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 ...

SAN DIEGO, Jan. 25, 2025 /PRNewswire/ -- The law firm of Robbins Geller Rudman & Dowd LLP announces that purchasers or acquirers of BioAge Labs, Inc. (NASDAQ: BIOA) stock pursuant and/or traceable to BioAge Labs' registration statement issued in connection with BioAge Labs' initial public offering (the "IPO") held on September 26, 2024, have until Monday, March 10, 2025 to seek appointment as lead plaintiff of the BioAge Labs class action lawsuit. Captioned Soto v. BioAge Labs, Inc., No. 25-cv-00196 (N.D. C ...

NEW YORK, Jan. 24, 2025 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in BioAge Labs, Inc. ("BioAge" or the "Company") (NASDAQ: BIOA) of a class action securities lawsuit.CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of BioAge investors who were adversely affected by alleged securities fraud. This lawsuit is on behalf of all shareholders that purchased stock pursuant and/or traceable to BioAge's registration statement for the initial public offering held on or about September 26 ...

SAN DIEGO, Jan. 22, 2025 /PRNewswire/ -- Robbins LLP reminds investors that a class action was filed on behalf of all shareholders who purchased stock pursuant and/or traceable to the BioAge Labs, Inc. (NASDAQ: BIOA) registration statement for the initial public offering (IPO) held on September 26, 2024. BioAge claims it is a "clinical stage biopharmaceutical company" that develops therapeutic product candidates for metabolic diseases, such as obesity, by targeting the biology of human aging.For more inform ...

Investors can contact the law firm at no cost to learn more about recovering their losses LOS ANGELES, Jan. 22, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises BioAge Labs, Inc. ("BioAge" or the "Company") (NASDAQ: BIOA) investors of a class action representing investors purchased or otherwise acquired BioAge securities pursuant to the registration statement and prospectus issued in connection with the Company's September 26, 2024 initial public offering ("IPO"). BioAge investors have until March 10, ...

RADNOR, Pa., Jan. 22, 2025 /PRNewswire/ -- The law firm of Kessler Topaz Meltzer & Check, LLP (www.ktmc.com)  informs investors that a securities class action lawsuit has been filed 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"). The lead plaintiff deadline is March 10, 2025.CONTACT KESSLER TOPAZ MELTZER & CH ...