The biotech space saw a few FDA decisions and clinical readouts over the last week.
The FDA handed down two verdicts, backing Nabriva Therapeutics PLC – ADR NBRV's novel antibiotic while turning down Sarepta Therapeutics Inc SRPT's second Duchenne muscular dystrophy drug.
TrovaGene Inc TROV was among the standout gainers as the company prepares for a weekend presentation at the 20th Asia-Pacific Prostate Cancer Conference.
The following are key catalysts that could create some ripples in the biotech space in the unfolding week.
Conferences
- 20th Asia-Pacific Prostate Cancer Conference – Aug. 24-26 in Melbourne, Australia
- 6th International conference on Infectious Diseases & Antibiotics – Aug. 28-29 in Paris, France
- 5th World Congress on Parkinson's & Huntington Disease – Aug. 29-31 in Vienna, Austria
- International Conference on Genetic Disorders – Aug. 30-31 in Bangkok, Thailand
PDUFA Dates
IntelliPharmaCeutics International Inc. IPCIF awaits an FDA nod for the NDA for its abuse-deterrent pain medication Rexista.
The PDUFA action date is Wednesday, Aug. 28. An Adcom meeting scheduled by the FDA has been postponed, casting doubt on whether the approval will come through by the scheduled date.
The FDA is scheduled to rule Thursday, Aug. 29, on Nektar Therapeutics NKTR's NDA for NKTR-181, a novel mu-opioid analgesic drug candidate to treat chronic low back pain in adult patients who are new to opioid therapy. The company communicated through a late July filing the postponement of a scheduled Adcom meeting, as the FDA continues to consider a number of scientific and policy issues relating to this class of drugs. Although the postponement is not unique to NKTR-181, the FDA said in the communication the PDUFA goal date may not be met.
Clinical Readouts
AVEO Pharmaceuticals, Inc. AVEO is scheduled to release additional interim overall survival analysis of the Phase 3 data for TIVO-3, which is being evaluated as a third-line treatment of patients with renal cell cancer.
AnaptysBio Inc ANAB is due to release Phase 2 data for ANB019 in generalized pustular psoriasis in mid-2019.
Earnings
Wednesday, Aug. 28
- Edap Tms SA EDAP (before the market open)
- Ascendis Pharma A/S ASND (after the market close)
- MEI Pharma Inc MEIP (after the market close)
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