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 Pharmace (MEDXF) is a North American specialty pharmaceutical leader focused on innovative therapies for complex conditions in oncology, hematology, and rheumatology. This page provides investors and healthcare professionals with essential updates on the company's latest developments.
Access timely press releases covering regulatory milestones, product launches, financial results, and strategic partnerships. Our curated news collection helps stakeholders track MEDXF's progress in commercializing treatments for rare diseases and autoimmune disorders.
Key updates include FDA/Health Canada submissions, licensing agreements, clinical trial developments, and market expansion initiatives. All content is verified for accuracy and relevance to support informed decision-making.
Bookmark this page for direct access to MEDXF's official announcements and analysis of its growing role in specialty pharmaceuticals. Check regularly for updates demonstrating the company's commitment to addressing unmet medical needs through targeted therapeutic solutions.
Medexus Pharmaceuticals (MEDXF) has secured a significant reimbursement agreement with Quebec's Public Prescription Drug Insurance Plan (RAMQ) for Trecondyv® (treosulfan for injection). This achievement marks public reimbursement coverage in Canada's three most populous provinces, reaching approximately 75% of the Canadian population.
The company is actively pursuing reimbursement approvals from remaining provincial, territorial, and federal government organizations to expand Trecondyv® accessibility through public drug plans. This development also signals positive prospects for both Trecondyv® in Canada and GRAFAPEX™ (treosulfan) for Injection in the US market.
Medexus Pharmaceuticals (MEDXF) reports positive initial progress on the commercial launch of GRAFAPEX™ (treosulfan) for Injection in the United States since its February 24 launch. The company has already sold the product to 16 unique institutions, with several procedures completed using commercially available GRAFAPEX™.
Key highlights include:
- Expected annual product-level Adjusted Gross Margin of approximately 80%, compared to recent portfolio-wide margins of 56.3% (Q3 2025) and 59.5% (Q2 2025)
- Projected annual product-level revenue of at least US$100 million within five years after launch
- Inclusion in NCCN Clinical Practice Guidelines in Oncology on February 28
- 34 presentations and abstracts relating to treosulfan presented at the 2025 EBMT Annual Meeting
The company expects GRAFAPEX™ to be accretive to quarterly operating cash flows by fiscal Q4 2026 and is monitoring potential impacts of new U.S. tariffs on imports.
Medexus Pharmaceuticals (OTCQX: MEDXF) has finalized an agreement to return the US commercialization rights for Gleolan® to NX Development Corp. (NXDC). The transition will be completed by March 31, 2025.
Under the termination agreement, Medexus will receive a per-unit compensation on Gleolan® units sold by NXDC through June 30, 2025. This amount is comparable to the product's historical per-unit contribution to Medexus and will reduce the company's royalty payment to NXDC for fiscal year 2025, due in June 2025.
Medexus Pharmaceuticals (MEDXF) announces the commercial launch of GRAFAPEX (treosulfan) for Injection in the United States, approximately one month after FDA approval. The company has set the wholesale acquisition cost at US$3,050 per 5-gram vial and US$610 per 1-gram vial.
The company projects that GRAFAPEX's annual product-level revenue in the US market could exceed US$100 million within five years after commercial launch. The product has already received orders and positive feedback from the 2025 Tandem Meetings, with several key US institutions expressing interest. GRAFAPEX is available as treosulfan in a lyophilized powder form in single-dose vials for injection.
Medexus Pharmaceuticals (MEDXF) reported strong fiscal Q3 2025 results with revenue of $30.0 million, representing a 19.0% increase from the previous year. The company achieved net income of $0.7 million and Adjusted EBITDA of $5.8 million, an 81.3% year-over-year increase.
Key developments include FDA approval of GRAFAPEX in January 2025, with commercial launch expected by April 2025. Management believes GRAFAPEX has potential to exceed $100 million in annual revenue within five years post-launch. The company completed a public offering in January 2025, raising C$30 million in gross proceeds.
Notable product performance includes strong growth in Rupall and Trecondyv, while IXINITY showed stable demand. The company's available liquidity increased to $8.4 million as of December 31, 2024, up from $5.3 million in March 2024.
Medexus Pharmaceuticals (MEDXF) has successfully completed listing agreements with Ontario's Ministry of Health and Ontario Health for Trecondyv (treosulfan for injection). This enables public reimbursement through Ontario Public Drug Programs for eligible claims, marking a significant milestone following the pCPA negotiation process.
The company is now focused on securing similar reimbursement agreements with other provincial, territorial, and federal government organizations across Canada. This development follows the recent FDA approval of GRAFAPEX (treosulfan) for Injection in the US market, highlighting the expanding potential of Medexus's treosulfan products in North America.
Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) has announced its upcoming third fiscal quarter 2025 conference call, scheduled for Thursday, February 6, 2025, at 8:00 am Eastern Time. The company will discuss financial results for the quarter ended December 31, 2024, with financial statements and MD&A expected to be filed after market close on February 5, 2025.
The call will be accessible via toll-free numbers for Canadian and U.S. callers (888-506-0062) and international callers (+1 973-528-0011) using access code 571655. A live webcast will be available on Medexus's corporate website's Investors section. A replay will be accessible until February 13, 2025, through dedicated phone numbers, and the webcast recording will remain available until February 6, 2026.
Medexus Pharmaceuticals announces FDA approval of GRAFAPEX (treosulfan), an alkylating agent used with fludarabine for allogeneic hematopoietic stem cell transplantation in AML or MDS patients. The drug holds Orphan Drug Designation, providing up to 7.5 years of regulatory exclusivity.
The company targets commercial launch in first half of 2025, projecting annual product-level revenue to exceed $100 million within five years. A $15 million regulatory milestone payment to medac GmbH will be made in installments: $2.5M by June 2025, $5M by October 2025, and $7.5M by January 2026.
Preliminary Q3 2025 estimates show revenue between $29.5-30.5 million (17% YoY increase), Adjusted EBITDA of $5.5-6.0 million (70% YoY increase), and operating income of $3.5-4.0 million (123% YoY increase). The company reports $8.5 million in available liquidity as of December 31, 2024.
Medexus Pharmaceuticals (MEDXF) has secured a listing agreement with British Columbia's Provincial Health Services Authority for Trecondyv (treosulfan for injection) to be included on the BC Cancer Benefit Drug List. This agreement enables public reimbursement for eligible patients using Trecondyv in combination with fludarabine as conditioning treatment before allogeneic hematopoietic stem cell transplantation in adult patients with acute myeloid leukemia or myelodysplastic syndromes who are at increased risk for standard conditioning therapies.
This marks the first reimbursement milestone following the successful completion of the pCPA negotiation process. Medexus is actively working with other provincial, territorial, and federal government organizations to expand public reimbursement coverage across Canada. The company views this development as an important indicator of the product's potential in both the Canadian market and potentially the US market, pending FDA approval.
Medexus Pharmaceuticals has amended its US treosulfan licensing agreement with medac, establishing new regulatory milestone payments tied to FDA approval. The payment structure varies based on product labeling: US$15 million for basic approval, US$20 million for non-inferiority, or US$45 million for clinical superiority. Payments will be made in three installments: one-sixth by June 2025, one-third by October 2025, and the remaining 50% by January 2026. The company expects FDA approval by January 30, 2025, projecting potential annual US revenue exceeding US$100 million within five years post-launch.
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