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Tag: vTv Therapeutics Stock

  • 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.

  • 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.

  • Early Morning Vibes: 3 Upgraded & 4 Pre Market Hot Stocks Inside

    Early Morning Vibes: 3 Upgraded & 4 Pre Market Hot Stocks Inside

    On December 10, the American stock indexes finished trading in different directions. The S&P 500 Index dropped 0.13% to 3668 points, the Dow Jones lost 0.23% and the NASDAQ rose 0.54%. Investors could not determine the direction of movement and took a wait and see attitude. Note that small-cap stocks showed more pronounced positive dynamics: the Russel 2000 index rose 1.08%. The industrial sector was an outsider, shedding 0.93%. 

    Corporate updates 

    Starbucks (SBUX: 5%) management presented a positive outlook for the company over the next few years.

    Snap (SNAP: + 8.1%) and Twitter (TWTR: + 8.4%) have announced a service integration partnership. Tweets can be shared on the Snapchat platform.

    Adobe’s quarterly results (ADBE: -1.4%) were better than expected, but its stock corrected.

    Today, global stock exchanges are showing mostly negative dynamics. The focus of attention is the decision of the FDA expert panel, which recommended approval of the coronavirus vaccine developed by Pfizer and BioNTech. However, no official permission was issued for the use of this drug, although market participants were counting on this. The market now assumes that a positive decision will be made this weekend, and then within 24 hours the first 6.4 million doses will be shipped to different states. Waiting for a vaccine approval within three months was the main driver of market growth.

    Lack of further progress in negotiations on the US economic aid package, persisting tensions with China and COVID-19 incidence statistics are factors that reduce risk appetite in the short term. The alarming signal yesterday was the publication of data on applications for unemployment benefits. Their number unexpectedly increased to 853 thousand in a week, while the forecast was 725 thousand. Macro statistics were ignored by the market, however, in our opinion, it serves as a harbinger of a deterioration in the state of the economy in early 2021 due to quarantine restrictions reintroduced by some states.

    Economic Update

    The University of Michigan Preliminary Expectations and Consumer Sentiment Index for December will be released today. The consensus assumes an increase in the first indicator from 70.5 to 71.0, while the second decreases from 76.9 to 76.5 points. The Expectations Index should be boosted by consumer hopes for mass vaccinations. Before the pandemic, the sentiment index was at the level of 99-100, the pressure on it continues to be the absence of a new package of economic assistance measures and stabilization of the epidemiological situation.

    Top Upgrades & Downgrades

    Morgan Stanley turned bullish on Diamondback Energy Inc. (FANG), upgrading the stock to “Overweight” and assigning a $65.0 price target.

    CommScope Holding Company Inc. (COMM) has won the favor of JP Morgan’s equity research team. The firm upgraded the shares from Neutral to Overweight and moved their price target to $18.0.

    Cognizant Technology Solutions Corporation (CTSH) received an upgrade from analysts at JP Morgan, who also set their one-year price target on the stock to $93.0. They changed their rating on CTSH to Overweight from Neutral in a recently issued research note.

    Earlier Friday JP Morgan reduced its rating on Juniper Networks Inc. (JNPR) stock to Neutral from Overweight and assigned the price target to $25.0.

    JP Morgan analysts reduced their investment ratings, saying in research reports covered by the media that its rating for Corning Incorporated (GLW) has been changed to Neutral from Overweight and the new price target is set at $39.0.

    Today Top Movers

    vTv Therapeutics Inc (VTVT) share price soared 184.47% at $6.23 in today’s pre-market session after the report that in compliance with the terms of the letter arrangement between the Firm and the Investor dated December 23, 2019, the company exercised the right to allow MacAndrews & Forbes Group LLC buy 625,000 shares of the Company’s Class A common stock at a per share price of $1.60.

    In trading session of premarket today, BioNTech SE (BNTX) share price went up 0.07% at $29.63 after the company and Pfizer reported the receipt FDA advisory committee vote in supporting potential first emergency use authorization for vaccine to combat COVID-19 in the U.S.

    Sonoma Pharmaceuticals Inc (SNOA) showing bullish trend in early morning on Friday, increasing 33.44% of its share price at $8.18 following an announcement of agreement with Crown Laboratories, Inc., to Launch Microcyn technology-based anti-Itch over-the-counter products.

    Zedge Inc (ZDGE) is going up 21.48% in premarket session on Friday after reporting first fiscal quarter revenue growth of 85% and record overall quarterly financial results.

    Latest Insider Activity

    Advanced Micro Devices Inc. (AMD) President & CEO Su Lisa T announced the sale of shares taking place on Dec 08 at $92.89 for some 150,000 shares. The total came to more than $13.93 million.

    Twitter Inc. (TWTR) Chief Financial Officer SEGAL NED D. sold on Dec 08 a total 634,970 shares at $47.93 on average. The insider’s sale generated proceeds of almost $0.34 million.

    Regulus Therapeutics Inc. (RGLS) 10% Owner Sonsini Peter W. declared the purchase of shares taking place on Dec 04 at $0.62 for some 4,398,602 shares. The transaction amount was around $2.74 million.

    Boxlight Corporation (BOXL) CHIEF EXECUTIVE OFFICER Pope Michael Ross bought on Dec 09 a total 287,942 shares at $1.65 on average. The purchase cost the insider an estimated $66,000.

    Earnings To Watch

    Top US earnings releases scheduled for today include Construction Partners Inc. (NASDAQ:ROAD). It will announce its Sep 2020 financial results. The company is expected to report earnings of $0.3 per share from revenues of $241.5M in the three-month period.

    Analysts expect Johnson Outdoors Inc. (NASDAQ:JOUT) to report a net income (adjusted) of $0.8 per share, when the bank releases its quarterly results shortly. Revenue for the fiscal quarter ended Sep 2020 is predicted to come in at $125.44M.