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美国

证券交易委员会

华盛顿特区 20549

表格 8-K

当前报告

根据《1934年证券交易法》第13或15(d)条

\n \n \n \n \n \n

报告日期（最早报告事件日期）： 2026年10月28日

PALVELLA THERAPEUTICS, INC.

（注册人章程中规定的准确名称）

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

\n	\n	\n	\n	\n
内华达州	001-37471	30-0784346
（注册成立所在州或其他司法管辖区）	（委员会档案编号）	（国税局雇主识别号）

353 W. Lancaster Ave, Suite 200
Wayne, Pennsylvania		19087
（主要行政办公室地址）		（邮政编码）

\n \n \n \n \n \n

注册人电话号码（含区号）：(484) 253-1461

（自上次报告以来，如有变更，列示原名称或原地址）

如果本8-K表格申报旨在同时履行注册人根据以下任何规定承担的申报义务，请勾选相应方框：

☐根据《证券法》规则425（17 CFR 230.425）进行的书面通信

☐根据《交易法》规则14a-12（17 CFR 240.14a-12）提交的征求材料

☐根据《交易法》规则14d-2(b)（17 CFR 240.14d-2(b)）进行的预启动通信

☐根据《交易法》规则13e-4(c)（17 CFR 240.13e-4(c)）进行的预启动通信

根据该法第12(b)条注册的证券：

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

各类别证券名称

交易

代码

注册所在交易所名称

普通股，每股面值$0.001

PVLA

Nasdaq 全球市场

请勾选标记，说明注册人是否为《1933年证券法》规则405（本章§ 230.405）或《1934年证券交易法》规则12b-2（本章§ 240.12b-2）所定义的新兴成长型公司。

新兴成长型公司 ☐

如果注册人为新兴成长型公司，请勾选标记，说明注册人是否选择不采用《交易法》第13(a)条规定的、遵守任何新订或修订财务会计准则的延长过渡期。 ☐

第8.01项\t其他事项。

2026年10月28日，Palvella Therapeutics, Inc.（“公司”）发布新闻稿，宣布美国食品药品监督管理局（“FDA”）已受理公司的新药申请并授予优先审评，该申请涉及用于治疗微囊性淋巴管畸形的 QTORIN™ 3.9% 无水雷帕霉素凝胶。FDA 已将《处方药使用者付费法案》的目标行动日期定为2027年2月28日。该新闻稿副本作为本8-K表格当前报告的附件99.1提交，并以引用方式纳入本文。

第9.01项\t财务报表和附件。

(d) 附件

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

\n	\n	\n
附件编号		说明
99.1		Palvella Therapeutics, Inc. 于2026年10月28日发布的新闻稿*
104		封面交互式数据文件（嵌入在 Inline XBRL 文档中）

* 随文提交

签名

根据1934年《证券交易法》的要求，注册人已正式授权下述签署人代表其签署本报告。

\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n

\n	\n	\n	\n
			PALVELLA THERAPEUTICS, INC.

日期：	2026年10月28日	签署：	/s/ Matthew Korenberg
			Matthew Korenberg
			首席财务官

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