| Over a week ago | ||||
Checkpoint Therapeutics… Checkpoint Therapeutics announced that it has received Pediatric Investigation Plan, PIP, product-specific waivers from the European Medicines Agency, EMA. and the U.K. Medicines & Healthcare products Regulatory Agency, MHRA, for cosibelimab in cutaneous squamous cell carcinoma, cSCC. Following the announcement of positive topline data from Checkpoint's registration-enabling clinical trial in January 2022, a U.S. Biologics License Application, BLA, submission for cosibelimab is planned for later this year, to be followed by marketing authorization applications, MAAs, in Europe. "These waivers from the EMA and MHRA are important milestones in the European regulatory process for cosibelimab in cSCC," said James Oliviero, President and Chief Executive Officer of Checkpoint Therapeutics. "Such PIP waivers enable us to proceed more quickly and cost-effectively when advancing our marketing approval applications with the EMA and MHRA, avoiding the significant time and expense required to conduct a pediatric clinical study in Europe. As such, these PIP waivers enhance the value of the cosibelimab program in Europe for Checkpoint and potential partners." | ||||
James F. Oliviero,… James F. Oliviero, President and CEO of Checkpoint, said, "The positive topline results generated in the first quarter from our ongoing registrational trial of cosibelimab in metastatic cutaneous squamous cell carcinoma laid the foundation for a potentially transformational year for our lead immunotherapy product candidate and for our company as a whole. We remain on track to submit our U.S. Biologics License Application for cosibelimab later this year and continue to evaluate partnership opportunities for the potential commercialization of cosibelimab in Europe and other key territories worldwide." Mr. Oliviero continued, "Our focus remains on advancing our pipeline of potentially life-saving novel oncology therapies with the goal of expanding patient access globally through a disruptive pricing strategy, beginning with the $30 billion and growing PD-(L)1 market." | ||||
| Over a month ago | ||||
Virtual Meeting to be… Virtual Meeting to be held on April 12 hosted by Lake Street. | ||||
Fortress Biotech… Fortress Biotech Corporate Access Virtual Summit to be held on April 5-6.Webcast Link | ||||
Fortress Biotech… Fortress Biotech Corporate Access Virtual Summit to be held on April 5-6.Webcast Link | ||||
Virtual Meeting to be… Virtual Meeting to be held on April 12 hosted by Lake Street. | |
Virtual Meetings to be… Virtual Meetings to be held April 4-5 hosted by Cantor Fitzgerald. | |
Virtual Meetings to be… Virtual Meetings to be held April 4-5 hosted by Cantor Fitzgerald. | |
Virtual Meetings to be… Virtual Meetings to be held April 4-5 hosted by Cantor Fitzgerald. | |
Reports 2021 revenue… Reports 2021 revenue $268,000, consensus $350,000. James Oliviero, President and CEO of Checkpoint, said, "The past year represented a truly transformational period for Checkpoint Therapeutics, with the foundation laid for multiple significant potentially value enhancing catalysts in 2022. Following the positive topline results from our ongoing registrational trial of cosibelimab in metastatic cutaneous squamous cell carcinoma announced earlier this year, we look forward to a planned Biologics License Application submission for cosibelimab later in 2022." Mr. Oliviero continued, "We remain focused on expeditiously advancing our pipeline of product candidates with the goal of expanding patient access globally to potentially life-saving novel oncology therapies through a disruptive pricing strategy." |
