Supernus Pharma Stock Price, News & Analysis

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.

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.