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Palatin Technologies, Inc. (NYSE American: PTN) is a specialized biopharmaceutical company based in Cranbury, New Jersey. The company focuses on developing first-in-class medicines that target the melanocortin and natriuretic peptide receptor systems. These therapies are aimed at treating a variety of diseases with significant unmet medical needs and commercial potential.
The company's lead product is Vyleesi, a melanocortin receptor agonist for premenopausal women suffering from hypoactive sexual desire disorder (HSDD). Recently, Palatin announced the divestiture of Vyleesi to better focus on its robust development and clinical pipeline.
Palatin is also advancing several promising candidates through clinical trials:
- PL9643: A melanocortin receptor agonist for treating dry eye disease (DED). The company recently reported successful results from its Phase 3 MELODY-1 trial, demonstrating significant efficacy and safety.
- PL8177: This selective melanocortin receptor 1 (MC1R) agonist peptide has completed Phase 1 trials for inflammatory bowel diseases and systemic non-infectious uveitis. It is being further developed for treating COVID-19.
- PL3994: A natriuretic peptide receptor (NPR)-A agonist aimed at treating cardiovascular diseases and other conditions.
Palatin’s strategic focus is on developing targeted, receptor-specific product candidates and forming marketing collaborations with industry leaders to maximize their commercial potential. The company's research and development efforts are guided by a commitment to innovative science and a focus on areas with high probability of success and differentiation.
Financially, Palatin has shown strong operational progress. As of the latest fiscal quarter, the company announced a substantial cash position, ensuring the funding of its ongoing projects into the second half of 2024. The company's leadership believes that their internal research and development efforts, concentrating on melanocortin receptor-based therapies, hold significant promise for the treatment of various conditions, including obesity and erectile dysfunction.
Palatin’s approach to biopharmaceutical development underscores a commitment to addressing significant medical needs through innovative receptor-specific therapies. For more information, visit www.Palatin.com and follow them on Twitter at @PalatinTech.
Palatin Technologies presented promising data on its Phase 3 clinical trial for PL9643, a treatment for dry eye disease (DED), at the ARVO Annual Conference. The data shows consistent efficacy across multiple signs and symptoms of DED, demonstrating PL9643's potential as a leading treatment option. The ongoing MELODY-1 clinical study aims to finalize data in the second half of 2023, highlighting the significant differences in effectiveness compared to existing therapies. Notably, PL9643 showed no ocular adverse events, illustrating its strong safety and tolerability profile. The findings reinforce PL9643's potential to address unmet needs in DED patients, with over 20 million affected in the U.S.
Palatin Technologies (NYSE American: PTN) presented a poster at the ARVO Annual Conference showcasing their research on PL9588, a novel treatment aimed at reducing intraocular pressure (IOP) for glaucoma patients. The study demonstrated that PL9588 effectively lowered IOP in normotensive rabbits, showcasing effects comparable to established treatments like latanoprost and timolol. The results indicate that the treatment could persist for 24 hours and may offer neuroprotective benefits. The global glaucoma market, valued at $5.71 billion in 2021, is expected to reach $9.77 billion by 2030, signaling significant potential for new treatments. Palatin plans to advance PL9588 into clinical development, subject to resources. This innovative approach may significantly improve patient outcomes and enhance treatment options for glaucoma.
Palatin Technologies, Inc. (NYSE American: PTN) reported preliminary revenue results for its product Vyleesi for the fiscal third quarter ending March 31, 2023. The company achieved $3.4 million in gross product revenue, marking a 31% increase from the previous quarter and 165% growth year-over-year. Net product revenue reached $1.2 million, representing a 22% increase over 2Q23 and 469% growth compared to 3Q22. The total prescriptions dispensed grew by 27% over the prior quarter and 147% year-over-year. Palatin's focus on targeted digital marketing is credited for this growth, with net product revenue exceeding the operating expenses of Vyleesi.
Palatin Technologies (NYSE American: PTN) announced the publication of a manuscript in the International Journal of Molecular Sciences, highlighting PL8331’s therapeutic effects in diabetic retinopathy and uveitis. The study, funded by Palatin and NIH, demonstrated PL8331's efficacy as a melanocortin agonist in mouse models, showing promise in reducing inflammation and preserving retinal structure. Notably, in the EAU model, PL8331 protected retinal cells from damage, while in the DR model, it enhanced cell survival and suppressed VEGF, crucial in DR pathology. The findings underscore the potential of melanocortin agonists in treating inflammatory eye diseases and support future clinical development for Palatin. CEO Carl Spana emphasized the growing pre-clinical data supporting these prospects.
Palatin Technologies, Inc. (NYSE American: PTN) announced a study published in Frontiers in Immunology, highlighting the therapeutic effects of its oral formulation, PL8177, in preclinical models of inflammatory bowel disease. The study reports that PL8177 remains gut-restricted, showing promising results such as reduced immune cell infiltration and improved colon structure. Pharmacokinetic studies indicated that PL8177 is effective in the colon without systemic absorption. The company is currently enrolling patients in a Phase 2 clinical trial for ulcerative colitis. Initial results from the trial are expected in mid-2023, with final data anticipated later in the year.
On February 28, 2023, Palatin Technologies, Inc. (NYSE American: PTN) announced the issuance of U.S. Patent No. 11,590,209 for the use of bremelanotide in patients with controlled hypertension. This patent strengthens the intellectual property surrounding Vyleesi, its FDA-approved treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women. The patent extends to April 29, 2041, enhancing the company's competitive positioning in the market. CEO Carl Spana expressed optimism regarding the patent’s contribution to Palatin's innovation efforts and the expansion of its Vyleesi portfolio, which the company is actively seeking to commercialize further.
Palatin Technologies (PTN) reported financial results for the fiscal second quarter ending December 31, 2022, highlighting a net product revenue of approximately $1 million for Vyleesi®, marking an 18% increase over the previous quarter and a staggering 1,323% increase compared to last year. Operating expenses decreased to $6.6 million from $8.8 million, contributing to a reduced net loss of $1.4 million, down from $8.7 million a year prior. The company closed a $10 million direct offering and received $4.7 million in non-dilutive funding. Key clinical trials, including the Phase 3 study of PL9643 for dry eye disease, are ongoing, with topline results expected in mid-2023.
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