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The Week Ahead In Biotech: Urogen FDA Decision, Amarin, J&J Earnings And More COVID-19 Updates

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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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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. (NASDAQ: ALNY).

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

Mid-April Schedule

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

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

Ovid Therapeutics Inc (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: AMRN) (after the close)

Tuesday

  • Johnson & Johnson (NYSE: JNJ) (before the market open)

Thursday

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

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