{"id":995847,"date":"2026-08-17T07:33:05","date_gmt":"2026-08-17T11:33:05","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/faeth-therapeutics-announces-fda-grant-of-fast-track-designation-for-piktor-plus-paclitaxel-in-biomarker-selected-advanced-endometrial-cancer\/"},"modified":"2026-08-17T07:33:05","modified_gmt":"2026-08-17T11:33:05","slug":"faeth-therapeutics-announces-fda-grant-of-fast-track-designation-for-piktor-plus-paclitaxel-in-biomarker-selected-advanced-endometrial-cancer","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/faeth-therapeutics-announces-fda-grant-of-fast-track-designation-for-piktor-plus-paclitaxel-in-biomarker-selected-advanced-endometrial-cancer\/","title":{"rendered":"Faeth Therapeutics Announces FDA Grant of Fast Track Designation for PIKTOR Plus Paclitaxel in Biomarker-Selected Advanced Endometrial Cancer"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>Faeth Therapeutics Announces FDA Grant of Fast Track Designation for PIKTOR Plus Paclitaxel in Biomarker-Selected Advanced Endometrial Cancer<\/b><\/p>\n<p><i>\u2014 Fast Track designation applies to sapanisertib and serabelisib (PIKTOR) in combination with paclitaxel for the treatment of patients with advanced or recurrent endometrial cancer whose tumors harbor a PI3K\/AKT\/mTOR pathway alteration<\/i><\/p>\n<p><i>\u2014 Faeth expects topline data from its ongoing Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201) by year-end 2026<\/i><\/p>\n<p>AUSTIN, Texas&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Ffaeththerapeutics.com&amp;esheet=54589549&amp;newsitemid=20260817276941&amp;lan=en-US&amp;anchor=Faeth+Therapeutics&amp;index=1&amp;md5=b998f3c86e055a400a68806b161a111e\">Faeth Therapeutics<\/a> (Nasdaq: FTH), a clinical-stage oncology company developing multi-node therapies for cancer patients, including its lead program PIKTOR, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the combination of sapanisertib and serabelisib (PIKTOR) with paclitaxel for the treatment of patients with advanced or recurrent endometrial cancer whose tumors harbor a PI3K\/AKT\/mTOR pathway alteration and who have previously been treated with platinum-based chemotherapy and an immune checkpoint inhibitor (ICI).<\/p>\n<p>\n&#8220;Fast Track designation for PIKTOR reflects the significant unmet need in advanced endometrial cancer for patients whose disease has progressed despite platinum-based chemotherapy and an immune checkpoint inhibitor,&#8221; said Anand Parikh, Chief Executive Officer of Faeth Therapeutics. &#8220;We believe PIKTOR&#8217;s multi-node approach to the PI3K\/AKT\/mTOR pathway is well suited to this population as our preclinical data suggests that PIKTOR can resensitize patients to chemotherapy.\u201d<\/p>\n<p><b>About PIKTOR<\/b><\/p>\n<p>\nPIKTOR is an investigational, proprietary, all-oral combination of serabelisib, a selective PI3K-alpha inhibitor, and sapanisertib, an mTORC1\/mTORC2 inhibitor, designed to inhibit multiple nodes of the PI3K\/AKT\/mTOR pathway. According to published literature, this pathway is dysregulated in up to 50% of all solid tumors, making it one of the most prevalent therapeutic targets in oncology. PIKTOR is being evaluated in a Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201), with topline data anticipated by year-end 2026. PIKTOR is also being evaluated in a Phase 1b\/2 trial in HR+\/HER2- advanced breast cancer (Study FTH-PIK-101), in which the first patient was dosed in April and interim data is anticipated in 2027.<\/p>\n<p><b>About Faeth Therapeutics<\/b><\/p>\n<p>\nFaeth Therapeutics, Inc. (Nasdaq: FTH) is a clinical-stage biotechnology company focused on improving outcomes for cancer patients through multi-node inhibition of critical oncogenic pathways. The Company\u2019s lead program is PIKTOR, an investigational all-oral combination of serabelisib and sapanisertib in development for endometrial and breast cancer. Faeth was co-founded in 2019 by Anand Parikh and Oliver Maddocks, Ph.D., together with scientific founders Lewis Cantley, Ph.D., the discoverer of the PI3K pathway; Siddhartha Mukherjee, M.D., D.Phil.; Karen Vousden, Ph.D.; Scott Lowe, Ph.D.; and Greg Hannon, Ph.D. For more information, please visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.faeththerapeutics.com&amp;esheet=54589549&amp;newsitemid=20260817276941&amp;lan=en-US&amp;anchor=www.faeththerapeutics.com&amp;index=2&amp;md5=afad8c77da3ac51a5432e535d31e5282\">www.faeththerapeutics.com<\/a> and follow the Company on <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2F71552694%2F&amp;esheet=54589549&amp;newsitemid=20260817276941&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=3&amp;md5=e28238f0829ab1cc5e3e80802b806047\">LinkedIn<\/a>.<\/p>\n<p><b>Cautionary Note Regarding Forward-Looking Statements<\/b><\/p>\n<p>\nThis press release contains \u201cforward-looking statements\u201d within the meaning of the federal securities laws, including the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts and may be identified by words such as \u201canticipate,\u201d \u201cbelieve,\u201d \u201cexpect,\u201d \u201cintend,\u201d \u201cplan,\u201d \u201cmay,\u201d \u201cwill,\u201d \u201cwould,\u201d \u201ccould,\u201d \u201cshould,\u201d \u201cestimate,\u201d \u201cpotential,\u201d \u201ctarget,\u201d \u201con track\u201d and similar expressions, although not all forward-looking statements contain these words. These statements include, but are not limited to, statements regarding: the change of the Company\u2019s corporate name to Faeth Therapeutics, Inc.; the expected commencement of trading of the Company\u2019s common stock under the new name and ticker symbol \u201cFTH\u201d and the timing thereof; the Company\u2019s expectations regarding its pipeline and development plans, including the Phase 2 trial of PIKTOR in advanced endometrial cancer and the anticipated timing of topline data, and the Phase 1b\/2 trial of PIKTOR in HR+\/HER2- advanced breast cancer and the anticipated timing of interim data; the potential therapeutic benefits, tolerability profile and differentiation of PIKTOR; the anticipated benefits of Fast Track Designation; and the Company\u2019s expectations regarding its cash runway.<\/p>\n<p>\nForward-looking statements are based on management\u2019s current expectations and assumptions and are subject to a number of risks and uncertainties, many of which are beyond the Company\u2019s control, that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, risks related to clinical development and the conduct, timing and results of clinical trials; the Company\u2019s need for additional financing; its limited operating history and history of operating losses; risks related to the integration of Faeth; the Company\u2019s ability to satisfy applicable Nasdaq listing requirements and to maintain the listing of its common stock; and the other risks and uncertainties described under the headings \u201cRisk Factors\u201d and \u201cSummary of Risk Factors\u201d in the Company\u2019s Annual Report on Form 10-K filed with the Securities and Exchange Commission (the \u201cSEC\u201d) on March 30, 2026, its Quarterly Report on Form 10-Q filed with the SEC on May 15, 2026, and its definitive proxy statement filed with the SEC on April 27, 2026, as well as in the Company\u2019s subsequent filings. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statement, except as required by law.<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260817276941r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20260817276941\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20260817276941\/en\/<\/a><\/span><\/p>\n<p><b>Investor Contact:<br \/>\n<\/b><br \/>Matthew Biegler, SVP, Investor Relations<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:matt@faeththerapeutics.com\">matt@faeththerapeutics.com<\/a><\/p>\n<p><b>Media Contact:<br \/>\n<\/b><br \/>Patrick Schmidt, Consort Partners<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:faeththerapeutics@consortpartners.com\">faeththerapeutics@consortpartners.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> Texas United States North America<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Oncology FDA Health Clinical Trials Pharmaceutical Biotechnology<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260817276941\/en\/2876317\/3\/Faeth_Therapeutics_Logo.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>Faeth Therapeutics Announces FDA Grant of Fast Track Designation for PIKTOR Plus Paclitaxel in Biomarker-Selected Advanced Endometrial Cancer \u2014 Fast Track designation applies to sapanisertib and serabelisib (PIKTOR) in combination with paclitaxel for the treatment of patients with advanced or recurrent endometrial cancer whose tumors harbor a PI3K\/AKT\/mTOR pathway alteration \u2014 Faeth expects topline data from its ongoing Phase 2 trial in second-line advanced endometrial cancer (Study FTH-PIK-201) by year-end 2026 AUSTIN, Texas&#8211;(BUSINESS WIRE)&#8211;Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company developing multi-node therapies for cancer patients, including its lead program PIKTOR, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the combination of sapanisertib and serabelisib (PIKTOR) with paclitaxel for the treatment &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/faeth-therapeutics-announces-fda-grant-of-fast-track-designation-for-piktor-plus-paclitaxel-in-biomarker-selected-advanced-endometrial-cancer\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Faeth Therapeutics Announces FDA Grant of Fast Track Designation for PIKTOR Plus Paclitaxel in Biomarker-Selected Advanced Endometrial Cancer&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-995847","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Faeth Therapeutics Announces FDA Grant of Fast Track Designation for PIKTOR Plus Paclitaxel in Biomarker-Selected Advanced Endometrial Cancer - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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trial in second-line advanced endometrial cancer (Study FTH-PIK-201) by year-end 2026 AUSTIN, Texas&#8211;(BUSINESS WIRE)&#8211;Faeth Therapeutics (Nasdaq: FTH), a clinical-stage oncology company developing multi-node therapies for cancer patients, including its lead program PIKTOR, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the combination of sapanisertib and serabelisib (PIKTOR) with paclitaxel for the treatment &hellip; Continue reading &quot;Faeth Therapeutics Announces FDA Grant of Fast Track Designation for PIKTOR Plus Paclitaxel in Biomarker-Selected Advanced Endometrial Cancer&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/faeth-therapeutics-announces-fda-grant-of-fast-track-designation-for-piktor-plus-paclitaxel-in-biomarker-selected-advanced-endometrial-cancer\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta 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