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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.
On October 31, 2022, Palatin Technologies (NYSE: PTN) announced a definitive agreement to issue 1,818,182 shares of common stock and warrants to purchase an equal number of shares, priced at $5.50 each. The offering, expected to close by November 2, 2022, is projected to generate approximately $10 million in gross proceeds. Funds will be allocated for general corporate purposes. The offering is conducted under a shelf registration statement filed with the SEC, ensuring compliance and market readiness.
Palatin Technologies, Inc. (NYSE American: PTN) announced the presentation of preclinical and human pharmacokinetic data for PL8177 at the American College of Gastroenterology meeting. The data demonstrated efficacy in animal models of ulcerative colitis, showing that oral PL8177 reduces colonic inflammation without systemic absorption. PL8177, a melanocortin receptor agonist, is currently being evaluated in a Phase 2 trial with interim results expected in early 2023. This research highlights the potential of PL8177 as a safer alternative to traditional immunosuppressive therapies.
Palatin Technologies (NYSE American: PTN) has initiated the PL8177-205 Phase 2 clinical study, enrolling its first patient. This study evaluates PL8177, an oral melanocortin-1 receptor agonist, as a potential treatment for ulcerative colitis (UC), particularly before immunosuppressive therapies. The primary endpoint is the Mayo Endoscopic Subscore, assessing colon mucosa disease levels. Interim data is expected in Q1 2023, with topline results anticipated in Q3 2023. PL8177 aims to address the unmet needs of the estimated 1 million UC patients in the U.S.
Palatin Technologies (NYSE: PTN) announced the publication of a study showcasing the effects of bremelanotide (Vyleesi) on sexual desire in women with hypoactive sexual desire disorder (HSDD). The double-blinded, placebo-controlled trial demonstrated that bremelanotide significantly increased sexual desire for up to 24 hours post-administration (P ≤ 0.01). This research correlates imaging data with increased sexual desire and enhances understanding of Vyleesi's mechanism of action. The study was funded by AMAG Pharmaceuticals and UK health institutions and is registered under NCT04179734.
Palatin Technologies reported a 20% increase in net product revenue for Vyleesi®, reaching $856,000, for the first fiscal quarter of 2023. The number of prescriptions dispensed rose by 17% from the previous quarter, with refills surpassing 50% of total prescriptions, indicating strong patient satisfaction. Compared to the same quarter in fiscal 2022, net revenue has surged by 400%, and prescriptions dispensed have grown by 108%. However, the reported figures are preliminary and not audited, which could result in material changes.
Palatin Technologies (PTN) announced its presentation at the Eyecelerator@AAO 2022 in Chicago, focusing on its melanocortin receptor research pipeline aimed at treating ocular inflammatory conditions. The company is conducting a Phase 3 clinical trial for PL9643, a novel melanocortin agonist for dry eye disease, with results expected in 2Q 2023. Previous Phase 2 studies showed positive outcomes in symptom relief with no safety concerns. Palatin aims to develop innovative treatments supported by genomics and proteomics data for addressing inflammatory diseases.
Palatin Technologies, Inc. (NYSE American: PTN) announced its participation in the Ladenburg Thalmann Healthcare Conference on September 29, 2022, in Cranbury, N.J. Carl Spana, Ph.D., President and CEO, will present an update on the Company's pipeline and partake in an Analyst-led Fireside Chat. Palatin is focused on developing first-in-class medicines targeting the melanocortin receptor system, addressing significant unmet medical needs. For more details, visit www.Palatin.com.
Palatin Technologies, Inc. (PTN) reported a net loss of $12.8 million for Q4 2022, reduced from $13.9 million in Q4 2021, with a net loss per share of $(1.34) compared to $(1.47) the previous year. Vyleesi sales surged, with gross product sales increasing by 79% and net revenue by 257% from the previous quarter. The ongoing Phase 3 study of PL9643 for dry eye disease shows positive interim results, prompting the data monitoring committee's recommendation to expand the study size to 350 patients. The company closed a $15 million private placement of redeemable convertible preferred stock.
Palatin Technologies, Inc. (NYSE American: PTN) will announce its Q4 and FY 2022 operating results on September 22, 2022, before U.S. market opens. A conference call will follow at 11:00 a.m. ET to discuss results and updates on development programs. Investors can access the audio webcast via Palatin's website. The company focuses on first-in-class biopharmaceuticals targeting melanocortin receptor systems, aiming for collaborations to enhance commercial potential. For updates, visit palatin.com.
Palatin Technologies, Inc. (NYSE American: PTN) has initiated a Phase 2 clinical study of PL8177, a melanocortin-1 receptor agonist, aimed at treating active ulcerative colitis (UC). The trial will evaluate the drug's safety, tolerability, and efficacy in adult patients, enrolling up to 28 subjects across 22 sites. Following a successful Phase 1 study, where PL8177 showed promising results without systemic exposure, this Phase 2 trial is expected to yield interim results in early 2023 and final data by mid-2023. PL8177 targets inflammation in UC, a disease affecting about 1 million people in the U.S.
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