Palatin Tech - PTN STOCK NEWS

Palatin Technologies has initiated a Phase 2 clinical study of bremelanotide (BMT) co-administered with a PDE5 inhibitor (PDE5i) for treating erectile dysfunction (ED) in patients unresponsive to PDE5i monotherapy. With 30-40% of ED patients not responding to current PDE5i treatments, this study aims to address significant unmet medical needs. The trial will involve around 50 patients and assess the safety and efficacy of the combination therapy. Topline data from the study is anticipated by the end of 2024. The study is FDA and IRB approved. Furthermore, a Phase 3 clinical study of a new co-formulated BMT plus PDE5i is expected to start in the first half of 2025. ED affects approximately 30 million men in the U.S., and current PDE5i monotherapy represents over $4 billion in annual sales but is ineffective for a significant portion of patients.

Palatin Technologies (NYSE American: PTN) has initiated a Phase 2 clinical study to evaluate the safety and efficacy of bremelanotide, a melanocortin 4 receptor (MC4R) agonist, co-administered with tirzepatide (GLP-1/GIP) in obese patients. The trial aims to demonstrate the safety and improved efficacy of this combination in reducing body weight. The study, cleared by the FDA, involves 60 patients across five U.S. sites, with topline data expected by the end of 2024. Palatin believes this combination could lead to significant weight loss with improved tolerability, addressing the high discontinuation rates associated with current GLP-1 treatments. The company is also exploring additional studies for metabolic conditions and rare genetic diseases of obesity.

Palatin Technologies announced its Q3 FY2024 financial results and corporate updates. The company reported successful Phase 3 results for its dry eye treatment, PL9643, showing statistical significance in the co-primary endpoint of pain and several secondary endpoints. Interim analysis for their Phase 2 oral PL8177 study in ulcerative colitis is expected in Q2 2024, with topline results in 2H 2024. They plan to initiate Phase 2 trials in obesity and erectile dysfunction in Q2 2024. Revenue for the quarter ended March 31, 2024, was $0 due to the sale of Vyleesi rights. Operating expenses increased to $9.2 million, and net loss was $8.4 million. Cash position as of March 31, 2024, was $10 million. The company believes it has sufficient funds for its operations into the second half of 2024.

Palatin Technologies, Inc. (NYSE American: PTN) will report its third quarter fiscal year 2024 results on May 15, 2024, before the U.S. financial markets open. A conference call and webcast will follow at 11:00 a.m. ET to discuss the operating results and programs under development.

Palatin Technologies, Inc. (NYSE American: PTN) has received FDA clearance to begin a Phase 2 clinical study for the co-administration of bremelanotide with tirzepatide for treating obesity. The study is expected to start in mid-2024 with data by the end of the year. The company is hosting a virtual KOL event on May 8, 2024, to discuss its metabolic program.

Palatin Technologies, Inc. (NYSE American: PTN) will host a virtual KOL event on May 8, 2024, focusing on novel melanocortin receptor 4 agonists for treating obesity. The event will feature discussions on the current treatment landscape, the need for new treatments, and combining melanocortin agonists with incretins for optimal treatment. Palatin's Phase 2 clinical study is set to begin in mid-2024, with results expected by the end of the year.

Palatin Technologies, Inc. (NYSE American: PTN) announces positive Phase 3 study results for PL9643 in treating dry eye disease. The study showed statistically significant improvements in pain and secondary symptom endpoints, including safety and tolerability. Discussions with the FDA for regulatory approval are planned for 2Q 2024.

Palatin Technologies, Inc. (PTN) announces positive results from its PL9643 MELODY-1 pivotal Phase 3 clinical trial for dry eye disease. The trial met co-primary symptom endpoint with statistical significance. PL9643 showed superiority over vehicle in multiple symptom endpoints and demonstrated excellent safety. Future discussions with FDA are planned.

Palatin Technologies, Inc. focuses on developing its Melanocortin Receptor System Pipeline, with upcoming Phase 3 and Phase 2 clinical study results expected in 2024. The company completed an asset sale of Vyleesi for up to $171 million and raised $10 million through a Registered Direct Offering. Financially, Palatin reported increased revenue and gross product sales, offset by higher operating expenses and a net loss of $7.8 million for the quarter ended December 31, 2023.