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Biopharma Daily Stock Updates - 05/10/21


 

Covid Updates

$BNTX Plan to supply 900M doses of COMIRNATY to the European Commission. source



Pipeline Updates

$ASND Announces Preliminary 58-Week Results from Open-Label Extension of Phase 2 PaTH Forward Trial of TransCon PTH in Adult Hypoparathyroidism Demonstrated Durable Benefit and a Well-Tolerated Safety Profile. source


$HRTX PDUFA date for HTX-011 set at May 12, 2021. source


$IMGN Mirvetuximab FORWARD II study selected to present at ASCO on June 4-8. source


$KOD Plan to initiate two pivotal Phase 3 studies and complete additional pivotal study of KSI-301 in 2021. source


$SAVA Initiates Cognition Maintenance Study to evaluate simufilam in patients with Alzheimer's disease. source


$OSMT Upneeq wins 2021 MedTech Breakthrough Award. source


$CUE Reports confirmed partial response in Phase 1 monotherapy study of CUE-101. source


$LQDA Resubmitted NDA on 5/7/21 for LIQ861 which included additional chemistry, manufacturing, and controls clarification. source


$MBIO FDA has accepted IND application to initiate Phase 1/2 study of MB-106. source


$ALXO Announces first patient dosed in Phase 2 ASPEN-03 study. source


$GTHX Initiates PRESERVE 4 Phase 2 study of COSELA. source


$EGRX Announces TREAKISYM RI has been filed with PMDA in Japan. source


$FBIO Enters into licensing agreement with Fuji Yakuhin Co. Ltd. for development of Dotinurad. source


$AUPH Phase 3 AURORA 1 study results published in The Lance. source


$CMPI Expands vidutolimod program into non-melanoma skin cancers in combo with Libtayo. source


$IDYA Announced dose expansion in Phase 1/2 Darovasertib and Crizotinib combo study. source



Financial Updates

$BNTX Plan to establish first regional headquarters for southeast Asian in Singapore. source


$DVAX Announces proposed private offering of $200M of convertible senior notes. source


$INSM Intends to offer and sell $250M of its common stock. source

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