NEW YORK, Jan. 14, 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 ...

FDA Approval and Regulatory Updates - The FDA has accepted BioArctic's partner Eisai's Biologics License Application (BLA) for Leqembi subcutaneous autoinjector (SC-AI) for weekly maintenance dosing, with a PDUFA action date set for August 31, 2025 [1] - Leqembi is already approved in the US, Japan, China, Great Britain, and other markets, and received a positive opinion from the CHMP of the EMA in November 2024 [2] - Eisai has submitted applications for regulatory approval of lecanemab in several other countries and regions, including the European Union, and a supplemental BLA for less frequent intravenous maintenance dosing was accepted by the FDA in June 2024 [3] Clinical Data and Study Progress - The BLA for Leqembi SC-AI is based on data from the Clarity AD open-label extension (OLE) and modeling of observed data [6] - Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical AD is ongoing, with full recruitment completed in October 2024 [8] - The Tau NexGen clinical study for Dominantly Inherited AD (DIAD), which includes lecanemab as the backbone anti-amyloid therapy, has been ongoing since January 2022 [12] Product Features and Benefits - Leqembi is the only FDA-approved anti-amyloid therapy that offers the convenience of a subcutaneous injection with at-home administration option [1] - The SC-AI 360 mg weekly maintenance regimen allows patients to receive weekly doses that maintain clinical and biomarker benefits after completing the biweekly IV initiation phase [6] - The SC-AI is expected to be simple and easy to use, reducing the need for hospital or infusion site visits and nursing care for IV administration [10] Collaboration and Commercialization - BioArctic has a long-term collaboration with Eisai since 2005 for the development and commercialization of drugs for Alzheimer's disease, including lecanemab and Leqembi [9] - BioArctic has the right to commercialize lecanemab in the Nordic region under certain conditions and is preparing for commercialization in the Nordics together with Eisai [9] - Eisai is responsible for the clinical development, application for market approval, and commercialization of the products for Alzheimer's disease globally [9] Company Overview - BioArctic is a Swedish research-based biopharma company focusing on innovative treatments for neurodegenerative diseases, including Alzheimer's, Parkinson's, and ALS [13] - The company invented Leqembi, the world's first drug proven to slow the progression of Alzheimer's disease and reduce cognitive impairment in early stages [13] - BioArctic's research portfolio includes several projects utilizing its proprietary BrainTransporter™ technology to enhance the efficacy of treatments by transporting antibodies across the blood-brain barrier [13]

NEW YORK, Jan. 13, 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=122004&from=4 CLASS PERIOD: This lawsuit is on ...

Lawsuit Overview - The class action lawsuit against BioAge Labs alleges violations of the Securities Act of 1933, specifically that the IPO offering documents contained materially false and/or misleading statements regarding the safety and expected results of the STRIDES clinical trial [1][3] - The lawsuit is captioned Soto v BioAge Labs, Inc, No 25-cv-00196 (N D Cal) and purchasers or acquirers of BioAge Labs stock pursuant to the IPO have until March 10, 2025 to seek appointment as lead plaintiff [1] BioAge Labs Background - BioAge Labs is a clinical-stage biopharmaceutical company developing therapeutic product candidates for metabolic diseases [2] - In its IPO on September 26, 2024, BioAge Labs sold 12 65 million shares at $18 00 per share [2] Allegations and Impact - The lawsuit alleges that on December 6, 2024, BioAge Labs announced discontinuation of the STRIDES Phase 2 study of its investigational drug candidate azelaprag due to liver transaminitis observed in some subjects [4] - Following this announcement, BioAge Labs stock price fell more than 76% and was trading at or around $5 82 per share, significantly below the $18 00 IPO price [4] Lead Plaintiff Process - Under the Private Securities Litigation Reform Act of 1995, any investor who purchased or acquired BioAge Labs stock pursuant to the IPO can seek appointment as lead plaintiff [5] - The lead plaintiff, typically the movant with the greatest financial interest, acts on behalf of all class members and can select a law firm to litigate the case [5] Robbins Geller Law Firm - Robbins Geller Rudman & Dowd LLP is representing investors in this securities fraud case [6] - The firm has recovered $6 6 billion for investors in securities-related class action cases over the last four years, including the largest securities class action recovery ever of $7 2 billion in the Enron case [6]

NEW YORK, Jan. 10, 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 ...

LOS ANGELES, Jan. 10, 2025 /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, announces the firm has filed a class action lawsuit against BioAge Labs, Inc. ("BioAge" or "the Company") (NASDAQ: BIOA) for violations of the federal securities laws.Investors who purchased the Company's securities pursuant and/or traceable to the Company's initial public offering ("IPO") conducted on September 26, 2024, are encouraged to contact the firm before March 10, 2025.      If you are a s ...

NEW YORK, Jan. 9, 2025 /PRNewswire/ -- Why: Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of stock of BioAge Labs, Inc. (NASDAQ: BIOA) pursuant and/or traceable to BioAge's initial public offering conducted on September 26, 2024 (the "IPO"). A class action lawsuit has already been filed. If you wish to serve as lead plaintiff, you must move the Court no later than March 10, 2025.So what: If you purchased BioAge stock you may be enti ...

SAN FRANCISCO, Jan. 9, 2025 /PRNewswire/ -- BioAge Labs (NASDAQ: BIOA), a biopharmaceutical company focused on metabolic diseases, is facing a class-action lawsuit from shareholders who allege the company misled investors about the safety and prospects of a key drug candidate before its initial public offering last September.Hagens Berman urges investors who purchased BioAge shares in the company's IPO or on the open market and suffered substantial losses to submit your losses now.Defined Class: Purchasers ...

ATLANTA, Jan. 09, 2025 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against BioAge Labs, Inc. (“BioAge” or the “Company”) (NASDAQ: BIOA). The lawsuit alleges that the Company’s registration statement issued in connection with its IPO was false and/or misleading because Defendants failed to disclose safety concerns related to its lead product candidate, azelaprag. If you bought shares of BioAge on or after September 26, 2024 and you suffered a significant loss on that investment, you ...

NEW YORK, Jan. 09, 2025 (GLOBE NEWSWIRE) -- Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against BioAge Labs, Inc. (NASDAQ: BIOA) and certain of its senior executives for potential violations of the federal securities laws. If you invested in BioAge, you are encouraged to obtain additional information by visiting https://www.bfalaw.com/cases-investigations/bioage-labs-inc. Investors have until March 10, 2025, to ask the Court to be appointed to lead the case ...