FDA confirms acceptability of Palatin's remaining Phase 3 pivotal clinical trials for PL9643 in DED

Palatin Technologies Inc received FDA approval for PL9643 Phase 3 trials for dry eye disease, with MELODY-2 and MELODY-3 set to begin in Q4 this year. PL9643 aims to address DED inadequacies with early efficacy and good tolerability, with potential NDA submission in H1 2026 if trials succeed. MELODY-1 showed significant symptom relief and safety.


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Palatin Technologies advances clinical programs in dry eye disease, obesity, male sexual dysfunction, and ulcerative colitis. Key milestones include FDA agreements on trial protocols, patient enrollment for dry eye disease studies in Q4 2024, and Phase 2 obesity study results in H1 2025. The company also sold Vyleesi to Cosette Pharmaceuticals for up to $171 million, retaining rights for obesity and erectile dysfunction. Palatin faces financial challenges with a net loss of $8.4 million in Q3 2024, but secured $6.1 million from warrant exercises.

FDA confirms acceptability of remaining Phase 3 pivotal clinical trials for Palatin's PL9643 in DED

Palatin Technologies Inc received FDA approval for PL9643 Phase 3 trials for dry eye disease, with MELODY-2 and MELODY-3 expected to start Q4 2024. PL9643 aims to address DED inadequacies with early efficacy and good tolerability, with potential NDA submission in H1 2026. MELODY-1 showed significant pain reduction and positive safety profile.

Palatin Provides Update on Clinical Programs, Strategic Priorities, and Anticipated Milestones

Palatin Technologies updates on clinical programs: MELODY-2 & MELODY-3 Phase 3 trials for Dry Eye Disease targeting 4Q 2024 enrollment, with topline results expected 4Q 2025; Phase 2 obesity study with MC4R agonist + GLP-1 initiated, topline results expected 1Q 2025; Phase 3 study for erectile dysfunction with bremelanotide co-formulated with PDE5i anticipated to start 1Q 2025; Phase 2 ulcerative colitis study interim analysis expected 4Q 2024, topline results 1Q 2025.

FDA accepts protocols, endpoints for remaining phase 3 trials on PL9643 for dry eye

FDA and Palatin Technologies agree on protocols and endpoints for PL9643 phase 3 trials for dry eye disease, with MELODY-2 and MELODY-3 set to begin in Q4 2024, aiming for NDA submission in H1 2026.

FDA confirms acceptability of Palatin's remaining Phase 3 pivotal clinical trials for PL9643 in DED

Palatin Technologies Inc received FDA approval for PL9643 Phase 3 trials for dry eye disease, with MELODY-2 and MELODY-3 set to begin in Q4 this year. PL9643 aims to address DED inadequacies with early efficacy and good tolerability, with potential NDA submission in H1 2026 if trials succeed. MELODY-1 showed significant symptom relief and safety.

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