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X4 Pharmaceuticals, Inc. (Nasdaq: XFOR) is a late-stage clinical biopharmaceutical company committed to the development of novel therapeutics aimed at improving immune cell trafficking and reversing immune suppression. The company's core focus is on treating rare diseases and conditions resulting from immune system dysfunction, including cancer and genetic primary immunodeficiency diseases.
X4’s lead clinical candidate, mavorixafor, is a selective, small-molecule antagonist of the chemokine receptor CXCR4. Designed as an oral, once-daily therapy, mavorixafor targets immune cell mobilization and has shown promising results in clinical trials. It is currently under priority review by the FDA for the treatment of WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare primary immunodeficiency. The company’s recent NDA submission is supported by positive results from the global, pivotal 4WHIM Phase 3 clinical trial, which demonstrated mavorixafor's ability to reduce infection rates and improve immune cell counts without serious adverse events.
In addition to mavorixafor for WHIM syndrome, X4 is advancing its pipeline with ongoing investigations for mavorixafor in chronic neutropenic disorders and other immunodeficiencies. The company has also initiated preclinical development of other CXCR4 antagonists, including X4P-002 and X4P-003, to address different properties and mechanisms within the immune system.
Headquartered in Boston, Massachusetts, with a research center in Vienna, Austria, X4 leverages its deep understanding of CXCR4 biology to innovate and bring transformative therapies to patients with limited treatment options. The company's mission is driven by a commitment to improve the lives of those affected by rare and severe immune diseases through rigorous scientific research and strategic investment in its proprietary pipeline.
For more updates and detailed information, visit X4 Pharmaceuticals.
X4 Pharmaceuticals (Nasdaq: XFOR) announced it will report its first-quarter financial results for 2023 on May 4, 2023. The company is known for developing small molecule therapeutics aimed at treating immune system diseases. A conference call will take place at 8:30 a.m. ET on the same day to discuss the results and recent business developments. X4's lead candidate, mavorixafor, is in late-stage clinical trials for chronic neutropenic disorders, including WHIM syndrome. Following positive results from a pivotal Phase 3 trial, the company is preparing a U.S. regulatory submission for mavorixafor. X4 aims to enhance patient treatment options by mobilizing white blood cells, showcasing its commitment to innovative immune therapies.
X4 Pharmaceuticals (XFOR) has announced a virtual investor event on May 16, 2023, to discuss new data from its Phase 3 trial of mavorixafor for patients with WHIM syndrome. This follows the acceptance of a late-breaking abstract for oral presentation at the Annual Meeting of the Clinical Immunology Society (CIS) on May 21, 2023. The 4WHIM trial met its primary and key secondary endpoints, showing mavorixafor to be well tolerated with no serious treatment-related adverse events. The company will also provide updates on its U.S. regulatory plans for a New Drug Application submission, expected in H2 2023. Mavorixafor has received multiple designations including Breakthrough Therapy and Orphan Drug status, emphasizing its potential in treating WHIM syndrome, a rare immunodeficiency disorder.
X4 Pharmaceuticals issued inducement awards to new employees under the 2019 Inducement Equity Incentive Plan on March 31, 2023. The awards included options for an aggregate of 595,000 shares of common stock with an exercise price of $0.87 per share, matching the closing stock price on the grant date. These options will vest over four years, with 25% vesting after the first year and the remainder monthly thereafter, contingent on continued employment. X4 is advancing its lead candidate, mavorixafor, aimed at treating chronic neutropenic disorders, and is preparing for a U.S. regulatory submission.
X4 Pharmaceuticals (Nasdaq: XFOR) reported its financial results for Q4 and FY 2022, with a net loss of $29.1 million for Q4 and $93.9 million for the full year. Despite the losses, the company highlighted the successful Phase 3 results for mavorixafor, achieving its primary endpoints in WHIM syndrome trials. Upcoming milestones include additional Phase 3 data presentation in Q2 2023, an NDA submission in early H2 2023, and a potential U.S. launch in H1 2024. X4's strong cash position of $123 million supports operations through Q2 2024, fueled by recent financings totaling $120 million.
X4 Pharmaceuticals (Nasdaq: XFOR) announced it will report its financial results for the fourth quarter and full year ending December 31, 2022, on March 21, 2023. A conference call will follow at 9:00 a.m. ET to discuss these results and recent business highlights. X4 is focused on developing mavorixafor, a novel therapy for chronic neutropenic disorders, including WHIM syndrome. The company is preparing for a U.S. regulatory submission after positive Phase 3 trial results. The investor webcast will be available on X4's website post-call.
X4 Pharmaceuticals (Nasdaq: XFOR) announced the issuance of inducement awards for new employees, totaling 54,900 options to purchase common stock at an exercise price of $0.94 per share. These awards, granted under the 2019 Inducement Equity Incentive Plan, were approved by the board's compensation committee and are part of Nasdaq Listing Rule 5635(c)(4). The options vest over four years, with 25% vesting after one year. X4 focuses on developing therapies for immune system diseases, with its lead candidate mavorixafor showing promise in treating WHIM syndrome, currently preparing for a U.S. regulatory submission after positive Phase 3 trial results.
X4 Pharmaceuticals has announced positive developments regarding its clinical candidate mavorixafor for treating chronic neutropenic disorders. Highlights from the Phase 1b clinical trial presented at the American Society of Hematology meeting indicate that a single oral dose significantly increased absolute neutrophil count (ANC) across all participants, with overall good tolerance. The company also revealed that between 37,000–48,000 people in the U.S. have chronic neutropenia, emphasizing the substantial unmet medical needs in this patient population.
X4 Pharmaceuticals, Inc. (Nasdaq: XFOR) announced a public offering of 52.3 million shares, including pre-funded warrants for 6.8 million shares, alongside Class C warrants for 29.55 million shares, priced at $1.10 each. The offering aims to raise approximately $65 million, or up to $74.8 million if the underwriters' option is exercised. The offering is expected to close on December 9, 2022. Piper Sandler, Stifel, and Cantor are the joint book-running managers. The offering is filed under a shelf registration statement with the SEC.
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