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Tag: vTv

  • FDA Lifts Clinical Hold, vTv Therapeutics (VTVT) Stock Surges

    FDA Lifts Clinical Hold, vTv Therapeutics (VTVT) Stock Surges

    Shares of vTv Therapeutics Inc. (NASDAQ: VTVT) are on a significant surge today following the lifting of a clinical hold on a key trial. As of the most recent market check, VTVT stock was soaring 64.75%, trading at $24.42.

    FDA Clears Cadisegliatin Clinical Program

    The FDA has removed the clinical hold on vTv Therapeutics’ cadisegliatin clinical program, which includes the CATT1 Phase 3 study for type 1 diabetes (T1D), the company stated. Cadisegliatin is a liver-selective glucokinase activator that is taken orally. It has been shown to have good tolerability in more than 500 patients, and therapy can last up to six months.

    After a chromatographic signal was found in a human absorption, distribution, metabolism, and excretion (ADME) study of cadisegliatin, the regulatory hold was first put in place on July 26, 2024. The trial was temporarily halted due to this abnormality, which was not resolvable with conventional mass spectroscopy methods.

    Resolution and Resumption of the Trial

    At the time of the clinical hold, no patients had been administered doses in the CATT1 trial, and prior clinical investigations had not identified any safety concerns. Following an extensive review, vTv Therapeutics submitted a comprehensive response letter, concluding that the chromatographic signal was an experimental artifact. As a result, on March 14, 2025, the FDA formally removed the hold.

    With a revised protocol, vTv Therapeutics now intends to restart the study with a shorter period of six months instead of twelve. The purpose of this modification is to expedite the production of topline data and make it easier to begin bigger pivotal studies that are required for a subsequent New Drug Application (NDA) filing.

    There will be no changes to the primary endpoint, which evaluates level 2 and level 3 hypoglycemia rates at six months. However, the extended six-month safety data collection period will be omitted.

    Possible Advancement in the Management of Diabetes

    With the restart of the CATT1 study, vTv Therapeutics is still assessing how well cadisegliatin works with insulin treatment to improve glycemic control and lower the incidence of hypoglycemia. If cadisegliatin is effective, it may be the first oral adjunctive medication for type 1 diabetes, which would represent a major improvement in the treatment of the disease.

  • vTv Therapeutics (VTVT) Stock Skyrockets Post-Equity Completion

    vTv Therapeutics (VTVT) Stock Skyrockets Post-Equity Completion

    The shares of vTv Therapeutics Inc. (NASDAQ: VTVT) have experienced a notable surge this morning. Thia marked a significant increase of 153.26% in vTv stock to reach $21.02 per share, as verified in the current session. This uptrend in VTVT stock value coincides with the finalization of a financial operation.

    VTVT Therapeutics (VTVT) has completed a private offering with Samsara BioCapital, LLC (“Samsara”), a firm specializing in life sciences investments, along with the JDRF T1D Fund. On January 29, 2024, VTVT offered 464,377 shares of its common stock at a price of $11.81 per share, based on the 45-day Volume Weighted Average Price (VWAP).

    Furthermore, the private placement offering involved the purchase of warrants equivalent to 3,853,997 shares of common stock. A total of $51 million was generated from the PIPE. Also, in conjunction with the PIPE, vTv reduced the size of its Board of Directors from nine to seven members.

    Among the reconstituted board, three members will be appointed by the new investors, including Srinivas Akkaraju, MD, PhD, who serves as the Founder and Managing General Partner at Samsara. These strategic maneuvers aim to provide impetus to vTv’s pursuit, with the allocated funds intended to facilitate the commencement of the initial Phase 3 trial for its flagship product candidate, cadisegliatin, projected to begin in the middle of 2024.

    The company is poised to attract further investments of commendable quality as it readies itself for the inaugural Phase 3 trial of cadisegliatin. The resources amassed through the PIPE are anticipated to sustain vTv’s operations until the unveiling of topline data from the pivotal Phase 3 study of cadisegliatin, representing a significant milestone for the company.

    Having monitored vTv’s progress over an extended period, Samsara possesses an intimate understanding of cadisegliatin and harbors strong conviction regarding its potential to deliver substantial benefits to individuals grappling with T1D. Samsara pledges close collaboration with the VTVT Board and its team, offering guidance to propel the continued advancement of this highly promising initiative as it progresses towards Phase 3 development.

  • What Motivated VTVT Stock To Climb 20% Premarket?

    What Motivated VTVT Stock To Climb 20% Premarket?

    The stock of vTv Therapeutics Inc. (VTVT) increased 19.92% to $2.83 at the last check in premarket trades today. The price of the stock dropped -3.28% to $2.36 at the end of the last trading session during which VTVT stock has traded between $2.32 and $2.422. A total of 0.74 million shares were traded, which was below the daily average of 5.21 million shares over the past 100 days.

    A look at the last five days of trading for VTVT shares shows a loss of -11.61%, while the last month shows a decline of -7.81%. As a result of announcing a strategic licensing agreement for the development and commercialization of azeliragon in cancer treatment, VTVT stock has increased.

    Who has VTVT signed a licensing agreement with?

    vTv Therapeutics is a clinical-stage biopharma company developing small molecule drugs for oral administration. Clinical trials for type 1 diabetes and psoriasis are at the forefront of VTVT’s pipeline of approved drugs. Additional indications for VTVT being pursued by its development partners include diabetes type 2, chronic obstructive pulmonary disease, renal disease, as well as primary mitochondrial myopathies.

    A licensing agreement was announced today between VTVT and Cantex Pharmaceuticals.

    • VTVT granted Cantex exclusive worldwide rights to develop and market azeliragon, which is VTVT’s new RAGE antagonist.
    • RAGE encodes the receptor for advanced glycation endproducts.
    • VTVT’s RAGE has been associated with a number of serious cancer complications that increase mortality and decrease quality of life.
    • With deep expertise and an extensive track record of successful drug development projects, Cantex can successfully turn known medicines into innovative products with wide clinical and commercial potential.
    • Cantex is therefore well suited to develop Azeliragon.
    • Aszeliragon is a phase 2-ready oral medication that is administered once daily and has been shown to be safe in several Alzheimer’s trials.
    • Cantex plans to move quickly to prepare for clinical trials that assess azeliragon’s potential for treating cancer-related complications.
    • VTVT’s RAGE is an intriguing target for treating many different disorders.
    • Azeliragon, which VTVT has studied for Alzheimer’s disease, is a perfect candidate for use in new therapeutic indications.
    • VTVT considers Cantex as a suitable partner for such development.
    • The companies will use a tiered arrangement to allocate downstream profits as Cantex is responsible for developing and commercializing azeliragon.

    VTVT’s other milestones:

    Based on vTv Therapeutics (VTVT)’s recent announcement, the Food and Drug Administration (FDA) has designated TTP399 as a Breakthrough Therapy for the treatment of type 1 diabetes. The novel glucokinase activator TTP399 was developed by VTVT for oral administration once daily.