The Week Ahead In Biotech: FDA Goes Into Overdrive In A Quiet Week
Biotech stocks succumbed to the broader market weakness, as trade tensions and recession fears shook the broader markets. Earnings and stray clinical readouts triggered some activity in the space.
Here are the key biotech catalysts for the unfolding week.
Conferences
The World Heart Congress – Aug. 19-20, in Vienna, Austria
11th international Conference on Clinical and Cellular Immunology – Aug. 22-23, in Vienna
2019 Asia-Pacific Prostate Cancer Conference - Aug. 24-26, in Melbourne, Australia
PDUFA Dates
Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV) awaits FDA decision on its NDA for intravenous and oral formulations of Lefamulin for treating community-acquired bacterial pneumonia. The PDUFA date is set for Monday, Aug. 19.
Sarepta Therapeutics Inc (NASDAQ: SRPT)'s NDA for Duchenne muscular dystrophy drug Golodirsen has a FDA action date of Monday. Golodirsen is being studied by Sarepta for the treatment of exon 53 amenable patients, who account for about eight percent of DMD patients.
Clinical Trial Readout
TrovaGene Inc (NASDAQ: TROV) is due to present new Phase 2 data for Onvansertib and Zytiga at the Asia-Pacific Prostate Cancer Conference Saturday, Aug. 24.
Earnings
Tuesday, Aug. 20
Medtronic PLC (NYSE: MDT)
IPO Quiet Period Expiry
Castle Biosciences Inc (NASDAQ: CSTL)
Related Links:
Attention Biotech Investors: Mark Your Calendar For These August PDUFA Dates
Biotech Stock On The Radar: Is Vanda A Buy Ahead Of Its PDUFA Date?
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