Welcome to our dedicated page for Supernus Pharmaceuticals news (Ticker: SUPN), a resource for investors and traders seeking the latest updates and insights on Supernus Pharmaceuticals stock.
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) announced FDA approval for Qelbree (viloxazine) to treat ADHD in adults, marking the first new nonstimulant treatment in 20 years. ADHD impacts 10 million adults in the U.S., with up to 90% of diagnosed children continuing into adulthood. The approval follows positive Phase III trial results, demonstrating significant symptom reduction compared to placebo (p=0.0040). Qelbree, a once-daily capsule, has shown a favorable safety profile, but may increase suicidal thoughts in some patients.
Supernus Pharmaceuticals (SUPN) filed its Annual Report on Form 10-K, revealing fourth-quarter and full-year results for 2021. Total revenues for Q4 were $159.1 million, with net product sales matching the revenue figure. However, combined R&D and SG&A expenses rose to $122.8 million, impacting operating earnings which dropped to $6.1 million from $43.0 million in Q4 2020. The full-year guidance for 2022 projects revenues between $640 million and $680 million and operating earnings of $20 million to $40 million, reflecting ongoing investment in R&D while addressing acquisition-related costs.
Supernus Pharmaceuticals (Nasdaq: SUPN) announced the upcoming filing of its Annual Report on Form 10-K for the fiscal year ending December 31, 2021. The company reaffirms its full-year 2022 financial guidance with anticipated total revenues between $640 million and $680 million, combined R&D and SG&A expenses of $460 million to $490 million, and operating earnings projected to be $20 million to $40 million. Additionally, a non-GAAP operating earnings estimate ranges from $130 million to $165 million.
Supernus Pharmaceuticals (Nasdaq: SUPN) announced a delayed filing of its Annual Report on Form 10-K for the fiscal year ending December 31, 2021, via Form 12b-25 on March 1, 2022. This delay puts the company out of compliance with Nasdaq Rule 5250(c)(1). However, Supernus expects to file the report by April 4, 2022, to regain compliance. The company specializes in developing treatments for central nervous system diseases, including epilepsy and ADHD, and is working on new treatments for various CNS disorders.
Supernus Pharmaceuticals (Nasdaq: SUPN) announced that President and CEO Jack Khattar will participate in a fireside chat at the Cowen 42nd Annual Health Care Conference on March 9, 2022, at 1:30 p.m. ET. The discussion will focus on the company's activities in developing products for central nervous system diseases.
Investors can access a live webcast of the presentation on the company's website, with an archived replay available for 60 days post-conference.
Supernus Pharmaceuticals (SUPN) announced preliminary 2021 revenues of $579.8 million, an 11% increase from 2020, driven by product sales growth and the acquisition of Adamas Pharmaceuticals. The company reported net product sales of $567.5 million, with Qelbree prescriptions reaching 34,328 in Q4 2021, marking a 122% increase from Q3 2021. SPN-830's NDA has been accepted with a PDUFA date set for October 2022. However, operating earnings are expected to decline significantly, and cash reserves decreased to approximately $458.8 million, down from $772.9 million in 2020.
Supernus Pharmaceuticals (Nasdaq: SUPN) will announce its preliminary financial results for Q4 and full year 2021, along with its guidance for 2022, on February 28, 2022, after market close. A conference call hosted by CEO Jack Khattar and CFO Tim Dec will take place at 4:30 PM ET the same day. Investors can access the live webcast on the company's website. Supernus develops treatments for CNS diseases, with a portfolio covering epilepsy, migraine, and more.
Supernus Pharmaceuticals (Nasdaq: SUPN) has received notice from the FDA regarding its New Drug Application (NDA) resubmission for the apomorphine infusion device (SPN-830) aimed at treating motor fluctuations in Parkinson’s disease. The FDA has classified the review as Standard, with a timeline set for 10 months, leading to a target action date in early October 2022. Supernus plans to prepare for a commercial launch of SPN-830 in Q1 2023, contingent on FDA approval.
Supernus Pharmaceuticals (NASDAQ: SUPN) has resubmitted its New Drug Application (NDA) for the apomorphine infusion device (SPN-830) to treat motor fluctuations in Parkinson’s Disease (PD). This follows a Refusal to File (RTF) letter from the FDA in November 2020, which noted the application was incomplete. The resubmission is significant as SPN-830 could provide a novel treatment option for PD patients, offering a less invasive alternative for managing OFF episodes. The company remains focused on CNS disease treatments, with various approved and developing products in their pipeline.
Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN) announced it was targeted by a ransomware attack that began around mid-November 2021. The Company reported that the attack had no significant impact on its operations and that no ransom payments were made. Following detection, it engaged cybersecurity experts and successfully recovered the affected files. The Company remains vigilant, monitoring the situation and ensuring the protection of any confidential information. Despite the incident, Supernus continues to operate normally as it develops treatments for CNS diseases.
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