Welcome to our dedicated page for Supernus Pharma news (Ticker: SUPN), a resource for investors and traders seeking the latest updates and insights on Supernus Pharma stock.
Supernus Pharmaceuticals (SUPN) is a leading biopharmaceutical innovator focused on developing advanced treatments for central nervous system disorders. This dedicated news hub provides investors and healthcare professionals with timely updates on the company's clinical developments, regulatory milestones, and strategic initiatives in neurology and psychiatry.
Access comprehensive coverage of SUPN's progress in treating epilepsy, ADHD, and movement disorders through reformulated therapeutics. Our curated news feed includes updates on FDA submissions, partnership announcements, clinical trial results, and market expansion efforts – all essential for understanding the company's position in CNS therapeutics.
Key areas of focus include non-stimulant ADHD treatments, extended-release neurology medications, and novel approaches to Parkinson's-related conditions. Stay informed about SUPN's pipeline advancements and commercial strategies through verified press releases and objective analysis.
Bookmark this page for direct access to Supernus Pharmaceuticals' latest developments in neuroscience innovation. Check regularly for updates on product approvals, research collaborations, and financial performance indicators relevant to CNS treatment advancements.
Supernus Pharmaceuticals (SUPN) announced that its Phase 2b study of SPN-820 in adults with treatment-resistant depression (TRD) failed to meet its primary endpoint. The study did not show statistically significant improvement in depressive symptoms compared to placebo, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
The trial results showed minimal difference between SPN-820 (LS mean ± Standard Error: -12.3 ± 0.96) and placebo (-11.9 ± 0.96), with no statistical significance. Secondary endpoints also showed no treatment difference. However, the drug demonstrated a favorable safety profile with few adverse events, consistent with previous clinical trials.
Supernus Pharmaceuticals (SUPN) has announced it will release its fourth quarter and full year 2024 financial results after market close on Tuesday, February 25, 2025. The company will host a conference call and webcast at 4:30 p.m. ET on the same day, featuring CEO Jack Khattar and CFO Tim Dec, who will present the results and host a Q&A session.
Investors can access the live webcast through the Events & Presentations section of Supernus's Investor Relations website. Pre-registration is available for participants who wish to join via phone. A replay of the call will be available on the company's website for 60 days following the live presentation.
Supernus Pharmaceuticals (SUPN) has received FDA approval for ONAPGO (apomorphine hydrochloride), the first and only subcutaneous apomorphine infusion device for treating motor fluctuations in adults with advanced Parkinson's disease. The device will be available in the U.S. in Q2 2025.
The approval is based on a Phase 3, 12-week study (N=107) that demonstrated significant reduction in daily OFF time and increase in GOOD ON time. ONAPGO provides continuous treatment during waking hours through a wearable subcutaneous infusion device, offering more consistent control without requiring invasive surgery.
The treatment has a 30-year history in Europe, where it has helped thousands of patients. Supernus will launch ONAPGO with comprehensive support, including a nurse education program and access support.
Supernus Pharmaceuticals (SUPN) announced FDA approval for an updated label of its ADHD treatment Qelbree. The update includes new pharmacodynamic data detailing serotonin 5-HT2C partial agonist activity and norepinephrine transporter inhibition, highlighting the drug's multimodal pharmacodynamics.
The label update also includes new lactation data showing low transfer of Qelbree into breastmilk, making it the first ADHD treatment to meet post-marketing requirements following the 2019 FDA guidance on Clinical Lactation Studies. The study, involving 15 healthy lactating women, demonstrated that the relative infant dose was approximately 1% of the maternal daily dose.
Qelbree is approved for ADHD treatment in patients 6 years and older. The medication carries important safety information, including risks of increased suicidal thoughts and actions, blood pressure elevation, and heart rate changes.
Supernus Pharmaceuticals (Nasdaq: SUPN), a CNS-focused biopharmaceutical company, announced its participation in the 36th Annual Piper Sandler Healthcare Conference. President and CEO Jack A. Khattar will engage in a fireside chat on December 4, 2024, at 12:00 p.m. ET at the Lotte New York Palace.
The presentation will be accessible via live audio webcast through the company's website investor relations section, with a replay available for 60 days post-conference. Investors seeking meetings with management should contact the conference coordinator.
Supernus Pharmaceuticals (Nasdaq: SUPN) has announced its participation in the 2024 Jefferies London Healthcare Conference. President and CEO Jack Khattar will engage in a fireside chat on Wednesday, November 20, 2024, at 9:30 a.m. GMT (4:30 a.m. EST) at the Waldorf Hilton in London.
The event will be accessible via live audio webcast through the company's website investor relations section. Interested investors can arrange meetings with management through the Jefferies conference coordinator. A replay of the webcast will remain available for 60 days following the conference on the company's website.
Supernus Pharmaceuticals reported strong Q3 2024 financial results with total revenues of $175.7 million, up 14% year-over-year. Qelbree sales increased 68% to $62.4 million, while GOCOVRI sales grew 8% to $35.6 million. Operating earnings reached $40.9 million, compared to $8.1 million in Q3 2023. The company raised its full-year 2024 guidance, now expecting total revenues of $630-$650 million and operating earnings of $50-$65 million. Key pipeline developments include positive Phase 2a results for SPN-820 in major depressive disorder and progress in SPN-817's development for epilepsy.
Supernus Pharmaceuticals (SUPN) presented promising Phase 2a study results for SPN-820 in treating Major Depressive Disorder at Psych Congress 2024. The study, involving 40 participants, demonstrated significant improvements in depressive symptoms. Key findings include a rapid MADRS response rate reaching 84.2% by Day 10, an 80% decrease in suicidal ideation, and clinically meaningful improvements in HAM-D6 and MADRS scores. The drug was well-tolerated with mostly mild to moderate side effects, showing potential as a first-in-class, oral treatment for depression with rapid-acting properties.
Supernus Pharmaceuticals (Nasdaq: SUPN), a biopharmaceutical company focused on central nervous system (CNS) diseases, has announced its plans to report third quarter 2024 financial and business results on November 4, 2024, after market close. The company will host a conference call and webcast at 4:30 p.m. ET on the same day.
Jack Khattar, President and CEO, and Tim Dec, Senior Vice President and CFO, will lead the call, presenting the results and answering questions. Investors can access the live webcast through the company's Investor Relations website. Pre-registration is available for participants, who will receive a personalized dial-in number and conference code.
Supernus Pharmaceuticals (Nasdaq: SUPN) announced promising data from its open-label Phase 2a study of SPN-820 in adults with major depressive disorder. The study demonstrated a rapid and substantial decrease in depressive symptoms, with clinically meaningful improvements observed in both HAM-D6 and MADRS scores. Key findings include:
- Improvement of -6.1 at two hours and -9.6 at Day 10 on HAM-D6 total score
- Improvement of -16.6 at four hours and -22.9 at Day 10 on MADRS total score
- 80% decrease in suicidal ideation
- Well-tolerated with few adverse events
SPN-820, a novel intracellular modulator of mTORC1, shows potential as a treatment option for depression. Supernus expects to complete enrollment in the Phase 2b randomized double-blind placebo-controlled study in November, with topline results anticipated in the first half of 2025.
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