Medexus Pharmace Stock Price, News & Analysis

The FDA has requested additional information from medac regarding the NDA resubmission for treosulfan, delaying the approval process. Medexus Pharmaceuticals (OTCQX: MEDXF) has taken full responsibility for Gleolan's U.S. commercialization and recognizes 100% of its net sales starting September 2022, aiming for strong revenue growth with a record US$23 million revenue in Q1. CEO Ken d’Entremont remains optimistic about treosulfan's potential impact on U.S. patients, despite the FDA's prolonged response timeline.

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.