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. 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 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 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. 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 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. MLSS (before the market open)
Adamis Pharmaceuticals Corp ADMP (after the close)

Tuesday

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

Wednesday

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

Thursday

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

IPO Quiet Period Expiry

ORIC Pharmaceuticals Inc ORIC