UroGen Pharma Says FDA Approves Plan For Rolling NDA Submission For UGN-102 From January 2024

RTTNews | 640 days ago
Stocktwits
UroGen Pharma Says FDA Approves Plan For Rolling NDA Submission For UGN-102 From January 2024

(RTTNews) - Biotech company UroGen Pharma Ltd. (URGN) announced Tuesday that it has reached agreement with the U.S. Food and Drug Administration (FDA) on plans for submission of a New Drug Application (NDA) for UGN-102 (mitomycin) for intravesical solution.

The FDA indicated that the current clinical development plan for UGN-102, which includes evaluation of duration of complete response (CR) at 12 months from the pivotal ENVISION trial, will support submission of an NDA for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

The FDA also agreed that the UGN-102 NDA can utilize a rolling review, allowing for early submission of the Chemistry, Manufacturing and Controls (CMC) sections of the NDA, which is planned for January 2024.

If approved, UGN-102 has the potential to introduce a new non-surgical treatment paradigm for LG-IR-NMIBC, a subset of bladder cancer patients characterized by high recurrence rates and the need for multiple surgeries.

The UGN-102 clinical development plan centers around the Phase 3 ENVISION pivotal trial and is supported by robust clinical data from the ATLAS Phase 3 and OPTIMA Phase 2b trials.

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UroGen Pharma Files Patent Infringement Lawsuit Against Teva Pharma

UroGen Pharma Files Patent Infringement Lawsuit Against Teva Pharma

Biotech company UroGen Pharma Ltd. (URGN) announced Wednesday that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd. (TEVA), alleging infringement of U.S. Patent Numbers 9,040,074 and 9,950,069.
RTTNews | 457 days ago
TSX Settles Roughly Flat

TSX Settles Roughly Flat

The Canadian stock market ended flat on Friday, amid uncertainty on US-Canada trade deal even as July 9 deadline set by the US President for tariff agreement is fast approaching.
RTTNews | 3h 23min ago
Swiss Market Ends Slightly Down

Swiss Market Ends Slightly Down

After languishing in negative territory till a little before the final hour of the day's trading session, the Switzerland market managed to emerge into positive zone on Friday but failed to hold firm and eventually settled with a marginal loss.
RTTNews | 10h 6min ago
TSX Up Marginally After Posting New Record High

TSX Up Marginally After Posting New Record High

The Canadian market is up marginally a little past noon on Friday with investors largely making cautious moves on weak private sector activity report, and amid uncertainty about Trump administration's tariff moves.
RTTNews | 11h 35min ago
German Factory Orders Log Bigger-Than-Expected Fall

German Factory Orders Log Bigger-Than-Expected Fall

Germany's factory orders declined more than expected in May on falling demand from both the domestic market and other euro area economies, official data revealed on Friday. Factory orders decreased 1.4 percent from a month ago, Destatis reported. Orders were expected to drop 0.2 percent after an upwardly revised 1.6 percent rise in April. Orders declined for the first time in four months.
RTTNews | 15h 4min ago
Bay Street Headed For Weak Start

Bay Street Headed For Weak Start

Canadian shares are likely to open on a negative note Friday morning, tracking weak European stocks and lower crude oil prices. Concerns about tariffs may weigh down on sentiment. Trading volumes are likely to remain thin as the U.S. market is closed for Independence Day holiday.
RTTNews | 15h 26min ago
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