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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) has announced an underwritten public offering of its common stock and accompanying warrants. The offering, conducted by Piper Sandler, Stifel, and Cantor, includes a 30-day option for underwriters to purchase additional shares. The offering's completion is subject to market conditions, and no assurance is provided regarding the final terms. X4 is focused on developing mavorixafor, a treatment for immune system diseases, particularly chronic neutropenic disorders.
X4 Pharmaceuticals announced positive top-line results from its Phase 3 clinical trial (4WHIM) of mavorixafor for WHIM syndrome. The trial met its primary endpoint, demonstrating clinical superiority over placebo in increasing absolute neutrophil counts (P < 0.0001) and absolute lymphocyte counts (P < 0.0001). Mavorixafor was well tolerated, with no serious adverse events reported. Following the trial, over 90% of participants chose to continue treatment, highlighting its potential. The company aims to meet U.S. regulatory authorities in early 2023 for further steps towards regulatory approval.
X4 Pharmaceuticals (Nasdaq: XFOR) announced management's participation in a fireside chat at the Stifel Healthcare Conference on November 15, 2022, at 3:00 PM ET. The event will be streamed live on their website, with an archive available for 90 days post-event. X4 Pharmaceuticals focuses on novel therapies for immune system diseases, including their leading candidate, mavorixafor, a small-molecule therapy targeting CXCR4, currently in global Phase 3 trials for WHIM syndrome.
Scorpion Therapeutics has announced the formation of a Clinical Scientific Advisory Board (Clinical SAB) to enhance its Precision Oncology 2.0 strategy. This board comprises esteemed physician-scientists specialized in cancer treatment and development. The Clinical SAB will provide insights to expedite the company's lead programs, including STX-478 and STX-721, aimed at advancing toward investigational new drug applications in 2023. CEO Axel Hoos expressed optimism about the expertise of the members and their potential impact on improving cancer therapies.
X4 Pharmaceuticals (Nasdaq: XFOR) announced the issuance of inducement awards for new employees under the 2019 Inducement Equity Incentive Plan. On November 3, 2022, the company granted options to purchase 410,000 shares of its common stock, with 341,000 shares awarded to the new Chief Commercial Officer, Mark Baldry. The options have a ten-year term and an exercise price of $1.89 per share, matching the closing price on the grant date. Vesting occurs over four years, contingent on continued employment. X4 focuses on developing therapies for immune system diseases, including its lead candidate mavorixafor.
X4 Pharmaceuticals (Nasdaq: XFOR) reported its third-quarter 2022 financial results, highlighting key advancements in its lead candidate, mavorixafor, after positive Phase 1b data in chronic neutropenic disorders. The company anticipates top-line results from the pivotal Phase 3 WHIM syndrome trial in Q4 2022, potentially leading to a U.S. regulatory submission in H2 2023. X4 ended Q3 2022 with $81.1 million in cash, supporting operations into Q3 2023. Despite a net loss of $21.6 million, X4 is focused on advancing mavorixafor as a new treatment option for underserved patients.
X4 Pharmaceuticals has appointed Mark Baldry as the new Chief Commercial Officer, effective November 3, 2022. Baldry brings over 30 years of experience in launching specialty pharmaceuticals and will oversee pre-commercial and product launch efforts for mavorixafor, X4's lead candidate for chronic neutropenic disorders, including WHIM syndrome. The company is preparing to reveal Phase 3 data from the mavorixafor clinical trial, which holds significant potential as a first line therapy. This leadership change may strengthen the company’s market position.
X4 Pharmaceuticals (Nasdaq: XFOR) will report its Q3 financial results on November 3, 2022. The company will also host a conference call at 8:30 a.m. ET to discuss key milestones, particularly the results from its Phase 3 trial of mavorixafor for WHIM syndrome. This investigational therapy, a small molecule antagonist of CXCR4, aims to improve white blood cell mobilization for various immune system diseases. X4 is focusing resources on chronic neutropenic disorders and has additional studies ongoing for mavorixafor. More details can be found on their investor relations website.
X4 Pharmaceuticals announced promising results from its Phase 1b trial of mavorixafor, targeting chronic neutropenia (CN). All 25 participants in the study responded positively, achieving significant increases in absolute neutrophil count (ANC). Notably, the treatment normalized ANC levels in 100% of the neutropenic subjects, suggesting mavorixafor could become the first oral therapy for CN disorders. The trial included idiopathic, cyclic, and congenital variants, with an estimated patient population of 50,000 in the U.S. Further studies are planned to confirm the long-term efficacy and safety of mavorixafor.
X4 Pharmaceuticals (Nasdaq: XFOR) will host a webcast on September 27, 2022, at 8:00 a.m. ET to discuss data from its Phase 1b trial of mavorixafor in patients with neutropenia. The event will include insights from patients and clinical experts about treatment needs. Management will present data on 25 fully enrolled patients and explore mavorixafor's potential beyond WHIM syndrome. A Q&A session will follow. The trial aims to assess the safety and tolerability of mavorixafor, a novel small-molecule therapy for immune system diseases.
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