http://www.streetinsider.com Latest StreetInsider.com News Articles en-us Copyright 2026, StreetInsider.com rss@streetinsider.com (SI RSS) rss@streetinsider.com (SI RSS) Fri, 28 Aug 2026 16:02:00 -0400 http://blogs.law.harvard.edu/tech/rss http://www.streetinsider.com/images/rss_logo.gif http://www.streetinsider.com 143 28 0 1 2 3 21 22 23 Saturday Sunday http://www.streetinsider.com/SEC+Filings/Form++4++++++++++UroGen+Pharma+Ltd.++++++++For%3A+Aug+26++Filed+by%3A+Robinson+James+A.+Jr./26997753.html si-local-file:///var/storage/secattach/20260828/26997753.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++UroGen+Pharma+Ltd.++++++++For%3A+Aug+26++Filed+by%3A+Robinson+James+A.+Jr./26997753.html Fri, 28 Aug 2026 16:02:00 -0400 O.13811655 URGN http://www.streetinsider.com/SEC+Filings/Form++4++++++++++UroGen+Pharma+Ltd.++++++++For%3A+Aug+26++Filed+by%3A+Robinson+James+A.+Jr./26997753.html si-local-file:///var/storage/secattach/20260828/26997753.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++UroGen+Pharma+Ltd.++++++++For%3A+Aug+26++Filed+by%3A+Robinson+James+A.+Jr./26997753.html Fri, 28 Aug 2026 16:02:00 -0400 O.13811655 URGN http://www.streetinsider.com/SEC+Filings/Form++4++++++++++UroGen+Pharma+Ltd.++++++++For%3A+Aug+20++Filed+by%3A+Schoenberg+Mark/26969010.html si-local-file:///var/storage/secattach/20260824/26969010.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++UroGen+Pharma+Ltd.++++++++For%3A+Aug+20++Filed+by%3A+Schoenberg+Mark/26969010.html Mon, 24 Aug 2026 17:03:00 -0400 O.13811655 URGN http://www.streetinsider.com/SEC+Filings/Form++4++++++++++UroGen+Pharma+Ltd.++++++++For%3A+Aug+20++Filed+by%3A+Schoenberg+Mark/26969010.html si-local-file:///var/storage/secattach/20260824/26969010.html http://www.streetinsider.com/SEC+Filings/Form++4++++++++++UroGen+Pharma+Ltd.++++++++For%3A+Aug+20++Filed+by%3A+Schoenberg+Mark/26969010.html Mon, 24 Aug 2026 17:03:00 -0400 O.13811655 URGN http://www.streetinsider.com/SEC+Filings/Form++144++++++++UroGen+Pharma+Ltd.+++++++++++++++++++++Filed+by%3A+Schoenberg+Mark/26955369.html si-local-file:///var/storage/secattach/20260820/26955369.html http://www.streetinsider.com/SEC+Filings/Form++144++++++++UroGen+Pharma+Ltd.+++++++++++++++++++++Filed+by%3A+Schoenberg+Mark/26955369.html Thu, 20 Aug 2026 13:25:00 -0400 O.13811655 URGN http://www.streetinsider.com/SEC+Filings/Form++144++++++++UroGen+Pharma+Ltd.+++++++++++++++++++++Filed+by%3A+Schoenberg+Mark/26955369.html si-local-file:///var/storage/secattach/20260820/26955369.html http://www.streetinsider.com/SEC+Filings/Form++144++++++++UroGen+Pharma+Ltd.+++++++++++++++++++++Filed+by%3A+Schoenberg+Mark/26955369.html Thu, 20 Aug 2026 13:25:00 -0400 O.13811655 URGN http://www.streetinsider.com/Corporate+News/UroGen+to+invest+%247M+in+IntraGel+for+head+and+neck+cancer+therapy/26952691.html <p>UroGen Pharma Ltd. (Nasdaq: URGN) has agreed to invest up to $7 million in IntraGel Therapeutics and signed an option and research license agreement with the Israel-based drug delivery company, according to a press release.</p><p>Under the equity investment agreement, UroGen's funds will support the Phase 2 clinical development of TumoCure, IntraGel's investigational cisplatin-based therapy for advanced head and neck cancer. TumoCure uses IntraGel's proprietary SRGel platform, a biodegradable sustained-release gel designed to deliver cisplatin directly into tumor tissue over several months while limiting systemic exposure.</p><p>The accompanying option agreement grants UroGen an exclusive option to obtain a worldwide license to develop http://www.streetinsider.com/Corporate+News/UroGen+to+invest+%247M+in+IntraGel+for+head+and+neck+cancer+therapy/26952691.html Thu, 20 Aug 2026 07:06:32 -0400 URGN http://www.streetinsider.com/Press+Releases/IntraGel+Therapeutics+and+UroGen+Pharma+Sign+Strategic+Collaboration+and+Investment+Agreements+to+Advance+Sustained-Released+Investigational+Oncology+Therapies/26952680.html <div class="xn-content"> <ul type="disc"><li>IntraGel secures up to <money>$7 million</money> equity investment from UroGen® to advance the Phase 2 clinical study of TumoCure, for the treatment of advanced head and neck cancer</li><li>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</li></ul><p><span class="legendSpanClass">NAZARETH, <location value="LC/il" idsrc="xmltag.org" >Israel</location></span>, <span class="legendSpanClass"><chron>Aug. 20, 2026</chron></span> /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 <span value="NASDAQ-NMS:URGN" idsrc="xmltag.org" >UroGen Pharma Ltd.</span> (Nasdaq: http://www.streetinsider.com/Press+Releases/IntraGel+Therapeutics+and+UroGen+Pharma+Sign+Strategic+Collaboration+and+Investment+Agreements+to+Advance+Sustained-Released+Investigational+Oncology+Therapies/26952680.html Thu, 20 Aug 2026 07:05:00 -0400 A.50216726 O.13811655 O.21612337 URGN http://www.streetinsider.com/Press+Releases/IntraGel+Therapeutics+and+UroGen+Pharma+Sign+Strategic+Collaboration+and+Investment+Agreements+to+Advance+Sustained-Released+Investigational+Oncology+Therapies/26952680.html <div class="xn-content"> <ul type="disc"><li>IntraGel secures up to <money>$7 million</money> equity investment from UroGen® to advance the Phase 2 clinical study of TumoCure, for the treatment of advanced head and neck cancer</li><li>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</li></ul><p><span class="legendSpanClass">NAZARETH, <location value="LC/il" idsrc="xmltag.org" >Israel</location></span>, <span class="legendSpanClass"><chron>Aug. 20, 2026</chron></span> /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 <span value="NASDAQ-NMS:URGN" idsrc="xmltag.org" >UroGen Pharma Ltd.</span> (Nasdaq: http://www.streetinsider.com/Press+Releases/IntraGel+Therapeutics+and+UroGen+Pharma+Sign+Strategic+Collaboration+and+Investment+Agreements+to+Advance+Sustained-Released+Investigational+Oncology+Therapies/26952680.html Thu, 20 Aug 2026 07:05:00 -0400 A.50216726 O.13811655 O.21612337 URGN http://www.streetinsider.com/Press+Releases/IntraGel+Therapeutics+and+UroGen+Pharma+Sign+Strategic+Collaboration+and+Investment+Agreements+to+Advance+Sustained-Released+Investigational+Oncology+Therapies/26952680.html <div class="xn-content"> <ul type="disc"><li>IntraGel secures up to <money>$7 million</money> equity investment from UroGen® to advance the Phase 2 clinical study of TumoCure, for the treatment of advanced head and neck cancer</li><li>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</li></ul><p><span class="legendSpanClass">NAZARETH, <location value="LC/il" idsrc="xmltag.org" >Israel</location></span>, <span class="legendSpanClass"><chron>Aug. 20, 2026</chron></span> /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 <span value="NASDAQ-NMS:URGN" idsrc="xmltag.org" >UroGen Pharma Ltd.</span> (Nasdaq: http://www.streetinsider.com/Press+Releases/IntraGel+Therapeutics+and+UroGen+Pharma+Sign+Strategic+Collaboration+and+Investment+Agreements+to+Advance+Sustained-Released+Investigational+Oncology+Therapies/26952680.html Thu, 20 Aug 2026 07:05:00 -0400 A.50216726 O.13811655 O.21612337 URGN http://www.streetinsider.com/Press+Releases/IntraGel+Therapeutics+and+UroGen+Pharma+Sign+Strategic+Collaboration+and+Investment+Agreements+to+Advance+Sustained-Released+Investigational+Oncology+Therapies/26952680.html <div class="xn-content"> <ul type="disc"><li>IntraGel secures up to <money>$7 million</money> equity investment from UroGen® to advance the Phase 2 clinical study of TumoCure, for the treatment of advanced head and neck cancer</li><li>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</li></ul><p><span class="legendSpanClass">NAZARETH, <location value="LC/il" idsrc="xmltag.org" >Israel</location></span>, <span class="legendSpanClass"><chron>Aug. 20, 2026</chron></span> /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 <span value="NASDAQ-NMS:URGN" idsrc="xmltag.org" >UroGen Pharma Ltd.</span> (Nasdaq: http://www.streetinsider.com/Press+Releases/IntraGel+Therapeutics+and+UroGen+Pharma+Sign+Strategic+Collaboration+and+Investment+Agreements+to+Advance+Sustained-Released+Investigational+Oncology+Therapies/26952680.html Thu, 20 Aug 2026 07:05:00 -0400 A.50216726 O.13811655 O.21612337 URGN http://www.streetinsider.com/PRNewswire/IntraGel+Therapeutics+and+UroGen+Pharma+Sign+Strategic+Collaboration+and+Investment+Agreements+to+Advance+Sustained-Released+Investigational+Oncology+Therapies/26952680.html <div class="xn-content"> <ul type="disc"><li>IntraGel secures up to <money>$7 million</money> equity investment from UroGen® to advance the Phase 2 clinical study of TumoCure, for the treatment of advanced head and neck cancer</li><li>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</li></ul><p><span class="legendSpanClass">NAZARETH, <location value="LC/il" idsrc="xmltag.org" >Israel</location></span>, <span class="legendSpanClass"><chron>Aug. 20, 2026</chron></span> /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 <span value="NASDAQ-NMS:URGN" idsrc="xmltag.org" >UroGen Pharma Ltd.</span> (Nasdaq: http://www.streetinsider.com/PRNewswire/IntraGel+Therapeutics+and+UroGen+Pharma+Sign+Strategic+Collaboration+and+Investment+Agreements+to+Advance+Sustained-Released+Investigational+Oncology+Therapies/26952680.html Thu, 20 Aug 2026 07:05:00 -0400 A.50216726 O.13811655 O.21612337 URGN http://www.streetinsider.com/PRNewswire/IntraGel+Therapeutics+and+UroGen+Pharma+Sign+Strategic+Collaboration+and+Investment+Agreements+to+Advance+Sustained-Released+Investigational+Oncology+Therapies/26952680.html <div class="xn-content"> <ul type="disc"><li>IntraGel secures up to <money>$7 million</money> equity investment from UroGen® to advance the Phase 2 clinical study of TumoCure, for the treatment of advanced head and neck cancer</li><li>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</li></ul><p><span class="legendSpanClass">NAZARETH, <location value="LC/il" idsrc="xmltag.org" >Israel</location></span>, <span class="legendSpanClass"><chron>Aug. 20, 2026</chron></span> /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 <span value="NASDAQ-NMS:URGN" idsrc="xmltag.org" >UroGen Pharma Ltd.</span> (Nasdaq: http://www.streetinsider.com/PRNewswire/IntraGel+Therapeutics+and+UroGen+Pharma+Sign+Strategic+Collaboration+and+Investment+Agreements+to+Advance+Sustained-Released+Investigational+Oncology+Therapies/26952680.html Thu, 20 Aug 2026 07:05:00 -0400 A.50216726 O.13811655 O.21612337 URGN http://www.streetinsider.com/PRNewswire/IntraGel+Therapeutics+and+UroGen+Pharma+Sign+Strategic+Collaboration+and+Investment+Agreements+to+Advance+Sustained-Released+Investigational+Oncology+Therapies/26952680.html <div class="xn-content"> <ul type="disc"><li>IntraGel secures up to <money>$7 million</money> equity investment from UroGen® to advance the Phase 2 clinical study of TumoCure, for the treatment of advanced head and neck cancer</li><li>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</li></ul><p><span class="legendSpanClass">NAZARETH, <location value="LC/il" idsrc="xmltag.org" >Israel</location></span>, <span class="legendSpanClass"><chron>Aug. 20, 2026</chron></span> /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 <span value="NASDAQ-NMS:URGN" idsrc="xmltag.org" >UroGen Pharma Ltd.</span> (Nasdaq: http://www.streetinsider.com/PRNewswire/IntraGel+Therapeutics+and+UroGen+Pharma+Sign+Strategic+Collaboration+and+Investment+Agreements+to+Advance+Sustained-Released+Investigational+Oncology+Therapies/26952680.html Thu, 20 Aug 2026 07:05:00 -0400 A.50216726 O.13811655 O.21612337 URGN http://www.streetinsider.com/PRNewswire/IntraGel+Therapeutics+and+UroGen+Pharma+Sign+Strategic+Collaboration+and+Investment+Agreements+to+Advance+Sustained-Released+Investigational+Oncology+Therapies/26952680.html <div class="xn-content"> <ul type="disc"><li>IntraGel secures up to <money>$7 million</money> equity investment from UroGen® to advance the Phase 2 clinical study of TumoCure, for the treatment of advanced head and neck cancer</li><li>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</li></ul><p><span class="legendSpanClass">NAZARETH, <location value="LC/il" idsrc="xmltag.org" >Israel</location></span>, <span class="legendSpanClass"><chron>Aug. 20, 2026</chron></span> /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 <span value="NASDAQ-NMS:URGN" idsrc="xmltag.org" >UroGen Pharma Ltd.</span> (Nasdaq: http://www.streetinsider.com/PRNewswire/IntraGel+Therapeutics+and+UroGen+Pharma+Sign+Strategic+Collaboration+and+Investment+Agreements+to+Advance+Sustained-Released+Investigational+Oncology+Therapies/26952680.html Thu, 20 Aug 2026 07:05:00 -0400 A.50216726 O.13811655 O.21612337 URGN http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++UroGen+Pharma+Ltd.++++++++For%3A+Aug+18/26952684.html si-local-file:///var/storage/secattach/20260820/26952684.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++UroGen+Pharma+Ltd.++++++++For%3A+Aug+18/26952684.html Thu, 20 Aug 2026 07:05:00 -0400 O.13811655 URGN http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++UroGen+Pharma+Ltd.++++++++For%3A+Aug+18/26952684.html si-local-file:///var/storage/secattach/20260820/26952684.html http://www.streetinsider.com/SEC+Filings/Form++8-K++++++++UroGen+Pharma+Ltd.++++++++For%3A+Aug+18/26952684.html Thu, 20 Aug 2026 07:05:00 -0400 O.13811655 URGN http://www.streetinsider.com/Corporate+News/UroGen+strikes+option+deal+with+IntraGel%2C+invests+up+to+%247M/26952623.html <p>UroGen Pharma Ltd. (Nasdaq: URGN) announced an Option and Research License Agreement and a related equity investment agreement with IntraGel Therapeutics, Ltd., granting UroGen access to IntraGel's SRGel biodegradable sustained-release drug delivery platform.</p> <p>Under the Option Agreement, UroGen receives a research license and exclusive options to license and develop up to three oncology products combining the SRGel platform with compounds designated by UroGen. UroGen also receives an exclusive option to license TumoCure, IntraGel's investigational cisplatin therapy for advanced head and neck cancer, contingent on IntraGel completing a Phase 2 clinical study.</p> <p>In connection with the agreement, UroGen will invest up to $7 http://www.streetinsider.com/Corporate+News/UroGen+strikes+option+deal+with+IntraGel%2C+invests+up+to+%247M/26952623.html Thu, 20 Aug 2026 07:00:31 -0400 URGN http://www.streetinsider.com/Press+Releases/UroGen+Announces+Strategic+Collaboration+and+Investment+Agreements+with+IntraGel+to+Access+Biodegradable+Sustained-Release+Gel+Platform+and+Expand+Oncology+Pipeline/26952579.html <ul type="disc"><li style="margin-bottom:8pt;">Collaboration grants UroGen a research license and exclusive options to license and develop up to three oncology products utilizing IntraGel's proprietary SRGel platform</li><li style="margin-bottom:8pt;">Agreement also includes an exclusive option to acquire worldwide rights to TumoCure, an investigational therapy for advanced head and neck cancer<br /><br /></li></ul> <p>PRINCETON, N.J., Aug. 20, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced a strategic Option and Research License Agreement (the Option Agreement) and a related equity investment agreement http://www.streetinsider.com/Press+Releases/UroGen+Announces+Strategic+Collaboration+and+Investment+Agreements+with+IntraGel+to+Access+Biodegradable+Sustained-Release+Gel+Platform+and+Expand+Oncology+Pipeline/26952579.html Thu, 20 Aug 2026 07:00:00 -0400 URGN http://www.streetinsider.com/Globe+Newswire/UroGen+Announces+Strategic+Collaboration+and+Investment+Agreements+with+IntraGel+to+Access+Biodegradable+Sustained-Release+Gel+Platform+and+Expand+Oncology+Pipeline/26952579.html <ul type="disc"><li style="margin-bottom:8pt;">Collaboration grants UroGen a research license and exclusive options to license and develop up to three oncology products utilizing IntraGel's proprietary SRGel platform</li><li style="margin-bottom:8pt;">Agreement also includes an exclusive option to acquire worldwide rights to TumoCure, an investigational therapy for advanced head and neck cancer<br /><br /></li></ul> <p>PRINCETON, N.J., Aug. 20, 2026 (GLOBE NEWSWIRE) -- UroGen Pharma Ltd. (Nasdaq: URGN), a biotechnology company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced a strategic Option and Research License Agreement (the Option Agreement) and a related equity investment agreement http://www.streetinsider.com/Globe+Newswire/UroGen+Announces+Strategic+Collaboration+and+Investment+Agreements+with+IntraGel+to+Access+Biodegradable+Sustained-Release+Gel+Platform+and+Expand+Oncology+Pipeline/26952579.html Thu, 20 Aug 2026 07:00:00 -0400 URGN http://www.streetinsider.com/Analyst+Comments/H.C.+Wainwright+Reiterates+Buy+Rating+on+UroGen+Pharma+%28URGN%29/26952543.html <p>H.C. Wainwright analyst Raghuram Selvaraju reiterated a Buy rating and $75.00 price target on UroGen Pharma (NASDAQ: URGN).</p><p>The analyst commented: "UroGen Pharma recently announced the submission of a New Drug Application (NDA) to the FDA for its investigational drug UGN-103 (mitomycin) for intravesical solution. UGN-103 is a next-generation mitomycin formulation being developed for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). It is built on the clinical and commercial foundation of ZUSDURI (mitomycin) for intravesical solution. As a reminder, UGN-103 represents the next evolution in the company's portfolio and is designed to provide a more http://www.streetinsider.com/Analyst+Comments/H.C.+Wainwright+Reiterates+Buy+Rating+on+UroGen+Pharma+%28URGN%29/26952543.html Thu, 20 Aug 2026 06:57:03 -0400 URGN http://www.streetinsider.com/Corporate+News/UroGen+files+NDA+with+FDA+for+bladder+cancer+drug+UGN-103/26935142.html <p>UroGen Pharma Ltd. (Nasdaq: URGN) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for UGN-103, an investigational mitomycin formulation for intravesical solution intended to treat adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).</p><p>The NDA is supported by data from the ongoing Phase 3 UTOPIA trial, a single-arm, multicenter study of 99 patients. UGN-103 showed a 77.8% three-month complete response rate (95% CI: 68.3%, 85.5%) and a 94.5% six-month duration of response by Kaplan-Meier estimate (95% CI: 86.1%, 97.9%). UroGen noted these results are consistent with those from the pivotal ENVISION trial of http://www.streetinsider.com/Corporate+News/UroGen+files+NDA+with+FDA+for+bladder+cancer+drug+UGN-103/26935142.html Mon, 17 Aug 2026 08:04:18 -0400 URGN http://www.streetinsider.com/FDA/UroGen+files+NDA+with+FDA+for+bladder+cancer+drug+UGN-103/26935142.html <p>UroGen Pharma Ltd. (Nasdaq: URGN) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for UGN-103, an investigational mitomycin formulation for intravesical solution intended to treat adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).</p><p>The NDA is supported by data from the ongoing Phase 3 UTOPIA trial, a single-arm, multicenter study of 99 patients. UGN-103 showed a 77.8% three-month complete response rate (95% CI: 68.3%, 85.5%) and a 94.5% six-month duration of response by Kaplan-Meier estimate (95% CI: 86.1%, 97.9%). UroGen noted these results are consistent with those from the pivotal ENVISION trial of http://www.streetinsider.com/FDA/UroGen+files+NDA+with+FDA+for+bladder+cancer+drug+UGN-103/26935142.html Mon, 17 Aug 2026 08:04:18 -0400 URGN http://www.streetinsider.com/Hot+Corp.+News/UroGen+files+NDA+with+FDA+for+bladder+cancer+drug+UGN-103/26935142.html <p>UroGen Pharma Ltd. (Nasdaq: URGN) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for UGN-103, an investigational mitomycin formulation for intravesical solution intended to treat adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).</p><p>The NDA is supported by data from the ongoing Phase 3 UTOPIA trial, a single-arm, multicenter study of 99 patients. UGN-103 showed a 77.8% three-month complete response rate (95% CI: 68.3%, 85.5%) and a 94.5% six-month duration of response by Kaplan-Meier estimate (95% CI: 86.1%, 97.9%). UroGen noted these results are consistent with those from the pivotal ENVISION trial of http://www.streetinsider.com/Hot+Corp.+News/UroGen+files+NDA+with+FDA+for+bladder+cancer+drug+UGN-103/26935142.html Mon, 17 Aug 2026 08:04:18 -0400 URGN http://www.streetinsider.com/Press+Releases/UroGen+Submits+NDA+for+UGN-103%2C+an+Investigational+Treatment+of+Recurrent+LG-IR-NMIBC/26934990.html <p>PRINCETON, N.J., Aug. 17, 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 submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug UGN-103 (mitomycin) for intravesical solution. UGN-103 is a next-generation mitomycin formulation being developed for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). It is built on the clinical and commercial foundation of ZUSDURI (mitomycin) for intravesical solution.</p> <p>"The NDA submission for http://www.streetinsider.com/Press+Releases/UroGen+Submits+NDA+for+UGN-103%2C+an+Investigational+Treatment+of+Recurrent+LG-IR-NMIBC/26934990.html Mon, 17 Aug 2026 08:00:00 -0400 URGN