United States — Food and Drug Administration & MiNK Therapeutics

United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) granted MiNK Therapeutics' appeal, concluding that substantial evidence of effectiveness has been established for LYTENAVA, and will now review the resubmitted BLA with a decision expected within 60 days.

MiNK Therapeutics: MiNK Therapeutics resubmitted its Biologics License Application (BLA) for ONS-5010/LYTENAVA to the United States — Food and Drug Administration (FDA) for the treatment of neovascular age-related macular degeneration (nAMD), which is a significant step towards potential FDA approval and commercialization in the United States.

United States — Food and Drug Administration: The FDA placed a full clinical hold on ARD-101's IND, halting all ongoing studies. This regulatory action is central to the lawsuit and has severely impacted Aardvark's operations and stock price.

MiNK Therapeutics: MiNK Therapeutics is the defendant in the securities class action. The FDA clinical hold on ARD-101 and the alleged misrepresentations have caused a dramatic stock price decline and significant legal and financial exposure.

United States — Food and Drug Administration: The United States — Food and Drug Administration placed a full clinical hold on MiNK Therapeutics' investigational new drug application for ARD-101, directly impacting the company's drug development and stock performance.

MiNK Therapeutics: MiNK Therapeutics is facing a securities fraud investigation by Pomerantz LLP due to significant stock price drops following the voluntary pause and subsequent clinical hold on its HERO trial for ARD-101. This event negatively impacts its reputation and financial standing.

United States — Food and Drug Administration: The FDA approved LYTENAVA for the treatment of wet AMD. The offering does not directly affect the FDA.

MiNK Therapeutics: MiNK Therapeutics is the issuer of the offering, raising approximately $55 million to fund the U.S. commercial launch of LYTENAVA and for working capital. The offering provides necessary capital but may dilute existing shareholders.

United States — Food and Drug Administration: The United States — Food and Drug Administration cleared the Zeta TMS Navigation System, which is a prerequisite for its commercial use in the United States.

MiNK Therapeutics: MiNK Therapeutics, a subsidiary of NRx Pharmaceuticals, has transitioned from system deployment to active patient care using the Zeta TMS Navigation System, offering advanced psychiatric and neurological care.

United States — Food and Drug Administration: The United States — Food and Drug Administration has granted various designations to MiNK Therapeutics' programs and is involved in the approval pathway for its Fabry gene therapy.

MiNK Therapeutics: MiNK Therapeutics is exploring strategic alternatives to maximize stakeholder value, including potential transactions for its gene therapy programs and technology platforms. This could lead to partnerships, acquisitions, or other deals that impact its financial future and stock price.

MiNK Therapeutics: MiNK Therapeutics announced new clinical and translational data for its Agent 797 therapy, which could significantly boost its market position and future revenue streams.