<p>，/PRNewswire/ -- 国家股东权益律师事务所 Hagens Berman 正在调查 <strong>Alvotech (NASDAQ: ALVO)</strong> 关于其制造运营和主要生物仿制药候选产品 AVT05 的监管状态的披露是否合规。</p>
<p>此次调查是在 Alvotech 透露其收到了来自 FDA 的 &#34;完整回应信&#34; (CRL) 后，股价暴跌 34% 的背景下进行的。购买了 Alvotech (ALVO) 证券并遭受重大损失的投资者被鼓励与该事务所联系。</p>
<p><strong>[点击这里提交您的 Alvotech 损失]</strong></p>
<p><strong>ALVO 调查概览</strong></p>
<table>
<thead>
<tr>
<th></th>
<th></th>
</tr>
</thead>
<tbody>
<tr>
<td><strong>关键细节</strong></td>
<td><strong>ALVO 投资者信息</strong></td>
</tr>
<tr>
<td><strong>股票代码</strong></td>
<td><strong>ALVO</strong> (NASDAQ)</td>
</tr>
<tr>
<td><strong>触发事件</strong></td>
<td>FDA 对 AVT05 的完整回应信 (CRL)</td>
</tr>
<tr>
<td><strong>股价下跌</strong></td>
<td><strong>-34%</strong> 在单个交易日内</td>
</tr>
<tr>
<td><strong>立即联系事务所</strong></td>
<td>[email protected] / <strong>844-916-0895</strong></td>
</tr>
</tbody>
</table>
<p><strong>Alvotech (ALVO) 调查：</strong></p>
<p>调查的重点是 Alvotech 是否误导投资者关于其位于冰岛雷克雅未克的制造设施是否准备好符合 FDA 标准。在 2025 年，Alvotech 管理层多次宣传 <strong>AVT05</strong>（一种 Simponi® 的生物仿制药）的商业前景，甚至将其全年收入预期提高至高达 7 亿美元。</p>
<p>但在 <strong>2025 年 11 月 2 日</strong>，Alvotech 令投资者震惊，宣布 FDA 已对 AVT05 发出 CRL，指出在 2025 年 7 月对雷克雅未克工厂的检查中发现了 &#34;某些缺陷&#34;。因此，Alvotech 被迫大幅下调其 2025 年收入预期，并将调整后的 EBITDA 前景削减了惊人的 <strong>58%</strong>。在这一消息发布后，Alvotech 的股价在一天内暴跌 34%，从 7.65 美元跌至 5.03 美元。</p>
<p>&#34;我们正在调查 Alvotech 是否在承认这些重大制造缺陷之前几个月就已知晓这些问题，&#34; Hagens Berman 的合伙人 <strong>Reed Kathrein</strong> 说道，他正在领导该事务所的调查。</p>
<p><strong>常见问题解答 (FAQs)</strong></p>
<p><strong>为什么 Hagens Berman 正在调查 Alvotech (ALVO)？</strong> 该事务所正在调查 Alvotech 是否就其制造能力和生物仿制药管线的 FDA 批准可能性发布了虚假或误导性声明。</p>
<p><strong>什么是 FDA CRL，为什么它会对 ALVO 股价造成伤害？</strong> 完整回应信 (CRL) 是 FDA 的一份通信，表明申请在当前形式下不会获得批准。对于 Alvotech 来说，这份 CRL 表明了制造缺陷，导致公司大幅下调其 2025 年财务预测，抹去了大量市值。</p>
<p><strong>我如何能帮助 Alvotech 的调查？</strong> Hagens Berman 希望与任何拥有关于 Alvotech 雷克雅未克工厂或内部 FDA 通信的非公开信息的人士交谈。</p>
<p>如果您投资了 Alvotech 并遭受了重大损失，或者有可能帮助该事务所调查的信息，请立即提交您的损失 »</p>
<p>如果您想要更多信息以及关于 Alvotech 调查的其他常见问题的答案，请阅读更多 »</p>
<p><strong>举报人：</strong> 拥有关于 Alvotech 的非公开信息的人士应考虑他们在调查中提供帮助的选项或利用 SEC 举报人计划。在新计划下，提供原始信息的举报人可能会获得高达 SEC 成功追回金额 30% 的奖励。有关更多信息，请致电 <strong>844-916-0895</strong> 联系 Reed Kathrein 或发送电子邮件至 [email protected]。</p>
<p>关于 Hagens Berman</p>
<p>Hagens Berman 是一家全球性的原告权益复杂诉讼事务所，专注于企业问责制。该事务所拥有强大的业务，代表投资者、举报人、工人、消费者及其他在因企业疏忽和其他不当行为而受到伤害的案件中取得实际成果。Hagens Berman 的团队在这一法律领域已获得超过 29 亿美元的赔偿。有关该事务所及其成功的更多信息，请访问 hbsslaw.com。关注该事务所以获取更新和新闻，账号为 @ClassActionLaw。</p>
<p>来源 Hagens Berman Sobol Shapiro LLP</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMTE0Jk5ld3NJdGVtSWQ9U0Y2MzQ0MSZUcmFuc21pc3Npb25fSWQ9MjAyNjAxMTQxNDMwUFJfTkVXU19VU1BSX19fX19TRjYzNDQx?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMTE0Jk5ld3NJdGVtSWQ9U0Y2MzQ0MSZUcmFuc21pc3Npb25fSWQ9MjAyNjAxMTQxNDMwUFJfTkVXU19VU1BSX19fX19TRjYzNDQx"/></p>

ALVO

<p>Hagens Berman 正在调查 Alvotech (NASDAQ: ALVO) 可能存在的证券欺诈行为，此前该公司在收到 FDA 关于其主要生物仿制药候选产品 AVT05 的完整回应信 (CRL) 后，股价下跌了 34%。调查的重点是 Alvotech 是否误导了投资者关于其制造运营和雷克雅未克设施是否准备好符合 FDA 标准的信息。该公司正在寻求遭受损失或对调查有相关知识的投资者提供信息</p>

<p>, /PRNewswire/ -- National shareholder rights firm Hagens Berman is investigating <strong>Alvotech (NASDAQ: ALVO)</strong> regarding the propriety of its disclosures concerning the company's manufacturing operations and the regulatory status of its lead biosimilar candidate, AVT05.</p>
<div class="lb-trans"><p>，/PRNewswire/ -- 国家股东权益律师事务所 Hagens Berman 正在调查 <strong>Alvotech (NASDAQ: ALVO)</strong> 关于其制造运营和主要生物仿制药候选产品 AVT05 的监管状态的披露是否合规。</p>
</div><p>The investigation follows a staggering 34% stock drop after Alvotech revealed it received a &#34;Complete Response Letter&#34; (CRL) from the FDA. Investors who purchased Alvotech (ALVO) securities and suffered significant losses are encouraged to contact the firm.</p>
<div class="lb-trans"><p>此次调查是在 Alvotech 透露其收到了来自 FDA 的 &#34;完整回应信&#34; (CRL) 后，股价暴跌 34% 的背景下进行的。购买了 Alvotech (ALVO) 证券并遭受重大损失的投资者被鼓励与该事务所联系。</p>
</div><p><strong>[CLICK HERE TO SUBMIT YOUR ALVOTECH LOSSES]</strong></p>
<div class="lb-trans"><p><strong>[点击这里提交您的 Alvotech 损失]</strong></p>
</div><p><strong>ALVO Investigation at a Glance</strong></p>
<div class="lb-trans"><p><strong>ALVO 调查概览</strong></p>
</div><table>
<thead>
<tr>
<th></th>
<th></th>
</tr>
</thead>
<tbody>
<tr>
<td><strong>Key Detail</strong></td>
<td><strong>Information for ALVO Investors</strong></td>
</tr>
<tr>
<td><strong>Ticker Symbol</strong></td>
<td><strong>ALVO</strong> (NASDAQ)</td>
</tr>
<tr>
<td><strong>Trigger Event</strong></td>
<td>FDA Complete Response Letter (CRL) for AVT05</td>
</tr>
<tr>
<td><strong>Stock Price Drop</strong></td>
<td><strong>-34%</strong> in a single trading session</td>
</tr>
<tr>
<td><strong>Contact the Firm Now</strong></td>
<td>[email protected] / <strong>844-916-0895</strong></td>
</tr>
</tbody>
</table>
<div class="lb-trans"><table>
<thead>
<tr>
<th></th>
<th></th>
</tr>
</thead>
<tbody>
<tr>
<td><strong>关键细节</strong></td>
<td><strong>ALVO 投资者信息</strong></td>
</tr>
<tr>
<td><strong>股票代码</strong></td>
<td><strong>ALVO</strong> (NASDAQ)</td>
</tr>
<tr>
<td><strong>触发事件</strong></td>
<td>FDA 对 AVT05 的完整回应信 (CRL)</td>
</tr>
<tr>
<td><strong>股价下跌</strong></td>
<td><strong>-34%</strong> 在单个交易日内</td>
</tr>
<tr>
<td><strong>立即联系事务所</strong></td>
<td>[email protected] / <strong>844-916-0895</strong></td>
</tr>
</tbody>
</table>
</div><p><strong>Alvotech (ALVO) Investigation:</strong></p>
<div class="lb-trans"><p><strong>Alvotech (ALVO) 调查：</strong></p>
</div><p>The investigation focuses on whether Alvotech misled investors about the readiness of its Reykjavik, Iceland, manufacturing facility to meet FDA standards. Throughout 2025, Alvotech management repeatedly touted the commercial prospects of <strong>AVT05</strong> (a biosimilar to Simponi®) and even raised its full-year revenue guidance to as high as $700 million.</p>
<div class="lb-trans"><p>调查的重点是 Alvotech 是否误导投资者关于其位于冰岛雷克雅未克的制造设施是否准备好符合 FDA 标准。在 2025 年，Alvotech 管理层多次宣传 <strong>AVT05</strong>（一种 Simponi® 的生物仿制药）的商业前景，甚至将其全年收入预期提高至高达 7 亿美元。</p>
</div><p>But on <strong>November 2, 2025</strong>, Alvotech shocked investors when it announced that the FDA had issued a CRL for AVT05, citing &#34;certain deficiencies&#34; found during a July 2025 inspection of the Reykjavik plant. As a result, Alvotech was forced to slash its 2025 revenue guidance and cut its adjusted EBITDA outlook by a staggering <strong>58%</strong>. On this news, Alvotech's stock price crashed 34%, falling from $7.65 to $5.03 in one day.</p>
<div class="lb-trans"><p>但在 <strong>2025 年 11 月 2 日</strong>，Alvotech 令投资者震惊，宣布 FDA 已对 AVT05 发出 CRL，指出在 2025 年 7 月对雷克雅未克工厂的检查中发现了 &#34;某些缺陷&#34;。因此，Alvotech 被迫大幅下调其 2025 年收入预期，并将调整后的 EBITDA 前景削减了惊人的 <strong>58%</strong>。在这一消息发布后，Alvotech 的股价在一天内暴跌 34%，从 7.65 美元跌至 5.03 美元。</p>
</div><p>&#34;We are looking into whether Alvotech was aware of these significant manufacturing failures months before they admitted them to the public,&#34; said <strong>Reed Kathrein</strong>, the Hagens Berman partner leading the firm's investigation.</p>
<div class="lb-trans"><p>&#34;我们正在调查 Alvotech 是否在承认这些重大制造缺陷之前几个月就已知晓这些问题，&#34; Hagens Berman 的合伙人 <strong>Reed Kathrein</strong> 说道，他正在领导该事务所的调查。</p>
</div><p><strong>Frequently Asked Questions (FAQs)</strong></p>
<div class="lb-trans"><p><strong>常见问题解答 (FAQs)</strong></p>
</div><p><strong>Why is Hagens Berman investigating Alvotech (ALVO)?</strong> The firm is investigating whether Alvotech issued false or misleading statements regarding its manufacturing capabilities and the likelihood of FDA approval for its biosimilar pipeline.</p>
<div class="lb-trans"><p><strong>为什么 Hagens Berman 正在调查 Alvotech (ALVO)？</strong> 该事务所正在调查 Alvotech 是否就其制造能力和生物仿制药管线的 FDA 批准可能性发布了虚假或误导性声明。</p>
</div><p><strong>What is an FDA CRL and why did it hurt ALVO stock?</strong> A Complete Response Letter (CRL) is an FDA communication stating that an application will not be approved in its current form. For Alvotech, this CRL indicated manufacturing deficiencies that allegedly caused the company to significantly downgrade its 2025 financial projections, wiping out significant market cap.</p>
<div class="lb-trans"><p><strong>什么是 FDA CRL，为什么它会对 ALVO 股价造成伤害？</strong> 完整回应信 (CRL) 是 FDA 的一份通信，表明申请在当前形式下不会获得批准。对于 Alvotech 来说，这份 CRL 表明了制造缺陷，导致公司大幅下调其 2025 年财务预测，抹去了大量市值。</p>
</div><p><strong>How can I help the Alvotech investigation?</strong> Hagens Berman is interested in speaking with anyone who has non-public information about Alvotech's Reykjavik facility or internal FDA communications.</p>
<div class="lb-trans"><p><strong>我如何能帮助 Alvotech 的调查？</strong> Hagens Berman 希望与任何拥有关于 Alvotech 雷克雅未克工厂或内部 FDA 通信的非公开信息的人士交谈。</p>
</div><p>If you invested in Alvotech and have substantial losses, or have knowledge that may assist the firm's investigation, submit your losses now »</p>
<div class="lb-trans"><p>如果您投资了 Alvotech 并遭受了重大损失，或者有可能帮助该事务所调查的信息，请立即提交您的损失 »</p>
</div><p>If you'd like more information and answers to additional frequently asked questions about the Alvotech investigation, read more »</p>
<div class="lb-trans"><p>如果您想要更多信息以及关于 Alvotech 调查的其他常见问题的答案，请阅读更多 »</p>
</div><p><strong>Whistleblowers:</strong> Persons with non-public information regarding Alvotech should consider their options to help in the investigation or take advantage of the SEC Whistleblower program. Under the new program, whistleblowers who provide original information may receive rewards totaling up to 30 percent of any successful recovery made by the SEC. For more information, call Reed Kathrein at <strong>844-916-0895</strong> or email [email protected].</p>
<div class="lb-trans"><p><strong>举报人：</strong> 拥有关于 Alvotech 的非公开信息的人士应考虑他们在调查中提供帮助的选项或利用 SEC 举报人计划。在新计划下，提供原始信息的举报人可能会获得高达 SEC 成功追回金额 30% 的奖励。有关更多信息，请致电 <strong>844-916-0895</strong> 联系 Reed Kathrein 或发送电子邮件至 [email protected]。</p>
</div><p>About Hagens Berman</p>
<div class="lb-trans"><p>关于 Hagens Berman</p>
</div><p>Hagens Berman is a global plaintiffs' rights complex litigation firm focusing on corporate accountability. The firm is home to a robust practice and represents investors as well as whistleblowers, workers, consumers and others in cases achieving real results for those harmed by corporate negligence and other wrongdoings. Hagens Berman's team has secured more than $2.9 billion in this area of law. More about the firm and its successes can be found at hbsslaw.com. Follow the firm for updates and news at @ClassActionLaw.</p>
<div class="lb-trans"><p>Hagens Berman 是一家全球性的原告权益复杂诉讼事务所，专注于企业问责制。该事务所拥有强大的业务，代表投资者、举报人、工人、消费者及其他在因企业疏忽和其他不当行为而受到伤害的案件中取得实际成果。Hagens Berman 的团队在这一法律领域已获得超过 29 亿美元的赔偿。有关该事务所及其成功的更多信息，请访问 hbsslaw.com。关注该事务所以获取更新和新闻，账号为 @ClassActionLaw。</p>
</div><p>SOURCE Hagens Berman Sobol Shapiro LLP</p>
<div class="lb-trans"><p>来源 Hagens Berman Sobol Shapiro LLP</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjYwMTE0Jk5ld3NJdGVtSWQ9U0Y2MzQ0MSZUcmFuc21pc3Npb25fSWQ9MjAyNjAxMTQxNDMwUFJfTkVXU19VU1BSX19fX19TRjYzNDQx" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=SF63441&amp;Transmission_Id=202601141430PR_NEWS_USPR_____SF63441&amp;DateId=20260114"/></p>

14:30 ET
			
			
				ALVO INVESTOR ALERT: Hagens Berman Investigates Alvotech (ALVO) for Potential Securities Fraud Following Massive FDA-Induced Stock Crash

ALVO 投资者警报：Hagens Berman 正在调查 Alvotech（ALVO），因 FDA 导致的股价暴跌，可能涉及证券欺诈