The Week Ahead In Biotech: Urogen FDA Decision, Amarin, J&J Earnings And More COVID-19 Updates
Biotech stocks moved higher last week along with the broader market. The week witnessed a few clinical readouts and pre-announcements that reflected the coronavirus (COVID-19) impact.
Keros Therapeutics Inc KROS 7.42% had a dream debut, with the company pricing the shares at the high-end of the estimated range and the shares closing the debut session about 26% higher than the IPO price.
This upcoming week is likely to continue to see more pre-announcements and disclosures regarding how the COVID-19 pandemic is impacting operations, cash position, financials and clinical trials.
Conferences
Needham Virtual Healthcare Conference: April 14-15
PDUFA Date
The FDA is set to rule Saturday on Urogen Pharma Ltd's URGN 6.23% NDA for UGN-101 (mitomycin gel), which is being evaluated for the treatment of low-grade, upper tract urothelial cancer.
Clinical Readouts
Vir Biotechnology Inc VIR 1.37% on Wednesday will present at a Key Opinion leader call, an update on its Phase 1/2 hepatitis B virus clinical trial with small interfering ribonucleic acid VIR-2218. Vir had licensed the investigational asset from Alnylam Pharmaceuticals, Inc. ALNY 4.48%.
See Also: Novavax Identifies COVID-19 Vaccine Candidate, Human Testing To Begin In Mid-May
Mid-April Schedule
Ascendis Pharma A/S ASND 0.5%: top-line data from PaTH Forward Phase 2 study of TransCon hGH in treating hypoparathryroidism
Gilead Sciences, Inc. GILD 1.97% could release results from the Phase 3 China studies of remdesivir for the treatment of COVID-19 (sell-side estimate a mid-April release)
Early Q2 Schedule
Axsome Therapeutics Inc AXSM 3.52%: top-line data from the Phase 2/3 study dubbed ADVANCE-1 that is evaluating AXS-05 for treating agitation in patients with Alzheimer's disease
SCYNEXIS Inc SCYX 2.45%: top-line data from Phase 3 VANISH program, evaluating oral ibrexafungerp for the treatment of Vulvovaginal Candidiasis
Ovid Therapeutics Inc OVID 0.35%: data from the signal-finding Phase 2 ROCKET trial in Fragile X syndrome along with SKYROCKET, its non-interventional trial in Fragile X syndrome.
Iterum Therapeutics PLC ITRM 3.58%: top-line results from the Phase 3 study of sulopenem in complicated urinary tract infection and uncomplicated urinary tract infection
Earnings
Monday
- Amarin Corporation plc AMRN 4.13% (after the close)
Tuesday
- Johnson & Johnson JNJ 1.4% (before the market open)
Thursday