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<p>新泽西州伊瑟林，2026 年 6 月 1 日（全球新闻通讯）——Outlook Therapeutics, Inc.（纳斯达克：OTLK）是一家专注于 ONS-5010/LYTENAVA™（贝伐单抗-vikg，贝伐单抗 gamma）用于治疗视网膜疾病的生物制药公司，今天宣布向美国食品药品监督管理局（FDA）重新提交其生物制品许可申请（BLA），用于治疗新生血管性年龄相关性黄斑变性（nAMD）。</p>
<p>正如之前所宣布的，Outlook Therapeutics 成功对 FDA 审查的 ONS-5010 生物制品许可申请相关的 2026 年 12 月的完整回应信（CRL）提出了上诉。在他们的决定中，FDA 新药办公室得出结论，LYTENAVA™在治疗新生血管性年龄相关性黄斑变性（nAMD）方面已建立了实质性的有效性证据，因此不需要额外的试验。</p>
<p>FDA 的决定指示眼科部门和专业医学办公室与 Outlook Therapeutics 合作，专注于达成最终产品标签的协议。此外，正式决定中指出，这将是一次 1 类重新提交，预计在 FDA 收到重新提交后的 60 天内做出 PDUFA 日期和决定。</p>
<p>加州大学欧文分校眼科与视觉科学系斯坦特教授、主任 Gavin Herbert 眼科研究所的 Baruch Kuppermann 博士表示：“ONS-5010/LYTENAVA™有潜力为临床医生和患者提供治疗湿性 AMD 的重要额外选择。如果作为首个标签内的眼科贝伐单抗制剂获得批准，ONS-5010 将使患者受益于更广泛的获取，并为湿性 AMD 的抗 VEGF 治疗提供一个有吸引力的替代方案。”</p>
<p>“我们非常高兴能够达到这一重要里程碑。这次重新提交代表了我们申请的实力和我们整个组织的巨大奉献，” Outlook Therapeutics 首席执行官 Bob Jahr 表示。“我们的团队经历了广泛而严格的审查和上诉过程，与 FDA 保持了密切的合作。我们对 1 类审查的指定感到鼓舞。我们仍然致力于将 ONS-5010/LYTENAVA™带给那些应得 FDA 批准治疗 nAMD 的患者。”</p>
<p>一旦获得批准，ONS-5010/LYTENAVA™将成为首个也是唯一一个获得 FDA 批准的贝伐单抗眼科制剂，支持标准化生产、FDA 批准的标签和强大的药物警戒。</p>
<p><strong>关于 ONS-5010 / LYTENAVA™（贝伐单抗-vikg，贝伐单抗 gamma）</strong></p>
<p>ONS-5010/LYTENAVA™是美国生产的贝伐单抗眼科制剂，用于治疗湿性 AMD。LYTENAVA™（贝伐单抗 gamma）是欧盟委员会在欧盟授予的集中市场授权的对象，并获得英国药品和健康产品监管局（MHRA）授予的市场授权，用于治疗湿性 AMD。在某些欧盟成员国，ONS-5010/LYTENAVA™必须获得定价和报销批准才能销售。</p>
<p>在美国，ONS-5010/LYTENAVA™（贝伐单抗-vikg）仍处于研究阶段。一旦获得批准，它将成为 FDA 批准的首个眼科制剂。</p>
<p>贝伐单抗-vikg（在欧盟和英国为贝伐单抗 gamma）是一种重组人源化单克隆抗体（mAb），能够选择性地以高亲和力结合所有人类血管内皮生长因子（VEGF）的亚型，并通过立体阻挡 VEGF 与其受体 Flt-1（VEGFR-1）和 KDR（VEGFR-2）在内皮细胞表面的结合来中和 VEGF 的生物活性。通过玻璃体内注射后，贝伐单抗与 VEGF 的结合阻止了 VEGF 与内皮细胞表面受体的相互作用，减少了内皮细胞增殖、血管渗漏和视网膜中新血管的形成。</p>
<p><strong>关于 Outlook Therapeutics, Inc.</strong></p>
<p>Outlook Therapeutics 是一家专注于 ONS-5010/LYTENAVA™（贝伐单抗-vikg，贝伐单抗 gamma）开发和商业化的生物制药公司。LYTENAVA™（贝伐单抗 gamma）是首个获得欧洲委员会和 MHRA 市场授权的贝伐单抗眼科制剂，用于治疗湿性 AMD。Outlook Therapeutics 已在德国、奥地利和英国开始 LYTENAVA™（贝伐单抗 gamma）的商业发布，作为治疗湿性 AMD 的方案。</p>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿包含可能被视为 “前瞻性声明” 的陈述。除历史事实陈述外，所有陈述均为 “前瞻性声明”，包括与未来事件相关的陈述。在某些情况下，您可以通过诸如 “预期”、“相信”、“可以”、“可能”、“继续”、“期望”、“或许”、“在轨”、“计划”、“潜力”、“目标”、“将” 或 “会” 等术语，或这些术语的否定形式或其他类似术语，以及其他含义相似的词语来识别前瞻性声明。这些包括但不限于与 FDA 持续互动的计划，以及就 ONS-5010 的监管路径达成协议的潜力，ONS-5010/LYTENAVA™作为湿性 AMD 治疗的潜力，ONS-5010 获得 FDA 批准的潜力，以及其他非历史事实的陈述。尽管 Outlook Therapeutics 相信其对本声明中包含的前瞻性声明有合理依据，但这些声明是基于对影响 Outlook Therapeutics 未来事件的当前预期，并且受到与其运营和商业环境相关的风险、不确定性和因素的影响，这些因素都难以预测，且许多因素超出其控制范围。这些风险因素包括与开发和商业化药品候选产品相关的风险、获得必要监管批准的风险、监管机构决策的内容和时机的风险，以及在 Outlook Therapeutics 向证券交易委员会（SEC）提交的文件中详细列出的风险，包括截至 2025 年 9 月 30 日的财政年度的 10-K 表格年报，该年报于 2025 年 12 月 19 日提交给 SEC，并由截至 2025 年 12 月 31 日的财政季度的 10-Q 表格季报补充，以及 Outlook Therapeutics 未来向 SEC 提交的报告，这些报告包括市场条件的不确定性和与宏观经济因素相关的未来影响，包括由于持续的海外冲突、关税和贸易紧张局势、利率和通货膨胀波动，以及潜在的未来银行倒闭对全球商业环境的影响。这些风险可能导致实际结果与本新闻稿中所表达或暗示的前瞻性声明存在重大差异。本新闻稿中包含的所有前瞻性声明均受到上述警示声明的全面限制。您被提醒不要对这些前瞻性声明过度依赖，这些声明仅在本声明日期有效。Outlook Therapeutics 不承担任何更新、修订或澄清这些前瞻性声明的义务，无论是由于新信息、未来事件还是其他原因，除非适用证券法要求。</p>
<p><strong>投资者咨询：</strong> Jenene Thomas</p>
<p>首席执行官</p>
<p>JTC Team, LLC</p>
<p>电话：908.824.0775</p>
<p>OTLK@jtcir.com</p>
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OTLK

<p>Outlook Therapeutics 宣布重新提交其生物制品许可申请（BLA）给美国 FDA，申请药物为 ONS-5010/LYTENAVA™，这是一种用于治疗新生血管性年龄相关性黄斑变性（nAMD）的贝伐单抗眼用制剂。这是在成功对之前的完整回应信进行上诉后进行的，FDA 确认了有效性的实质性证据。此次重新提交被归类为 1 类，预计将在 60 天内做出 PDUFA 决定</p>

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</div><p>ISELIN, N.J., June 01, 2026 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma) for the treatment of retinal diseases, today announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010/LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD).</p>
<div class="lb-trans"><p>新泽西州伊瑟林，2026 年 6 月 1 日（全球新闻通讯）——Outlook Therapeutics, Inc.（纳斯达克：OTLK）是一家专注于 ONS-5010/LYTENAVA™（贝伐单抗-vikg，贝伐单抗 gamma）用于治疗视网膜疾病的生物制药公司，今天宣布向美国食品药品监督管理局（FDA）重新提交其生物制品许可申请（BLA），用于治疗新生血管性年龄相关性黄斑变性（nAMD）。</p>
</div><p>As previously announced, Outlook Therapeutics successfully appealed the December 2026 Complete Response Letter (CRL) related to the ONS-5010 Biologics License Application reviewed by the FDA. In their decision, the FDA Office of New Drugs concluded that substantial evidence of effectiveness has been established for LYTENAVA™ for the treatment of neovascular age-related macular degeneration (nAMD), therefore additional trials are not required.</p>
<div class="lb-trans"><p>正如之前所宣布的，Outlook Therapeutics 成功对 FDA 审查的 ONS-5010 生物制品许可申请相关的 2026 年 12 月的完整回应信（CRL）提出了上诉。在他们的决定中，FDA 新药办公室得出结论，LYTENAVA™在治疗新生血管性年龄相关性黄斑变性（nAMD）方面已建立了实质性的有效性证据，因此不需要额外的试验。</p>
</div><p>The FDR decision directed the Division of Ophthalmology and Office of Specialty Medicine to work with Outlook Therapeutics to focus on reaching an agreement on final product labeling. Additionally, as indicated in the formal decision, this will be a Class 1 resubmission with a PDUFA date and decision expected within 60 days of FDA’s receipt of the resubmission.</p>
<div class="lb-trans"><p>FDA 的决定指示眼科部门和专业医学办公室与 Outlook Therapeutics 合作，专注于达成最终产品标签的协议。此外，正式决定中指出，这将是一次 1 类重新提交，预计在 FDA 收到重新提交后的 60 天内做出 PDUFA 日期和决定。</p>
</div><p>Dr. Baruch Kuppermann, Steinert Endowed Professor, Chair, Dept of Ophthalmology and Visual Sciences, Director, Gavin Herbert Eye Institute University of California, Irvine, stated, “ONS-5010/LYTENAVA™ has the potential to offer clinicians and patients an important additional option for treating wet AMD. If approved as the first on-label ophthalmic formulation of bevacizumab, ONS-5010 will enable patients to benefit from wider access and provide an attractive alternative for anti-VEGF treatment of wet AMD.”</p>
<div class="lb-trans"><p>加州大学欧文分校眼科与视觉科学系斯坦特教授、主任 Gavin Herbert 眼科研究所的 Baruch Kuppermann 博士表示：“ONS-5010/LYTENAVA™有潜力为临床医生和患者提供治疗湿性 AMD 的重要额外选择。如果作为首个标签内的眼科贝伐单抗制剂获得批准，ONS-5010 将使患者受益于更广泛的获取，并为湿性 AMD 的抗 VEGF 治疗提供一个有吸引力的替代方案。”</p>
</div><p>“We are incredibly pleased to reach this important milestone. This resubmission represents the strength of our application and the tremendous dedication of our entire organization,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “Our team worked through an extensive and rigorous review and appeal process, maintaining close collaboration with the FDA. We are encouraged with the Class 1 review designation. We remain committed to bringing ONS-5010/LYTENAVA™ to patients who deserve FDA-approved options for the treatment of nAMD.”</p>
<div class="lb-trans"><p>“我们非常高兴能够达到这一重要里程碑。这次重新提交代表了我们申请的实力和我们整个组织的巨大奉献，” Outlook Therapeutics 首席执行官 Bob Jahr 表示。“我们的团队经历了广泛而严格的审查和上诉过程，与 FDA 保持了密切的合作。我们对 1 类审查的指定感到鼓舞。我们仍然致力于将 ONS-5010/LYTENAVA™带给那些应得 FDA 批准治疗 nAMD 的患者。”</p>
</div><p>When approved, ONS-5010/LYTENAVA™ will be the first and only FDA-approved ophthalmic formulation of bevacizumab supported by standardized manufacturing, FDA-approved labeling, and robust pharmacovigilance.</p>
<div class="lb-trans"><p>一旦获得批准，ONS-5010/LYTENAVA™将成为首个也是唯一一个获得 FDA 批准的贝伐单抗眼科制剂，支持标准化生产、FDA 批准的标签和强大的药物警戒。</p>
</div><p><strong>About ONS-5010 / LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma)</strong></p>
<div class="lb-trans"><p><strong>关于 ONS-5010 / LYTENAVA™（贝伐单抗-vikg，贝伐单抗 gamma）</strong></p>
</div><p>ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab produced in the United States for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD. In certain European Union Member States, ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold.</p>
<div class="lb-trans"><p>ONS-5010/LYTENAVA™是美国生产的贝伐单抗眼科制剂，用于治疗湿性 AMD。LYTENAVA™（贝伐单抗 gamma）是欧盟委员会在欧盟授予的集中市场授权的对象，并获得英国药品和健康产品监管局（MHRA）授予的市场授权，用于治疗湿性 AMD。在某些欧盟成员国，ONS-5010/LYTENAVA™必须获得定价和报销批准才能销售。</p>
</div><p>In the United States, ONS-5010/LYTENAVA ™ (bevacizumab-vikg) is investigational. When approved, it will be the first ophthalmic formulation approved by the FDA.</p>
<div class="lb-trans"><p>在美国，ONS-5010/LYTENAVA™（贝伐单抗-vikg）仍处于研究阶段。一旦获得批准，它将成为 FDA 批准的首个眼科制剂。</p>
</div><p>Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.</p>
<div class="lb-trans"><p>贝伐单抗-vikg（在欧盟和英国为贝伐单抗 gamma）是一种重组人源化单克隆抗体（mAb），能够选择性地以高亲和力结合所有人类血管内皮生长因子（VEGF）的亚型，并通过立体阻挡 VEGF 与其受体 Flt-1（VEGFR-1）和 KDR（VEGFR-2）在内皮细胞表面的结合来中和 VEGF 的生物活性。通过玻璃体内注射后，贝伐单抗与 VEGF 的结合阻止了 VEGF 与内皮细胞表面受体的相互作用，减少了内皮细胞增殖、血管渗漏和视网膜中新血管的形成。</p>
</div><p><strong>About Outlook Therapeutics, Inc.</strong></p>
<div class="lb-trans"><p><strong>关于 Outlook Therapeutics, Inc.</strong></p>
</div><p>Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma). LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany, Austria, and the UK as a treatment for wet AMD.</p>
<div class="lb-trans"><p>Outlook Therapeutics 是一家专注于 ONS-5010/LYTENAVA™（贝伐单抗-vikg，贝伐单抗 gamma）开发和商业化的生物制药公司。LYTENAVA™（贝伐单抗 gamma）是首个获得欧洲委员会和 MHRA 市场授权的贝伐单抗眼科制剂，用于治疗湿性 AMD。Outlook Therapeutics 已在德国、奥地利和英国开始 LYTENAVA™（贝伐单抗 gamma）的商业发布，作为治疗湿性 AMD 的方案。</p>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>This press release contains statements that may or are considered “forward-looking statements”. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “can,” “could,” “continue,” “expect,” “may,” “on track,” “plan,” “potential,” “target,” “will,” or “would”, the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, plans for continued engagement with the FDA and the potential to agree on a regulatory pathway for ONS-5010, the potential of ONS-5010/LYTENAVA™ as a treatment for wet AMD, the potential for ONS-5010 to receive approval from the FDA, and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties, and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory bodies, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (the SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2025, filed with the SEC on December 19, 2025, as supplemented by the Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 2025 and future reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, tariffs, and trade tensions, fluctuations in interest rates and inflation, and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend, or clarify these forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required under applicable securities law.</p>
<div class="lb-trans"><p>本新闻稿包含可能被视为 “前瞻性声明” 的陈述。除历史事实陈述外，所有陈述均为 “前瞻性声明”，包括与未来事件相关的陈述。在某些情况下，您可以通过诸如 “预期”、“相信”、“可以”、“可能”、“继续”、“期望”、“或许”、“在轨”、“计划”、“潜力”、“目标”、“将” 或 “会” 等术语，或这些术语的否定形式或其他类似术语，以及其他含义相似的词语来识别前瞻性声明。这些包括但不限于与 FDA 持续互动的计划，以及就 ONS-5010 的监管路径达成协议的潜力，ONS-5010/LYTENAVA™作为湿性 AMD 治疗的潜力，ONS-5010 获得 FDA 批准的潜力，以及其他非历史事实的陈述。尽管 Outlook Therapeutics 相信其对本声明中包含的前瞻性声明有合理依据，但这些声明是基于对影响 Outlook Therapeutics 未来事件的当前预期，并且受到与其运营和商业环境相关的风险、不确定性和因素的影响，这些因素都难以预测，且许多因素超出其控制范围。这些风险因素包括与开发和商业化药品候选产品相关的风险、获得必要监管批准的风险、监管机构决策的内容和时机的风险，以及在 Outlook Therapeutics 向证券交易委员会（SEC）提交的文件中详细列出的风险，包括截至 2025 年 9 月 30 日的财政年度的 10-K 表格年报，该年报于 2025 年 12 月 19 日提交给 SEC，并由截至 2025 年 12 月 31 日的财政季度的 10-Q 表格季报补充，以及 Outlook Therapeutics 未来向 SEC 提交的报告，这些报告包括市场条件的不确定性和与宏观经济因素相关的未来影响，包括由于持续的海外冲突、关税和贸易紧张局势、利率和通货膨胀波动，以及潜在的未来银行倒闭对全球商业环境的影响。这些风险可能导致实际结果与本新闻稿中所表达或暗示的前瞻性声明存在重大差异。本新闻稿中包含的所有前瞻性声明均受到上述警示声明的全面限制。您被提醒不要对这些前瞻性声明过度依赖，这些声明仅在本声明日期有效。Outlook Therapeutics 不承担任何更新、修订或澄清这些前瞻性声明的义务，无论是由于新信息、未来事件还是其他原因，除非适用证券法要求。</p>
</div><p><strong>Investor Inquiries:</strong> Jenene Thomas</p>
<div class="lb-trans"><p><strong>投资者咨询：</strong> Jenene Thomas</p>
</div><p>Chief Executive Officer</p>
<div class="lb-trans"><p>首席执行官</p>
</div><p>JTC Team, LLC</p>
<div class="lb-trans"><p>JTC Team, LLC</p>
</div><p>T: 908.824.0775</p>
<div class="lb-trans"><p>电话：908.824.0775</p>
</div><p>OTLK@jtcir.com</p>
<div class="lb-trans"><p>OTLK@jtcir.com</p>
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Outlook Therapeutics 宣布已向美国 FDA 重新提交生物制品许可申请，涉及 ONS-5010/LYTENAVA™（bevacizumab-vikg）| OTLK 股票新闻