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The Week Ahead In Biotech: FDA Goes Into Overdrive In A Quiet Week

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.


  • 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


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.


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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