KayoThera, Inc. Nominates First-in-Class, Oral Inhibitor of the Retinoid Pathway in Genetically Defined Oncology Indications as a Development Candidate
Unique safety profile positions KAYO-1609 as the first retinoid pathway inhibitor to enter Investigational New Drug (IND)-enabling studies
Company expects to file IND application with the U.S. Food & Drug Administration (FDA) by the end of 2024
Relmada Therapeutics Announces Dosing of First Patient in Relight, a Phase 3 Trial of REL-1017 for the Adjunctive Treatment of Major Depressive Disorder
Venatorx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI), including Pyelonephritis, in Adults
Cefepime-taniborbactam has also demonstrated in vitro activity against CDC Urgent and Serious Threat Pathogens carbapenem-resistant Enterobacterales, multidrug-resistant Pseudomonas aeruginosa and Extended Spectrum Beta-lactamase-producing Enterobacterales
In the CERTAIN-1 cUTI Phase 3 study, cefepime-taniborbactam demonstrated clinical efficacy in patients with infections due to Extended Spectrum Beta-lactamase producing Enterobacterales and carbapenem-resistant Enterobacterales
PDUFA action date set for February 22, 2024
Venatorx Pharmaceuticals Highlights Two Recent Publications Indicating Rising Metallo-Beta-Lactamases for Carbapenem-Resistant Enterobacterales in US
Growing Global Incidence of Carbapenem-Resistant Enterobacterales Metallo-beta-lactamases were the most frequently identified carbapenem resistance
mechanism among Enterobacterales isolates in IHMA global surveillance
Relmada Therapeutics Provides Corporate Update and Reports Second Quarter 2023 Financial Results
Palvella Therapeutics Announces Planned Pivotal Phase 3 Study Design of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations and Topline Results from Phase 2b CODY Study in Gorlin Syndrome
QTORIN™ rapamycin has potential to become first approved therapy and standard of care for Microcystic Lymphatic Malformations in U.S.; significant commercial opportunity based on an estimated more than 30,000 individuals in the U.S. with Microcystic Lymphatic Malformations
Phase 3 SELVA pivotal study to enroll approximately 50 subjects with Microcystic Lymphatic Malformations; productive FDA end-of-phase 2 meeting completed in Q1 2023
Phase 2 study of QTORIN™ rapamycin demonstrated 100% of participants with Microcystic Lymphatic Malformations were either “Much Improved” or “Very Much Improved” as rated by the Clinician Global Impression of Change following 12-weeks of QTORIN™ rapamycin
Phase 2b CODY study of QTORIN™ rapamycin for Basal Cell Carcinomas in Gorlin Syndrome did not meet primary endpoint of new Basal Cell Carcinoma prevention at 24-weeks; pre-specified secondary endpoint demonstrated nominally statistically significant reduction in existing Clinically Suspicious and Biopsy Confirmed Basal Cell Carcinoma lesion size compared to placebo
Palvella Therapeutics Reports Topline Results from Pivotal Phase 3 VAPAUS Study of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Pachyonychia Congenita
KayoThera, Inc. Strengthens Financial Position with $5.2 Million in Grant and Expanded Series A Funding, Bringing Total Financial Support to $14 Million
New funding comprised of grants from the National Institutes of Health, The Andy Hill Cancer Research Endowment (CARE) Fund, and additional Equity Funding
Additional funding will support advancement of KayoThera’s development programs in diabetes and oncology