MEDEXUS PHARMACEUTICALS INC


Associated tags: TSX, Patient, Pharmaceutical industry, Methotrexate, Hematopoietic stem cell transplantation, Hematology, Customer service, Blood, Treosulfan, Rheumatoid arthritis, Allergy, Health Canada, FDA, Collaboration, World Health Organization, Glioma

Medexus Schedules Fourth Quarter and Fiscal Year 2022 Conference Call

Retrieved on: 
Tuesday, June 14, 2022

TORONTO and CHICAGO, June 14, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX:MDP) (OTCQX:MEDXF) plans to host a conference call at 8:00am Eastern Time on Thursday, June23, 2022 to discuss Medexuss results for its fourth quarter and fiscal year ended March31, 2022.

Key Points: 
  • TORONTO and CHICAGO, June 14, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX:MDP) (OTCQX:MEDXF) plans to host a conference call at 8:00am Eastern Time on Thursday, June23, 2022 to discuss Medexuss results for its fourth quarter and fiscal year ended March31, 2022.
  • Medexus expects to file its financial statements and MD&A after markets close on June 22, 2022.
  • Medexus is a leader in innovative rare disease treatment solutions with a strong North American commercial platform and a portfolio of proven best-in-class products.
  • We strive to deliver on this mission by acting on our core values: Quality, Innovation, Customer Service, and Collaboration.

Treosulfan Pivotal Study Results Published

Retrieved on: 
Monday, June 6, 2022

TORONTO and CHICAGO, June 06, 2022 (GLOBE NEWSWIRE) --  Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) today announced that the American Journal of Hematology has accepted for publication the final study results and analysis of the pivotal phase 3 clinical trial of treosulfan conducted by medac, a strategic partner of Medexus. The publication has undergone full peer review and has already been published online.

Key Points: 
  • Study found event-free survival and overall survival superior after treosulfan compared to RIC busulfan, also found non-relapse mortality lower in treosulfan arm than busulfan arm
    Study results accepted for publication with American Journal of Hematology, now available online
    discuss data on June6, 2022 at 4:00PM Eastern Time
    TORONTO and CHICAGO, June 06, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX:MDP) (OTCQX:MEDXF) today announced that the American Journal of Hematology has accepted for publication the final study results and analysis of the pivotal phase3 clinical trial of treosulfan conducted by medac, a strategic partner of Medexus.
  • The publication concludes that the study demonstrates clinically relevant superiority of treosulfan over RIC busulfan with regard to its primary endpoint, EFS.
  • The study found that EFS of patients in the study (median age 60years) was superior after treosulfan compared to RIC busulfan.
  • This publication presents the final study results and pre-specified subgroup analyses of all 570randomized patients with completed longer term follow-up.

Medexus Pharmaceuticals Provides Update on Resubmission of Treosulfan NDA

Retrieved on: 
Tuesday, May 24, 2022

TORONTO and CHICAGO, May 24, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX:MDP) (OTCQX:MEDXF) has been informed by medac, a strategic partner of Medexus, that medac received acknowledgement of receipt from the U.S.Food and Drug Administration (FDA) of the New Drug Application resubmission for Treosulfan (NDA) submitted on April21, 2022, together with a request to submit information in order to complete medacs NDA resubmission and initiate FDA review.

Key Points: 
  • TORONTO and CHICAGO, May 24, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX:MDP) (OTCQX:MEDXF) has been informed by medac, a strategic partner of Medexus, that medac received acknowledgement of receipt from the U.S.Food and Drug Administration (FDA) of the New Drug Application resubmission for Treosulfan (NDA) submitted on April21, 2022, together with a request to submit information in order to complete medacs NDA resubmission and initiate FDA review.
  • medac expects to respond to the FDAs information requests within the 12-month timeline required by the FDAs July2021 Complete Response Letter.
  • The review clock for the NDA resubmission will start after the response is considered complete by the FDA.
  • Medexus continues preparing to implement the companys commercial launch plan and will provide additional information as it becomes available.

Medexus Pharmaceuticals Announces Resubmission of Treosulfan NDA

Retrieved on: 
Friday, April 22, 2022

TORONTO and CHICAGO, April 22, 2022 (GLOBE NEWSWIRE) --  Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) and medac, a strategic partner of Medexus, are pleased to announce that medac has resubmitted its New Drug Application for Treosulfan (NDA) with the U.S. Food and Drug Administration (FDA). The NDA requests approval of Treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT). The resubmission includes additional clinical data and statistical analysis relating to the previously-completed phase 3 clinical trial of Treosulfan as well as an update of the integrated summary of safety, which the FDA had requested in their July 2021 Complete Response Letter to medac.

Key Points: 
  • TORONTO and CHICAGO, April 22, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX:MDP) (OTCQX:MEDXF) and medac, a strategic partner of Medexus, are pleased to announce that medac has resubmitted its New Drug Application for Treosulfan (NDA) with the U.S.Food and Drug Administration (FDA).
  • The NDA requests approval of Treosulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT).
  • We and our partners at medac look forward to an FDA decision within six months from resubmission.
  • An FDA approval would then pave the way for a commercial launch of Treosulfan in the United States within Medexuss fiscal year2023.

Medexus to Present at the Bloom Burton & Co. Healthcare Investor Conference

Retrieved on: 
Tuesday, April 19, 2022

TORONTO and CHICAGO, April 19, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX:MDP) (OTCQX:MEDXF) will be presenting at the Bloom Burton&Co.

Key Points: 
  • TORONTO and CHICAGO, April 19, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX:MDP) (OTCQX:MEDXF) will be presenting at the Bloom Burton&Co.
  • The conference brings together U.S., Canadian, and international investors interested in the latest developments in the Canadian healthcare sector.
  • Ken dEntremont, Medexuss Chief Executive Officer, and Marcel Konrad, Medexuss Chief Financial Officer, will attend the conference in person.
  • They will deliver a presentation on May2, 2022, at 11:30am and will also host one-on-one meetings throughout the conference.

Medexus to Participate in the 34th Annual Roth Conference

Retrieved on: 
Wednesday, March 9, 2022

TORONTO and CHICAGO, March 09, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (Medexus or the Company) (TSX: MDP) (OTCQX: MEDXF) is pleased to announce that it will be participating in the 34th Annual Roth Conference from March 13 to 15, 2022.

Key Points: 
  • TORONTO and CHICAGO, March 09, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (Medexus or the Company) (TSX: MDP) (OTCQX: MEDXF) is pleased to announce that it will be participating in the 34th Annual Roth Conference from March 13 to 15, 2022.
  • Ken dEntremont, Chief Executive Officer, and Marcel Konrad, Chief Financial Officer of Medexus, will be hosting in person one-on-one meetings throughout the conference.
  • As a full-service investment bank, Roth provides capital raising, M&A advisory, analytical research, trading, market-making services and corporate access.
  • Headquartered in Newport Beach, California, Roth is privately held and owned by its employees and maintains offices throughout the U.S. For more information on Roth, please visit www.roth.com .

Medexus Pharmaceuticals Announces Deal for Gleolan in the United States

Retrieved on: 
Tuesday, March 1, 2022

TORONTO and CHICAGO, March 01, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) is pleased to announce that its U.S. subsidiary, Medexus Pharma (Medexus US), has acquired the exclusive right to commercialize Gleolan in the United States from NX Development Corp. (NXDC), the U.S. subsidiary of photonamic GmbH & Co. (Photonamic). This transaction extends Medexus’s strong relationship with Photonamic and complements Medexus’s existing commercialization rights to Gleolan in Canada, where Medexus recently launched the product. Using information provided by NXDC, Medexus estimates that Gleolan generated U.S. net sales of $3 million to $4 million in the fourth calendar quarter of 2021. Based on Medexus’s evaluation of Gleolan’s effectiveness, Medexus is confident in Gleolan’s prospects in both Canada and the United States, and expects strong sales and institutional uptake in both markets. Medexus and NXDC plan to work together closely to ensure a seamless transition for existing customers.

Key Points: 
  • Medexus has acquired exclusive rights to commercialize Gleolan in the United States,
    Gleolan generated $3-4million U.S.net sales in the fourth calendar quarter of 2021
    TORONTO and CHICAGO, March 01, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX:MDP) (OTCQX:MEDXF) is pleased to announce that its U.S.subsidiary, Medexus Pharma (MedexusUS), has acquired the exclusive right to commercialize Gleolan in the United States from NX DevelopmentCorp.
  • Using information provided by NXDC, Medexus estimates that Gleolan generated U.S.net sales of $3million to $4million in the fourth calendar quarter of 2021.
  • Based on Medexuss evaluation of Gleolans effectiveness, Medexus is confident in Gleolans prospects in both Canada and the United States, and expects strong sales and institutional uptake in both markets.
  • We are thrilled to license Gleolan in the United States and continue to drive our business forward, said Ken dEntremont, Medexuss chief executive officer.

Medexus Pharmaceuticals Announces Normal Course Issuer Bid, or NCIB, for Convertible Debentures

Retrieved on: 
Monday, February 14, 2022

TORONTO and CHICAGO, Feb. 14, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) is pleased to announce that the Toronto Stock Exchange (TSX) has accepted Medexus’s notice of intention to make a normal course issuer bid (NCIB). Under the NCIB, Medexus may purchase for cancellation up to C$3,530,000 principal amount of its 6% unsecured convertible debentures due 2023 (Debentures), representing approximately 10% of the public float (defined under TSX rules) and approximately 8.5% of the C$41,546,000.00 principal amount of Debentures outstanding as of January 31, 2022.

Key Points: 
  • Under the NCIB, Medexus may purchase for cancellation up to C$3,530,000 principal amount of its 6%unsecured convertible debentures due2023 (Debentures), representing approximately 10% of the public float (defined under TSX rules) and approximately 8.5% of the C$41,546,000.00 principal amount of Debentures outstanding as of January31, 2022.
  • We believe that purchases of our Debentures will allow us to deleverage our balance sheet, said Ken dEntremont, Medexuss chief executive officer.
  • Purchases under the NCIB may commence on February16, 2022 and continue through February15, 2023 or such earlier date as Medexus completes its purchases pursuant to the NCIB.
  • From August1, 2021 to January31, 2022 the average daily trading volume (ADTV) of the Debentures was C$7,592.00 principal amount.

Medexus Pharmaceuticals Generated $21.3M in Fiscal 2022 Third Quarter Revenues and Achieved $1.9M Positive EBITDA for the Three Months Ended December 31, 2021

Retrieved on: 
Wednesday, February 9, 2022

TORONTO and CHICAGO, Feb. 09, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (“Medexus” or the “Company”) (TSX: MDP) (OTCQX: MEDXF) today announced its financial results and provided a business update for the three-month period ended December 31, 2021. All dollar amounts below are in United States dollars unless specified otherwise.

Key Points: 
  • Adjusted EBITDA* of $1.9 million, an increase from ($2.0) million in Q2 of fiscal 2022 and a decrease from $3.9 million in Q3 of fiscal 2021.
  • Cash and cash equivalents of $9.6 million (with $10.1 million of total available liquidity) at end of Q3 of fiscal 2022.
  • Ken dEntremont, Chief Executive Officer of Medexus, commented, We are encouraged to see sequential quarter-over-quarter growth in revenue and adjusted EBITDA this past quarter.
  • In particular, IXINITY saw improved sales in Q3 versus Q2 of fiscal 2022 aided by supply chain improvements.

Medexus to Present at The MicroCap Rodeo’s 2nd Annual Winter Wonderland Best Ideas Investor Conference

Retrieved on: 
Tuesday, February 1, 2022

TORONTO and CHICAGO, Feb. 01, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the Company orMedexus) (TSX: MDP) (OTCQX: MEDXF) is pleased to announce that it will be presenting at The MicroCap Rodeos 2nd Annual Winter Wonderland Best Ideas Investor Conference being held virtually from Feb 8th to 11th, 2022.

Key Points: 
  • TORONTO and CHICAGO, Feb. 01, 2022 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (the Company orMedexus) (TSX: MDP) (OTCQX: MEDXF) is pleased to announce that it will be presenting at The MicroCap Rodeos 2nd Annual Winter Wonderland Best Ideas Investor Conference being held virtually from Feb 8th to 11th, 2022.
  • The MicroCap Rodeos Winter Wonderland Conference Presentation Details:
    Ken dEntremont, Chief Executive Officer, and Marcel Konrad, Chief Financial Officer of Medexus, will present the Company overview and will be hosting virtual one-on-one meetings throughout the conference.
  • Please contact The MicroCap Rodeo to learn more about the event.
  • Medexus is a leader in innovative rare disease treatment solutions with a strong North American commercial platform and a portfolio of proven best-in-class products.