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

RTTNews | 757 days ago
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 | 574 days ago
Japan Rate Decision On Tap For Thursday

Japan Rate Decision On Tap For Thursday

The Bank of Japan will wrap up its monetary policy meeting on Thursday and then announce its decision on interest rates, highlighting a modest day for Asia-Pacific economic activity. The BoJ is expected to keep its benchmark lending rate steady at 0.50 percent.
RTTNews | 46 minutes ago
Swiss Market Ends On Weak Note

Swiss Market Ends On Weak Note

After spending a few minutes in positive territory at the start, Switzerland stock market's benchmark SMI drifted down and then stayed weak right through the trading session on Wednesday, with investors digesting corporate earnings updates and looking ahead to the Federal Reserve's rate decision due later in the day.
RTTNews | 4h 3min ago
Fed Announces Widely Expected Decision To Cut Rates By Another Quarter Point

Fed Announces Widely Expected Decision To Cut Rates By Another Quarter Point

After cutting interest rates for the first time this year in September, the Federal Reserve on Wednesday announced its widely expected decision to lower rates by another quarter point. The Fed said it decided to lower the target range for the federal funds rate by 25 basis points to 3.75 percent to 4.0 percent in support of its dual goals.
RTTNews | 4h 31min ago
Major European Markets Close On Mixed Note Ahead Of Fed Rate Decision

Major European Markets Close On Mixed Note Ahead Of Fed Rate Decision

European stocks turned in a mixed performance on Wednesday with investors reacting to a slew of earnings announcements, and looking ahead to the monetary policy announcement from the Federal Reserve later in the day, and the upcoming meeting between U.S. President Donald Trump and his Chinese counterpart Xi Jinping. Investors also looked ahead to the ECB's policy announcement due tomorrow.
RTTNews | 4h 32min ago
Canadian Market Drifts Lower After BoC Rate Decision; Energy, Materials Shares Rise

Canadian Market Drifts Lower After BoC Rate Decision; Energy, Materials Shares Rise

The Canadian market is down in negative territory around noon on Wednesday, weighed down by losses in consumer, healthcare, industrials and real estate sectors. Investors are digesting the Bank of Canada's rate cut decision, and looking ahead to the Federal Reserve's interest rate announcement due later in the day.
RTTNews | 6h 41min ago
U.S. Pending Home Sales Unexpectedly Unchanged In September

U.S. Pending Home Sales Unexpectedly Unchanged In September

After reporting a sharp increase by pending home sales in the U.S. in the previous month, the National Association of Realtors released a report on Wednesday showing pending home sales unexpectedly came in flat in the month of September. NAR said its pending homes sales index was unchanged at 74.8 in September after surging by 4.2 percent in August.
RTTNews | 8h 45min ago
Bank Of Canada Cuts Interest Rates By Another Quarter Point

Bank Of Canada Cuts Interest Rates By Another Quarter Point

The Bank of Canada on Wednesday announced its widely expected decision to lower interest rates once again, cutting rates by a quarter point for the second consecutive meeting. The Canadian central bank said it reduced its target for the overnight rate by 25 basis points to 2.25 percent, with the Bank Rate at 2.5 percent and the deposit rate at 2.20 percent.
RTTNews | 8h 47min ago