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

RTTNews | 757 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 | 574 days ago
French GDP Growth Accelerates Unexpectedly

French GDP Growth Accelerates Unexpectedly

France's economic growth accelerated in the third quarter despite political uncertainty and trade tensions, official data revealed on Thursday. Gross domestic product registered a quarterly growth of 0.5 percent, following a 0.3 percent rise in the second quarter, the statistical office INSEE reported. The growth was expected to ease to 0.2 percent.
RTTNews | 10 minutes ago
Bank Of Japan Keeps Key Rate On Hold

Bank Of Japan Keeps Key Rate On Hold

The Bank of Japan left its interest rate unchanged even as inflation continued to remain above 2 percent, and also left its real growth and inflation outlook more or less unchanged. The policy board of the Bank of Japan decided, by a 7-2 majority vote, to hold the uncollateralized overnight call rate at around 0.5 percent.
RTTNews | 1h 15min ago
Sensex, Nifty Drift Lower In Cautious Trade

Sensex, Nifty Drift Lower In Cautious Trade

Indian shares traded lower on Thursday as investors reacted to hawkish remarks from Fed Chair Jerome Powell and a mixed bag of U.S. tech earnings.
RTTNews | 2h 58min ago
Yen Falls Against Majors

Yen Falls Against Majors

The Japanese yen weakened against other major currencies in the Asian session on Thursday.
RTTNews | 3h 25min ago
Australian Market Trims Early Losses In Mid-market

Australian Market Trims Early Losses In Mid-market

The Australian market is trimming its early losses in mid-market moves on Thursday, but adding to the losses in the previous two sessions, following the mixed cues from Wall Street overnight. The benchmark S&P/ASX 200 is falling to near the 8,900 level, with gains in iron ore miners and financial stocks partially offset by weakness in technology stocks.
RTTNews | 4h 12min ago
Asian Markets Trade Mostly Higher

Asian Markets Trade Mostly Higher

Asian markets are trading mostly higher on Thursday, following the mixed cues from Wall Street overnight, amid optimism about a potential trade deal between the U.S. and China as US President Donald Trump and Chinese President Xi Jinping meet. Traders also react to another quarter point interest rate cut by the US Fed. Asian markets closed mostly higher on Wednesday.
RTTNews | 4h 26min ago
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