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SAN FRANCISCO - Nektar Therapeutics (NASDAQ:NKTR) announced today that its drug candidate, rezpegaldesleukin, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 and older. The company, currently valued at $125 million, maintains a strong liquidity position with a current ratio of 4.24x, according to InvestingPro data.
The Fast Track process is designed to accelerate the development and review of drugs intended to treat serious conditions with unmet medical needs. Rezpegaldesleukin, an investigational biologic, aims to stimulate regulatory T cells by targeting the interleukin-2 receptor complex, potentially restoring immune balance. While the company holds more cash than debt on its balance sheet, InvestingPro analysis indicates it’s quickly burning through cash, with negative free cash flow of $178 million in the last twelve months.
Data from a Phase 1b study presented last October at the EADV Congress showed that rezpegaldesleukin rapidly improved disease outcomes over a 12-week induction phase and sustained these benefits for at least 36 weeks post-treatment. The ongoing Phase 2b REZOLVE-AD study is expected to release topline data from its induction period in the second quarter of this year.
The REZOLVE-AD trial has enrolled 398 patients who have not responded to or are unsuitable for topical prescriptions. These patients have not previously received biologic or JAK inhibitor therapies. The study’s primary measure of success is the mean improvement in Eczema Area and Severity Index (EASI) score at the end of a 16-week treatment period.
Nektar is also investigating rezpegaldesleukin in a Phase 2b trial for severe-to-very-severe alopecia areata. The company specializes in developing treatments for autoimmune and inflammatory diseases and has a pipeline that includes other investigational therapies.
Atopic Dermatitis affects around 30 million Americans and is characterized by a compromised skin barrier leading to inflammation. Rezpegaldesleukin’s Fast Track designation could potentially expedite its availability to patients if further clinical trials prove successful.
This announcement is based on a press release statement from Nektar Therapeutics.
In other recent news, Nektar Therapeutics has seen a flurry of activity. The biopharmaceutical company has announced a significant change in its senior leadership team, with Mary Tagliaferri, MD, stepping down from her position as Senior Vice President and Chief Medical (TASE:PMCN) Officer. In her stead, Brian Kotzin, MD, will serve as the interim Chief Medical Officer, bringing decades of immunology expertise to the role.
Nektar Therapeutics has also reached its enrollment goal for a key Phase 2b clinical trial, REZOLVE-AD, which is investigating the efficacy of rezpegaldesleukin in treating moderate-to-severe atopic dermatitis. B.Riley has initiated coverage on shares of Nektar Therapeutics with a Buy rating, based on the potential of REZPEG, which is currently in Phase IIb trials for atopic dermatitis and alopecia areata.
In addition, Piper Sandler has highlighted Nektar Therapeutics as one of several companies with key Phase 2b readouts expected in 2025. Lastly, the company has completed the sale of its Huntsville, Alabama manufacturing facility and related assets to an affiliate of Ampersand Capital Partners (WA:CPAP), aligning with its strategic initiatives to streamline operations. These are the recent developments in Nektar Therapeutics.
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