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 lead plaintiff in the class action, representing the interests of all class members [3]. - The lead plaintiff is typically the investor or 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].

Advancement of next-generation APJ agonists with discontinuation of azelaprag Nomination of NLRP3 inhibitor BGE-102 as a development candidate, with initial Ph1 clinical data anticipated by end of 2025 Expansion of discovery efforts based on insights from BioAge’s platform, including a target identification collaboration with Novartis and a newly announced antibody therapeutics development collaboration with Lilly ExploR&D RICHMOND, Calif., Jan. 28, 2025 (GLOBE NEWSWIRE) -- BioAge Labs, Inc. ("BioAge", “the ...

NEW YORK, Jan. 27, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of BioAge Labs, Inc. (NASDAQ: BIOA).Shareholders who purchased shares of BIOA during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.CONTACT US HERE:https://securitiesclasslaw.com/securities/bioage-labs-inc-loss-submission-form/?id=124878&from=4 CLASS PERIOD: This lawsuit is on ...

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].