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...
21:06 , Apr 6, 2018 |  BioCentury  |  Finance

Smid-cap smorgasbord

While the biggest milestone of the second quarter came early and turned out to be a disappointment, investors still have plenty to look forward to in immuno-oncology. In addition, specialist investors’ current strategy of overweighting...
19:42 , Jan 26, 2018 |  BC Week In Review  |  Financial News

Follow-on roundup: Ultragenyx, Adamas, Rocket

Rare disease company Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) raised $250 million on Jan. 23 through the sale of 4.4 million shares at $57 in a bumped-up follow-on underwritten by J.P. Morgan, BofA Merrill Lynch, Goldman Sachs...
22:56 , Jan 24, 2018 |  BC Extra  |  Financial News

Follow-on roundup

At least six companies priced follow-ons, raising more than $600 million total. Rare disease company Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) raised $250 million on Tuesday through the sale of 4.4 million shares at $57 in a...
23:25 , Jan 9, 2018 |  BioCentury  |  Finance

Stars in China

A major clinical flop and a spate of weak earnings reports by U.S. large cap biotechs reverberated throughout the sector in the fourth quarter, breaking a three-quarter-long streak of outperformance. Across all market cap bands,...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
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...
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...