Supernus Pharma Stock Price, News & Analysis

Supernus Pharmaceuticals has announced the availability of its FDA-approved ADHD treatment, Qelbree (viloxazine extended-release capsules), for pediatric patients aged 6 to 17. This non-stimulant medication has shown efficacy in improving ADHD symptoms as early as the first week of treatment. Alongside its launch, Supernus has implemented comprehensive patient support programs, including co-pay assistance and a sampling initiative. The company plans to submit a supplemental New Drug Application for Qelbree's use in adults in Q3 2021.

Supernus Pharmaceuticals (SUPN) reported Q1 2021 total revenues of $130.9 million, a 38% increase from Q1 2020. Net product sales totaled $128.4 million, up 39% year-over-year, driven by Trokendi XR and Oxtellar XR. The FDA approved Qelbree for pediatric ADHD, with a planned launch in Q2 2021 and an sNDA for adults anticipated in Q3 2021. Operating earnings were $13.2 million, down from $29.0 million in the previous year. The company has $807.7 million in cash and reiterates its full-year revenue guidance of $550 - $580 million.

Supernus Pharmaceuticals (Nasdaq: SUPN) has reported that Newron Pharmaceuticals has received a Paragraph IV Notice Letter from Aurobindo Pharma regarding its application for safinamide tablets. This letter targets three XADAGO patents expiring between June 2027 and December 2028. Supernus holds a license agreement with Zambon S.p.A. concerning these patents. The company is reviewing the Notice Letter details to safeguard its intellectual property rights related to XADAGO, which is under FDA exclusivity until March 21, 2022.

Supernus Pharmaceuticals (Nasdaq: SUPN) will announce its Q1 2021 results on May 5, 2021, after market close. The conference call, led by CEO Jack Khattar and CFO Jim Kelly, is scheduled for 4:30 p.m. ET that day, with a live webcast available on the company’s website. Supernus specializes in CNS diseases, offering treatments for several conditions, including epilepsy and ADHD. The company is also developing new products aimed at various CNS disorders. Further details can be found in the Investor Relations section of their website.

Supernus Pharmaceuticals announced FDA approval for Qelbree (viloxazine extended-release capsules), a new non-stimulant treatment for ADHD in pediatric patients aged 6-17. This marks a decade's first introduction of such an option. Qelbree is designed to provide a significant alternative for ADHD management, enhancing treatment accessibility without the risks associated with controlled substances. The product is expected to be available in the U.S. by Q2 2021, and a supplemental application for adult usage is anticipated in late 2021.

Supernus Pharmaceuticals (Nasdaq: SUPN) announced Jack Khattar, President and CEO, will participate in a fireside chat at the Cowen 41^st Annual Health Care Conference on March 3, 2021, at 12:20 p.m. ET. A live webcast will be available on the Company's website, and an archived replay will be accessible for 60 days after the event. Supernus focuses on developing treatments for central nervous system diseases, including epilepsy and migraines, and is expanding its portfolio to address ADHD and other CNS disorders.

For full year 2020, Supernus Pharmaceuticals reported total revenues of $520.4 million, a 32% increase from 2019, with operating earnings at $173.7 million, up 17%. Q4 2020 net product sales reached $140.7 million, a 44% year-over-year increase. The firm anticipates 2021 total revenues between $550 million and $580 million. SPN-812, for ADHD, is expected to launch in Q2 2021 pending FDA approval. Positive results for SPN-812's Phase III study were reported in December 2020, while SPN-830 awaits further FDA discussions.

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.