BioCentury | Aug 1, 2019
Distillery Therapeutics

Stabilizing the closed form of RyR2 for nephrotic syndrome

DISEASE CATEGORY: Renal INDICATION: Renal damage Preventing podocyte injury by stabilizing the closed form of the calcium channel RyR2 could treat nephrotic syndrome. Phosporylation of RyR2's serine at position 2808 (S2808) causes calcium leakage through...
BioCentury | Sep 14, 2018
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...
BioCentury | Sep 14, 2017
Strategy

Numerate’s Intelligence

With three new partnerships formed since June, Numerate Inc. is picking up steam and demonstrating that industry and academic groups alike are finding utility in its AI platform, which can build robust predictive models for...
BioCentury | Jul 28, 2017
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...
BioCentury | Jul 26, 2017
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...
BioCentury | Jun 23, 2017
Clinical News

InCarda's inhaled flecainide well tolerated in Phase I

InCarda Therapeutics Inc. (San Francisco, Calif.) reported top-line data from an Australian Phase I trial in 40 healthy volunteers showing that single doses of 20-60 mg InRhythm inhaled flecainide were well tolerated. The company also...
BioCentury | Mar 31, 2017
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...
BioCentury | Mar 27, 2017
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...
BioCentury | Sep 5, 2016
Clinical News

Inhaled flecainide: Phase I started

InCarda began a double-blind, placebo-controlled, Australian Phase I trial to evaluate single ascending doses of inhaled flecainide in 38 healthy volunteers. InCarda Therapeutics Inc. , San Francisco, Calif. Product: Inhaled flecainide ( InRhythm ) Business: Cardiovascular Molecular target:...
BioCentury | Jan 4, 2016
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...
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