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, Inc. (SUPN) is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The company’s news flow reflects its role in neurology and psychiatry, with updates on commercial performance, pipeline progress, and strategic transactions.
Recent press releases highlight quarterly financial results, where Supernus reports net product sales for CNS therapies such as Qelbree, GOCOVRI, APOKYN, Trokendi XR, Oxtellar XR, ONAPGO, and other products including MYOBLOC, XADAGO, and Osmolex ER. The company also reports collaboration revenue from ZURZUVAE, an oral treatment for postpartum depression, reflecting its collaboration with Biogen Inc. in the U.S. following Supernus’s acquisition of Sage Therapeutics, Inc.
Investors following SUPN news can expect coverage of product launches and commercialization updates, such as the U.S. launch and demand trends for ONAPGO, described as a subcutaneous apomorphine infusion device for motor fluctuations in adults with advanced Parkinson’s disease. Company announcements also discuss supply constraints and prioritization of existing patients when demand exceeds available inventory.
Supernus regularly issues news about its R&D pipeline, including clinical progress for SPN-817 in epilepsy, SPN-820 in depression, and SPN-443 for ADHD/CNS. In addition, the company announces participation in healthcare and therapeutics conferences hosted by investment banks and other organizations, providing forums where management discusses its CNS portfolio, financial performance, and strategy.
This news page aggregates these disclosures so readers can track earnings releases, collaboration developments around ZURZUVAE, clinical trial updates, and investor conference appearances related to Supernus Pharmaceuticals, Inc. (SUPN).
Supernus Pharmaceuticals (Nasdaq: SUPN) announced receipt of a Class I resubmission notice from the FDA for its New Drug Application (NDA) for SPN-812, aimed at treating ADHD in pediatric patients. This classification sets a review timeline of two months, with a new target action date in early April 2021. Should the FDA approve, the company plans to launch SPN-812 commercially in Q2 2021. Following positive Phase III results in adults with ADHD, Supernus also intends to file a supplemental NDA for adult treatment in the latter half of 2021.
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.