BioCentury | Dec 19, 2020
Product Development

Dec. 18 Quick Takes: FDA approves expanded label for Benlysta and first oral prostate cancer therapy; plus Novartis, FibroGen, A2i, China’s NRDL and more

FDA expands Benlysta label to include lupus nephritisFDA approved Benlysta belimumab from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for adults with active lupus nephritis, making it the first therapy specifically approved for the systemic lupus erythematosus complication....
BioCentury | Apr 6, 2019
Finance

Everybody up

...Parkinson’s disease patients. Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) FDA rescinds breakthrough therapy designation for Tonix's Tonmya...
BioCentury | Mar 14, 2019
Company News

Tonix's PTSD therapy loses breakthrough therapy designation

...FDA rescinded breakthrough therapy designation for Tonix's Tonmya cyclobenzaprine (Sublingual TNX-102) to treat military-related posttraumatic stress disorder...
...company announced that it enrolled the first patient in the Phase III Recovery trial of Tonmya...
BioCentury | Aug 3, 2018
Clinical News

Tonix stops Phase III of PTSD candidate on lack of separation from placebo

...Pharmaceuticals Holding Corp. (NASDAQ:TNXP) said it will stop the Phase III HONOR trial of Tonmya (Sublingual TNX-102...
...placebo or two 2.8 mg tablets of Tonmya given each day at bedtime. Tonix said Tonmya...
...SDS) and patient-reported sleep quality Status: Interim Phase III data Milestone: NA Elizabeth S. Eaton Tonmya (Sublingual TNX-102, TNX-102 SL...
BioCentury | Jun 30, 2018
Finance

Eyes on launches

.../ Mylan N.V. (NASDAQ:MYL) Revefenacin (TD-4208) COPD PDUFA date 11/13/18 Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) Tonmya...
BioCentury | Jan 6, 2018
Finance

Burgeoning bellwethers

...511/Toca FC) Recurrent high-grade glioma Interim Ph III data 2H18 Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) Tonmya...
BioCentury | Apr 20, 2017
Clinical News

TNX-102 SL: Ph III HONOR started

...Tonix began the double-blind, placebo-controlled, U.S. Phase III HONOR trial to evaluate 5.6 mg sublingual TNX-102 daily...
...top-line data in 2H18. Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), New York, N.Y. Product: Sublingual TNX-102 , TNX-102 SL...
...quality Status: Phase III started Milestone: Interim Phase III data (1H18); Phase III data (2H18) Alex Himes Sublingual TNX-102 TNX-102 SL Tonix...
BioCentury | Jan 27, 2017
Clinical News

TNX-102 SL: Ph II AtEase data

...Phase II AtEase trial in 231 patients with military-related PTSD showed that once-daily 2.8 mg sublingual TNX-102...
...of TNX-102 SL to treat military-related PTSD. Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), New York, N.Y. Product: Sublingual TNX-102...
...to treat military-related PTSD. Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), New York, N.Y. Product: Sublingual TNX-102 , TNX-102 SL...
BioCentury | Dec 21, 2016
Clinical News

TNX-102 SL regulatory update

...FDA granted breakthrough therapy designation to TNX-102 SL from Tonix to treat post-traumatic stress disorder (PTSD). In...
...PTSD. Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), New York, N.Y. Product: TNX-102 SL, sublingual cyclobenzaprine Business: Neurology Alicia Parker TNX-102 SL Tonmya Tonix...
BioCentury | Sep 12, 2016
Clinical News

Tonmya: Phase III data

...double-blind, U.S. Phase III AFFIRM trial in 519 fibromyalgia patients showed that once-daily 2.8 mg sublingual TNX-102...
...disorder (PTSD). Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP), New York, N.Y. Product: Tonmya ( Sublingual TNX-102 , TNX-102 SL...
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