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Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN) is a leading specialty pharmaceutical company dedicated to developing and commercializing innovative products for the treatment of central nervous system (CNS) disorders. With over two decades of experience in the industry, Supernus has made significant strides in neurology and psychiatry.
Supernus’ product portfolio is diverse, including approved treatments for epilepsy, migraine, attention-deficit hyperactivity disorder (ADHD), hypomobility in Parkinson's Disease (PD), cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa-based therapy, and drug-induced extrapyramidal reactions in adult patients. Flagship products include Trokendi XR®, Oxtellar XR®, Qelbree®, APOKYN®, XADAGO®, MYOBLOC®, GOCOVRI®, and Osmolex ER®.
In 2013, Supernus successfully launched two groundbreaking products: Oxtellar XR® and Trokendi XR®, both aimed at treating epilepsy. These innovative formulations offer extended-release solutions, enhancing patient convenience and compliance.
Beyond these milestones, Supernus is actively developing new therapeutic candidates in psychiatry to address unmet medical needs in ADHD, depression, and their co-existing disorders. The company leverages proprietary and in-licensed technologies to create differentiated products. By focusing on known drug compounds with established mechanisms of action, Supernus minimizes the risks, costs, and time associated with new drug development.
Supernus has recently announced notable developments:
- Financial and business results for Q4 and the full year of 2023 will be reported on February 27, 2024.
- Actress Busy Philipps has partnered with Supernus to raise awareness about ADHD during Mental Health Awareness Month, spotlighting Qelbree® as a non-stimulant medication for ADHD.
- Supernus signed an exclusive licensing agreement with M8 Pharmaceuticals to commercialize Qelbree® in Latin America, expanding its reach and impact.
With a strong foundation and ongoing projects, Supernus Pharmaceuticals continues to make significant contributions to the field of CNS disorders, enhancing patient lives through innovative solutions.
Supernus Pharmaceuticals (Nasdaq: SUPN) will announce its Q4 and full year 2020 financial results on February 25, 2021, after market close. CEO Jack Khattar and CFO Jim Kelly will host a conference call at 4:30 p.m. ET to discuss the results. The call will be accessible via a live webcast on the company's website, followed by a replay available for 60 days. Supernus focuses on CNS diseases, with a portfolio that includes treatments for epilepsy and migraine, alongside ongoing developments for ADHD and other CNS disorders.
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.
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