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...
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...
18:32 , Mar 31, 2017 |  BC Week In Review  |  Clinical News

Ryanodex regulatory update

FDA accepted and granted Priority Review to an NDA from Eagle for Ryanodex dantrolene to treat exertional heat stroke. The PDUFA date is July 23. Ryanodex is a lyophilized formulation of dantrolene, a sodium muscle...
18:32 , Mar 27, 2017 |  BC Extra  |  Company News

Priority Review for Eagle's heat stroke treatment

FDA accepted and granted Priority Review to an NDA for Ryanodex dantrolene from Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) to treat exertional heat stroke. Its PDUFA date is July 23. The lyophilized formulation of dantrolene, a sodium...
08:00 , Jan 4, 2016 |  BC Week In Review  |  Clinical News

Dantrolene: Additional Phase II data

Additional data from the open-label, Saudi Arabian Phase II Study EGL-4104-C-1502 in 34 EHS patients showed that IV Ryanodex plus standard of care (SOC) consisting of body cooling by physical methods and supportive measures led...
08:00 , Dec 21, 2015 |  BC Week In Review  |  Clinical News

S48168 regulatory update

FDA granted rare pediatric disease and Orphan Drug designation to ARM210 from Armgo to treat Duchenne muscular dystrophy (DMD). ARM210 is in Phase I testing for DMD. The product is an oral Rycal, a small...
07:00 , Oct 12, 2015 |  BC Week In Review  |  Clinical News

Dantrolene: Phase II data

The open-label, Saudi Arabian Phase II Study EGL-4104-C-1502 in 34 EHS patients showed that IV Ryanodex plus standard of care (SOC) consisting of body cooling by physical methods and supportive measures led to no significant...
07:00 , Sep 26, 2013 |  BC Innovations  |  Distillery Therapeutics

Indication: Neurology

This week in therapeutics Indication Target/marker/pathway Summary Licensing status Publication and contact information Neurology Alzheimer's disease (AD) Ryanodine receptor 1 (RyR1); RyR2 Studies in mice suggest ryanodine receptor agonists could be useful for treating AD....
07:00 , Sep 10, 2012 |  BC Week In Review  |  Clinical News

Armgo preclinical data

In a mouse model of stress-induced cognitive dysfunction, oral S107 significantly improved learning and memory as measured by the Morris water maze test (p<0.05) and the novel object recognition test (p<0.05) vs. untreated stressed control...