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.
Medexus Pharmaceuticals (OTCQX:MEDXF) reported strong fiscal year 2025 results, with revenue of $108.3 million and record net income of $2.2 million. The company achieved record Adjusted EBITDA of $20.2 million, up 3.6% year-over-year.
A key highlight was the early commercial launch of GRAFAPEX in February 2025, following FDA approval in January. Initial market response has been positive, with 34 transplant centers ordering the product and four large commercial payers covering approximately 34 million patient lives making positive formulary inclusion determinations. Medexus expects GRAFAPEX annual revenue to exceed $100 million within five years post-launch.
The company's available liquidity increased to $24.0 million as of March 31, 2025, up from $5.3 million the previous year, primarily due to a public offering of Common Shares in January 2025.
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.