Mesoblast is due to report the make-or-break phase three trial results for its back pain and chronic heart failure treatments in the final quarter of 2020. aGVHD approval. Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, and these numbers are increasing.
It’s also being developed for biologic refractory Crohn’s disease.The company’s products for localized inflammatory diseases are based on the rexlemestrocel platform. Act (PDUFA) action date of September 30, 2020, and if approved, Mesoblast will make RYONCIL immediately available in the United States. As in study 275, clinical response at day 28 was highly predictive of improved survival through day 100 (87% compared to 47% in patients that did not achieve day 28 OR P = 0.0001). These include REVASCOR for advanced chronic heart failure and MPC-06-ID for chronic low back pain due to degenerative disc disease, which are in phase 3 with readouts expected in the upcoming quarter.Trial data from the three phase 3 trials of RYONCIL for pediatric steroid-refractory aGVHD is summarized below. "Today Mesoblast achieved a very important step," he said. According to an article in the Australian Financial Review (AFR), the ODAC meeting voted 8 to 2 in favour of the Mesoblast drug this morning. But after that, the company predicts a steady revenue stream and so on; buyout offers are also not unlikely. "As an Australian company developing a potential treatment for COVID-19 ARDS, the primary cause of death in patients infected with COVID-19, we have a responsibility to evaluate remestemcel-L in Australian patients as the country continues to grapple with COVID-19," Dr Itescu said.The phase three trial was given the go-ahead based on results from a pilot study using remestemcel-L in patients under emergency compassionate care at Mt Sinai Hospital in New York.Nine of the 12 patients with moderate-to-severe ARDS were successfully taken off a ventilator and discharged from hospital within a median of 10 days.The new trial will test the treatment in ventilator-dependent patients in intensive care units with moderate-to-severe COVID-19 ARDS.The trial will be randomised — meaning some patients will receive a placebo instead of the remestemcel-L therapy. Mesoblast's stem cell therapy candidate has had an outstanding advisory committee meeting where it was voted 9-1.Here's a quick look at future prospects for this company which we recommended to our subscribers last year.Speaking at the 2020 Full-Year Financial Results and Corporate Highlights Webcast on 8/27/2020, CEO Dr. Silviu Itescu said the lead product candidate RYONCIL has a targeted market. Graft-versus-host is a severe immune response which can occur after bone marrow transplants.Over eight hours, the panel heard presentations from the company and experts, then grappled with the question of whether the drug was shown to be effective. Mesoblast’s Biologics License Application is seeking approval of its product candidate RYONCIL™ (remestemcel-L) for SR-aGVHD, which if approved is expected to launch in the US in 2020. (RTTNews) - Mesoblast Limited (MESO) gave investors a pleasant surprise today, securing the FDA panel's overwhelming recommendation … The most advanced indication is for pediatric steroid-refractory aGVHD. Now, right before PDUFA, there does not seem to be much opportunity, especially since the positive adcom has probably priced in the PDUFA as well. Stem cell researcher Mesoblast (MSB) has been granted ethics approval for a trial of its remestemcel-L therapy in Australian COVID-19 patients. This was statistically significant compared to the pre-specified control value of 45% (70.4% versus 45%, P =0.0003). The company is also developing Remestemcel-L for other inflammatory diseases concerning moderate to severe acute respiratory distress syndrome in children and adults. Mesoblast, which acquired the remestemcel-L product in 2013 from Osiris Therapeutics, already has it approved for the treatment of SR-a-GVHD in children in Japan.