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 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.
Medexus Pharmaceuticals Inc. (TSXV: MDP, OTCQX: MEDXF) will present at the Raymond James Human Health Innovation Conference on June 21, 2021, at 2:40 PM ET. CEO Ken d’Entremont and CFO Roland Boivin will provide a company overview and business update, which will be available for live webcast and replay on the company's website. The management team will also engage in virtual one-on-one meetings throughout the conference. Medexus focuses on innovative products for rare diseases, with key products including Rasuvo™, IXINITY®, and Rupall®.
Medexus Pharmaceuticals Inc. (TSXV: MDP, OTCQX: MEDXF) will host a conference call on June 17, 2021, at 8:00 AM ET to discuss its financial results for the fiscal year ended March 31, 2021. Financial statements and MD&A will be filed post-market on June 16, 2021. The call can be accessed via telephone or through a webcast. Medexus focuses on innovative rare disease treatments, including Rasuvo™, IXINITY®, and Rupall®, and aims to advance its portfolio to support growth over the next decade.
Medexus Pharmaceuticals has expanded its medical affairs team in anticipation of launching treosulfan, an innovative agent for patients receiving allo-HSCT. This proactive measure aims to ensure a successful launch by the scheduled PDUFA date in August 2021. Treosulfan, which showed a 64.0% two-year event-free survival rate in clinical trials, is projected to become the new standard of care, filling a significant market gap. The team includes experienced leaders like Keith Steward and J. Lynn Bass, enhancing Medexus's capability to engage with key stakeholders.
Medexus Pharmaceuticals (MEDXF) has announced the immediate availability of Triamcinolone Hexacetonide (TH) Injectable Suspension in the U.S. through the FDA’s Drug Shortage program. This drug is indicated for treating various inflammatory joint diseases. Medexus is collaborating with Ethypharm to expedite the data necessary for filing an Abbreviated New Drug Application (ANDA). The company aims to establish a solid portfolio in rare diseases, focusing on innovative healthcare products and expanding its commercial presence across North America.