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Clarus Therapeutics Holdings (Nasdaq: CRXT) announced new data for JATENZO (testosterone undecanoate) will be presented at the 2022 American Urological Association Annual Meeting in New Orleans from May 13-16, 2022. The abstract, titled Linear Relationship between the Time of Dosing and 24-Hour Average Concentration of Total Testosterone, will be presented on May 14 at 4:30 p.m. CT. Male hypogonadism affects 20 million men in the U.S., with treatment options including testosterone replacement therapy.
Clarus Therapeutics has received a notice of allowance from the USPTO for a new patent covering its testosterone replacement therapy, JATENZO. The patent, which will be listed in the FDA’s Orange Book, adds to the existing seven patents already covering the product, extending its market exclusivity. JATENZO is the first FDA-approved oral softgel for testosterone therapy, targeting the approximately 20 million men in the U.S. with hypogonadism. The new patent is set to expire in 2026, enhancing the intellectual property portfolio of the company.
Clarus Therapeutics announced the closing of a public offering, selling 26,680,720 units at $1.10 each, consisting of common stock and Class A warrants, generating approximately $30 million in gross proceeds. Additionally, 590,000 pre-funded warrants were offered. The underwriters received a 45-day option to purchase up to 4,090,608 additional shares or warrants. The net proceeds will support working capital and general corporate purposes. Maxim Group LLC served as the sole book-running manager for this offering.
Clarus Therapeutics Holdings (NASDAQ: CRXT) has priced an underwritten public offering of 26,680,720 units, each consisting of a share of common stock and a Class A warrant, alongside 590,000 pre-funded units. The units are priced at $1.10 each, potentially raising approximately $30 million in gross proceeds before expenses. The offering is expected to close on April 27, 2022. Proceeds will be used for working capital and general corporate purposes. Maxim Group LLC is the sole book-running manager for the offering.
Clarus Therapeutics announced new data for JATENZO (testosterone undecanoate) will be presented at the Androgen Society 4th Annual Meeting in Orlando, Florida, from April 21-23, 2022. Two abstracts will be showcased: one explores the relationship between testing timing and testosterone levels in hypogonadal men, while the other compares JATENZO and AndroGel after one year of therapy. Male hypogonadism affects an estimated 20 million men in the U.S. Clarus focuses on developing androgen and metabolic therapies, with JATENZO being its first commercial product.
Oragenics, Inc. (NYSE American: OGEN) announced its participation in the World Vaccine Congress Washington from April 18-22, showcasing its lead product, NT-CoV2-1, an intranasal COVID-19 vaccine candidate. The vaccine aims for patient-friendly administration and robust immune response. NT-CoV2-1 has shown promising results in animal studies, with a Phase 1 trial expected to begin this year. Kimberly Murphy, a board member and former GSK executive, will represent the company. Oragenics focuses on combating infectious diseases, leveraging research from NIH and NRC.
Clarus Therapeutics (Nasdaq:CRXT) reported a 119% increase in net revenue for 2021, reaching $14.0 million, with fourth-quarter revenue up 88% to $4.6 million. Demand for JATENZO® drove total prescriptions up 81% year-over-year. Despite this, operating expenses rose by 13.6% to $51.0 million. The company continues to explore strategic alternatives to maximize shareholder value amidst increasing net losses, which reached $40.6 million for 2021. Upcoming clinical trials and a new patient portal launched in partnership with Vault Health aim to enhance market presence.
Clarus Therapeutics Holdings, a pharmaceutical company focused on androgen and metabolic therapies, will release its fourth quarter and full year 2021 financial results on March 30, 2022, after market closure. A conference call is scheduled for the same day at 5:15 p.m. ET, accessible via specific dial-in numbers for domestic and international callers. The details will also be available through their Investors section online. Clarus's first commercial product is JATENZO (testosterone undecanoate), aimed at addressing unmet medical needs.
Clarus Therapeutics announced the start of a Phase 4 clinical trial for JATENZO, the first FDA-approved oral testosterone replacement therapy, targeting adult men with chronic kidney disease (CKD) and hypogonadism. The trial, which began screening patients on March 16, 2022, will evaluate the safety and efficacy of JATENZO over 26 weeks. The results are expected in the first half of 2023. This initiative aims to address the needs of over two million men with CKD suffering from testosterone deficiency, potentially improving their health outcomes.
NORTHBROOK, Ill., March 10, 2022 (GLOBE NEWSWIRE) -- Clarus Therapeutics announces its upcoming virtual presentation at the Oppenheimer 32nd Annual Healthcare Conference on March 15, 2022, at 10:00 a.m. ET. Investors can access the live webcast through the Investors section of Clarus’ website, with an archived version available for 90 days post-event. Clarus focuses on developing androgen and metabolic therapies, with its first product, JATENZO® (testosterone undecanoate). For more details, visit ClarusTherapeutics.com.
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