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

RTTNews | 759日前
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.

read more
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 | 576日前
Bay Street May Open On Positive Note

Bay Street May Open On Positive Note

The Canadian market may open on a positive note on Friday as technology stocks are likely to see some brisk buying thanks to encouraging earnings guidance from U.S. tech majors Apple Inc., and Amazon.
RTTNews | 22分前
FTSE 100 Modestly Lower; Bank Stocks Among Notable Losers

FTSE 100 Modestly Lower; Bank Stocks Among Notable Losers

The UK stock market's benchmark index FTSE 100 is down in negative territory on Friday, weighed down by losses in the banking sector. After nine successive days of gains, the index looks likely to settle on a weak note today.
RTTNews | 56分前
CAC 40 Modestly Lower In Cautious Trade After Inflation Data

CAC 40 Modestly Lower In Cautious Trade After Inflation Data

The French market is modestly lower on Friday with investors reacting to regional inflation data, and recent earnings updates and central bank policy decisions, in addition to weighing the developments on trade and geopolitical fronts.
RTTNews | 1時48分前
UK Nationwide House Price Growth Softens

UK Nationwide House Price Growth Softens

UK house prices increased at a slower pace in October as buyers were cautious ahead of the budget, data from the Nationwide Building Society showed Friday. House price posted a monthly growth of 0.3 percent in October, slower than the 0.5 percent rise seen a month ago. Nonetheless, the figure was better than the forecast of nil growth.
RTTNews | 1時53分前
DAX Drops To 2-month Low

DAX Drops To 2-month Low

German stocks are down in negative territory on Friday and the benchmark DAX is near two-month lows, as investors, assessing the recent interest rate decisions of the major central banks, and the developments on the trade front, remain cautious and mostly making cautious moves.
RTTNews | 2時36分前
European Shares Subdued Before Key Inflation Reading

European Shares Subdued Before Key Inflation Reading

European stocks drifted lower on Friday, and the euro consolidated losses ahead of key Eurozone inflation data due later in the day. Earlier in the day, data showed that French consumer price inflation slowed further below the European Central Bank's target in October despite an unexpectedly strong upswing in the economy.
RTTNews | 4時4分前