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

RTTNews | 753 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 | 570 days ago
Russia Central Bank Cuts Rates For Fourth Policy Session

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Canadian Market Rises On Rate Cut Bets

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The Canadian market is up firmly in positive territory Friday afternoon, thanks to strong gains in the technology sector. A few stocks from financial and communications sectors are also up with notable gains.
RTTNews | 1 day ago
Swiss Market Ends Marginally Up After Choppy Ride

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The market started off on a positive note on Friday but slipped into the red around mid morning and then struggled for direction till the end with stocks swinging between gains and losses amid cautious moves by investors.
RTTNews | 1 day ago
European Stocks Close Higher After Cautious Session

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RTTNews | 1 day ago
U.S. Consumer Sentiment Deteriorates More Than Previously Estimated In October

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Revised data released by the University of Michigan on Friday showed consumer sentiment in the U.S. deteriorated by more than initially estimated in the month of October. The University of Michigan said its consumer sentiment index was downwardly revised to 53.6 from the preliminary reading of 55.0. Economists had expected the consumer sentiment index to be unrevised from the preliminary reading.
RTTNews | 1 day ago
U.S. Consumer Prices Rise 0.3% In September, Slightly Less Than Expected

U.S. Consumer Prices Rise 0.3% In September, Slightly Less Than Expected

A closely watched report released by the Labor Department on Friday showed consumer prices in the U.S. increased by slightly less than expected in the month of September. The Labor Department said its consumer price index rose by 0.3 percent in September after climbing by 0.4 percent in August. Economists had expected consumer prices to rise by another 0.4 percent.
RTTNews | 1 day ago
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