19:02 , Aug 10, 2018 |  BC Week In Review  |  Financial News

Zogenix, Progenics raise follow-ons

Zogenix Inc. (NASDAQ:ZGNX) and Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) each priced follow-on offerings late Aug. 7th. Zogenix raised $312 million through the sale of 6 million shares at $52 in an offering underwritten by BofA Merrill...
17:08 , Aug 3, 2018 |  BC Week In Review  |  Clinical News

Sunovion's high-dose dasotraline meets primary in Phase III for binge eating disorder

The Sunovion Pharmaceuticals Inc. subsidiary of Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506) said the once-daily 6 mg dose of dasotraline (SEP-225289) met the primary endpoint of reducing the number of binge days, defined as days...
18:18 , Jul 27, 2018 |  BC Week In Review  |  Clinical News

Aerie's Roclatan under FDA review with March PDUFA

Aerie Pharmaceuticals Inc. (NASDAQ:AERI) said FDA accepted for review an NDA for Roclatan netarsudil/latanoprost to reduce intraocular pressure (IOP) in glaucoma or ocular hypertension. The PDUFA date is March 14, 2019. Roclatan met its primary...
19:57 , Jul 13, 2018 |  BC Week In Review  |  Clinical News

FDA accepts resubmitted NDA for Ironshore's HLD200 for ADHD

The Ironshore Pharmaceuticals & Development Inc. subsidiary of Highland Therapeutics Inc. (Toronto, Ontario) said FDA accepted a resubmitted NDA for HLD200 to treat ADHD. The PDUFA date is Aug. 8. HLD200 is a modified-release formulation...
23:12 , Jan 3, 2018 |  BC Week In Review  |  Clinical News

Progenics gets Priority Review for Azedra in rare NETs

Progenics Pharmaceuticals Inc. (NASDAQ:PGNX) said FDA accepted and granted Priority Review to an NDA for Azedra iobenguane I 131 (Ultratrace I-131-MIBG, Ultratrace iobenguane I 131) to treat malignant recurrent and/or unresectable pheochromocytoma and paraganglioma. Its...
18:41 , Dec 22, 2017 |  BC Week In Review  |  Clinical News

FDA approves Aerie's Rhopressa to lower IOP

FDA approved Rhopressa netarsudil 0.02% from Aerie Pharmaceuticals Inc. (NASDAQ:AERI) to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The company plans to launch the drug in 2Q18. The approval...
21:38 , Dec 19, 2017 |  BC Extra  |  Company News

FDA approves Aerie's Rhopressa

FDA approved Rhopressa netarsudil 0.02% from Aerie Pharmaceuticals Inc. (NASDAQ:AERI) to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. The company plans to launch the drug in 2Q18. The approval...
04:17 , Dec 8, 2017 |  BC Week In Review  |  Financial News

Axsome raises $9.5M in direct offering

CNS company Axsome Therapeutics Inc. (NASDAQ:AXSM) raised $9.5 million through the sale of 1.8 million units at $5.33 in a registered direct offering led by HC Wainwright. Each unit represents one share of common stock...
00:32 , Oct 20, 2017 |  BC Week In Review  |  Clinical News

Aerie's Rhopressa wins FDA panel votes

An FDA advisory committee voted 9-1 on Oct. 13 that the efficacy of Rhopressa netarsudil 0.02% (AR-13324) from Aerie Pharmaceuticals Inc. (NASDAQ:AERI) shown in clinical trials outweighs the candidate's safety risks. The panel also voted...
21:41 , Oct 13, 2017 |  BC Extra  |  Company News

Aerie's Rhopressa wins FDA panel votes

An FDA advisory committee voted 9-1 on Friday that the efficacy of Rhopressa netarsudil 0.02% from Aerie Pharmaceuticals Inc. (NASDAQ:AERI) shown in clinical trials outweighs the candidate's safety risks. The panel also voted 10-0 that...