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.

X4 Pharmaceuticals has dipped considerably following updated results presented in ASH suggesting that mavorixafor may not be effective as monotherapy in chronic neutropenia (excluding WHIM). Mavorixafor will likely still have a role in chronic neutropenia as add-on to G-CSF. Mavorixafor can enable reductions in G-CSF dosing, which can improve tolerability and is meaningful for patients. FDA has granted priority review for mavorixafor in WHIM, with a PDUFA date of April 30, 2024, and a potential PRV worth $100M upon approval.

X4: Dip Following Mixed Results In Chronic Neutropenia Indication Worth Buying

Initial data continue to support advancement of mavorixafor into pivotal, global Phase 3 trial in certain chronic neutropenic disorders; company on track to initiate in 1H 2024

X4 Pharmaceuticals Announces Presentation of Additional Data from Mavorixafor Phase 2 Trial in Chronic Neutropenia at ASH 2023

BOSTON, Nov. 10, 2023 (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 fireside chats at the upcoming Stifel Healthcare Conference being held in New York City, from November 14-15, 2023, and the Piper Sandler 35th Annual Healthcare Conference being held in New York City, from November 28-30, 2023.

X4 Pharmaceuticals to Participate in Upcoming November Investor Conferences

X4 Pharmaceuticals, Inc. (NASDAQ:XFOR ) Q3 2023 Earnings Conference Call November 9, 2023 8:30 AM ET Company Participants Dan Ferry – LifeSci Advisors Paula Ragan – Chief Executive Officer Mark Baldry – Chief Commercial Officer Christophe Arbet-Engels – Chief Medical Officer Adam Mostafa – Chief Financial Officer Conference Call Participants Eva Privitera – TD Cowen Stephen Willey – Stifel Edward Tenthoff – Piper Sandler Andy Fleszar – B. Riley Securities Kristen Kluska – Cantor Fitzgerald Swayampakula Ramakanth – H.C.

X4 Pharmaceuticals, Inc. (XFOR) Q3 2023 Earnings Call Transcript

U.S. New Drug Application for mavorixafor in WHIM syndrome accepted for Priority Review, establishing a PDUFA target action date of April 30, 2024; X4 eligible to receive  Priority Review Voucher if approved

X4 Pharmaceuticals Reports Third-Quarter 2023 Financial Results and Provides Corporate Updates

BOSTON, Nov. 02, 2023 (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 third quarter ended September 30, 2023 and providing corporate updates on Thursday, November 9, 2023.

X4 Pharmaceuticals to Report Third-Quarter 2023 Financial Results and Host a Conference Call and Webcast on November 9, 2023

FDA sets a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024 If the NDA is approved, company eligible to receive a Priority Review Voucher (PRV) resulting from mavorixafor's rare pediatric designation in WHIM syndrome NDA supported by positive results from global, pivotal 4WHIM Phase 3 clinical trial BOSTON, Oct. 31, 2023 (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 United States Food and Drug Administration (FDA) has accepted for filing the company's New Drug Application (NDA) for once-daily, oral mavorixafor to treat individuals aged 12 and older with WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis) syndrome, a rare, primary immunodeficiency. The FDA granted Priority Review of the mavorixafor NDA, establishing a goal of six months review from the date of acceptance and assigning a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.

X4 Pharmaceuticals Announces FDA Acceptance with Priority Review of U.S. NDA for Mavorixafor in WHIM Syndrome

BOSTON, Oct. 18, 2023 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced the appointment of R. Keith Woods as an independent director to the company's Board of Directors.

X4 Pharmaceuticals Announces Appointment of Industry Veteran R. Keith Woods to Board of Directors

BOSTON, Sept. 19, 2023 (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 a fireside chat at the upcoming Cantor Global Healthcare Conference being held in New York City, from September 26-28, 2023.

X4 Pharmaceuticals to Participate in the Cantor Global Healthcare Conference

BOSTON, Sept. 06, 2023 (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 a fireside chat at the upcoming Morgan Stanley 21st Annual Global Healthcare Conference in New York City.

X4 Pharmaceuticals to Participate in the Morgan Stanley 21st Annual Global Healthcare Conference

Submission supported by positive results from global, pivotal 4WHIM Phase 3 clinical trial Submission supported by positive results from global, pivotal 4WHIM Phase 3 clinical trial

X4 Pharmaceuticals Announces Submission of New Drug Application (NDA) to U.S. FDA for Mavorixafor in WHIM Syndrome

X4 is nearing approval of its lead candidate for WHIM syndrome and aims for label expansion to a much larger market of chronic neutropenias. Despite very small WHIM target population, orphan designation (=premium pricing) and potential for non-dilutive funding from monetization of a priority review voucher justify upside potential. Early data from 3 patients in ongoing phase 2 study in chronic neutropenia patients are promising and showing durable responses. More data are expected in December.

X4: De-Risking By WHIM Indication, Promising Potential For Expansion To Larger Market

X4 Pharmaceuticals, Inc. (NASDAQ:XFOR ) Q2 2023 Results Conference Call August 10, 2023 8:30 AM ET Company Participants Dan Ferry - LifeSci Advisors Paula Ragan - CEO Adam Mostafa - CFO Murray Stewart - Interim CMO Mark Baldry - CCO Conference Call Participants Stephen Willey - Stifel Kristen Kluska - Cantor Fitzgerald Ted Tenthoff - Piper Sandler Mark Brown - Cowen and Company Mayank Mamtani - B. Riley RK - H.C.

X4 Pharmaceuticals, Inc. (XFOR) Q2 2023 Earnings Call Transcript

Submission of first U.S. New Drug Application for mavorixafor in WHIM syndrome  on track for early 2H 2023 Emerging data from ongoing Phase 2 trial in certain chronic neutropenic disorders show mavorixafor durably increased neutrophil counts and enabled reductions in G-CSF dosing New market research confirms significant initial target population for mavorixafor given  high unmet needs within U.S. chronic neutropenia (CN) market Plans underway for initiation of Phase 3 trial in certain chronic neutropenic disorders in 1H 2024 Conference call to be hosted today at 8:30 a.m. ET BOSTON, Aug. 10, 2023 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a leader in the discovery and development of novel small-molecule therapeutics to benefit people with rare diseases of the immune system, today reported financial results for the second quarter ended June 30, 2023, highlighted key recent and upcoming expected milestones, and presented emerging data from its ongoing Phase 2 clinical trial of mavorixafor in people with certain chronic neutropenic disorders.

X4 Pharmaceuticals Reports Second-Quarter 2023 Financial Results, Provides Corporate Updates, and Reports Emerging Data from Chronic Neutropenia Clinical Program

BOSTON, Aug. 08, 2023 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel small molecule therapeutics to benefit patients with diseases of the immune system, today announced that Christophe Arbet-Engels, MD, PhD, will be joining the company as its new Chief Medical Officer, bringing more than 25 years' experience in strategic global drug development across a wide range of therapeutic areas including rare and orphan diseases.

X4 Pharmaceuticals Announces Industry Veteran Dr. Christophe Arbet-Engels to Join as Chief Medical Officer

BOSTON, Aug. 03, 2023 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a leader in the discovery and development of novel small-molecule therapeutics to benefit people with rare diseases of the immune system, today announced the closing of a $115 million loan facility with Hercules Capital, Inc. (NYSE: HTGC) (“Hercules”). The company also announced that it drew down $22.5 million upon the transaction's closing.

X4 Pharmaceuticals Closes $115 Million Loan Facility with Hercules Capital

BOSTON, Aug. 02, 2023 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals, Inc.  (Nasdaq: XFOR), a leader in the discovery and development of novel small molecule therapeutics to benefit patients with diseases of the immune system, today announced that it will be reporting financial results for the second quarter ended June 30, 2023, and providing corporate and clinical program updates on Thursday, August 10, 2023.

X4 Pharmaceuticals to Report Second-Quarter 2023 Financial Results and Host a Conference Call and Webcast on August 10, 2023

The new drug application submission of mavorixafor for the treatment of patients with WHIM syndrome is expected in the 2nd half of 2023. Results from an ongoing phase 2 study using mavorixafor for idiopathic, cyclic, or congenital chronic neutropenia are expected to be released in Q2 or Q3 of 2023. A regulatory update on whether it can begin a phase 3 study using mavorixafor for idiopathic, cyclic, or congenital chronic neutropenia is expected Q2 or Q3 of 2023.

X4 Pharmaceuticals: Mavorixafor Could Change Chronic Neutropenic Treatment Landscape

BOSTON, June 13, 2023 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a leader in the discovery and development of novel small-molecule therapeutics to benefit people with rare diseases of the immune system, today announced that it expects to be added to the broad-market Russell 3000 Index at the conclusion of the 2023 Russell indexes annual reconstitution, effective after the U.S. market opens on June 26, 2023, according to a preliminary list of additions posted on June 9, 2023.

X4 Pharmaceuticals Expected to Join Russell 3000® Index

~60% reduction in annualized infection rate seen in the mavorixafor arm vs. placebo (p75% reduction in the percentage of individuals experiencing severe infections (Grade 3 or higher) in the mavorixafor group vs.

X4 Pharmaceuticals Announces Positive Phase 3 Results Showing Mavorixafor Reduced the Rate, Severity, and Duration of Infections vs. Placebo in Participants Diagnosed with WHIM Syndrome

BOSTON, May 16, 2023 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel small molecule therapeutics to benefit people with rare diseases of the immune system, today announced that it has agreed to sell an aggregate of 42,784,203 shares of common stock (or pre-funded warrants in lieu thereof) to certain institutional accredited investors in a private investment in public equity (PIPE) financing. X4 anticipates that gross proceeds from the PIPE will be approximately $65 million, before deducting fees to the placement agents and other estimated offering expenses payable by the Company.

X4 Pharmaceuticals Announces $65 Million Private Placement Priced At-the-Market

X4 Pharmaceuticals, Inc. (NASDAQ:XFOR ) Q1 2023 Results Conference Call May 4, 2023 8:30 AM ET Company Participants Dan Ferry - IR, LifeSci Advisors Dr. Paula Ragan - President and CEO Adam Mostafa - CFO Mark Baldry - Chief Commercial Officer Conference Call Participants William Wood - B. Riley Securities Eva Privitera - TD Cowen Swayampakula Ramakanth - Wainwright Rick Miller - Cantor Fitzgerald Operator Greetings, and welcome to X4 Pharmaceuticals' First Quarter 2023 Earnings Conference Call.

X4 Pharmaceuticals, Inc. (XFOR) Q1 2023 Earnings Call Transcript

Company to host webinar event on May 16 th presenting new clinical data from the 4WHIM Phase 3 trial; oral presentation to follow on May 21 st at the 2023 Clinical Immunology Society (CIS) Annual Meeting

X4 Pharmaceuticals Reports First-Quarter 2023 Financial Results and Provides Corporate Update

BOSTON, April 26, 2023 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals, Inc. (Nasdaq: XFOR), a leader in the discovery and development of novel small molecule therapeutics to benefit patients with diseases of the immune system, today announced that it will be reporting financial results for the first quarter ended March 31, 2023 on Thursday, May 4, 2023.

X4 Pharmaceuticals to Report First-Quarter 2023 Financial Results and Host a Conference Call and Webcast on May 4, 2023

X4 Pharmaceuticals, the Boston-based drug developer, saw its stock trading higher on Wednesday as investors gear up for new results from a Phase 3 trial of its oral cxcr4 antagonist, mavorixafor, for treatment of patients with WHIM syndrome. The firm will present new data at the Annual Meeting of the Clinical Immunology Society (CIS), which is taking place May 18-21, 2023, in St.

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