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<p>Palvella Therapeutics（PVLA）宣布，FDA 已授予 QTORIN 雷帕霉素用于治疗血管角化瘤的快速通道认证。该公司指出，如果满足相关标准，获得快速通道认证的项目可以有资格获得加速批准和优先审查。</p>
<p>在 2025 年 9 月，Palvella 宣布将 QTORIN 雷帕霉素的开发计划扩展到临床显著的血管角化瘤。该公司计划在 2026 年上半年与 FDA 会面，讨论约 1020 名患者的第二阶段研究的拟议设计，研究预计将在 2026 年下半年启动。</p>
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PVLA

<p>Palvella Therapeutics 宣布，FDA 已授予 QTORIN 雷帕霉素用于治疗血管角化瘤的快速通道认证。该认证可能会在满足条件的情况下导致加速批准和优先审查。Palvella 计划在 2026 年与 FDA 讨论第二阶段研究，目标是在下半年启动该研究</p>

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</div><p>Palvella Therapeutics ((PVLA) announced that the FDA has granted Fast Track Designation to QTORIN rapamycin for the treatment of angiokeratomas. The company noted that, if relevant criteria are met, programs with Fast Track designation can become eligible for accelerated approval and priority review.</p>
<div class="lb-trans"><p>Palvella Therapeutics（PVLA）宣布，FDA 已授予 QTORIN 雷帕霉素用于治疗血管角化瘤的快速通道认证。该公司指出，如果满足相关标准，获得快速通道认证的项目可以有资格获得加速批准和优先审查。</p>
</div><p>In September 2025, Palvella announced the expansion of QTORIN rapamycin development program into clinically significant angiokeratomas. The company plans to meet with the FDA in the first half of 2026 to discuss the proposed design of a Phase 2 study of approximately 1020 patients, with study initiation expected in the second half of 2026.</p>
<div class="lb-trans"><p>在 2025 年 9 月，Palvella 宣布将 QTORIN 雷帕霉素的开发计划扩展到临床显著的血管角化瘤。该公司计划在 2026 年上半年与 FDA 会面，讨论约 1020 名患者的第二阶段研究的拟议设计，研究预计将在 2026 年下半年启动。</p>
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Palvella：FDA 授予 QTORIN 雷帕霉素用于血管角化瘤的快速通道认证