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H.C. Wainwright Reiterates Buy Rating on UroGen Pharma (URGN)

Tue, 20 Oct 2026 06:49:30 -0400

H.C. Wainwright analyst Raghuram Selvaraju reiterated a Buy rating and $75.00 price target on UroGen Pharma (NASDAQ: URGN).

The analyst commented: "This morning, UroGen Pharma announced FDA acceptance of the New Drug Application (NDA) for investigational drug UGN-103 (mitomycin) for intravesical solution for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 14, 2027. Building on the company's experience with ZUSDURI (mitomycin) for intravesical solution, UGN-103 combines UroGen's proprietary RTGel technology with a novel mitomycin formulation, which leverages a streamlined manufacturing

FDA accepts UroGen's NDA for bladder cancer drug UGN-103

Mon, 19 Oct 2026 08:00:25 -0400

UroGen Pharma Ltd. (NASDAQ: URGN) announced that the U.S. Food and Drug Administration has accepted its New Drug Application for UGN-103 (mitomycin) for intravesical solution, an investigational treatment for adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).

The FDA has assigned a Prescription Drug User Fee Act target action date of June 14, 2027.

The NDA is supported by data from the ongoing Phase 3 UTOPIA trial, a single-arm, multicenter study of 99 patients. Treatment with UGN-103 produced a 77.8% complete response rate at three months. Among patients who achieved a complete response at three months, the Kaplan-Meier estimated probability

UroGen Announces FDA Acceptance of the New Drug Application for UGN-103, an Investigational Treatment for Adults with Recurrent LG-IR-NMIBC

Mon, 19 Oct 2026 08:00:00 -0400

PRINCETON, N.J., Oct. 19, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced U.S. Food and Drug Administration (FDA) acceptance of the New Drug Application (NDA) for investigational drug UGN-103 (mitomycin) for intravesical solution for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 14, 2027.

“FDA acceptance of the UGN-103 NDA advances our vision for the next evolution

UroGen Announces FDA Acceptance of the New Drug Application for UGN-103, an Investigational Treatment for Adults with Recurrent LG-IR-NMIBC

Mon, 19 Oct 2026 08:00:00 -0400

“FDA acceptance of the UGN-103 NDA advances our vision for the next evolution

Form 4 UroGen Pharma Ltd. For: Oct 08 Filed by: Degnan Chris

Fri, 09 Oct 2026 12:57:00 -0400

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Form 144 UroGen Pharma Ltd. Filed by: Degnan Chris

Fri, 09 Oct 2026 06:24:00 -0400

si-local-file:///var/storage/secattach/20261009/27168891.html

Jefferies Reiterates Buy Rating on UroGen Pharma (URGN)

Thu, 10 Sep 2026 02:43:11 -0400

Jefferies analyst Amin Makarem reiterated a Buy rating and $56.00 price target on UroGen Pharma (NASDAQ: URGN)

The analyst comments: “TYRA’s initial dabogratinib data are favorable for URGN, w/ the 57% 3mo CR at 60mg trailing Zusduri’s ~80% despite limited residual disease and pts w/ multiple marker lesions accounting for most nonresponders. Incomplete disease clearance suggests dabogratinib would more likely shift tx sequencing than materially reduce Zusduri’s addressable population. Up next, PIVOT-006 data in 2H26 represent the key competitive readthrough for URGN (stock +/-20%).

TYRA reported a 57% 3mo CR at the selected 60mg dose in SURF302, a ph.II evaluating dabogratinib against

UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Fri, 04 Sep 2026 08:00:00 -0400

PRINCETON, N.J., Sept. 04, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 19 new employees in connection with their employment with UroGen. These new team members will support the ongoing commercialization of JELMYTO^® (mitomycin) for pyelocalyceal solution and ZUSDURI™ (mitomycin) for intravesical solution, UroGen’s only approved products, and the continued development of UroGen’s pipeline.

Up to 117,100 ordinary shares of UroGen are issuable upon the vesting and settlement of the

UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Fri, 04 Sep 2026 08:00:00 -0400

Up to 117,100 ordinary shares of UroGen are issuable upon the vesting and settlement of the

UroGen Pharma to Present at Upcoming Investor Conferences

Wed, 02 Sep 2026 08:00:00 -0400

PRINCETON, N.J., Sept. 02, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced that it will participate in the following investor conferences in September.

Wells Fargo 21^st Annual Healthcare Conference

Date / Time:	September 9th, at 3:00 PM ET
Format:	Fireside Chat
Location:	Boston, MA
Webcast Link:
Date / Time:	September 9th, at 3:00 PM ET
Format:	Fireside Chat
Location:	Boston, MA
Webcast Link:	IntraGel secures up to $7 million equity investment from UroGen® to advance the Phase 2 clinical study of TumoCure, for the treatment of advanced head and neck cancer UroGen gains access to IntraGel's biodegradable sustained-release gel platform with broad potential across solid tumors, as well as an exclusive option to acquire worldwide rights to TumoCure NAZARETH, Israel, Aug. 20, 2026 /PRNewswire/ -- IntraGel Therapeutics, developer of next generation long-acting injectables, today announced an equity investment agreement and a strategic Option and Research License Agreement (the Option Agreement) with UroGen Pharma Ltd. (Nasdaq: IntraGel Therapeutics and UroGen Pharma Sign Strategic Collaboration and Investment Agreements to Advance Sustained-Released Investigational Oncology Therapies Thu, 20 Aug 2026 07:05:00 -0400 IntraGel secures up to $7 million equity investment from UroGen® to advance the Phase 2 clinical study of TumoCure, for the treatment of advanced head and neck cancer UroGen gains access to IntraGel's biodegradable sustained-release gel platform with broad potential across solid tumors, as well as an exclusive option to acquire worldwide rights to TumoCure NAZARETH, Israel, Aug. 20, 2026 /PRNewswire/ -- IntraGel Therapeutics, developer of next generation long-acting injectables, today announced an equity investment agreement and a strategic Option and Research License Agreement (the Option Agreement) with UroGen Pharma Ltd. (Nasdaq: IntraGel Therapeutics and UroGen Pharma Sign Strategic Collaboration and Investment Agreements to Advance Sustained-Released Investigational Oncology Therapies Thu, 20 Aug 2026 07:05:00 -0400 IntraGel secures up to $7 million equity investment from UroGen® to advance the Phase 2 clinical study of TumoCure, for the treatment of advanced head and neck cancer UroGen gains access to IntraGel's biodegradable sustained-release gel platform with broad potential across solid tumors, as well as an exclusive option to acquire worldwide rights to TumoCure NAZARETH, Israel, Aug. 20, 2026 /PRNewswire/ -- IntraGel Therapeutics, developer of next generation long-acting injectables, today announced an equity investment agreement and a strategic Option and Research License Agreement (the Option Agreement) with UroGen Pharma Ltd. (Nasdaq: IntraGel Therapeutics and UroGen Pharma Sign Strategic Collaboration and Investment Agreements to Advance Sustained-Released Investigational Oncology Therapies Thu, 20 Aug 2026 07:05:00 -0400 IntraGel secures up to $7 million equity investment from UroGen® to advance the Phase 2 clinical study of TumoCure, for the treatment of advanced head and neck cancer UroGen gains access to IntraGel's biodegradable sustained-release gel platform with broad potential across solid tumors, as well as an exclusive option to acquire worldwide rights to TumoCure NAZARETH, Israel, Aug. 20, 2026 /PRNewswire/ -- IntraGel Therapeutics, developer of next generation long-acting injectables, today announced an equity investment agreement and a strategic Option and Research License Agreement (the Option Agreement) with UroGen Pharma Ltd. (Nasdaq: IntraGel Therapeutics and UroGen Pharma Sign Strategic Collaboration and Investment Agreements to Advance Sustained-Released Investigational Oncology Therapies Thu, 20 Aug 2026 07:05:00 -0400 IntraGel secures up to $7 million equity investment from UroGen® to advance the Phase 2 clinical study of TumoCure, for the treatment of advanced head and neck cancer UroGen gains access to IntraGel's biodegradable sustained-release gel platform with broad potential across solid tumors, as well as an exclusive option to acquire worldwide rights to TumoCure NAZARETH, Israel, Aug. 20, 2026 /PRNewswire/ -- IntraGel Therapeutics, developer of next generation long-acting injectables, today announced an equity investment agreement and a strategic Option and Research License Agreement (the Option Agreement) with UroGen Pharma Ltd. (Nasdaq:

StreetInsider.com News Articles

H.C. Wainwright Reiterates Buy Rating on UroGen Pharma (URGN)

FDA accepts UroGen's NDA for bladder cancer drug UGN-103

UroGen Announces FDA Acceptance of the New Drug Application for UGN-103, an Investigational Treatment for Adults with Recurrent LG-IR-NMIBC

UroGen Announces FDA Acceptance of the New Drug Application for UGN-103, an Investigational Treatment for Adults with Recurrent LG-IR-NMIBC

Form 4 UroGen Pharma Ltd. For: Oct 08 Filed by: Degnan Chris

Form 144 UroGen Pharma Ltd. Filed by: Degnan Chris

Jefferies Reiterates Buy Rating on UroGen Pharma (URGN)

UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

UroGen Pharma to Present at Upcoming Investor Conferences

IntraGel Therapeutics and UroGen Pharma Sign Strategic Collaboration and Investment Agreements to Advance Sustained-Released Investigational Oncology Therapies

IntraGel Therapeutics and UroGen Pharma Sign Strategic Collaboration and Investment Agreements to Advance Sustained-Released Investigational Oncology Therapies

IntraGel Therapeutics and UroGen Pharma Sign Strategic Collaboration and Investment Agreements to Advance Sustained-Released Investigational Oncology Therapies

IntraGel Therapeutics and UroGen Pharma Sign Strategic Collaboration and Investment Agreements to Advance Sustained-Released Investigational Oncology Therapies