$SUPN (Supernus Pharmaceuticals, Inc.)

$SUPN {{ '2015-12-04T17:10:17+0000' | timeago}} • Announcement

Specialty pharmaceutical company $SUPN said it has received notice that, effective following the close of trading on Dec. 3, 2015, New Enterprise Associates (NEA) distributed an aggregate of 3,820,625 shares of $SUPN common stock to its partners, and as a result no longer holds common stock in the company.

$SUPN {{ '2018-01-12T20:44:15+0000' | timeago}} • Announcement

Pharmaceuticals company $SUPN said William Nuerge, a member of its board of directors, passed away. Nuerge, pharmaceutical industry veteran, had served as CEO of Shire US and Xanodyne Pharmaceuticals until his retirement. He had joined the board of Supernus in 2006.

$SUPN {{ '2017-09-18T20:39:00+0000' | timeago}} • Announcement

$SUPN provided update on SPN-810 phase 3 clinical trials. Based on the predefined criteria for dropping a dose arm, the lower dose of 18 mg will be eliminated. $SUPN said this will maximize probability of reaching statistically significant outcome for the 36 mg dose, which will start immediately. $SUPN still expects enrollment through mid-2018.

$SUPN {{ '2017-09-18T20:37:20+0000' | timeago}} • Announcement

$SUPN provided update on SPN-810 phase 3 clinical trials. The company is developing SPN-810 as a novel treatment for impulsive aggression (IA) in patients aged 6 to 12 years who have attention deficit hyperactivity disorder (ADHD). The interim analysis has been completed and both trials will continue through to completion.

$SUPN {{ '2017-08-15T21:18:52+0000' | timeago}} • Announcement

$SUPN said the US District Court for the District of New Jersey ruled that TWi Pharmaceuticals, Inc. infringed $SUPN’s patents by submitting to the FDA an ANDA seeking permission to market a generic version of Oxtellar XR before the expiration of $SUPN’s patents. The Court also confirmed the validity of $SUPN’s patents.

$SUPN {{ '2017-06-21T16:52:36+0000' | timeago}} • Announcement

$SUPN said the FDA has approved Mydayis, a once-daily treatment for patients with Attention Deficit Hyperactivity Disorder. Mydayis is not for use in children 12 years and younger. The treatment will be commercially available in the US in 3Q17.

$SUPN {{ '2017-05-10T18:07:37+0000' | timeago}} • Webcast

$SUPN stated that its drug SPN 812 for the treatment of Attention Deficit Hyperactivity disorder and other related disorders is undergoing phase 3 of of clinical trials. It added that the company sees enormous potential in SPN 812 as there are no other clinically approved treatments for the disease.

$SUPN {{ '2017-05-10T13:30:13+0000' | timeago}} • Announcement

For FY17, $SUPN sees net product sales of $265-275MM, incurring R&D expenses of approximately $55MM. Operating income is expected at $75-80MM, including about $5MM of non-cash royalty revenue.

$SUPN {{ '2017-05-10T13:28:10+0000' | timeago}} • Announcement

As of 1Q17 end, $SUPN had $176.3MM in cash, cash equivalents, marketable securities, and long-term marketable securities. During 2Q17, Supernus initiated the process of calling the remaining outstanding principal balance of its six-year notes and expects that process to be completed in the quarter.

$SUPN {{ '2017-05-10T13:25:53+0000' | timeago}} • Announcement

Net product sales for $SUPN soared 31% to $56.4MM in 1Q17, with net income more than doubling to $10.3MM from last year's $4.8MM. Earnings hiked 138% to $0.19 per diluted share, as total product prescriptions jumped 17% to 134,855 in the quarter.

$SUPN {{ '2017-04-06T13:27:12+0000' | timeago}} • Announcement

$SUPN received FDA's final approval to its supplemental new drug applications (sNDAs) requesting a label expansion for the topiramate drug, Trokendi XR, to include prophylaxis of migraine headache in adults and adolescents 12 years and older.

$SUPN {{ '2017-03-07T17:45:21+0000' | timeago}} • Announcement

$SUPN entered into a settlement agreement with Zydus Pharmaceutical (USA) and Cadila Healthcare involving the ongoing patent litigation regarding Zydus' Abbreviated New Drug Application (ANDA) seeking approval to market generic versions of $SUPN's Trokendi XR (extended-release topiramate) capsules.

$SUPN {{ '2017-02-08T19:39:11+0000' | timeago}} • Announcement

$SUPN announced the issuance on Jan. 31, 2017 of an eighth patent by the United States Patent and Trademark Office (USPTO) covering Trokendi XR, its antiepileptic novel once-daily extended-release topiramate product. The patent provides protection for the product with expiration that is no earlier than 2027.

$SUPN {{ '2016-10-11T12:46:51+0000' | timeago}} • Announcement

$SUPN announced positive topline results from its Phase IIb clinical trial of SPN-812, a drug for the treatment of attention deficit hyperactivity disorder (ADHD) in children. The trial succeeded in meeting the primary endpoint. The company plans for an end-of-Phase II meeting with the U.S. FDA and then it will start the Phase III clinical testing.

$SUPN {{ '2016-06-17T10:57:26+0000' | timeago}} • Announcement

$SUPN said it is in talks with the FDA on sNDA for migraine. The FDA had asked $SUPN to resubmit the Trokendi XR product label with migraine as an indication prior to completing its review. Company will resubmit the revised label before end June. For 2016, $SUPN expects net product sales to be $200-210MM and operating income to be $28-35MM.

$SUPN {{ '2016-06-03T05:26:48+0000' | timeago}} • Announcement

Pharma company $SUPN said a sixth patent has been issued by the United States Patent and Trademark Office on May 31 covering Oxtellar XR, a once-daily extended-release oxcarbazepine product. Oxtellar XR is an antiepileptic drug indicated for adjunctive therapy in treating partial seizures in adults and in children 6-17 years of age.

$SUPN {{ '2016-05-10T13:21:15+0000' | timeago}} • Announcement

$SUPN said it has dismissed two patent infringement actions pending in the U.S. District Court for the District of New Jersey against Actavis and its subsidiaries, pursuant to a confidential partial settlement agreement. The dismissed actions concerned two of Supernus' Orange Book patents covering Oxtellar XR.

$SUPN {{ '2016-02-08T14:24:48+0000' | timeago}} • Announcement

$SUPN said Oxtellar XR, a tablet used to treat partial epilepsy seizures in adults and children, is also protected by two other patents. The FDA's Orange Book lists all three patents as expiring on April 13, 2027, it added.

$SUPN {{ '2016-02-08T14:07:23+0000' | timeago}} • Announcement

Pharmaceutical company $SUPN, specialized in the treatment for central nervous system diseases, said a federal judge confirmed that rival Actavis and its subsidiaries infringed patents belonging to $SUPN. Actavis intended to sell a generic version of Oxtellar XR before the expiration of $SUPN patents, the company said.

$SUPN {{ '2015-12-04T17:10:17+0000' | timeago}} • Announcement

Specialty pharmaceutical company $SUPN said it has received notice that, effective following the close of trading on Dec. 3, 2015, New Enterprise Associates (NEA) distributed an aggregate of 3,820,625 shares of $SUPN common stock to its partners, and as a result no longer holds common stock in the company.

$SUPN {{ '2015-11-13T11:24:39+0000' | timeago}} • Announcement

Drugmaker $SUPN received a notice that effective Nov. 11, New Enterprise Associates (NEA) issued about 3.82MM shares of $SUPN to its partners. This is an extension of the issue NEA did in June 2015. NEA funds continue to hold about 3.82MM shares.

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