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 Inc. (OTCQX:MEDXF) will present at the SNN Network Summer Virtual Event 2021 on August 19 at 11:30 AM EST. CEO Ken d'Entremont and CFO Marcel Konrad will lead the presentation. Investors can access the live event here. Registration for 1x1 meetings is available here. If unable to attend, webcasts of all presentations will be accessible on the event platform under the Agenda tab here.
Medexus Pharmaceuticals Inc. plans to hold a conference call on August 17, 2021, at 8:00 AM ET to discuss its fiscal 2022 Q1 financial results, which will be filed post-market on August 16, 2021. The Company focuses on innovative treatment solutions for rare diseases in North America, featuring products like Rasuvo™, IXINITY®, and Rupall®. The call will be accessible via phone and webcast, with a replay available through August 24, 2021. Medexus aims to leverage its strong product portfolio for future growth.
Medexus Pharmaceuticals Inc. (TSX: MDP, OTCQX: MEDXF) will present at the Canaccord Genuity 41st Annual Growth Conference virtually from August 10-12, 2021. The presentation is scheduled for August 12, 2021, at 2:00 P.M. Eastern Time. CEO Ken d’Entremont and CFO Marcel Konrad will provide a company overview and host one-on-one meetings during the event. Medexus focuses on innovative treatment solutions for rare diseases, featuring products such as Rasuvo™, IXINITY®, and Rupall®. The company aims to excel in hematology, autoimmune diseases, and allergy therapy.
Medexus Pharmaceuticals has scheduled a webinar for August 5, 2021, to discuss the FDA's Complete Response Letter (CRL) concerning the New Drug Application for treosulfan. The FDA has indicated that it cannot approve the NDA in its current form, citing the need for additional clinical data regarding primary and secondary endpoints from a pivotal Phase III study. Despite this setback, Medexus remains optimistic about the drug's potential approval, given favorable responses from regulatory agencies worldwide and promising survival data for at-risk groups.
Medexus Pharmaceuticals announced that its licensor medac GmbH received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for treosulfan, aimed for hematopoietic stem cell transplantation. The FDA did not approve the NDA in its current form, citing the need for additional clinical data. Despite the setback, Medexus remains optimistic about future FDA discussions and highlights treosulfan's potential benefits for at-risk patient groups. The company is prepared for a commercial launch pending approval.
Medexus Pharmaceuticals announces the appointment of Marcel Konrad as the new Chief Financial Officer, succeeding Roland Boivin, effective immediately. Boivin will assist in the transition for about three months. Konrad has over 20 years of finance experience, most recently at CareDx, where he played a key role in scaling operations. His background also includes significant roles at Santen and Novartis. Medexus aims to expand its portfolio in rare disease treatments and innovate healthcare solutions.
Medexus Pharmaceuticals has established a licensing agreement with medac GmbH to commercialize treosulfan in Canada. This product, branded as Trecondyv®, is approved for treating adult patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS), and is expected to launch in September 2021. Medexus will manage sales and marketing, while medac will handle manufacturing. The partnership enhances Medexus's innovative portfolio and prepares for a similar launch in the U.S. with a PDUFA date set for August 11.
Medexus Pharmaceuticals has received Health Canada's Notice of Compliance (NOC) for treosulfan, enabling its commercialization in Canada under the brand name Trecondyv®. This drug, indicated for adults with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS), will be available commercially soon, having previously been distributed under a Special Access Program. The company anticipates launching Trecondyv® in Q3 2021 and is optimistic about receiving FDA approval in the U.S. following positive clinical data.
Medexus Pharmaceuticals reported financial results for Q4 and fiscal year 2021, with revenue reaching $79.7 million, a 43.5% increase from the prior year. Q4 revenue was $17.6 million, a decline from $18.8 million due to IXINITY® sales reduction. The company posted a net loss of $10.5 million in Q4 and $28.3 million for the year. As of March 31, 2021, cash and cash equivalents totaled $18.7 million. The firm emphasizes growth in the U.S. market driven by the licensing of treosulfan, with a PDUFA date on August 11, 2021.
Medexus Pharmaceuticals announced the final approval for its common shares to list on the Toronto Stock Exchange (TSX), with trading set to begin on June 17, 2021. This upgrade from the TSX Venture Exchange aims to enhance the company’s profile and liquidity, attracting a wider range of institutional investors. The company also confirmed that its previous plans for a Nasdaq listing are postponed but remain a future goal. Alongside common shares, convertible debentures and warrants will also transition to TSX.