FDA Grants Breakthrough Therapy Designation (BTD) for UroGen Pharma’s UGN-101 for the Treatment of Patients with Low-Grade Upper Tract Urothelial Cancer (LG UTUC)
Last urogen pharma ltd earnings: 11/12 08:00 am
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US:NASDAQ Investor Relations: investors.urogen.com
UGN-101 Joins Select Group of Urologic Oncology Product Candidates to Receive BTD On Track to Initiate Rolling Submission of UGN-101 New Drug Application (NDA) in Q4 2018 RA’ANANA, Israel & NEW YORK--(BUSINESS WIRE)-- UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to the Company’s lead product candidate, UGN-101, (mitomycin gel) for instillation. UGN-101 is currently in Phase 3 development for the treatment of patients with low-grade upper tract urothelial cancer (LG UTUC). Breakthrough Therapy Designation is designed to expedite the development and review of new drugs to treat serious or life-threatening conditions, so patients may have access to t
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URGN
News
- Urogen Pharma Ltd (NASDAQ: URGN) was downgraded by analysts at Zacks Investment Research from a "hold" rating to a "sell" rating.MarketBeat
- Urogen Pharma Ltd (NASDAQ: URGN) had its "buy" rating re-affirmed by analysts at Cowen Inc.MarketBeat
- Urogen Pharma Ltd (NASDAQ: URGN) had its price target lowered by analysts at Oppenheimer Holdings Inc. from $62.00 to $52.00. They now have an "outperform" rating on the stock.MarketBeat
- Urogen Pharma Ltd (NASDAQ: URGN) is now covered by analysts at National Securities. They set a "neutral" rating on the stock.MarketBeat
- UroGen to Present at 38th Annual J.P. Morgan Healthcare ConferenceBusiness Wire
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URGN
SEC Filings
- 1/7/20 - Form 4
- 1/3/20 - Form EFFECT
- 1/2/20 - Form 424B5
- URGN's page on the SEC website
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