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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 (PTN) announced a presentation by CEO Carl Spana at the Eyecelerator@ASCRS Conference in Las Vegas, discussing the role of melanocortins in reducing inflammation and presenting data from a Phase 2 study of PL9643 for dry eye disease (DED). The company is set to initiate a Phase 3 clinical trial in late 2021, with a potential NDA submission in late 2023. Notably, PL9643 demonstrated statistically significant improvements in patient symptomatology and showed excellent ocular tolerability in the Phase 2 study.
Palatin Technologies announced the adjournment of its 2021 Annual Meeting of Stockholders, initially held on June 8 and adjourned to July 8, now rescheduled for August 6. This adjournment is to solicit more proxies for an increase in authorized common stock from 300 million to 400 million shares. Approximately 71% of shares voted supported the proposal, but this was insufficient for approval. The Board believes this increase is vital for capital access to advance development programs and explore strategic opportunities. Stockholders are encouraged to vote before the new meeting date.
Palatin Technologies (NYSE American: PTN) has completed a favorable End-of-Phase 2 meeting with the FDA regarding PL9643 for treating dry eye disease (DED). The FDA and Palatin agreed on key elements for a pivotal Phase 3 clinical program, including study design and patient population. The Phase 3 study is set to begin in Q4 2021, with data expected in H2 2022 and a potential NDA submission in H2 2023. Previous Phase 2 results showed significant improvement in DED symptoms with no safety concerns.
Palatin Technologies, Inc. (NYSE American: PTN) has appointed three key executives to strengthen its leadership team. Michael B. Raizman, M.D. is now Chief Medical Officer, James E. Hattersley is Senior Vice President of Business Development, and J. Don Wang, Ph.D. is Vice President of Product Development. These appointments aim to enhance Palatin's capabilities in advancing its inflammatory and autoimmune programs. The new executives bring extensive experience in medical, business development, and product research, expected to aid the company in navigating market challenges effectively.
Palatin Technologies (PTN) announced the adjournment of its 2021 Annual Meeting of Stockholders from June 8 to July 8, 2021, to gather more proxies for Proposal 3, which seeks to increase the authorized common stock from 300 million to 400 million shares. Currently, approximately 69% of votes on Proposal 3 support the measure, but it lacks an absolute majority. The Board believes this increase is necessary for future flexibility and potential strategic opportunities. Shares must be voted before July 7, 2021, 11:59 PM EDT to be counted.
Palatin (PTN) reported third-quarter results for the period ending March 31, 2021, showing significant growth across its product Vyleesi, with gross sales increasing by 89% and net revenue rising by 154% compared to the previous quarter. The company plans to initiate a Phase 3 trial for PL9643 in dry eye disease and a Phase 2 study for PL8177 in ulcerative colitis, both expected in the second half of 2021. As of March 31, 2021, Palatin held $68.6 million in cash. Despite a net loss of $5.7 million, the company highlighted improving prescription trends and insurance coverage, boosting optimism moving forward.
Palatin Technologies, Inc. (NYSE American: PTN) announced a KOL webinar focusing on melanocortin agonists for ocular indications, particularly PL9643 for dry eye disease (DED). Scheduled for May 21, 2021, the webinar will feature experts discussing the biological underpinnings and clinical development of PL9643. A Phase 3 study for PL9643 is anticipated in the latter half of 2021. The event aims to showcase the company's advancements in treating eye inflammation and highlight the unmet medical needs in this field.
Palatin Technologies (NYSE American: PTN) will announce its Q3 fiscal year 2021 operating results on May 17, 2021, before the U.S. markets open. A conference call, led by the executive management team, is scheduled for the same day at 11:00 a.m. ET to discuss the results and provide updates on ongoing programs. The results will be released at 7:30 a.m. ET.
Investors can access the audio webcast and replay through the Investors-Webcasts section on the company's website.
Palatin Technologies (PTN) announced that the USPTO granted a 5-year patent term extension for one of its patents covering Vyleesi® (bremelanotide injection), now set to expire on June 25, 2025. Vyleesi is the only FDA-approved on-demand treatment for hypoactive sexual desire disorder (HSDD) in premenopausal women. The extension is in line with the Hatch-Waxman Amendments, compensating for time lost during drug development and FDA review. Additional patents related to methods of treating HSDD are valid until November 2033.
Palatin Technologies, Inc. (NYSE American: PTN) announced two presentations at the virtual ARVO 2021 Annual Meeting, occurring from May 1-7, 2021. The presentations will showcase clinical data for PL9643, a melanocortin agonist, focusing on its potential in treating dry eye disease and ocular inflammation. CEO Carl Spana emphasized the therapeutic promise of melanocortins in inflammatory conditions during the event. Presentations are set for May 1 and May 6, covering efficacy and safety studies and protective effects in ocular disease models, respectively.
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