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 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 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 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.

See Also: Novavax Identifies COVID-19 Vaccine Candidate, Human Testing To Begin In Mid-May

Mid-April Schedule

Ascendis Pharma A/S ASND: top-line data from PaTH Forward Phase 2 study of TransCon hGH in treating hypoparathryroidism

Gilead Sciences, Inc. GILD 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: 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: top-line data from Phase 3 VANISH program, evaluating oral ibrexafungerp for the treatment of Vulvovaginal Candidiasis

Ovid Therapeutics Inc OVID: 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: 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 (after the close)

Tuesday

• Johnson & Johnson JNJ (before the market open)

Thursday

• Abbott Laboratories ABT (before the market open)
• Intuitive Surgical, Inc. ISRG (after the close)