Palatin Technologies’ (NYSE: PTN)* Oral MC4R Agonist Gets FDA Orphan Drug Status; Phase 2 Results in Drug Targeting $44 Billion Obesity Market Expected Any Day According to the Company, alongside results from ulcerative colitis trial; Only Oral Option in Market Currently Dominated by Injections Uniquely Positioning Palatin;
In an exciting development for the biopharma market, Palatin Technologies (NYSE: PTN)* announced that it has secured FDA orphan drug designation for PL7737, its oral melanocortin-4 receptor (MC4R) agonist, targeting obesity caused by leptin receptor deficiency. According to the company, this designation offers Palatin significant benefits, including tax credits, fee waivers, and potential seven-year market exclusivity upon approval. The company has begun toxicology studies with plans to submit an IND in Q4 2025 and expects clinical data in early 2026.
Major catalysts are approaching for Palatin. Palatin also shared that it has completed analysis of two key Phase 2 studies: the BMT-801 trial testing bremelanotide with tirzepatide for obesity, and the PL8177 trial for ulcerative colitis. Results from both are expected within days. If positive, each could be a major development for the pharma company.
PL7737, the drug that just received orphan drug designation, could revolutionize treatment for rare genetic obesity disorders. Unlike the only current FDA-approved treatment requiring daily injections, Palatin’s oral formulation offers a more convenient alternative. The company is also exploring its use for hypothalamic obesity, with Phase 1 studies planned for late 2025. CEO Carl Spana called the designation “a key step in developing Palatin’s MC4R receptor agonists for rare obesity conditions.” The obesity therapeutics market is projected to reach $44 billion by 2030.
MC4R agonists represent a promising new class of therapeutics that may enhance existing GLP-1 treatments. Palatin’s development of both injectable and oral MC4R agonists positions it to address multiple segments of the obesity market. Reportedly, Pharma Analysts on Wall Street seem to be optimistic about Palatin’s prospects, with one analyst giving the company a Buy rating with a $7.00 price target, representing a significant premium over current levels.
Recent Palatin Technologies News Highlights:
- Completion of Phase 2 Obesity Study With MC4R Bremelanotide Plus GLP-1/GIP Tirzepatide
- Palatin Announces Positive Phase IIb BREAKOUT Study Results in Patients with Type 2 Diabetic Nephropathy
- Palatin Announces Completion of Patient Enrollment in Phase 2 Study of Orally Administered Melanocortin Agonist PL8177 in Ulcerative Colitis
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