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Mirati Plays Catch-Up With Amgen, Gilead’s 2nd Try With AIDS Drug, Cytokinetics’ Adcom Test And More: Key Nov FDA Decisions For Biotech Investors

Food and Drug Administration decisions and advisory committee verdicts slated for November were mostly positive. New molecular entity approvals so far this year trail 2021’s tally by about 35%.

AMGN

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Reported Late Thursday, ANAVEX2–73 Phase 2B/3 Study Met Primary And Key Secondary Endpoints, Showing Statistically Significant Reduction Of Clinical Decline In Global Clinical Study Of Patients With Early Alzheimer’s Disease; Shares Currently Halted

Robust, Statistically Significant and Clinically Meaningful Absolute Improvement in Cognitive Function as Measured by ADAS-Cog and ADCS-ADL   Key Secondary Endpoint CDR-SB Also Met, Demonstrating Statistically

AVXL

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Reported Late Thursday, UroGen Announces New Data From The OLYMPUS Trial that Shows Median Durability Of Response Of 28.9 Months For JELMYTO, A Non-Surgical, Chemoablative Treatment For Adults With Low-Grade Upper Tract Urothelial Cancer

--Results from this ongoing, non-interventional, rollover study were presented at the 23rd Annual Society of Urologic Oncology (SUO) Meeting in San Diego UroGen Pharma Ltd. (NASDAQ:URGN), a biotech company

URGN

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Reported Late Thursday, Theratechnologies Announces Update From Ongoing TH1902 Study; Decided To Pause The Enrollment Of Patients In Its Phase 1 Clinical Trial Of Th1902; Plans To Submit An Amendment To Its Protocol To The U.S. FDA For Approval

Theratechnologies Inc. ("Theratechnologies" or the "Company") (TSX:TH) (NASDAQ:THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today

THTX