FDA Submission Marks a Pivotal Milestone in Advancing Early Cancer Detection, Addressing Unmet Needs in Cancer Screening ® MENLO PARK, Calif., Jan. 29, 2026 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a healthcare company whose mission is to detect cancer early when it can be cured, today announced the submission of the final module of the Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its Galleri multi-cancer early detection (MCED) test. The FDA designated the test ...

NEW YORK, Jan. 29, 2026 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of REGENXBIO Inc. ("Regenxbio" or the "Company") (NASDAQ: RGNX). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980. The investigation concerns whether Regenxbio and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] On January 28, 2026, ...

NEW YORK, Jan. 29, 2026 /PRNewswire/ -- Pomerantz LLP announces that a class action lawsuit has been filed against Vistagen Therapeutics, Inc. ("Vistagen" or the "Company") (NASDAQ: VTGN). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.  The class action concerns whether Vistagen and certain of ...

Core Viewpoint - Regenxbio Inc. is under investigation for potential discrepancies between the information provided to investors and the actual safety developments in its gene therapy clinical programs, particularly following the FDA's clinical holds on its RGX-111 and RGX-121 programs due to safety concerns [1][2]. Group 1: Company Developments - On January 28, 2026, Regenxbio disclosed that the FDA placed clinical holds on its RGX-111 and RGX-121 programs after a tumor was identified in a trial participant, leading to a 30-35% decline in the company's share price [2]. - During the Q3 2025 earnings call on November 6, 2025, CEO Curran Simpson highlighted positive regulatory interactions, noting that the FDA completed inspections of clinical sites and the manufacturing facility with no observations, which may have created an asymmetric presentation of the company's regulatory standing [4]. - The Q3 2025 earnings call transcript did not mention the RGX-111 program for MPS I, despite it being a significant pipeline asset that would later face the same FDA clinical hold, raising concerns about the completeness of information provided to shareholders [5]. Group 2: Regulatory and Legal Context - SEC disclosure rules require public companies to provide material information necessary for informed investment decisions, and Rule 10b-5 prohibits material misstatements and omissions in securities transactions [3].

NEW YORK, Jan. 29, 2026 /PRNewswire/ -- Levi & Korsinsky, LLP is investigating Alector, Inc. (NASDAQ: ALEC) following the Company's announcement of topline results from its Phase 3 INFRONT-3 trial, evaluating latozinemab in individuals with frontotemporal dementia due to a gene mutation (FTD-GRN). Investors with concerns about Alec's biotech operations may click here for more information. On October 21, 2025, Alec reported the study results for its Phase 3 INFRONT-3 trial. The study failed to achieve its c ...

VANCOUVER, BC / ACCESS Newswire / January 29, 2026 / LIR Life Sciences Corp. (CSE:SKNY)(OTC PINK:BBCMF)(Frankfurt:N790, WKN:A41QA9) ("LIR" or the "Company")is pleased to announce positive interim results from its ongoing comparative mouse study evaluating cell penetrating peptide (CPP) enabled, needle-free delivery of GLP/GIP-based therapies. In this interim analysis, animals treated with a novel semaglutide/CPP topical formulation demonstrated reduced blood glucose following an oral glucose challenge compa ...

NEW YORK, Jan. 29, 2026 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Vistagen Therapeutics, Inc. ("Vistagen" or the "Company") (NASDAQ: VTGN) of a class action securities lawsuit. CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Vistagen investors who were adversely affected by alleged securities fraud between April 1, 2024 and December 16, 2025. Follow the link below to get more information and be contacted by a member of our team: https://zlk.com/pslra-1/vistagen-thera ...

New York, New York--(Newsfile Corp. - January 29, 2026) - WHY: Rosen Law Firm, a global investor rights law firm, continues to investigate potential securities claims on behalf of shareholders of Alvotech (NASDAQ: ALVO) resulting from allegations that Alvotech may have issued materially misleading business information to the investing public.SO WHAT: If you purchased Alvotech securities you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangem ...

As filed with the Securities and Exchange Commission on January 29, 2026 Registration No. 333-292085 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 AIM ImmunoTech Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 52-0845822 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Num ...

Streamlining production footprint and improving manufacturing efficiency through phased closure of Holliston, MA plant Initiative expected to deliver approximately $3 million in cost savings in 2027 and $4 million in annual cost savings beginning in 2028 while improving throughput and execution HOLLISTON, Mass., Jan. 29, 2026 (GLOBE NEWSWIRE) -- Harvard Bioscience, Inc. (Nasdaq: HBIO) (the “Company” or “Harvard Bioscience”), today announced a strategic consolidation of its manufacturing operations designed ...