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.


Needham Virtual Healthcare Conference: April 14-15


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

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