19:48 , May 3, 2019 |  BioCentury  |  Finance

Earnings on deck

Earnings on deck At least 22 profitable biotechs and pharmas are slated to report earnings this week. (A) During trading hours in Europe; premarket on U.S. exchange; (B) Fiscal 4Q; Company Date Pre/post mkt 1Q19...
20:30 , Mar 1, 2019 |  BC Week In Review  |  Clinical News

FDA concludes Treanda will benefit from Bendeka's exclusivity protection

FDA concluded that the scope of Orphan Drug exclusivity for cancer drug Bendeka bendamustine from Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) extends to all applications containing the same active ingredient unless a sponsor shows clinical superiority to...
20:49 , Feb 22, 2019 |  BioCentury  |  Finance

Earnings on deck

Earnings on deck At least 12 profitable biotechs and pharmas are slated to report earnings this week. (A) Six-month EPS Company Date Pre/post mkt 4Q18 EPS est 4Q17 EPS Expected chg Corcept Therapeutics Inc. (NASDAQ:CORT)...
13:05 , Sep 14, 2018 |  BC Week In Review  |  Clinical News

Eagle to meet with FDA to discuss Ryanodex exertional heat stroke data

Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) said it plans to meet with FDA to discuss next steps for Ryanodex dantrolene to treat exertional heat stroke after the candidate improved neurologic function in three of four patients in...
23:52 , Oct 6, 2017 |  BioCentury  |  Finance

Bargain shopping

With all companies valued over $1 billion increasing a median of at least 16.8% in 1H17, investors went bargain shopping in the $500-$999 million tier in 3Q17. The group outperformed all other market cap bands,...
23:10 , Oct 6, 2017 |  BioCentury  |  Finance

Coasting on catalysts

While buysiders do not expect any sector-moving milestones in the wake of a catalyst-heavy third quarter, they will have at least 21 Phase III milestones and 23 PDUFA dates on their radar. But the biggest...
20:24 , Jul 28, 2017 |  BC Week In Review  |  Clinical News

Eagle gets CRL for Ryanodex

Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) said FDA issued a complete response letter for Ryanodex dantrolene (EP-4104) to treat exertional heat stroke. FDA has requested an additional clinical trial in the indication, and the company said it...
18:50 , Jul 26, 2017 |  BC Extra  |  Company News

Eagle gets CRL for Ryanodex

Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) lost $16.67 (24%) to $53.37 on Wednesday after it said FDA issued a complete response letter for Ryanodex dantrolene to treat exertional heat stroke. The company said FDA has requested an...
00:20 , Jul 8, 2017 |  BioCentury  |  Finance

A clinical quarter

Buysiders will find themselves digesting at least 23 Phase III data readouts in the next quarter, two of which could provide clarity on increasingly competitive markets in lung cancer and hemophilia. The third quarter is...
23:31 , May 17, 2017 |  BC Extra  |  Company News

Management tracks

Protein therapeutics company Molecular Partners AG (SIX:MOLN) named Patrick Amstutz CEO. Amstutz had been acting CEO since the November 2016 resignation of Christian Zahnd. Autoimmune and inflammatory disease company Akari Therapeutics plc (NASDAQ:AKTX) said CEO...