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  • Positive Phase 3 PL9643 MELODY-1 Pivotal Study Results
    • Co-Primary Symptom Endpoint of Pain Met Statistical Significance (P<0.025) and 7 of 11 Secondary Symptom Endpoints Met Statistical Significance (P<0.05), at the12-Week Treatment Period
    • Rapid Onset of Efficacy and Multiple Symptom Endpoints, Including the Co-Primary Pain Endpoint, Met Statistical Significance (P<0.05) at the 2-Week Treatment Period and Continued to Improve Over the 12-Week Treatment Period
    • At the 2-Week Treatment Period, Multiple Sign Endpoints, Including All 4 Fluorescein Staining Endpoints, Met Statistical Significance (P<0.05)
    • Excellent Safety and Tolerability Profile
  • Oral Phase 2 PL8177 Clinical Study in Patients with Ulcerative Colitis
    • Interim Analysis Expected in 2Q Calendar Year 2024
    • Topline Results Expected in 2H Calendar Year 2024
  • Obesity: Melanocortin Receptor 4 (MCR4) Agonist + Glucagon Like Peptide-1 (GLP-1)
    • Phase 2 Clinical Study Targeted to Start 2Q Calendar Year 2024
  • Male Sexual Dysfunction: Bremelanotide Co-Formulated with a PDE5i for the Treatment of Erectile Dysfunction (ED) in Patients that do not Respond to PDE5i Monotherapy
    • Phase 2 Clinical Study Targeted to Start 2Q Calendar Year 2024
  • Teleconference and Webcast to be held on May 15, 2024, at 11:00 AM ET

CRANBURY, N.J., May 15, 2024 /PRNewswire/ — Palatin Technologies (NYSE:), Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules  that  modulate the  activity  of  the  melanocortin  receptor  system,  today  announced  financial  results for its fiscal third quarter ended March 31, 2024.

“Study results of our successful Phase 3 MELODY-1 clinical trial for DED demonstrate that PL9643, with its early onset of efficacy for multiple symptoms and signs of dry eye disease and the excellent ocular safety and tolerability profile, has the potential to be a highly differentiated product,” said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. “The efficacy results were statistically significant for the co-primary symptom endpoint of pain and 7 of 11 exploratory secondary endpoints, including eye dryness, as early as two weeks, which was the first time point measured. We are advancing discussions with potential collaboration partners and actively preparing for a meeting with the FDA later this year to discuss the remaining studies for the PL9643 program required to support an NDA submission.”

Dr. Spana further commented, “We are excited to launch…

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