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

RTTNews | 694 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.

Tags: URGN
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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 | 511 days ago
Higher Open Called For Japan Stock Market

Higher Open Called For Japan Stock Market

The Japan stock market bounced higher again on Wednesday, one session after ending the two-day winning streak in which it had advanced almost 200 points or 0.5 percent. The Nikkei 225 now rests just above the 42,520-point plateau and it's expected to open to the upside again on Thursday.
RTTNews | 3 minutes ago
KOSPI May Reclaim 3,200-Point Level

KOSPI May Reclaim 3,200-Point Level

The South Korea stock market bounced higher again on Wednesday, one day after ending the three-day winning streak in which it had improved almost 80 points or 2.6 percent. The KOSPI now sits just shy of the 3,190-point plateau and it may tick higher again on Thursday.
RTTNews | 18 minutes ago
Korea Interest Rate Decision Due On Thursday

Korea Interest Rate Decision Due On Thursday

The Bank of Korea will wrap up its monetary policy meeting this morning and then announce its decision on interest rates, highlighting a light day for Asia-Pacific economic activity. The BoK is expected to keep its benchmark lending rate unchanged at 2.50 percent.
RTTNews | 1h 18min ago
European Stocks Close On Mixed Note

European Stocks Close On Mixed Note

European stocks turned in a mixed performance on Wednesday as investors largely stayed cautious, looking ahead to chipmaker Nvidia's quarterly earnings announcement, and continuing to assess the political situation in France.
RTTNews | 6h 23min ago
Euro Falls Amid Political Uncertainty

Euro Falls Amid Political Uncertainty

The euro weakened against other major currencies in the European session on Wednesday, as trader's concern about the collapse of France's government.
RTTNews | 10h 39min ago
Bay Street Likely To Open On Positive Note

Bay Street Likely To Open On Positive Note

Canadian shares are likely to open on a positive note on Wednesday, riding on strong earnings from Royal Bank of Canada and National Bank of Canada. Weak commodity prices and concerns on the geopolitical and tariffs front may weigh limit market's upside.
RTTNews | 11h 4min ago
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