Supernus Pharmaceuticals, Inc., a specialty pharmaceutical company, focuses on the development and commercialization of products for the treatment of central nervous system diseases in the United States. Its marketed products for the treatment of epilepsy include Oxtellar XR, an extended-release oxcarbazepine; and Trokendi XR, an extended-release topiramate. The company’s product candidates comprise SPN-810, a molindone hydrochloride that is in Phase III clinical trials for the treatment of impulsive aggression in patients with attention deficit hyperactivity disorder (ADHD); and SPN-812, a viloxazine hydrochloride, which is in Phase IIb clinical trials for the treatment of ADHD. It is also ...
1550 East Gude Drive
Rockville, MD 20850
Founded in 2005
Supernus Pharmaceuticals Receives FDA Tentative Approval for Expanded Label of Trokendi XR to Include Migraine Prophylaxis in Adults
Aug 19 16
Supernus Pharmaceuticals announced that it has been granted tentative approval from the U.S. Food and Drug Administration for its Supplemental New Drug Application (sNDA) requesting a label expansion for Trokendi XR to include prophylaxis of migraine headache in adults. The approval of the sNDA is tentative because the FDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval, but is subject to the pediatric exclusivity which expires March 28, 2017. Final approval may not be made effective until this exclusivity period has expired. In addition, the company said the FDA has granted final approval to expand the label for Trokendi XR for monotherapy treatment of partial onset seizures to include adults and pediatric patients 6 years and older, rather than 10 years and older.
Supernus Pharmaceuticals, Inc. Announces Management Changes
Aug 12 16
Supernus Pharmaceuticals, Inc. announced that Dr. M. James Barrett, Ph.D., has resigned from its Board of Directors effective August 10, 2016. With the announcement of Dr. Barrett's departure, the Board unanimously elected Charles W. Newhall, III, a current independent director, as Chairman. Mr. Newhall has served as a member of its Board since 2005, and currently serves as Chair of the Governance and Nominating Committee. He currently serves on the Boards of Interfusion, Neuropace, and Vitae Pharmaceuticals, and as Chairman Emeritus of the Industry Advisory Board for Greenspring Associates.
Supernus Pharmaceuticals, Inc. Reports Unaudited Consolidated Earnings Results for the Second Quarter and Six Months Ended of June 30, 2016; Reiterates Earnings Guidance for the Full Year 2016
Aug 2 16
Supernus Pharmaceuticals, Inc. reported unaudited consolidated earnings results for the second quarter and six months ended of June 30, 2016. For the quarter, the company reported total revenue of $50,421,000 compared to $35,052,000 a year ago. Operating income was $10,440,000 compared to $3,076,000 a year ago. Earnings before income taxes were $10,732,000 compared to $2,667,000 a year ago. Net income was $10,018,000 compared to $2,005,000 a year ago. Diluted net income per share was $0.18 compared to $0.03 a year ago.
For the six months, the company reported total revenue of $93,495,000 compared to $63,185,000 a year ago. Operating income was $15,757,000 compared to $6,507,000 a year ago. Earnings before income taxes were $15,917,000 compared to $3,647,000 a year ago. Net income was $15,005,000 compared to $2,923,000 a year ago. Diluted net income per share was $0.28 compared to $0.06 a year ago.
For full year 2016, the company is reiterating guidance for net product sales and adjusting guidance for R&D expenses and operating income as set below: Net product sales will remain in the range of $200 million to $210 million. R&D expenses in the range of $50 million to $55 million, compared to the previously expected range of $55 million to $65 million. Operating income in the range of $32 million to $37 million, compared to the previously expected range of $28 million to $35 million.