Palatin Technologies Inc. (NASDAQ: PTN) stock gained by 23.49% at the last close while the PTN stock price rises by 0.18% in the after-market trading session. Palatin is a biopharmaceutical firm focused on creating first-in-class medications that target the melanocortin and natriuretic peptide receptor systems. The targeted, receptor-specific pharmaceutical candidates developed by PTN are used to treat illnesses with a high unmet medical need and economic potential.
What is happening?
Palatin Technologies has completed an End-of-Phase 2 (EOP2) meeting with the US Food and Drug Administration (FDA) for PL9643, a dry eye condition therapy (DED).
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The FDA and Palatin reached a deal on the essential elements of a pivotal Phase 3 clinical program, covering study design, endpoints, interim evaluation, and patient population, at the EOP2 conference, which covered all parts of PL9643’s development plan. A possible second Phase 3 trial, as well as a long-term safety study, were also considered in order to support a New Drug Application (NDA). Palatin expects to start the Phase 3 program in DED patients in the fourth quarter of 2021, with data readout in the second half of 2022. If all goes according to plan, an NDA will be submitted in the second half of the calendar year 2023.
Michael Raizman, Chief Medical Officer of Palatin stated,
As a practicing ophthalmologist, he is encouraged by the preliminary findings on the PL9643 program, which provides much-needed hope for successful dry eye therapy without side effects. However, he is also looking forward to seeing further evidence of PL9643’s potential to revolutionize the topical treatment of DED for the millions of individuals who suffer from it.
Carl Spana, President and Chief Executive Officer of Palatin commented that,
After reaching an agreement with the FDA on all major components of PL9643’s pivotal phase 3 study for DED, they now have insight on the registrational path necessary to establish the safety and effectiveness of the drug. This is a significant business milestone since they now have a second melanocortin agonist in phase 3 development, which they feel confirms their approach of developing melanocortin-based therapies for inflammatory and autoimmune diseases.