Supernus Pharmaceuticals, Inc. engages in the development and commercialization of products for the treatment of central nervous system diseases. It offers Trokendi XR, Oxtellar XR, APOKYN, XADAGO, and MYOBLOC products. The company was founded by Jack A. Khattar on March 30, 2005, and is headquartered in Rockville, MD.
相关临床试验
71
5 进行中
药物批准
6
批准总数
监管机构
1
监管机构数
成立时间
2005
进行中（未招募）
4
5.6%
Approved For Marketing
1
1.4%
已完成
49
69.0%
尚未招募
1
1.4%
招募中
6
8.4%
终止
7
9.9%
Unknown
2
2.8%
撤回
1
1.4%
- Qelbree (viloxazine extended-release capsules) celebrates its fifth anniversary since FDA approval, with approximately 3 million prescriptions filled since launch and over 1 million in 2025 alone. - It remains the first novel non-stimulant ADHD medication approved in over a decade and the only ADHD treatment with serotonin (5-HT2C) pharmacodynamics in its FDA labeling. - Originally approved for pediatric patients in April 2021, Qelbree gained an expanded indication for adults in April 2022, marking the first non-stimulant adult ADHD option in two decades. - A January 2025 labeling update added pharmacodynamic data and lactation information, making Qelbree the first ADHD treatment to meet the FDA's 2019 Clinical Lactation Studies guidance.
- Eli Lilly reported Q1 revenues of $19.8 billion, up 55.5% year-on-year, beating analyst estimates by 13.7% and posting the fastest revenue growth among branded pharma peers. - Merck delivered revenues of $16.29 billion, a 4.9% increase year-on-year, exceeding analyst expectations by 3% with a beat on EPS estimates. - Supernus Pharmaceuticals posted revenues of $207.7 million, up 38.6% year-on-year, driven by a 56% increase in combined growth product revenues, though EPS estimates were significantly missed. - The broader branded pharmaceuticals sector saw aggregate revenues beat consensus estimates by 3.6%, with tailwinds from precision medicine and AI adoption offset by pricing pressures and patent cliffs.
- Relmada Therapeutics has officially halted development of esmethadone, an investigational NMDA receptor blocker for major depressive disorder, following three consecutive Phase III trial failures. - The company terminated its January 2018 licensing agreement for the drug after the RELIANCE III, RELIANCE I, and RELIANCE II trials all failed to demonstrate significant efficacy versus placebo. - Relmada is now shifting focus to strategic product acquisitions, with primary emphasis on NDV-01, a Phase II sustained-release formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer. - The decision reflects broader challenges in depression drug development, with multiple biotechnology companies experiencing recent setbacks in this therapeutic area.
- Supernus Pharmaceuticals announced a definitive agreement to acquire Sage Therapeutics for $8.50 per share upfront plus contingent payments up to $3.50 per share, totaling up to $795 million. - The acquisition adds ZURZUVAE (zuranolone), the first and only FDA-approved oral treatment for postpartum depression, to Supernus' neuropsychiatry portfolio. - The deal is expected to be significantly accretive in 2026 with potential cost synergies of up to $200 million annually and strengthen Supernus' CNS discovery platforms. - ZURZUVAE generated $36.1 million in collaboration revenue for 2024, with Supernus receiving 50% of net revenue recorded by partner Biogen in the U.S.
- Supernus Pharmaceuticals agreed to acquire Sage Therapeutics for up to $795 million, offering $8.50 per share in cash plus contingent value rights worth $3.50 per share based on sales milestones. - The deal significantly exceeds Biogen's rejected $469 million unsolicited offer from January 2025, providing Sage shareholders with a 36% premium over previous trading levels. - Supernus gains exclusive U.S. rights to Zurzuvae, the only FDA-approved oral treatment for postpartum depression, which generated $36.1 million in 2024 sales and $13.8 million in Q1 2025. - The acquisition allows Supernus to diversify its CNS portfolio beyond its existing Parkinson's disease and ADHD treatments, while positioning the company for significant growth if Zurzuvae reaches projected sales milestones.
- Supernus Pharmaceuticals received Paragraph IV Notice Letters from third parties who submitted Abbreviated New Drug Applications (ANDAs) for generic versions of Qelbree (viloxazine extended-release capsules) in 100, 150, and 200 mg strengths. - The company plans to vigorously enforce its intellectual property rights, with six issued U.S. patents covering Qelbree that expire between September 2029 and April 2035. - This generic challenge represents a significant threat to Supernus's ADHD treatment franchise, as generic competition could substantially impact future revenue streams for the CNS-focused biopharmaceutical company.
• Supernus Pharmaceuticals' SPN-820, an mTORC activator for treatment-resistant depression, failed to demonstrate statistical significance against placebo in Phase IIb study, showing only a marginal 0.4-point difference in MADRS scores. • The disappointing results contrast with SPN-820's previous success in a Phase II major depressive disorder trial, where it showed rapid clinical improvement within four hours of dosing. • Following the trial failure, Supernus will analyze data and evaluate future development plans with partner Navitor Pharmaceuticals while focusing on their successful ADHD drug Qelbree.
• Sanofi has reached an agreement with CD&R to sell a 50% stake in its consumer health business Opella, with France's Bpifrance taking an additional 2% stake, deal expected to close in Q2. • Supernus Pharmaceuticals' experimental antidepressant SPN-820 failed to show significant improvement over placebo in a mid-stage study for treatment-resistant depression, sending shares down. • Gilead Sciences sets FDA decision deadline of June 2025 for lenacapavir as HIV pre-exposure prophylaxis (PrEP), potentially offering the first twice-yearly prevention option.
• The FDA is set to decide on Biogen and Eisai's Leqembi for monthly intravenous maintenance in early Alzheimer's disease, potentially improving patient convenience. • AstraZeneca and Daiichi Sankyo await a decision on Dato-DXd for metastatic HR-positive, HER2-negative breast cancer, offering a new antibody-drug conjugate approach. • Vertex's suzetrigine, a non-opioid analgesic for moderate-to-severe acute pain, anticipates FDA verdict, representing a novel drug class for pain management. • SpringWorks' mirdametinib is under priority review for neurofibromatosis type 1-associated plexiform neurofibromas, addressing a significant unmet need.
- The FDA has approved ONAPGO (apomorphine hydrochloride) as the first subcutaneous apomorphine infusion device for treating motor fluctuations in advanced Parkinson's disease. - ONAPGO, a wearable device, provides continuous subcutaneous apomorphine infusion, offering more consistent control of OFF time for Parkinson's patients. - Clinical trials demonstrated that ONAPGO significantly reduced daily OFF time by 2.6 hours compared to placebo, with improvements seen as early as week 1. - Supernus plans to launch ONAPGO in the U.S. in the second quarter of 2025, supported by a dedicated nurse education program and access support.
