{"id":31198,"date":"2025-03-04T15:37:10","date_gmt":"2025-03-04T10:07:10","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=31198"},"modified":"2025-03-05T16:01:47","modified_gmt":"2025-03-05T10:31:47","slug":"pharma-news-for-precigen-pyxis-defloria","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-precigen-pyxis-defloria","title":{"rendered":"PRGN-2012 Wins Priority Review for Recurrent Respiratory Papillomatosis; PYX-201 Granted Fast Track for R\/M HNSCC; AJA001 IND Cleared for Autism Spectrum Disorder; LAE120 IND Approved for Advanced Solid Tumors; Relacorilant NDA Accepted for Hypercortisolism Treatment"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a0aea9852821\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a0aea9852821\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-precigen-pyxis-defloria\/#FDA_Grants_Priority_Review_to_Precigens_BLA_for_PRGN-2012_in_Recurrent_Respiratory_Papillomatosis\" >FDA Grants Priority Review to Precigen\u2019s BLA for PRGN-2012 in Recurrent Respiratory Papillomatosis<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-precigen-pyxis-defloria\/#FDA_Grants_Fast_Track_Designation_to_Pyxis_PYX-201_for_RM_HNSCC\" >FDA Grants Fast Track Designation to Pyxis\u2019 PYX-201 for R\/M HNSCC<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-precigen-pyxis-defloria\/#DeFloria_Secures_FDA_Clearance_for_IND_Application_of_AJA001_in_Autism_Spectrum_Disorder\" >DeFloria Secures FDA Clearance for IND Application of AJA001 in Autism Spectrum Disorder<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-precigen-pyxis-defloria\/#FDA_Approves_Laeknas_IND_Application_for_LAE120_a_Novel_USP1_Inhibitor_for_Advanced_Solid_Tumors\" >FDA Approves Laekna\u2019s IND Application for LAE120, a Novel USP1 Inhibitor for Advanced Solid Tumors<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-precigen-pyxis-defloria\/#FDA_Accepts_Corcepts_NDA_for_Relacorilant_in_Hypercortisolism_Treatment\" >FDA Accepts Corcept&#8217;s NDA for Relacorilant in Hypercortisolism Treatment<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-grants-priority-review-to-precigen-s-bla-for-prgn-2012-in-recurrent-respiratory-papillomatosis\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Priority_Review_to_Precigens_BLA_for_PRGN-2012_in_Recurrent_Respiratory_Papillomatosis\"><\/span>FDA Grants Priority Review to Precigen\u2019s BLA for PRGN-2012 in Recurrent Respiratory Papillomatosis<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Precigen, Inc. announced that the <strong>FDA has accepted its Biologics License Application (BLA) for PRGN-2012<\/strong> (zopapogene imadenovec\u2020), an investigational <strong>AdenoVerse gene therapy<\/strong> for adults with <a href=\"https:\/\/www.delveinsight.com\/report-store\/recurrent-respiratory-papillomatosis-market\" class=\"ek-link\"><strong>recurrent <\/strong><\/a><strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/recurrent-respiratory-papillomatosis-market\" class=\"ek-link\">respiratory papilloma<\/a><\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/recurrent-respiratory-papillomatosis-market\" class=\"ek-link\"><strong>tosis (RRP)<\/strong><\/a><strong>.<\/strong> The FDA granted <strong>priority review<\/strong>, setting a <strong>target action date of August 27, 2025<\/strong>. No advisory committee meeting is currently planned for the application.<\/p>\n\n\n\n<p>If approved, PRGN-2012 would become the <strong><em>first and only FDA-approved therapy for RRP<\/em><\/strong>, a rare and lifelong neoplastic disease caused by HPV 6 or HPV 11, which currently requires repeated surgeries. Data from the pivotal Phase I\/II study, presented at <strong><a href=\"https:\/\/www.delveinsight.com\/asco-conference-2024\" class=\"ek-link\">ASCO 2024<\/a><\/strong> and published in <em>The Lancet Respiratory Medicine<\/em>, showed that over <strong>50% of patients achieved Complete Response<\/strong>, while <strong>85% experienced a reduction in surgical interventions<\/strong> compared to the previous year. The therapy has also received <strong>Breakthrough Therapy, Orphan Drug, and Accelerated Approval Designations<\/strong> from the FDA.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;The priority review designation is a testament to the FDA&#8217;s recognition of the significant unmet need for the RRP patient population,&#8221;<\/em> said <strong>Helen Sabzevari, PhD, President and CEO of Precigen<\/strong>. <em>&#8220;Treatment with PRGN-2012 has shown significant, durable clinical benefit. We have patients treated with PRGN-2012 who have been surgery-free for more than three years now, bringing hope for an alternative to the cycle of repeated surgeries, which carry immense risk for irreversible damage and significant morbidity.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>She added, <em>&#8220;We look forward to working with the FDA over the coming months during their BLA review and hope to introduce the first FDA-approved therapeutic option to the RRP patient population, estimated at more than 27,000 adults in the US, later this year.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-grants-fast-track-designation-to-pyxis-pyx-201-for-r-m-hnscc\"><span class=\"ez-toc-section\" id=\"FDA_Grants_Fast_Track_Designation_to_Pyxis_PYX-201_for_RM_HNSCC\"><\/span>FDA Grants Fast Track Designation to Pyxis\u2019 PYX-201 for R\/M HNSCC<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>The <strong>FDA has granted Fast Track designation<\/strong> to <strong>Pyxis Oncology\u2019s<\/strong> antibody-drug conjugate (ADC), <strong>PYX-201<\/strong>, for the treatment of adults with <a href=\"https:\/\/www.delveinsight.com\/report-store\/head-and-neck-squamous-cell-carcinoma-market\" class=\"ek-link\"><strong>recurrent or metastatic head and neck squamous cell <\/strong><\/a><strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/head-and-neck-squamous-cell-carcinoma-market\" class=\"ek-link\">carcinoma<\/a><\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/head-and-neck-squamous-cell-carcinoma-market\" class=\"ek-link\"><strong> (R\/M HNSCC)<\/strong><\/a>. The therapy is intended for patients whose disease has progressed after treatment with <strong>platinum-based chemotherapy and an anti-PD-L antibody<\/strong>.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;Receiving Fast Track designation for PYX-201 from the FDA marks a significant milestone for Pyxis Oncology, recognizing our potential to address the significant medical need in R\/M HNSCC,&#8221;<\/em> said <strong>Lara Sullivan, President and CEO of Pyxis Oncology<\/strong>.<\/p>\n<\/blockquote>\n\n\n\n<p>PYX-201 targets <strong>Extradomain-B Fibronectin (EDB+FN)<\/strong>, a structural component in the tumor extracellular matrix, and is currently being evaluated in two clinical trials. The <strong>PYX-201-101 study<\/strong> is assessing PYX-201 as a <strong>single-agent therapy<\/strong>, while the <strong>PYX-201-102 trial<\/strong>, conducted in partnership with <strong>MSD<\/strong>, is evaluating the ADC in combination with <strong>Keytruda (pembrolizumab)<\/strong> for patients with <strong>R\/M HNSCC and other advanced solid tumors<\/strong>.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;This designation underscores the urgency of bringing differentiated treatment options to patients and will help accelerate the development of PYX-201 as we recruit patients for our trial,&#8221;<\/em> Sullivan added. <em>&#8220;We look forward to working with the FDA to advance this promising therapy as efficiently as possible.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-defloria-secures-fda-clearance-for-ind-application-of-aja001-in-autism-spectrum-disorder\"><span class=\"ez-toc-section\" id=\"DeFloria_Secures_FDA_Clearance_for_IND_Application_of_AJA001_in_Autism_Spectrum_Disorder\"><\/span>DeFloria Secures FDA Clearance for IND Application of AJA001 in Autism Spectrum Disorder<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>DeFloria, Inc.,<\/strong> a collaboration between <strong>Ajna BioSciences PBC and Charlotte&#8217;s Web Holdings, Inc., <\/strong>has announced that the <strong>FDA has approved its Investigational New Drug (IND) application<\/strong> for <strong>AJA001<\/strong>, a multi-cannabinoid botanical drug. This clearance allows the company to proceed with a <strong>Phase II clinical trial<\/strong> evaluating AJA001 as a treatment for behavioral symptoms associated with <strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/autism-spectrum-disorder-asd-market\" class=\"ek-link\">autism spectrum disorder (ASD)<\/a><\/strong>. The study is set to begin by <strong>mid-2025<\/strong>.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;IND submission for AJA001 and the initiation of the Phase II study in the US mark a historic moment in our mission to develop a systemically absorbed botanical drug therapy that meets FDA guidelines,&#8221;<\/em> said <strong>Jared Stanley, CEO of DeFloria<\/strong>. <em>&#8220;DeFloria is committed to supporting the ASD community and developing AJA001 to treat the behavioral symptoms associated with ASD with a drug that is designed to provide broad therapeutic efficacy.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>AJA001 was developed using <strong>Charlotte\u2019s Web\u2019s decade of research, proprietary hemp genetics, and innovative cultivation processes<\/strong>. This botanical drug aims to provide a safer alternative to the <strong>two currently approved ASD treatments\u2014atypical antipsychotics, which often cause adverse side effects and have poor patient compliance<\/strong>. The Phase II trial will enroll <strong>60 adolescent and young adult patients (ages 13-29 years old)<\/strong> in an <strong>open-label, 12-week study<\/strong> to assess <strong>dosage and efficacy signals<\/strong> for future <strong>Phase III trials<\/strong>.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;For more than 15 years, my family and our team have been laying the foundation for this botanical drug,&#8221;<\/em> said <strong>Joel Stanley, CEO of Ajna BioSciences and Chairman of DeFloria<\/strong>. <em>&#8220;Now, with this Phase II milestone, we&#8217;re one step closer to delivering a potential treatment option for autism spectrum disorder, a condition for which few effective therapies exist despite impacting millions worldwide.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-approves-laekna-s-ind-application-for-lae120-a-novel-usp1-inhibitor-for-advanced-solid-tumors\"><span class=\"ez-toc-section\" id=\"FDA_Approves_Laeknas_IND_Application_for_LAE120_a_Novel_USP1_Inhibitor_for_Advanced_Solid_Tumors\"><\/span>FDA Approves Laekna\u2019s IND Application for LAE120, a Novel USP1 Inhibitor for Advanced Solid Tumors<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Laekna<\/strong> has announced that the <strong>FDA has approved its Investigational New Drug (IND) application for LAE120<\/strong>, an internally <a href=\"https:\/\/www.delveinsight.com\/report-store\/ubiquitin-specific-proteases-usp-inhibitor-pipeline-insight\" class=\"ek-link\">developed <\/a><strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/ubiquitin-specific-proteases-usp-inhibitor-pipeline-insight\" class=\"ek-link\">USP1<\/a><\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/ubiquitin-specific-proteases-usp-inhibitor-pipeline-insight\" class=\"ek-link\"><strong> inhibitor<\/strong><\/a> for the treatment of <strong>advanced solid tumors<\/strong>. LAE120 is a <strong>highly potent, allosteric USP1 inhibitor<\/strong> that has shown strong monotherapy activity and synergy with <strong>PARP inhibitors in HRD (homologous recombination deficiency) cancers<\/strong>. It has demonstrated <strong>robust tumor inhibition<\/strong> across multiple xenograft models and a favorable safety profile in preclinical toxicology studies.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;Leveraging our deep expertise in drug discovery, Laekna has built an innovative portfolio through the collaboration of our Med Chem, Biology, and AI-driven Drug Discovery (AIDD) teams,&#8221;<\/em> said <strong>Dr. Justin Gu, Chief Scientific Officer of Laekna<\/strong>. <em>&#8220;We are committed to accelerating the development of novel drugs to bring transformative therapies to patients as swiftly as possible.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>In addition to LAE120, Laekna is advancing <strong>LAE118<\/strong>, a <strong>potentially best-in-class, mutant-selective PI3K\u03b1 inhibitor<\/strong>, which has entered IND-enabling studies. PI3K\u03b1 mutations are commonly found in breast, colorectal, lung, and endometrial cancers, but first-generation inhibitors lack selectivity, leading to tolerability concerns. LAE118 has demonstrated <strong>superior potency and selectivity against PI3K\u03b1 mutants<\/strong>, positioning it as a potential breakthrough therapy.<\/p>\n\n\n\n<p>Laekna presented preclinical data on LAE118 at the <strong>San Antonio Breast Cancer Symposium (SABCS) in December 2024<\/strong> and plans to submit its IND application in <strong>Q4 2025<\/strong>. The company continues to actively explore strategic partnerships to accelerate clinical development and expand its innovative oncology pipeline.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-accepts-corcept-s-nda-for-relacorilant-in-hypercortisolism-treatment\"><span class=\"ez-toc-section\" id=\"FDA_Accepts_Corcepts_NDA_for_Relacorilant_in_Hypercortisolism_Treatment\"><\/span>FDA Accepts Corcept&#8217;s NDA for Relacorilant in Hypercortisolism Treatment<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><strong>Corcept Therapeutics Incorporated <\/strong>has announced that the <strong>FDA has officially filed its New Drug Application (NDA) for relacorilant<\/strong>, a <strong>selective cortisol modulator<\/strong> intended to <a href=\"https:\/\/www.delveinsight.com\/report-store\/cushings-syndrome-market\" class=\"ek-link\">treat <strong>endogenous hypercortisolism (<\/strong><\/a><strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/cushings-syndrome-market\" class=\"ek-link\">Cushing\u2019s syndro<\/a><\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/cushings-syndrome-market\" class=\"ek-link\"><strong>me)<\/strong><\/a>. The submission is supported by <strong>positive results from the pivotal GRACE trial<\/strong> and additional confirmatory evidence from the <strong>Phase III GRADIENT trial, a long-term extension trial, and a Phase II study<\/strong>.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p><em>&#8220;The FDA\u2019s acceptance of our New Drug Application takes us another step closer to bringing relacorilant to patients with hypercortisolism,&#8221;<\/em> said <strong>Joseph Belanoff, M.D., Chief Executive Officer of Corcept<\/strong>. <em>&#8220;Relacorilant\u2019s combination of efficacy and safety gives it the potential to become the new standard of care for patients struggling with the devastating impact of this disease.&#8221;<\/em><\/p>\n<\/blockquote>\n\n\n\n<p>Patients treated with <strong>relacorilant<\/strong> in clinical trials <strong>showed improvements across multiple symptoms of hypercortisolism<\/strong> while avoiding serious adverse effects such as <strong>adrenal insufficiency, hypokalemia, and QT prolongation<\/strong>, which are concerns with currently approved treatments. Unlike existing therapies, relacorilant <strong>does not exhibit progesterone receptor-related side effects<\/strong>, such as <strong>endometrial thickening or vaginal bleeding<\/strong>.<\/p>\n\n\n\n<p>With this regulatory milestone, Corcept moves one step closer to <strong>providing a safer and more effective treatment<\/strong> for patients suffering from <strong>Cushing\u2019s syndrome<\/strong>, a rare and challenging endocrine disorder.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA Grants Priority Review to Precigen\u2019s BLA for PRGN-2012 in Recurrent Respiratory Papillomatosis Precigen, Inc. announced that the FDA has accepted its Biologics License Application (BLA) for PRGN-2012 (zopapogene imadenovec\u2020), an investigational AdenoVerse gene therapy for adults with recurrent respiratory papillomatosis (RRP). The FDA granted priority review, setting a target action date of August 27, [&hellip;]<\/p>\n","protected":false},"author":20,"featured_media":31199,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[3038,768,204,704,19575,349,420,639,5789,22403,2450,17117],"industry":[17225],"therapeutic_areas":[17240,17238,17228,17243],"class_list":["post-31198","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-autism-spectrum-disorder","tag-cushings-syndrome","tag-delveinsight","tag-fda","tag-head-and-neck-squamous-cell-carcinoma-hnscc","tag-latest-pharma-news","tag-news","tag-pharma-news","tag-recent-pharma-news","tag-recurrent-respiratory-papillomatosis","tag-solid-tumors","tag-squamous-cell-carcinoma","industry-pharmaceutical","therapeutic_areas-endocrinology-and-metabolic-disorders","therapeutic_areas-genetic-disorders","therapeutic_areas-oncology","therapeutic_areas-respiratory-diseases"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Pharma News | Precigen, Pyxis, DeFloria<\/title>\n<meta name=\"description\" content=\"Precigen\u2019s PRGN-2012, Pyxis\u2019 PYX-201, DeFloria\u2019s AJA001, Laekna\u2019s LAE120, Corcept\u2019s Relacorilant\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/pharma-news-for-precigen-pyxis-defloria\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharma News | Precigen, Pyxis, DeFloria\" \/>\n<meta property=\"og:description\" content=\"Precigen\u2019s PRGN-2012, Pyxis\u2019 PYX-201, DeFloria\u2019s AJA001, Laekna\u2019s LAE120, Corcept\u2019s Relacorilant\" \/>\n<meta property=\"og:url\" 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