutis Biotherapeutics FDA EventsArtelo Biosciences FDA Events 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 Related Companies Veradermics FDA Events Erasca FDA Events Kiniksa Pharmaceuticals International FDA Events Tango Therapeutics FDA Events Edgewise Therapeutics FDA Events Catalyst Pharmaceuticals FDA Events Crinetics Pharmaceuticals FDA Events ACADIA Pharmaceuticals FDA Events Denali Therapeutics FDA Events Viking Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:COLL last updated on 10/22/2025 by MarketBeat.com Staff. 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Poster Presentation - October 22,2025Poster Presentation Drug: Jornay PMAnnounced Date: October 22, 2025Indication: for the treatment of attention deficit hyperactivity disorderAnnouncementCollegium 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 SummaryCollegium 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
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