tech/a
No Ordinary Duck
- Joined
- 14 October 2004
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From MSB website -
Mesoblast is using its proprietary mesenchymal lineage cell technology platform to develop and commercialize innovative allogeneic cellular medicines to treat complex diseases where inflammation plays a central role and are resistant to conventional standard of care.
The Company’s broad portfolio of late-stage product candidates are:
Mesoblast’s Biologics License Application (BLA) for RYONCIL for the treatment of children with steroid-refractory acute GVHD has been accepted for priority review by the United States Food and Drug Administration (FDA). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020, and if approved, Mesoblast will make RYONCIL immediately available in the United States.
- RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GVHD) in children
- REVASCOR® for advanced chronic heart failure
- MPC-06-ID for chronic low back pain due to degenerative disc disease
Remestemcel-L is also being developed for rare diseases in adults and children. Additionally, Mesoblast has a promising emerging pipeline of Phase 2 product candidates and next generation technologies.
On 24th April 2020 announcement from MSB -
Melbourne, Australia; April 24, 2020; and New York, USA; April 23, 2020: Mesoblast Limited (ASX:MSB; Nasdaq: MESO) today announced 83% survival in ventilator-dependent COVID-19 patients (10/12) with moderate/severe acute respiratory distress syndrome (ARDS) treated during the period March-April 2020 with two intravenous infusions of Mesoblast’s allogeneic mesenchymal stem cell product candidate remestemcel-L within the first five days. 75% (9/12) have successfully come off ventilator support at a median of 10 days. At this time, seven have been discharged from the hospital. Patients received a variety of experimental agents prior to remestemcel-L. All patients were treated under an emergency Investigational New Drug (IND) application or expanded access protocol at New York City’s Mt Sinai hospital. In contrast, only 9% (38/445) of ventilator-dependent COVID-19 patients at a major referral hospital network in New York City were able to come off ventilator support when treated with standard of care during March/April 2020.1 Moreover, there was 88% mortality with only 12% survival (38/320) among ventilator-dependent COVID19 patients at a second major referral hospital network in New York City during the same period.2 These poor outcomes are consistent with earlier published data from China where mortality rates of over 80% were reported in patients with COVID-19 and moderate/severe ARDS.3 Mesoblast Chief Executive Dr Silviu Itescu stated: “The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS. We intend to rapidly complete the randomized, placebo-controlled Phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients.” Mesoblast Chief Medical Officer Dr Fred Grossman said: “There is a significant need to improve the dismal survival outcomes in COVID-19 patients who progress to ARDS and require ventilators. We have implemented robust statistical analyses in our Phase 2/3 trial as recommended by the US Food and Drug Administration (FDA) in order to maximize our ability to evaluate whether remestemcel-L provides a survival benefit in moderate/severe COVID19 ARDS.”
Iggy
People seem to have missed this line.
So which one had the effect?
Its an equity raising. So no.Trading halt.
Better be good news.
??????
I read it on the Age/ SMH so hopefully they aren't bulldusting.Not doubting you but I haven't seen the Announcement.
My pick for next month.
Results out for Covid and I think at least one of the other 3 phase trials.
Raising completed so nothing to stop the rise (if it works).
I think people are buying on rumour, watch closely on results day.It's taking off a bit early...leakage of results?
It's taking off a bit early...leakage of results?
Quarterly out, worth a read. A lot happening over the next 3 months. Very encouraging.
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