Palvella Therapeutics, Inc. (PVLA) Q1 2026 Earnings Call

Investor webinar replay

Replay transcript excerpt

secondary and secondary endpoints with a safety and tolerability profile that we believe supports first line standard of care positioning in this serious chronically debilitating rare disease. The SELVA results, along with our Phase II results in microcystic lymphatic malformations, which supported FDA granting ketorin rapamycin breakthrough therapy designation, provide us with a robust evidence package as we move toward NDA submission later this year. On the NDA, I am pleased to share that our NDA submission remains on track for the second half of 2026. Since our last earnings call and corporate update just a few weeks ago, the FDA has granted Paul Vela an in-person pre-NDA meeting to be held later this quarter. In parallel to advancing towards our NDA submission, we continue to make strong progress preparing for and investing in a potential U.S. launch. I'm pleased to share that we have added commercial and medical leadership with deep experience launching highly relevant therapies in rare diseases and skin diseases, including successful products such as Vigevec, Zareve, Apsilura, Tepeza, and Oxirvate. At the same time, our pipeline progress extends well beyond microcystic lymphatic malformations. In cutaneous venous malformations, we are on track to initiate a pivotal phase three study in the second half of this year. In clinically significant angiocaritomas, a superficial lymphatic malformation, earlier this week, we announced that the first patients dosed in our phase two low two trial. Thanks to our clinical development and clinical operations teams, this study initiated ahead of our original schedule. And in disseminated superficial actinic poric keratosis, or DSAP, we continue to see strong patient and physician interest in our planned Phase II study, includi...