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Tag: ALDX Stock

  • Phase 3 TRANQUILITY Trial Results: Aldeyra Therapeutics Inc. (ALDX) Nose Dives After Hours

    Aldeyra Therapeutics Inc. (ALDX) stock fell by 36.33% in the after-hours following the announcement of results from its TRANQUILITY trial. On December 20, ALDX shared top-line results from its Phase 3 TRANQUILITY trial in dry eye disease. The company failed to meet the primary endpoint of the trial, hence causing the stock to plunge.

    During the regular session, the stock traded in the green with a gain of 1.28% at its close of $7.13. Following the results, the stock took a big hit in the after-hours, diving down to $4.54 at 1.3 million shares.

    Aldeyra Therapeutics Inc. has a market capitalization of $408.97 million for its 58.09 million outstanding shares.

    ADLX’s Top-line Results

    ALDX has been conducting the phase 3 trial of its TRANQUILITY study for 0.25% reproxalap ophthalmic solution for the treatment of dry eye disease. Reproxalap is the company’s investigational product candidate for dry eye disease and allergic conjunctivitis. Moreover, dry eye disease is an inflammatory disease that leads to dryness, pain, discomfort, irritation, and permanent vision impairment. An estimated 34 million people are affected by dry eye disease in the U.S. alone.

    On Monday, the company announced the top-line results from the phase 3 trial. According to this, ALDX was unable to meet the primary endpoint of ocular redness. Moreover, the study did achieve a secondary endpoint of statistical significance (p=0.0001) for the Schirmer test. Moreover, the Schirmer test is an accepted part of the basis approval of dry eye disease products by the FDA.

    Hence, the company modified the primary endpoint of the study to achieve statistical significance in ocular redness or the Schirmer test. Furthermore, ALDX also increased TRANQUILITY-2 target enrollment to 400 patients from 300. In addition, the company expects the top-line results from TRANQUILITY-2 in mid-2022.

    Q3 2021 Financial Results

    On October 28, ALDX reported its financial results for the third quarter of 2021, which ended on September 30, 2021. In the third quarter of 2021, the net loss was $15.8 million against $8.9 million in the year-ago quarter. Subsequently, the net loss per share for the third quarter of 2021, was $0.27, against $0.23 in Q3 of 2020.

    Moreover, ALDX ended the third quarter of 2021, with cash and cash equivalents of $241.4 million. According to the current operating plan of the company, ALDX expects this to be enough cash flow through the end of 2023.

  • Aldeyra (ALDX): What Is Driving The Stock Higher?

    Aldeyra (ALDX): What Is Driving The Stock Higher?

    Aldeyra Therapeutics Inc. (ALDX) is rising today on the charts, trading up 2.18% to $9.39 per share at the last check in early trading. Aldeyra stock has raised nearly 12% in the premarket session today. As of Monday, Aldeyra shares closed at $9.19, down 3.47% on day. The total volume traded in ALDX stock was 1.01 million shares, less than the 1.47 million average traded volumes over the past three months. The ALDX stock fluctuated between $8.52 and $9.7299 during the trading session.

    The earnings ratio for ALDX was -1.02. On a yearly basis, ALDX stock has gained 33.97% and lost 10.97% in the past five sessions. In the previous month, ALDX stock moved -24.36 percent. Currently, the 50-day moving average for ALDX stock is $11.56, which is above the 200-day moving average of $10.18. Furthermore, ALDX stock price is trading at an RSI of 24.28.

    ALDX stock is soaring since it received Orphan Drug Designation from the US Food and Drug Administration (FDA) for one of its products.

    Which ALDX drug received the designation?

    Aldeyra is a biotechnology company focused on the development of immunomodulating therapies for the treatment of ocular and systemic ailments. ALDX’s two lead product candidates, reproxalap and ADX-629, target RASPs (reactive aldehyde species), which are cytokine pre-cycling molecules that cause inflammation. Phase 3 clinical trials of Reproxalap are being conducted at ALDX in patients with dry eyes and allergies. ADX-2191 (methotrexate for intravitreal injection) is another potential drug candidate in ALDX’s clinical pipeline.

    In a press release today, Aldeyra announced that the FDA has granted the company orphan drug designation for its ADX-2191 drug candidate for the treatment of primary vitreoretinal lymphoma (PVRL).

    • The PVRL, a rare, aggressive, high-grade cancer that is diagnosed annually in approximately 600 US patients, has currently no approved treatment.
    • By Designating ADX-2191 as an orphan drug, the FDA opens the way for clinical trials and commercialization for the drug.
    • Additionally, this designation represents the first formulation of methotrexate specifically designed for intraocular use, giving ALDX a competitive advantage.
    • ALDX retinal disease program has taken another step forward with this designation, supporting it in its ongoing development of ADX-2191 to prevent proliferative vitreoretinopathy, which is the primary cause of retinal reattachment failure.

    Will this benefit ALDX?

    As an orphan drug developer, Aldeyra (ALDX) would qualify for federal financial incentives, as the program allows the same for pharmaceuticals and biologics for treating rare diseases. In consideration of its orphan drug designation, ALDX is also eligible to receive tax credits for its clinical trial costs, waivers of user fees for marketing applications, and consideration for seven years of marketing exclusivity, if approved.