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.
About Medexus Pharmaceuticals
Medexus Pharmaceuticals (TSX: MDP, OTCQX: MEDXF) is a North American specialty pharmaceutical company dedicated to providing innovative and rare disease treatment solutions. With a strong commercial platform spanning Canada and the United States, Medexus focuses on addressing unmet medical needs in therapeutic areas such as oncology, hematology, rheumatology, autoimmune diseases, allergy, and dermatology.
Core Business Model
Medexus operates primarily through exclusive licensing agreements with global pharmaceutical developers, enabling the company to commercialize and distribute niche pharmaceutical products in North American markets. The company’s revenue streams are derived from product sales, supported by strategic investments in market access, regulatory compliance, and commercialization infrastructure. This model allows Medexus to capitalize on high-value markets while mitigating the risks associated with in-house drug development.
Therapeutic Focus and Product Portfolio
Medexus’s portfolio includes a diverse range of specialty pharmaceutical products targeting rare and complex conditions:
- Hematology-Oncology: Products like Trecondyv® (treosulfan for injection) in Canada and GRAFAPEX™ in the United States are used as preparative regimens for allogeneic hematopoietic stem cell transplantation in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
- Autoimmune and Rheumatology: Rasuvo® and Metoject®, methotrexate-based therapies, offer solutions for autoimmune diseases like rheumatoid arthritis.
- Allergy and Dermatology: Rupall® addresses allergy symptoms, while NYDA® is a treatment for head lice.
The company’s emphasis on rare diseases and specialty conditions positions it as a key player in underserved markets, supported by its expertise in navigating complex regulatory environments.
Market Position and Competitive Landscape
Medexus differentiates itself through its focus on high-value, niche markets with limited competition. The company’s strategic licensing agreements and market exclusivity for products like GRAFAPEX™ provide a competitive edge. However, it faces challenges such as generic competition, regulatory scrutiny, and the need to sustain market share through innovative pricing and marketing strategies.
Operational Highlights
Recent milestones include the FDA approval and commercial launch of GRAFAPEX™ in the U.S. and successful public reimbursement agreements for Trecondyv® in Canada. These developments underscore Medexus’s ability to execute its growth strategy effectively while maintaining financial discipline. The company has also implemented cost-reduction initiatives and secured additional capital to support its operations and future product launches.
Commitment to Expertise and Trust
Medexus’s success is built on its deep industry expertise, robust regulatory compliance, and commitment to addressing critical healthcare needs. By focusing on specialty pharmaceuticals and rare diseases, the company continues to build a reputation for innovation, reliability, and patient-centric solutions.
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.
Medexus Pharmaceuticals has announced a normal course issuer bid (NCIB) for its 6% unsecured convertible debentures due in 2023. Commencing February 16, 2022, and lasting up to 12 months, the NCIB allows Medexus to repurchase up to C$3,530,000 principal amount, equating to 10% of the public float. The initiative aims to deleverage the balance sheet, potentially lowering debt levels and future obligations. The average daily trading volume of the debentures is C$7,592. The company is focused on innovative treatments in rare diseases.
Medexus Pharmaceuticals (OTCQX: MEDXF) reported Q3 FY2022 revenue of $21.3 million, a 19% increase sequentially but 12% lower year-over-year. IXINITY sales recovery contributed significantly to this growth. Adjusted EBITDA improved to $1.9 million from a loss in the prior quarter, though down from $3.9 million in Q3 FY2021. The company recorded a net loss of $1.2 million, significantly improved from $12.8 million a year ago. Total available liquidity stands at $10.1 million. The NDA resubmission for Treosulfan is anticipated in Q2 2022, with FDA approval expected 2-6 months later.
Medexus Pharmaceuticals will present at The MicroCap Rodeo’s 2nd Annual Winter Wonderland Best Ideas Investor Conference, taking place virtually from February 8-11, 2022. The presentation is scheduled for February 8 at 3:00 P.M. Eastern Time, featuring CEO Ken d’Entremont and CFO Marcel Konrad. Medexus focuses on innovative treatments for rare diseases, offering products like Rasuvo™, Metoject®, IXINITY®, and Rupall®. Additionally, their licensed product, Treosulfan, is pending FDA review after its approval in Canada.
Medexus Pharmaceuticals (OTCQX: MEDXF) will host a conference call on February 10, 2022, at 8:00 AM ET to discuss its financial results for Q3 FY2022, ending December 31, 2021. The financial statements will be released after market close on February 9, 2022. Investors can participate via telephone or access a webcast through the company’s website. Medexus focuses on rare disease treatments, highlighting products like Rasuvo™ and IXINITY®, and plans to commercialize Treosulfan in the U.S. and Canada, currently under FDA review.
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