Wes Kaupanen
Chief Executive Officer
Replay available
Palvella Therapeutics, Inc. (PVLA) Q1 2026 Earnings Call
Palvella Therapeutics, Inc. (NASDAQ: PVLA) Q1 2026 earnings conference call, held 2026-05-07. Replay captured from the company's public earnings webcast.
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David Osborne
Chief Innovation Officer
Investor Relations
Josh Skimmer
Analyst, Kantor
Josh Fleischman
Analyst, David Colvin
Annabel Cimini
Analyst, CIFL
Gaurav Maini
Analyst, LifeSite Capital
Kyra Pullman
Analyst, ClearStreet
Investor webinar replay
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Replay transcript excerpt
WEBVTT 00:00:00.031 -- 00:00:05.604 secondary and secondary endpoints with a safety and tolerability profile 00:00:05.604 -- 00:00:10.716 that we believe supports first line standard of care positioning in this 00:00:10.716 -- 00:00:14.240 serious chronically debilitating rare disease. 00:00:14.240 -- 00:00:19.448 The SELVA results, along with our Phase II results in microcystic lymphatic malformations, 00:00:19.448 -- 00:00:24.575 which supported FDA granting ketorin rapamycin breakthrough therapy designation, 00:00:24.575 -- 00:00:30.123 provide us with a robust evidence package as we move toward NDA submission 00:00:30.123 -- 00:00:32.647 later this year. 00:00:32.647 -- 00:00:38.255 On the NDA, I am pleased to share that our NDA submission remains on track 00:00:38.255 -- 00:00:41.307 for the second half of 2026. 00:00:41.307 -- 00:00:46.338 Since our last earnings call and corporate update just a few weeks ago, the FDA 00:00:46.338 -- 00:00:52.631 has granted Paul Vela an in-person pre-NDA meeting to be held later this quarter. 00:00:52.631 -- 00:00:57.882 In parallel to advancing towards our NDA submission, we continue to make strong progress 00:00:57.882 -- 00:01:01.670 preparing for and investing in a potential U.S. 00:01:01.670 -- 00:01:06.936 launch. I'm pleased to share that we have added commercial and medical leadership 00:01:06.936 -- 00:01:12.023 with deep experience launching highly relevant therapies in rare diseases and 00:01:12.023 -- 00:01:17.951 skin diseases, including successful products such as Vigevec, Zareve, 00:01:17.951 -- 00:01:21.916 Apsilura, Tepeza, and Oxirvate. 00:01:21.916 -- 00:01:28.135 At the same time, our pipeline progress extends well beyond microcystic lymphatic malformations. 00:01:28.135 -- 00:01:33.042 In cutaneous venous ...