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Sage Therapeutics and Biogen Announce that the Phase 3 SKYLARK Study of Zuranolone in Postpartum Depression Met its Primary and All Key Secondary Endpoints

01.06.2022 - Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today announced that the Phase 3 SKYLARK Study of zuranolone, an investigational oral drug being evaluated in women with postpartum depression (PPD), met its primary and all key . ....

New York , United States , Charles Weissmann , Walter Gilbert , Heinz Schaller , Wendyn Davis , Katherine Dawson , Kristina Deligiannidis , Barry Greene , Kenneth Murray , American Psychiatric Association , Committee Opinion No , Us Department Of Health , Human Services , Drug Administration , Feinstein Institutes For Medical Research In Manhasset , Postpartum Support International , Exchange Commission , Us Food Drug Administration , Associate Professor , Feinstein Institutes , Medical Research , Key Secondary Endpoint , Clinical Global Impression Severity , African American , Physician Withdrawal Checklist ,

SAGE Therapeutics (SAGE) and Biogen (BIIB) Report Phase 3 SKYLARK Study of Zuranolone in Postpartum Depression Met its Primary and All Key Secondary Endpoints

SAGE Therapeutics (SAGE) and Biogen (BIIB) Report Phase 3 SKYLARK Study of Zuranolone in Postpartum Depression Met its Primary and All Key Secondary Endpoints
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New York , United States , Charles Weissmann , Walter Gilbert , Heinz Schaller , Wendyn Davis , Becky Kern , Katherine Dawson , Ashleigh Koss , Mike Hencke , Kristina Deligiannidis , Helen Rubinstein , Barry Greene , Kenneth Murray , American Psychiatric Association , Feinstein Institutes For Medical Research In Manhasset , Biogen Inc , Sage Therapeutics Inc , Committee Opinion No , Human Services , Us Department Of Health , Drug Administration , Postpartum Support International , Exchange Commission , Us Food Drug Administration , Wall Street ,

Sage Therapeutics and Biogen Announce that the Phase 3 SKYLARK Study of Zuranolone in Postpartum Dep

Zuranolone 50 mg demonstrated a statistically significant and clinically meaningful improvement in depressive symptoms at Day 15, the primary endpoint, and at Days 3, 28, and 45, key secondary endpointsZuranolone 50 mg was generally well-tolerated and demonstrated a safety profile consistent with prior studiesPostpa. ....

United Kingdom , United States , New York , Charles Weissmann , Walter Gilbert , Heinz Schaller , Wendyn Davis , Becky Kern , Katherine Dawson , Ashleigh Koss , Mike Hencke , Kristina Deligiannidis , Helen Rubinstein , Barry Greene , Kenneth Murray , American Psychiatric Association , Feinstein Institutes For Medical Research In Manhasset , Biogen Inc , Sage Therapeutics Inc , Committee Opinion No , Human Services , Us Department Of Health , Drug Administration , Postpartum Support International , Exchange Commission , Us Food Drug Administration ,

Biogen Inc.: Biogen Announces Positive Topline Results from Phase 2 CONVEY Study in Small Fiber Neuropathy

Biogen Inc.: Biogen Announces Positive Topline Results from Phase 2 CONVEY Study in Small Fiber Neuropathy
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United Kingdom , Katherine Dawson , Mike Hencke , Walter Gilbert , Charles Weissmann , Heinz Schaller , Kenneth Murray , Allison Parks , Exchange Commission , Patient Global Impression , Senior Vice President , Therapeutics Development Unit , Study Results , Nobel Prize , Today Biogen , Private Securities Litigation Reform Act , ஒன்றுபட்டது கிஂக்டம் , க்யாதரிந் டாசன் , வால்டர் கில்பர்ட் , சார்லஸ் வெயிஸ்மேன் , ஹெய்ன்ஸ் ஸ்காலர் , கெநெத் முர்ரே , அல்லிசன் பூங்காக்கள் , பரிமாற்றம் தரகு , நோயாளி உலகளாவிய எண்ணம் , மூத்தவர் துணை ப்ரெஸிடெஂட் ,

Biogen Inc.: Biogen Announces Topline Results from Phase 3 Gene Therapy Study in Choroideremia

Biogen Inc.: Biogen Announces Topline Results from Phase 3 Gene Therapy Study in Choroideremia
Choroideremia is a rare inherited retinal disease that results in progressive vision loss, ultimately leading to blindness
CAMBRIDGE, Mass., June 14, 2021(Nasdaq: BIIB) today announced topline results from the Phase 3 STAR study of timrepigene emparvovec (BIIB111/AAV2-REP1), an investigational gene therapy for the potential treatment of choroideremia. The STAR study did not meet its primary endpoint of proportion of participants with a =15 letter improvement from baseline in best corrected visual acuity (BCVA) at Month 12, in the interventional group in comparison to the non-interventional control group, as measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart. In addition, the study did not demonstrate efficacy on key secondary endpoints. Safety results from the Phase 3 STAR study were consistent with previous studies. ....

United Kingdom , Katherine Dawson , Mike Hencke , Walter Gilbert , Charles Weissmann , Heinz Schaller , Kenneth Murray , Allison Parks , Exchange Commission , Therapeutics Development Unit At Biogen , Early Treatment , Diabetic Retinopathy Study , Therapeutics Development Unit , Nobel Prize , Today Biogen , Private Securities Litigation Reform Act , ஒன்றுபட்டது கிஂக்டம் , க்யாதரிந் டாசன் , வால்டர் கில்பர்ட் , சார்லஸ் வெயிஸ்மேன் , ஹெய்ன்ஸ் ஸ்காலர் , கெநெத் முர்ரே , அல்லிசன் பூங்காக்கள் , பரிமாற்றம் தரகு , ஆரம்ப சிகிச்சை , நீரிழிவு ரெட்டினோபதி படிப்பு ,