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The Week Ahead In Biotech: Aquestive Awaits FDA Decision, Earnings Flow Slows

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The Week Ahead In Biotech: Aquestive Awaits FDA Decision, Earnings Flow Slows

Biotech stocks had another up week, with the American Society of Gene & Stem Cell Therapy virtual conference presentations and the ASCO abstracts made available online Thursday calling the shots. Earnings news flow continued to taper.

Biopharma companies working on vaccines/therapies for COVID-19 continued to provide updates. Novavax, Inc. (NASDAQ: NVAX) shares more than doubled, thanks to an announcement concerning a $384 million grant from the Coalition for Epidemic Preparedness Innovations.

Here are the key catalysts for the unfolding week.

Conferences

  • UBS Virtual Global Healthcare Conference: May 18-20
  • RBC Capital Markets 2020 Global Healthcare Virtual Conference: May 19-20
  • European Society for Medical Oncology, or ESMO, Breast Cancer Virtual Meeting: May 23-24

PDUFA Dates

The FDA is due to rule on Aquestive Therapeutics Inc's (NASDAQ: AQST) NDA for apomorphine sublingual film (APL-130277), which is being evaluated for treating off episodes in Parkinson's disease patients. APL-130277 is being developed by Sunovion Pharmaceuticals, a subsidiary of Sumitomo Dainippon Pharma, in partnership with Aquestive.

Clinical Readouts

Entera Bio Ltd (NASDAQ: ENTX) is scheduled to report on Thursday interim three-month top-line biomarker data for the first 50% of the patients enrolled in the Phase 2 osteoporosis clinical trial of EB613.

Oncolytics Biotech, Inc. (NASDAQ: ONCY) is due to present at the ESMO Breast Cancer Conference, interim biomarker data from the AWARE-1 early-stage breast cancer study that is evaluating its pelareorep along with Roche Holdings AG's (OTC: RHHBY) Tecentriq.

See Also: Results From Oxford University's Human Trial Of Coronavirus Vaccine Could Arrive In June; Where Inovio, Moderna Stand

Earnings

Monday

Milestone Scientific Inc. (NYSE: MLSS) (before the market open)
Adamis Pharmaceuticals Corp (NASDAQ: ADMP) (after the close)

Tuesday

Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (after the close)
Ascendis Pharma A/S (NASDAQ: ASND) (after the close)

Wednesday

Mediwound Ltd (NASDAQ: MDWD) (before the market open)
China Biologic Products Holdings Inc (NASDAQ: CBPO) (after the close)

Thursday

Entera Bio (before the market open)
Medtronic PLC (NYSE: MDT) (before the market open)
PAVmed Inc (NASDAQ: PAVM) (after the close)
Xenon Pharmaceuticals Inc (NASDAQ: XENE) (after the close)

IPO Quiet Period Expiry

ORIC Pharmaceuticals Inc (NASDAQ: ORIC)

 

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