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 Pharmaceuticals Inc. reports news on its specialty pharmaceutical portfolio and North American commercial operations. The company's updates center on GRAFAPEX (treosulfan) for Injection in the United States, financial results, and product-level trends across therapeutic areas that include hematology and hematology-oncology, rheumatology, allergy, and dermatology.
Medexus news also covers capital allocation and capital structure actions, including credit facilities, warrant expirations, and normal course issuer bid activity, along with shareholder meeting results, conference calls, and management participation in investor conferences.
Medexus Pharmaceuticals reported Q1 fiscal 2022 revenue of $17.3 million, down from $20 million a year ago, mainly due to decreased IXINITY® sales as clients worked through existing inventory. However, patient demand for IXINITY® grew 25.3%. Adjusted EBITDA dropped to $(4.9) million and net loss rose to $(6.6) million. Notably, Rupall™ showed strong growth with a 44.4% increase in unit demand. The company anticipates improvements as inventory levels normalize.
Medexus Pharmaceuticals has completed enrollment in its Phase 4 Clinical Trial for IXINITY®, targeting label expansion for pediatric hemophilia B patients under 12 years. The trial's results could potentially allow the use of IXINITY® in younger patients, currently approved for ages 12 and older. Completion is expected by June 2022, with an FDA data submission anticipated by the end of 2022. The U.S. hemophilia B market is valued over $1 billion, presenting significant opportunities for Medexus if label expansion is successful.
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.