Welcome to our dedicated page for Medexus Pharmace news (Ticker: MEDXF), a resource for investors and traders seeking the latest updates and insights on Medexus Pharmace stock.
Medexus Pharms Inc (MEDXF), referred to in its disclosures as Medexus Pharmaceuticals, generates a steady flow of news related to its specialty pharmaceutical business in North America. Investors following MEDXF news can see updates on hematology and hematology-oncology products, as well as allergy, dermatology, and rheumatology therapies that form the company’s core portfolio.
Many Medexus news releases focus on GRAFAPEX (treosulfan) for Injection, an alkylating agent used as part of a preparative regimen for allogeneic hematopoietic stem cell transplantation in patients with acute myeloid leukemia or myelodysplastic syndrome. The company reports on FDA approval, Orphan Drug Designation, US commercial launch timing, and key reimbursement milestones such as CMS New Technology Add-On Payment (NTAP) approval, transitional pass-through status, and assignment of a permanent HCPCS Level II "J code". These items provide insight into how Medexus is building its hematology-oncology franchise in the United States.
MEDXF news also covers quarterly and annual financial results, including net revenue, net income, Adjusted EBITDA, and product-level performance for GRAFAPEX, Trecondyv, IXINITY, Rupall, Rasuvo, Metoject, and Gleolan. The company uses these releases to discuss unit demand trends, the impact of generic competition on products such as Rupall, and portfolio dynamics across the United States and Canada.
Additional news topics include financing and capital allocation decisions, such as new senior secured credit facilities with National Bank of Canada, repayment of prior credit agreements, and the launch or renewal of a normal course issuer bid (NCIB) for Medexus common shares on the Toronto Stock Exchange. Governance-related items, including annual meetings of shareholders, director elections, and auditor appointments, are also reported.
For anyone tracking MEDXF, this news stream offers detailed information on product launches, regulatory and reimbursement milestones, financial performance, credit arrangements, and share repurchase activity. Bookmarking the Medexus news feed on Stock Titan can help investors and researchers follow how the company’s North American specialty pharmaceutical platform evolves over time.
On September 15, 2022, Medexus Pharmaceuticals held its annual meeting where all director nominees were reelected with overwhelming support. Key proposals were also approved, including the appointment of PricewaterhouseCoopers LLP as auditors and the adoption of a new equity compensation plan. Specifically, 99.43% voted for Ken d’Entremont, and 97.07% approved the auditors. Medexus focuses on innovative treatments in rare diseases, with products like IXINITY®, Rasuvo™, and Rupall® driving growth.
Medexus Pharmaceuticals reported record total revenue of $23.0 million for fiscal Q1 2023, a 33% increase from fiscal Q1 2022, driven by strong net sales of IXINITY and initial U.S. revenue from Gleolan. Adjusted EBITDA improved to $1.9 million from a loss of $4.9 million a year prior. The company aims for a full commercial launch of Gleolan in fiscal Q2 and has resubmitted the NDA for treosulfan to the FDA, with milestone payments deferred to October 2023.
Medexus Pharmaceuticals (MEDXF) will host a conference call on August 9, 2022, at 8:00 am ET, to discuss its financial results for Q1 ended June 30, 2022. The financial statements will be filed after market close on August 8, 2022. Interested participants can join via a toll-free number or through a live webcast available on Medexus’s corporate website. The company focuses on innovative treatment solutions for rare diseases, including approved products like Rasuvo™ and IXINITY® and recently licensed Treosulfan for use in stem cell transplantation.
Medexus Pharmaceuticals, in partnership with medac, has resubmitted a New Drug Application (NDA) for treosulfan to the FDA, which, if approved, could significantly impact the company’s revenue. The NDA seeks approval for treosulfan in combination with fludarabine for allogeneic hematopoietic stem cell transplantation. The pivotal phase 3 trial met its primary and key secondary endpoints, enhancing the prospects for approval within six months. With the potential to capture a market previously generating $126 million annually, Medexus is optimistic about treosulfan's future in the U.S.
Medexus Pharmaceuticals (MEDXF) reported its fiscal Q4 and full-year results, revealing a total revenue of $20.3 million for Q4 2022, marking a 15% increase year-over-year, despite a 5% decrease compared to Q3 2022. The total revenue for the fiscal year was $76.7 million, a 4% decrease from 2021. Adjusted EBITDA for Q4 was $1.1 million, compared to a loss of $1.6 million in Q4 2021. The company recorded a net loss of $5.3 million for Q4, reflecting progress from a $10.5 million loss in Q4 2021.
Medexus anticipates improved operational efficiencies and revenue growth from Gleolan, with product revenue expected in fiscal Q2 2023.
Medexus Pharmaceuticals (OTCQX: MEDXF) will host a conference call on June 23, 2022, at 8:00 am ET to discuss its fourth-quarter and fiscal year results for the period ending March 31, 2022. Financial statements will be filed after market close on June 22, 2022. Participants can join via a toll-free number or through a live webcast available on Medexus’s corporate website. The company is focused on innovative treatment solutions for rare diseases, including products like Rasuvo™ and IXINITY®.
Medexus Pharmaceuticals (OTCQX: MEDXF) announces that the American Journal of Hematology has accepted the pivotal phase 3 study results of treosulfan for publication. The study demonstrated superior event-free survival (EFS) and overall survival (OS) rates for treosulfan compared to the reduced-intensity conditioning (RIC) busulfan in older patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Key findings include a 36-month EFS rate of 59.5% for treosulfan versus 49.7% for busulfan. Medexus will host a web conference on June 6, 2022, to discuss these findings.
Medexus Pharmaceuticals has received acknowledgment from the FDA regarding the NDA resubmission for Treosulfan, which was submitted on April 21, 2022. The FDA has requested additional data and supporting information, and medac, a strategic partner of Medexus, expects to respond within the required 12-month timeline. The review process will begin once the FDA confirms the submission is complete. Medexus is advancing its commercial launch plan for Treosulfan, which has already been approved in Canada.
Medexus Pharmaceuticals announces the resubmission of its New Drug Application (NDA) for Treosulfan to the FDA, requesting approval for its use with fludarabine in allogeneic hematopoietic stem cell transplantation. This NDA resubmission includes new clinical data and updates requested by the FDA. The FDA's review timeline is expected to be communicated within 30 days, with a decision anticipated within six months. If approved, Treosulfan will be launched commercially in the U.S. in fiscal year 2023, potentially becoming a new standard of care for certain hematological conditions.
Medexus Pharmaceuticals will present at the Bloom Burton & Co. Healthcare Investor Conference on May 2-3, 2022. CEO Ken d’Entremont and CFO Marcel Konrad will present on May 2, 2022, at 11:30 am Toronto time. The conference aims to connect investors interested in the Canadian healthcare sector. Attendees can view the presentation live through a link provided in the press release. Medexus focuses on innovative treatments for rare diseases, with key products like Rasuvo™, IXINITY®, and Trecondyv®.