NEW YORK CITY, NY / ACCESS Newswire / June 16, 2025 / Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against UroGen Pharma Ltd. (NASDAQ: URGN) and certain of the Company's senior executives for potential violations of the federal securities laws.

If you invested in UroGen you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/urogen-pharma-ltd-class-action-lawsuit.

Investors have until July 28, 2025, to ask the Court to be appointed to lead the case. The complaint asserts claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 on behalf of investors who purchased UroGen securities. The case is pending in the U.S. District Court for the District of New Jersey and is captioned: Cockrell v. UroGen Pharma Ltd., et al., No. 3:25-cv-06088.

Why was UroGen Sued for Securities Fraud?

UroGen develops treatments for specialty cancers. The Company's lead pipeline product is UGN-102 (mitomycin), an intravesical solution intended to treat low-grade intermediate risk non-muscle invasive bladder cancer. One of the Phase 3 trials for UGN-102 is named ENVISION. As alleged, UroGen stated that the ENVISION trial met its primary endpoint and that UroGen had reached "agreement with the FDA" that the ENVISION trial would support an NDA submission.

In truth, the FDA had previously expressed significant concerns to UroGen regarding the ENVISION trial, which lacked a concurrent control arm.

The Stock Declines as the Truth is Revealed

On May 16, 2025, the FDA published a briefing document stating that it doubted whether the submitted data was sufficient to conclude that UGN-102 was effective. FDA stated that because "ENVISION lacked a concurrent control arm,"the primary endpoints were "difficult to interpret" and that UroGen "chose not to conduct a randomized trial with a design and endpoints that the FDA considered appropriate." On this news, the price of UroGen stock declined $2.54 per share, or nearly 26%, from a closing price of $9.85 per share on May 15, 2025, to $7.31 per share on May 16, 2025.

Then, on May 21, 2025, the Oncologic Drugs Advisory Committee voted against approving the UGN-102 NDA, finding that the overall benefit-risk profile of UGN-102 was notfavorable in patients with recurrent low-grade, intermediate-risk non-muscle invasive bladder cancer. On this news, the price of UroGen stock declined $3.37 per share, or nearly 45%, from a closing price of $7.54 per share on May 20, 2025, to $4.17 per share on May 21, 2025.

Click here if you suffered losses: https://www.bfalaw.com/cases-investigations/urogen-pharma-ltd-class-action-lawsuit.

What Can You Do?

If you invested in UroGen you may have legal options and are encouraged to submit your information to the firm.

All representation is on a contingency fee basis, there is no cost to you. Shareholders are not responsible for any court costs or expenses of litigation. The firm will seek court approval for any potential fees and expenses.

Submit your information by visiting:

https://www.bfalaw.com/cases-investigations/urogen-pharma-ltd-class-action-lawsuit

Or contact:
Ross Shikowitz
ross@bfalaw.com
212-789-3619

Why Bleichmar Fonti & Auld LLP?

Bleichmar Fonti & Auld LLP is a leading international law firm representing plaintiffs in securities class actions and shareholder litigation. It was named among the Top 5 plaintiff law firms by ISS SCAS in 2023 and its attorneys have been named Titans of the Plaintiffs' Bar by Law360 and SuperLawyers by Thompson Reuters. Among its recent notable successes, BFA recovered over $900 million in value from Tesla, Inc.'s Board of Directors, as well as $420 million from Teva Pharmaceutical Ind. Ltd.

For more information about BFA and its attorneys, please visit https://www.bfalaw.com.

https://www.bfalaw.com/cases-investigations/urogen-pharma-ltd-class-action-lawsuit

Attorney advertising. Past results do not guarantee future outcomes.

SOURCE: Bleichmar Fonti & Auld LLP