TG Therapeutics to Present Results from the ULTIMATE I & II Phase 3 Trials Evaluating Ublituximab in Multiple Sclerosis at the Upcoming American Academy of Neurology 73rd Annual Meeting gurufocus.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from gurufocus.com Daily Mail and Mail on Sunday newspapers.
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ENGLEWOOD, Colo., March 3, 2021 /PRNewswire/ Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, today reported annual financial results for the year ended December 31, 2020 and provided a corporate overview / business update.
Mr. Michael Macaluso, President and CEO, noted, The FDA has recently responded to our requests to expand our IV and Inhalation Covid-19 studies, utilizing Ampion, by recommending we conduct a randomized, double-blinded, placebo-controlled Phase II trial in each. They also indicated that their recommended trial design for both will allow for an effective and efficient review of data results, determine the safety and statistical significance and effectiveness of Ampion in comparison to Standard of Care, all of which are necessary for the FDA to objectively determine that the known and potential benefit
Published: Feb 22, 2021
AUSTIN, Texas, Feb. 22, 2021 (GLOBE NEWSWIRE) Cassava Sciences Inc., (Nasdaq: SAVA), a biotechnology company developing product candidates for Alzheimer’s disease, today announced the successful completion of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for simufilam, its lead drug candidate for the treatment of Alzheimer’s disease. Official EOP2 meeting minutes indicate FDA and Cassava Sciences agree on key elements of a pivotal Phase 3 clinical program in support of a New Drug Application (NDA) filing for simufilam in Alzheimer’s disease. Agreements reached during the EOP2 meeting show a clear path forward for advancing simufilam into Phase 3 studies in the second half of 2021.
Press release content from Business Wire. The AP news staff was not involved in its creation.
GenSight Biologics Announces Publication of Results from LUMEVOQ® Phase I/IIa Clinical Trial REVEAL in BioDrugs
February 15, 2021 GMT
Regulatory News:
GenSight Biologics (Paris:SIGHT) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced that the journal
BioDrugs has published results from REVEAL, the Phase I/IIa clinical trial that evaluated the safety of LUMEVOQ ® gene therapy in subjects with
ND4 Leber Hereditary Optic Neuropathy (LHON) and determined the dose subsequently used in the Phase III trials RESCUE and REVERSE.