MEDEXUS PHARMS INC - MEDXF STOCK NEWS

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.

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.