Support a New Drug Application Filing for Simufilam in Alzheimer’s disease - - Agreement Reached to Use ADAS-Cog as Co-Primary Efficacy Endpoint -
- Pivotal Phase 3 Program Remains On-track to be Initiated 2
nd Half 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.
The FDA approved an expansion in the label for
Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and
Sanofi SA s (NASDAQ: SNY) immunotherapy Libtayo for treating patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor, HHI, or for whom an HHI is not appropriate.
Full approval was granted for patients with locally advanced BCC and accelerated approval was granted for patients with metastatic BCC.
Moderna Strikes Vaccine Supply Agreements With Taiwan and Columbia
Moderna Inc (NASDAQ: MRNA) announced two supply agreements for its COVID-19 Vaccine - one with the government of Taiwan for 5 million doses and another with the government of Colombia for 10 million doses. Under the terms of the agreements, deliveries would begin in mid-2021.
Press release content from Globe Newswire. The AP news staff was not involved in its creation.
Cassava Sciences Announces Significant Program Progress and Expected Key Milestones in 2021 for .
Cassava Sciences, Inc.February 8, 2021 GMT
AUSTIN, Texas, Feb. 08, 2021 (GLOBE NEWSWIRE) Cassava Sciences, Inc. (Nasdaq: SAVA), a clinical-stage biotechnology company developing product candidates for Alzheimer’s disease, today announced significant program progress and expected milestones for 2021.
“We started 2021 with tremendous momentum, led by results of a 6-month interim analysis from an open-label study of simufilam, our drug candidate for Alzheimer’s disease,” said Remi Barbier, President & CEO. “I believe the rest of the year may be equally exciting.”
Cassava Sciences Inc (NASDAQ: SAVA) shares were trading solidly higher Monday on above-average volume in reaction to updates from the company on clinical .