Skip to main content

Market Overview

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

Share:
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)
 

Related Articles (XBI + IBB)

View Comments and Join the Discussion!

Posted-In: Biotech Earnings News FDA Top Stories Movers Trading Ideas Best of Benzinga

Don't Miss Any Updates!
News Directly in Your Inbox
Subscribe to:
Benzinga Premarket Activity
Get pre-market outlook, mid-day update and after-market roundup emails in your inbox.
Market in 5 Minutes
Everything you need to know about the market - quick & easy.
Fintech Focus
A daily collection of all things fintech, interesting developments and market updates.
SPAC
Everything you need to know about the latest SPAC news.
Thank You

Thank you for subscribing! If you have any questions feel free to call us at 1-877-440-ZING or email us at vipaccounts@benzinga.com