X4 Pharmaceuticals Inc

X4 Pharmaceuticals, Inc. operates as a biotechnology company, which engages in developing human antibodies for treating infectious diseases. The company focuses on restoring healthy immune system function by developing novel therapeutics for the treatment of rare diseases. Its products in pipeline include X4P-001, X4P-002, and X4P-003. The company was founded by Henri A. Termeer, Keith T. Flaherty, Renato T. Skerlj, Richard Peters and Paula Ragan in 2010 and is headquartered in Boston, MA.

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X4 Pharmaceuticals reports positive trial results and financial resilience

X4 Pharmaceuticals showcased strong clinical performance with positive trial results for mavorixafor, while also strengthening its financial position despite reporting a net loss.
The company faces challenges in managing R&D expenses and addressing ongoing financial losses, but opportunities lie in market expansion and regulatory progress for mavorixafor.
By navigating challenges effectively and capitalizing on opportunities, X4 Pharmaceuticals can position itself for growth and success in advancing its lead candidate to market.
Investor interest, regulatory milestones, and strategic partnerships will play key roles in shaping X4 Pharmaceuticals' future trajectory and market competitiveness.

X4 Pharmaceuticals reports successful Phase III trial and plans FDA filing

X4 Pharmaceuticals demonstrated significant progress with mavorixafor and plans for regulatory filings, supported by a healthy cash position.
While facing challenges in managing expenses and achieving profitability, the company remains focused on advancing its pipeline and engaging with stakeholders.
Opportunities lie in upcoming events for collaboration and data dissemination, signaling potential growth avenues for X4 Pharmaceuticals.
Overall, X4 Pharmaceuticals' Q1 2023 earnings call highlighted achievements, financial standing, challenges, and future prospects for investors and stakeholders.

X4 Pharmaceuticals reports strong Q2 results and advances mavorixafor trials

X4 Pharmaceuticals showcased positive trial results and financial strength, positioning the company for future growth and market success.
While facing challenges in upcoming trials and commercialization, the company's strategic leadership and product potential offer opportunities for expansion.
Navigating regulatory processes and market dynamics will be key to realizing the full potential of mavorixafor and driving long-term value for stakeholders.
Overall, X4 Pharmaceuticals' focus on innovation, strategic partnerships, and market insights bode well for their competitive positioning and growth trajectory.

X4 Pharmaceuticals poised for mavorixafor launch in 2024

X4 Pharmaceuticals is on track for a significant mavorixafor launch in 2024, backed by strong financials and strategic initiatives. Challenges in patient diagnosis and access require focused efforts post-approval.

X4 Pharmaceuticals reports milestone achievements and financial stability for growth

X4 Pharmaceuticals showcased strong clinical advancements and financial stability in 2023, positioning them for potential FDA approval and market expansion.
While facing challenges in managing expenses and addressing stakeholder queries, the company remains optimistic about revenue opportunities and growth prospects.
With a focus on regulatory milestones, market entry strategies, and revenue generation, X4 Pharmaceuticals aims to capitalize on the momentum from their achievements.

X4 Pharmaceuticals reports FDA approval for XOLREMDI, faces financial challenges

X4 Pharmaceuticals faces financial challenges with a significant net loss despite having a substantial cash position.
The FDA approval of XOLREMDI for WHIM syndrome highlights the company's progress in drug development.
Opportunities lie in expanding XOLREMDI's market reach, monetizing PRV, and advancing R&D efforts for future growth.

X4 Pharmaceuticals excels in Phase II study and FDA approval, eyes market expansion in 2025

X4 Pharmaceuticals showcased positive results from the Phase II study of mavorixafor and FDA approval for XOLREMDI, signaling significant advancements in product development and market penetration.
While challenges exist in transitioning to Phase III trials and ensuring successful commercialization, the company's focus on physician comfort, disease awareness, and patient education presents opportunities for growth.
Overall, X4 Pharmaceuticals is well-positioned to capitalize on its recent achievements and drive further success through strategic initiatives in product development and market expansion.

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X4 Pharmaceuticals, Inc. is a late clinical-stage company, which engages in the development and discovery of novel therapeutics for the treatment of rare diseases and those with limited treatment options. Its clinical candidate is mavorixafor. The company was founded by Henri A. Termeer, Keith T. Flaherty, Renato T. Skerlj, Richard Peters and Paula Ragan in 2010 and is headquartered in Boston, MA.

BOSTON, Nov. 14, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that management will participate in the Stifel 2024 Healthcare Conference, taking place in New York, NY on November 18-19, 2024.

X4 Pharmaceuticals to Participate in the Stifel 2024 Healthcare Conference

X4 Pharmaceuticals, Inc. (NASDAQ:XFOR ) Q3 2024 Earnings Conference Call November 13, 2024 8:00 AM ET Company Participants Daniel Ferry - IR, LifeSci Advisors Paula Ragan - CEO Christophe Arbet-Engels - Chief Medical Officer Mark Baldry - CCO Conference Call Participants Kristen Kluska - Cantor Edward Tenthoff - Piper Sandler Swayampakula Ramakanth - H.C. Wainwright Stephen Willey - Stifel David Bautz - Zacks Operator Greetings, and welcome to the X4 Pharmaceuticals Call and Webcast.

X4 Pharmaceuticals, Inc. (XFOR) Q3 2024 Earnings Call Transcript

Positive results from completed Phase 2 study of mavorixafor in chronic neutropenia (CN) announced today Pivotal Phase 3 trial of mavorixafor in CN on track to fully enroll in mid-2025 U.S. launch of XOLREMDI® (mavorixafor) in WHIM underway; submission of Marketing Authorization Application (MAA) to European Medicines Agency (EMA) expected by early 2025 Conference call and webcast today at 8:00 a.m. ET BOSTON, Nov. 13, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today reported financial results for the third quarter ended September 30, 2024 and highlighted recent and key upcoming expected milestones.

X4 Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Corporate Update

Mavorixafor durably and meaningfully elevated participants' mean absolute neutrophil counts (ANC) Mavorixafor enabled substantial reductions in G-CSF dosing while maintaining  mean ANC at normal levels Phase 2 study results and new analysis confirming functionality of neutrophils in sub-study participants bolster confidence in achieving success in Phase 3 4WARD trial Company conference call and webcast today at 8:00 am ET BOSTON, Nov. 13, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced positive new clinical data from its now completed Phase 2 clinical trial evaluating mavorixafor, an oral CXCR4 antagonist, in the treatment of people with chronic neutropenia (CN). An analysis of final data from the six-month study showed that once-daily oral mavorixafor durably and meaningfully increased participants' mean absolute neutrophil counts (ANC).

X4 Pharmaceuticals Announces Positive Results from Completed Six-Month Phase 2 Trial of Mavorixafor in Chronic Neutropenia (CN)

BOSTON, Nov. 01, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that, effective on October 31, 2024, the company issued inducement awards to new employees under the X4 Pharmaceuticals, Inc. 2019 Inducement Equity Incentive Plan (the “2019 Inducement Plan”). The 2019 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee of X4. The inducement awards consist of options to purchase an aggregate of 271,764 shares of X4's common stock. These stock awards were granted as an inducement material to the new employees entering into employment with X4 in accordance with Nasdaq Listing Rule 5635(c)(4) and were approved by X4's Compensation Committee of the Board of Directors.

X4 Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

BOSTON, Oct. 24, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that it will report financial results for the third quarter ended September 30, 2024 and present results from its concluded Phase 2 clinical trial evaluating mavorixafor in people with chronic neutropenia on Wednesday, November 13, 2024.

X4 Pharmaceuticals to Report Third-Quarter 2024 Financial and Phase 2 Chronic Neutropenia Study Results During Conference Call and Webcast on November 13, 2024

BOSTON, Oct. 01, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that, effective on September 30, 2024, the company issued inducement awards to new employees under the X4 Pharmaceuticals, Inc. 2019 Inducement Equity Incentive Plan (the “2019 Inducement Plan”). The 2019 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee of X4. The inducement awards consist of options to purchase an aggregate of 744,468 shares of X4's common stock. These stock awards were granted as an inducement material to the new employees entering into employment with X4 in accordance with Nasdaq Listing Rule 5635(c)(4) and were approved by X4's Compensation Committee of the Board of Directors.

X4 Pharmaceuticals Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

BOSTON, Aug. 28, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that management will be participating in three upcoming investor conferences in September 2024:

X4 Pharmaceuticals to Participate in Upcoming September Investor Conferences

X4 Pharmaceuticals, Inc. (NASDAQ:XFOR ) Q2 2024 Results Conference Call August 8, 2024 8:30 AM ET Company Participants Dan Ferry - IR Paula Ragan - CEO Adam Mostafa - CFO Mark Baldry - CCO Conference Call Participants David Bautz - Zacks Small-Cap Research Stephen Willey - Stifel Leah Cann - Brookline Capital Markets RK - H.C. Wainwright Ed Tenthoff - Piper Sandler Kristen Kluska - Cantor Operator Good morning, everyone, and welcome to X4 Pharmaceuticals Second Quarter 2024 Earnings Conference Call.

X4 Pharmaceuticals, Inc. (XFOR) Q2 2024 Earnings Call Transcript

First U.S. commercial sales of XOLREMDI™ (mavorixafor) following April 2024 FDA approval Positive interim data from Phase 2 trial of mavorixafor in chronic neutropenia; full trial results expected in November 2024 Initiated global, pivotal Phase 3 trial of mavorixafor in chronic neutropenia Conference call to be hosted today at 8:30 a.m. ET BOSTON, Aug. 08, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today reported financial results for the second quarter ended June 30, 2024 and highlighted key recent and upcoming expected milestones.

X4 Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides Corporate Updates

X4 Pharmaceuticals, Inc. stock price dropped due to the discontinuation of Phase II study for chronic neutropenia, but the potential market for mavorixafor is substantial. X4 Pharmaceuticals is targeting rare diseases with mavorixafor, approved for WHIM syndrome, and moving forward with a Phase III trial for CN. X4 Pharmaceuticals has the potential for significant growth with mavorixafor addressing multiple rare diseases, but faces risks including FDA approval and market penetration.

X4 Pharmaceuticals: Catch The Falling Knife After Propitious Mavorixafor Data

100% of evaluable participants at Month 6 achieved target absolute neutrophil count (ANC) increase with once-daily, oral mavorixafor +/- stable-dose G-CSF as of the interim analysis data cut-off date

X4 Pharmaceuticals Announces Positive Interim Clinical Data from Ongoing Six-Month Phase 2 Trial of Mavorixafor in Chronic Neutropenia (CN) and Initiation of Pivotal Phase 3 CN Trial

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Webcast to include interim hematological results from at least 15 trial participants and feature experts in the treatment of chronic neutropenia Webcast to include interim hematological results from at least 15 trial participants and feature experts in the treatment of chronic neutropenia

X4 Pharmaceuticals to Host Virtual Investor Event on June 27, 2024 to Review New Mavorixafor Clinical Data from Ongoing Phase 2 Trial in Chronic Neutropenia

BOSTON, May 13, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that management will be participating in the upcoming H.C. Wainwright 2nd Annual BioConnect Investor Conference, taking place on May 20th, 2024, at the Nasdaq Stock Exchange in New York City.

X4 Pharmaceuticals to Participate in the H.C. Wainwright 2nd Annual BioConnect Investor Conference

$125 million of non-dilutive capital extends projected cash runway into late 2025, excluding expected commercial sales from XOLREMDI™ (mavorixafor)

X4 Pharmaceuticals Announces $125 Million Capital Infusion from $105 Million Sale of Priority Review Voucher and $20 Million Drawdown from Existing Loan Facility

U.S. launch underway for XOLREMDI™ (mavorixafor) in WHIM syndrome XOLREMDI Phase 3 4WHIM clinical trial data published online in Blood, the journal of the American Society of Hematology Presentation of interim clinical data from the ongoing mavorixafor Phase 2 trial in chronic neutropenia expected at a planned company investor event in June 2024 Conference call to be hosted today at 8:30 a.m. ET BOSTON, May 07, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today reported financial results for the first quarter ended March 31, 2024 and highlighted key recent and upcoming expected milestones.

X4 Pharmaceuticals Reports First-Quarter 2024 Financial Results and Provides Corporate Updates

BOSTON, April 30, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that it will be reporting financial results for the first quarter ended March 31, 2024 and providing corporate updates on Tuesday, May 7, 2024.

X4 Pharmaceuticals to Report First-Quarter 2024 Financial Results and Host a Conference Call and Webcast on May 7, 2024

X4 Pharmaceuticals, Inc. received FDA approval for mavorixafor in WHIM syndrome, along with a priority review voucher (typically worth $100M). X4 Pharmaceuticals has announced very premium pricing considering the benefits of mavorixafor and ultra-orphan target indication. Based on this pricing, considerable (relevant to current EV) peak sales are expected. X4 Pharmaceuticals is well-funded to support mavorixafor commercialization, and I expect a further run-up towards upcoming data in chronic neutropenia indication.

X4 Pharmaceuticals: FDA Approval For WHIM Warrants Further Upside

The U.S. FDA has approved X4 Pharmaceuticals' drug to treat a rare genetic immunodeficiency disease, the company said on Monday.

US FDA approves X4 Pharmaceuticals' drug for immunodeficiency disease

XOLREMDI targets CXCR4 pathway dysfunction, the underlying cause of WHIM syndrome Breakthrough Therapy approval follows Priority Review of 4WHIM Phase 3 clinical trial data X4 granted Rare Pediatric Disease Priority Review Voucher (PRV) concurrent with approval Conference call and webcast to be hosted today at 8:30 am ET BOSTON, April 29, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that the U.S. Food and Drug Administration (FDA) has approved XOLREMDI™ (mavorixafor) capsules for use in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) to increase the number of circulating mature neutrophils and lymphocytes. XOLREMDI, a selective CXC chemokine receptor 4 (CXCR4) antagonist, is the first therapy specifically indicated in patients with WHIM syndrome, a rare, combined primary immunodeficiency and chronic neutropenic disorder caused by CXCR4 pathway dysfunction.

X4 Pharmaceuticals Announces FDA Approval of XOLREMDI™ (mavorixafor) Capsules, First Drug Indicated in Patients with WHIM Syndrome

BOSTON, April 01, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that management will be participating in the upcoming Needham 23rd Annual Healthcare Conference being held virtually from April 8-11, 2024, and the Piper Sandler Spring Biopharma Symposium being held in Boston from April 16-17, 2024.

X4 Pharmaceuticals to Participate in Upcoming April Investor Conferences

X4 Pharmaceuticals, Inc. (XFOR) Q4 2023 Earnings Call Transcript

Launch preparations underway in anticipation of possible U.S. approval of mavorixafor for WHIM syndrome; U.S. PDUFA target action date set for April 30, 2024

X4 Pharmaceuticals Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides Corporate Update

BOSTON, March 12, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that it will be reporting financial results for the fourth-quarter and full year ended December 31, 2023 and providing corporate updates on Thursday, March 21, 2024.

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