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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) has announced that the FDA has accepted the resubmission of the new drug application (NDA) for SPN-830, its apomorphine infusion device. This device is designed for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson's disease. The FDA has set a PDUFA target action date of February 1, 2025 for the review of the application. This development marks a significant step forward in Supernus's efforts to bring a new treatment option to market for Parkinson's disease patients experiencing motor fluctuations.
Supernus Pharmaceuticals (Nasdaq: SUPN) reported strong financial results for Q2 2024. Total revenues increased 24% to $168.3 million, driven by significant growth in Qelbree and GOCOVRI sales. Qelbree net sales surged 92% to $59.4 million, while GOCOVRI net sales grew 10% to $31.7 million. The company achieved operating income of $22.6 million and adjusted operating earnings of $45.5 million. Supernus raised its full-year 2024 guidance for total revenues and operating earnings. The company also made progress in its product pipeline, including SPN-820 for depression and SPN-817 for epilepsy.
Supernus Pharmaceuticals (Nasdaq: SUPN) has resubmitted its New Drug Application (NDA) for SPN-830, an apomorphine infusion device designed for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson's disease. This resubmission addresses the FDA's questions from a Complete Response Letter (CRL) issued in April 2024. The CRL indicated that two areas required additional review or information, but no clinical safety or efficacy issues were identified as approval requirements. Supernus believes it has addressed the FDA's concerns and will continue to work closely with the agency during the review process. The company's CEO, Jack Khattar, expressed commitment to bringing SPN-830 to market, viewing it as a potentially important treatment option for Parkinson's disease patients and their families.
Supernus Pharmaceuticals (Nasdaq: SUPN), a biopharmaceutical company focused on central nervous system (CNS) diseases, has announced its plans to report second quarter 2024 financial and business results on August 6, 2024, after market close. The company will host a conference call at 4:30 p.m. ET on the same day, featuring Jack Khattar, President and CEO, and Tim Dec, Senior VP and CFO.
A live webcast will be available on the company's Investor Relations website. Participants can pre-register for the call and will receive a personalized dial-in number. The webcast replay will be accessible on the website for 60 days following the live call.
Supernus Pharmaceuticals (Nasdaq: SUPN), a biopharmaceutical company specializing in CNS disease treatments, announced its participation in the Jefferies Global Healthcare Conference. The event will feature a fireside chat with President and CEO Jack Khattar on June 6, 2024, at 1:30 p.m. ET, at the Marriott Marquis Hotel in New York City.
Investors can contact the Jefferies conference coordinator to arrange meetings with management. A live audio webcast of the presentation will be available on the company's website, with an archived replay accessible for 60 days post-conference.
Supernus announced interim results from its Phase 2a study of SPN-817 for treatment-resistant epilepsy. The study included 41 subjects, with 19 completing the maintenance period. Promising findings revealed a 75% median reduction in focal seizures at 3-4 mg doses twice daily. During the open-label extension period, this reduction increased to 86%. For subjects on three or more anti-seizure medications, a 70% median seizure reduction was observed initially, dropping to 60% in the extension period. Safety data showed SPN-817 to be well-tolerated with a 22% discontinuation rate due to adverse events in the titration period. Common side effects included nausea, diarrhea, and headache. Full results are expected in the second half of 2024, and a Phase 2b study is planned for later this year.
Supernus Pharmaceuticals, Inc. will host a webcast on May 23, 2024, to discuss interim data from the Phase IIa study of SPN-817 for treatment-resistant seizures. Investors can access the live webcast and presentation slides on the Company's Investor Relations website. A replay will be available for 60 days.
Supernus Pharmaceuticals, Inc. reported strong financial results for the first quarter of 2024, with net sales of Qelbree® increasing by 75% to $45.1 million. Total revenues were $143.6 million, with a 12% increase in revenues excluding Trokendi XR® and Oxtellar XR® net product sales. The Company reiterates its full year 2024 financial guidance, including total revenue guidance of $580 - $620 million. Key product pipeline updates include SPN-830 for Parkinson's disease and SPN-820 for depression. The Company also announced the initiation of a Phase I study for SPN-443 for ADHD/CNS.
M8 Pharmaceuticals, an Acino company, has signed an exclusive licensing agreement with Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) to commercialize Qelbree® (Viloxazine XR) in Latin America. Qelbree® is an extended-release capsule approved to treat ADHD in the US. This partnership aims to provide innovative treatment options for patients in Latin America.
Busy Philipps partners with Supernus Pharmaceuticals to share her experience with ADHD and treatment with Qelbree, a non-stimulant medication. The partnership aims to raise awareness during Mental Health Awareness Month for the millions of adults living with ADHD in the US.
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