MEDEXUS PHARMS INC - MEDXF STOCK NEWS

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®.

Medexus Pharmaceuticals announces its participation in the 34th Annual Roth Conference, scheduled for March 13-15, 2022, in Dana Point, CA. CEO Ken d’Entremont and CFO Marcel Konrad will conduct one-on-one meetings with investors during this event, which features small group meetings and industry panels from around 400 companies. Medexus is focused on innovative treatments for rare diseases, with products like Rasuvo™, Metoject®, IXINITY®, and Rupall®. The company also recently gained approval for Treosulfan in Canada and awaits FDA review.

Medexus Pharmaceuticals has secured exclusive commercialization rights for Gleolan in the U.S., enhancing its existing rights in Canada. Gleolan, an optical imaging agent, aids in glioma surgery by improving visualization of malignant tissues. It generated $3–4 million in U.S. net sales during Q4 2021. This agreement includes tiered royalty payments and milestone payments to NX Development Corp., and extends through March 31, 2028. Gleolan may also receive new indications, including meningioma, indicating potential for growth in U.S. revenues, particularly with the upcoming U.S. launch of Treosulfan.