FDA Approval and Dosing Regimen - The FDA approved Eisai's Supplemental Biologics License Application (sBLA) for Leqembi, allowing a once every four weeks intravenous (IV) maintenance dosing for patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease [1] - Patients who completed the 18-month biweekly initiation phase can transition to the 10 mg/kg once every four weeks dosing regimen [1] - The approval is based on modeling data from Phase 2 and Clarity AD studies, predicting that the new dosing regimen will maintain clinical and biomarker benefits [3] Clinical Benefits and Mechanism of Action - Leqembi reduces cognitive decline by -0.95 on the CDR-SB scale compared to a matched natural history cohort, more than double the placebo effect at 18 months (-0.45) [2] - The drug works by rapidly clearing amyloid-beta (Aβ) plaque and continuously clearing highly toxic protofibrils, addressing the progressive nature of Alzheimer's disease [2] - Discontinuation of treatment leads to reaccumulation of brain amyloid and reversion to placebo rates of clinical decline, emphasizing the importance of continuous administration [2] Global Market Approvals and Submissions - Leqembi is approved in the US, Japan, China, Great Britain, and several other markets [4] - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending approval in November 2024 [4] - Eisai has submitted applications for approval in 17 countries and regions, including the European Union [4][10] - The FDA accepted a Supplemental Biologics License Application (BLA) for a subcutaneous autoinjector formulation with a PDUFA action date of August 31, 2025 [4][10] Collaboration and Commercialization - Leqembi is the result of a long-standing collaboration between BioArctic and Eisai, with BioArctic having the right to jointly commercialize the drug in the Nordic region pending European approval [5][13] - Eisai is responsible for clinical development, regulatory applications, and global commercialization, while BioArctic is entitled to payments for regulatory approvals, sales milestones, and royalties on global sales [5][13] Ongoing Clinical Studies - Eisai's Phase 3 AHEAD 3-45 study, investigating lecanemab in preclinical Alzheimer's disease, was fully recruited in October 2024 and is ongoing [11] - The Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease (DIAD) includes lecanemab as the backbone anti-amyloid therapy and is ongoing since January 2022 [11] About Leqembi (Lecanemab) - Lecanemab is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody targeting aggregated soluble and insoluble forms of amyloid-beta (Aβ) [7] - It is approved for treating mild cognitive impairment (MCI) and mild Alzheimer's dementia in multiple markets, with approvals based on Phase 3 data from the Clarity AD trial [8][9] - Common adverse events include infusion reactions, ARIA-H, ARIA-E, headache, and fall [9]

RADNOR, Pa., Jan. 26, 2025 (GLOBE NEWSWIRE) -- The law firm of Kessler Topaz Meltzer & Check, LLP (www.ktmc.com) informs investors that a securities class action lawsuit has been filed in the United States District Court for the Northern District of California against BioAge Labs, Inc. (“BioAge”) (NASDAQ: BIOA) on behalf of those who purchased stock pursuant and/or traceable to BioAge's registration statement for its initial public offering (“IPO”) held on or about September 26, 2024 (the “Class Period”). T ...

Core Viewpoint - BioAge Labs, Inc. is facing a class action lawsuit due to alleged violations of the Securities Act of 1933 related to its IPO, which took place on September 26, 2024, where it sold 12.65 million shares at $18.00 each [1][2][3]. Group 1: Lawsuit Details - The class action lawsuit, titled Soto v. BioAge Labs, Inc., claims that the IPO offering documents were materially false and misleading, asserting that there were no safety concerns and that the company expected positive results from its STRIDES clinical trial [3][4]. - Following the announcement on December 6, 2024, regarding the discontinuation of the STRIDES Phase 2 study due to liver transaminitis observed in subjects, BioAge Labs' stock price plummeted over 76%, dropping to around $5.82 per share, significantly below the IPO price [4]. Group 2: Lead Plaintiff Process - The Private Securities Litigation Reform Act of 1995 allows any investor who purchased BioAge Labs stock in connection with the IPO to seek appointment as lead plaintiff in the class action lawsuit, representing the interests of all class members [5]. - The lead plaintiff has the authority to select a law firm for litigation and does not need to serve as lead plaintiff to share in any potential recovery [5]. Group 3: Company Background - BioAge Labs is a clinical-stage biopharmaceutical company focused on developing therapeutic product candidates for metabolic diseases [2].

Core Viewpoint - BioAge Labs, Inc. is facing a class action securities lawsuit due to alleged securities fraud related to its initial public offering and subsequent discontinuation of a key product trial, leading to significant stock price decline [1][3]. Group 1: Lawsuit Details - The lawsuit aims to recover losses for investors who purchased BioAge stock linked to its IPO on September 26, 2024 [2]. - The complaint highlights that BioAge announced the discontinuation of the STRIDES Phase 2 trial for azelaprag on December 6, 2024, due to safety concerns, which was unexpected given the positive outlook presented during the IPO [3]. - Following the announcement, BioAge's stock plummeted from $20.09 per share to $4.65 per share within a day [3]. Group 2: Next Steps for Investors - Investors who suffered losses during the relevant period have until March 10, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require this role [4]. - Class members may be entitled to compensation without incurring any out-of-pocket costs or fees [4]. Group 3: Legal Representation - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions for shareholders over the past 20 years [5]. - The firm has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [5].

Core Viewpoint - A class action lawsuit has been filed against BioAge Labs, Inc. for allegedly misleading investors regarding its lead drug candidate, azelaprag, in connection with its IPO held on September 26, 2024 [1][2]. Summary by Sections Allegations - The complaint states that prior to the IPO, BioAge promoted its lead product candidate azelaprag, linked to the STRIDES clinical trial, with expectations of topline results in 2025 [2]. - BioAge highlighted its collaboration with Lilly's Chorus clinical development organization for the STRIDES trial and discussed a potential second Phase 2 trial combining azelaprag and semaglutide for treating obesity in adults [2]. Discontinuation of Study - The STRIDES Phase 2 study of azelaprag was discontinued after subjects exhibited elevated liver enzyme levels, indicating potential organ damage [3]. - The complaint alleges that BioAge failed to disclose the risk of liver transaminitis from previous clinical trials and preclinical studies, rendering their statements in the registration statement false and misleading [3]. Stock Price Impact - Following the news of the study's discontinuation, BioAge's stock price plummeted from $20.09 per share on December 6, 2024, to $4.65 per share on December 9, 2024 [3]. - At the time of the lawsuit filing, BioAge's stock was trading around $5.82 per share, significantly below its IPO price of $18 per share [3].

Group 1 - The Portnoy Law Firm is advising investors of BioAge Labs, Inc. regarding a class action related to the company's IPO on September 26, 2024, with a deadline for filing a lead plaintiff motion by March 10, 2025 [1] - BioAge announced the discontinuation of its STRIDES Phase 2 trial for azelaprag on December 6, 2024, due to safety concerns, which was unexpected given the company's previous emphasis on the product's potential during the IPO [3] - Following the announcement of the trial discontinuation, BioAge's stock price fell significantly from $20.09 per share to $4.65 per share within one day [3] Group 2 - The Portnoy Law Firm offers complimentary case evaluations for investors seeking to recover losses due to corporate wrongdoing [2][4] - The founding partner of the Portnoy Law Firm has successfully recovered over $5.5 billion for investors in similar cases [4]

Core Viewpoint - A securities class action lawsuit has been filed against BioAge Labs, Inc. for alleged misleading statements in its IPO registration statement related to its STRIDES Phase 2 trial for azelaprag [1][2]. Group 1: Allegations Against BioAge - The lawsuit claims that BioAge made false and misleading statements regarding the potential for liver transaminitis in previous clinical trials and preclinical studies [2]. - It is alleged that BioAge misrepresented the safety concerns and expected outcomes of its STRIDES clinical trial, leading to materially false and misleading statements about the company's business and prospects [2]. Group 2: Legal Process for Investors - Investors in BioAge have until March 10, 2025, to seek appointment as a lead plaintiff representative in the class action lawsuit [3]. - A lead plaintiff is typically the investor or small group of investors with the largest financial interest and who are representative of the class [3]. Group 3: Firm Background - Kessler Topaz Meltzer & Check, LLP is known for prosecuting class actions and has a reputation for recovering billions for victims of corporate misconduct [4].

Lawsuit Overview - BioAge Labs is facing a class-action lawsuit from shareholders alleging the company misled investors about the safety and prospects of its key drug candidate, azelaprag, before its IPO [1][2] - The lawsuit claims BioAge's IPO offering documents contained "materially false and/or misleading" statements regarding the STRIDES Phase 2 clinical trial for azelaprag [2] - The company raised $227.7 million by selling 12.65 million shares at $18 each in its September 2024 IPO [2] Clinical Trial Issues - BioAge presented the STRIDES trial as free of safety concerns and predicted positive results, but halted the trial in December 2024 after participants experienced elevated liver enzymes [3] - The trial discontinuation caused BioAge's stock to plummet over 76%, dropping from the $18 IPO price to around $5.82 per share [4] Legal Allegations - Shareholders accuse BioAge and certain executives of violating the Securities Act of 1933 by making false statements in IPO documents [4] - The close timing between the IPO and trial discontinuation raises questions about the company's pre-IPO disclosures [5] Financial Impact - BioAge's stock price dropped significantly following the trial discontinuation announcement, with shares trading around $5.82 compared to the $18 IPO price [4]

Core Viewpoint - A class action lawsuit has been filed against BioAge Labs, Inc. regarding allegations of securities fraud and unlawful business practices [2][3]. Group 1: Lawsuit Details - The lawsuit involves claims that BioAge and certain officers and/or directors engaged in securities fraud or other unlawful business practices [2]. - Shareholders who purchased or acquired BioAge securities during the Class Period have until March 10, 2025, to request to be appointed as Lead Plaintiff [2]. Group 2: Company Events - BioAge conducted its initial public offering (IPO) on September 26, 2024, selling 12.65 million shares at a price of $18.00 per share [3]. - On December 6, 2024, BioAge announced the discontinuation of the STRIDES Phase 2 study of its investigational drug candidate azelaprag due to observed liver transaminitis in some subjects [3]. Group 3: Stock Price Impact - Following the announcement regarding the discontinuation of the study, BioAge's stock price fell by $15.44 per share, representing a decline of 76.85%, closing at $4.65 per share on December 9, 2024 [4].

Group 1 - BioAge Labs, Inc. is facing a class action lawsuit, which has been notified to investors by Levi & Korsinsky [1] - The lawsuit is related to potential violations of securities laws, indicating possible misrepresentation or omission of material facts [1] - Investors are urged to be aware of the upcoming deadline to participate in the class action [1] Group 2 - The class action lawsuit highlights concerns regarding the company's financial disclosures and overall governance practices [1] - This legal action may impact investor confidence and the company's stock performance in the near term [1] - The outcome of the lawsuit could have significant implications for BioAge Labs' operational strategies and market positioning [1]