Palatin’s obesity drug gains FDA orphan status

CRANBURY, N.J. - Palatin Technologies, Inc. (NYSE American: PTN) has received orphan drug designation from the U.S. Food & Drug Administration (FDA) for PL7737, an investigational oral treatment targeting the melanocortin-4 receptor for leptin receptor (LEPR) deficiency obesity, the company announced today.

The biopharmaceutical firm, which focuses on developing molecules that modulate the melanocortin receptor system, stated that PL7737 could potentially offer a more convenient alternative to the current FDA-approved injectable treatment for this rare genetic condition. Patients with LEPR deficiency obesity experience extreme and constant hunger leading to severe early-onset obesity due to mutations in the LEPR gene that disrupt signaling pathways regulating hunger and body weight.

The orphan drug status granted by the FDA provides various incentives, such as tax credits for clinical trials, exemption from user fees, and potentially seven years of market exclusivity after approval. This designation is part of the FDA’s commitment to support the development of treatments for rare diseases but does not equate to approval or licensing of the drug.

Palatin’s President and CEO, Carl Spana, Ph.D., highlighted the importance of this designation for the company’s melanocortin-4 receptor (MC4R) agonist program. Spana also mentioned ongoing statistical analysis for Phase 2 clinical studies of other Palatin products, with results expected to be released later this month. The announcement comes as the company’s stock has experienced significant pressure, down over 50% in the past year. InvestingPro analysis indicates the company is currently trading below its Fair Value, potentially offering an opportunity for investors interested in biotechnology stocks.

The company is also preparing to initiate a Phase 1 study of PL7737 for hypothalamic obesity by late 2025, following the planned Investigational New Drug (IND) submission in the fourth quarter of 2025. Clinical data from these studies are anticipated in the first half of 2026. With a current ratio of 0.38, the company’s ability to fund its development pipeline will be crucial. For deeper insights into Palatin’s financial health and development prospects, investors can access comprehensive analysis through InvestingPro’s detailed research reports, which cover over 1,400 US stocks with expert analysis and actionable intelligence.

Palatin’s strategy involves developing receptor-specific product candidates for diseases with unmet medical needs and forming marketing collaborations to maximize their commercial potential. The company’s progress is closely watched by investors interested in novel treatments for rare and common diseases alike.

This news article is based on a press release statement from Palatin Technologies, Inc.

In other recent news, Palatin Technologies reported its Q2 FY2025 earnings, showcasing a mixed financial performance with an earnings per share (EPS) of -0.12, significantly beating the forecasted -0.51. Despite zero product sales for the quarter, the company managed to reduce its net cash used in operations to $4.8 million, a substantial decrease from $10.5 million the previous year. Palatin also improved its net loss to $2.4 million from $7.8 million year-over-year. The company raised an additional $4.3 million through an equity offering, further bolstering its financial position. Palatin is advancing its obesity treatment programs, with expectations to move into IND-enabling activities in 2025. The company is actively seeking strategic partnerships and exploring expansion into rare disease markets. Analysts from H.C. Wainwright have shown interest in the company’s obesity study, focusing on the potential for innovative treatments in this area. These developments indicate Palatin’s strategic focus on innovation and partnerships to enhance its market position.

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