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 (Nasdaq: SUPN) has resubmitted its New Drug Application for SPN-812, targeting ADHD treatment in pediatric patients, after receiving a Complete Response Letter from the FDA in November 2020. The FDA indicated that the application was incomplete due to issues related to the company’s in-house laboratory, now removed from the NDA. The resubmission will undergo either a Class I or Class II review. Positive Phase III study results for SPN-812 in adults were announced in December 2020, with plans for a supplemental NDA submission in the latter half of 2021 pending pediatric approval.
Supernus Pharmaceuticals (Nasdaq: SUPN) announced its participation at the J.P. Morgan 39th Annual Healthcare Conference on January 14, 2021, at 9:10 a.m. ET. The company specializes in developing treatments for central nervous system diseases and markets products like Trokendi XR and Oxtellar XR. Investors can access a live webcast of the presentation from their website, with an archived replay available for 60 days. Supernus is also developing new medications for various CNS conditions, including ADHD and depression.
Supernus Pharmaceuticals announced positive topline results from the Phase III study of SPN-812 for treating ADHD in adults. The trial met its primary endpoint with robust statistical significance (p=0.0040), indicating significant symptom improvement. Efficacy was shown on hyperactivity/impulsivity and inattention subscales, with meaningful onset as early as week 2. The safety profile was good, with low discontinuation rates. The company plans to discuss a Complete Response Letter with the FDA in January 2021 and aims to submit a supplemental NDA for adult ADHD treatment in the latter half of 2021.
Supernus Pharmaceuticals (Nasdaq: SUPN) will participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference from December 1-3, 2020. The management team's pre-recorded fireside chat will be available starting November 23, 2020, accessible via the Investor Relations section on the company's website. An archived replay will be available for 60 days post-conference. Supernus focuses on CNS disease treatments, with products including Trokendi XR and Oxtellar XR, and is developing additional candidates for ADHD, Parkinson’s disease, and treatment-resistant depression.
Supernus Pharmaceuticals (Nasdaq: SUPN) announced its participation in two upcoming virtual investor conferences in November 2020. The company will present at the Stifel 2020 Healthcare Conference on November 16 at 9:20 a.m. ET and at the Jefferies Virtual London Healthcare Conference on November 17 at 1:45 p.m. ET. A live webcast of these presentations will be available, with an archived replay accessible for 60 days on Supernus' website. Supernus specializes in treatments for central nervous system diseases, with various marketed products and a pipeline of promising candidates.
Supernus Pharmaceuticals (Nasdaq: SUPN) provided regulatory updates regarding SPN-812 for ADHD and SPN-830 for Parkinson's disease. The FDA issued a Complete Response Letter (CRL) for SPN-812, indicating the application is not ready for approval due to facility-related issues, but no clinical efficacy or safety concerns were raised. Additionally, SPN-830 received a Refusal to File letter, requiring further documentation. The company plans to engage with the FDA to address these issues. Supernus reiterated its 2020 financial guidance, projecting net product sales between $500 million and $525 million.
Supernus Pharmaceuticals (SUPN) reported Q3 2020 revenues of $155.1 million, a 52% increase from Q3 2019, with net product sales at $152.1 million. Operating earnings reached $56.1 million, up from $39.7 million a year earlier. The company is set to launch SPN-812 for ADHD treatment in January 2021, pending FDA approval, with topline data from its Phase III trial expected in Q1 2021. Full-year net product sales guidance increased to $500-$525 million. Cash reserves stood at $740.1 million as of September 30, 2020.
Supernus Pharmaceuticals (Nasdaq: SUPN) will report its Q3 2020 business results on November 3, 2020, after 5:00 p.m. ET. A conference call hosted by President and CEO Jack Khattar will follow on November 4, 2020, at 9:00 a.m. ET, allowing for a discussion of the results and a Q&A session. The call can be accessed via dial-in or live webcast on the company's website. Supernus is focused on CNS diseases and markets several products, including Trokendi XR and Oxtellar XR, while developing new treatments for ADHD and depression.
Supernus Pharmaceuticals Announces CFO Transition
Greg Patrick will retire as Chief Financial Officer of Supernus Pharmaceuticals, effective October 12, 2020. James Kelly, formerly CFO at Vanda Pharmaceuticals, will assume the role, bringing over 25 years of experience in the biopharmaceutical industry. Kelly is expected to strengthen Supernus's financial operations and strategy to drive growth. Patrick will remain as an advisor to ensure a smooth transition. This leadership change highlights Supernus's commitment to maintaining a solid financial foundation while advancing its product pipeline focused on CNS diseases.
Supernus Pharmaceuticals will present an overview and update at the Morgan Stanley 18th Annual Global Healthcare Conference on September 16, 2020, at 2:00 p.m. ET. Investors can schedule virtual meetings with management during the conference. A live webcast of the presentation will be available on the company's website, with a replay accessible for 60 days post-conference. Supernus focuses on developing products for central nervous system diseases, including treatments for migraine, epilepsy, Parkinson’s disease, and chronic sialorrhea.