Wasn't PSTI not $13 not too long ago?
Lol, are you absolutely sure?
News out tomorrow for CYDY Tomorrow 4ET. Hopefully we’ll get treated better than MESO.
I'm thinking seriously bout getting out all the stemcell plays.
FDA is corrupt by big pharma.
The FDA recommended that Mesoblast conduct at least one additional randomized, controlled study in adults and/or children.
I Thought For Sure They Would Get Their Approval.
No Mesoblast Announcement Until Next Monday !!! IMO...MESO GOT THEIR APPROVAL !!! CONGRATS..IF IT WAS A NO... IT WOULD HAVE COME QUICK !!!
Yes. I believe it will likely pop.
It will be interesting to see what happens when trading resumes.
A breakout is eminent with US Oncologic Drugs Advisory Committee advising the FDA to proceed with MESO’s GvHD treatment in August. MESO also received a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020, for RYONCIL (remestemcel-L) for steroid-refractory aGVHD
MESO - ARDS review August 13th looking for approval in Sept.
I would think we should also see some results from phase 3 trial in Covid which started enrollment in May. Reduced usage of ventilators may have slowed this trial. 83% survival rate 10/12 patients on ventilators vs 9% come of ventilators with standard treatments.
July 5, 2020: Mesoblast Limited (ASX:MSB; Nasdaq:MESO) today announced that an expanded access protocol (EAP) has been initiated in the United States for compassionate use of its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in the treatment of COVID-19 infected children with cardiovascular and other complications of multisystem inflammatory syndrome (MIS-C). Patients aged between two months and 17 years may receive one or two doses of remestemcel-L within
Mesoblast Shares Surge 206% on Hopes for Its Covid-19 Treatment
By Jackie Edwards
Updated June 18, 2020 @ 8:56 PM
A health stock that’s undertaking a U.S. coronavirus drug trial and has seen its market value more than triple since March will be added to Australia’s benchmark equity gauge next week.
Mesoblast Ltd. shares are up 206% this quarter as one of its products is being assessed as a treatment for ventilator-dependent virus patients. The Melbourne-based company, which develops cell-based medicines to treat inflammatory conditions, has added more than $1-Bil. in market value from its 2020 low, boosted by results from a test using its therapy in a New York hospital.
“The support of the institutional and retail investment community reflects the positive view” of Mesoblast’s virus treatment and other products, Chief Executive Officer Silviu Itescu said in an interview. Investors are recognizing that Australian health firms, particularly ones focused on the U.S., are growing revenues “in a way that more old-fashioned industries have not been able to.”
Mesoblast shares have soared amid its coronavirus drug trial
A U.S. trial of its Remestemcel-L therapy to care for coronavirus patients is expected to be completed within three to four months. Mesoblast in April announced an 83% survival rate among 12 virus patients who were treated with the drug in a pilot study at Mt. Sinai hospital.
The study results spurred a 96% surge in its shares over the next two trading sessions. The company is currently worth A$2.5 Bil. ($1.7 Bil.), compared with around A$744 Mil. at the end of March.
Even short-sellers are starting to acknowledge the performance of the Australian drugmaker, with Mesoblasts’s short interest as a percentage of equity float declining to around 5.5% as of June 11, down from almost 14% in February 2019. This comes as revenues more than doubled in the 9 months to March 31, according to data compiled by Bloomberg, amid an increase in milestone payments from strategic partnerships and sales in Japan.
One of the firm’s key challenges lies in finding suitable partners to help bring products to market, according to Bell Potter Securities Ltd. A failure to reach deals would negatively impact the broker’s forecasts, analysts led by Tanushree Jain wrote in a June 5 note.
In addition to focusing on partnerships, Mesoblast has also bolstered its commercial capabilities over the last 18 months, Itescu said. The firm has built a sales team to support a product that helps treat complications that can arise when blood cancer patients get bone marrow transplants. The drug is awaiting regulatory approval in the U.S.
Mesoblast (ASX:MSB) reveals promising trial results for lung disease treatment
by Josh Smith - Markets Reporter
01 June 2020 12:30
• Stem cell specialist Mesoblast (MSB) has revealed encouraging results from a Phase II trial of its remestemcel-L product in treating lung disease
• The company was testing the product's ability to treat patients with chronic obstructive pulmonary disease (COPD)
• The trial showed that remestemcel-L was able to bring about improved respiratory and functional outcomes to patients
• Importantly, those treated with the product were able to walk 55 metres further in a six-minute walk test than those who weren't
• Mesoblast is testing the same product for treating patients who develop acute respiratory distress syndrome (ARDS) from COVID-19
• Shares in Mesoblast are currently trading 0.63 per cent lower and worth $3.98 each
Stem cell specialist Mesoblast (MSB) has reported encouraging results from a Phase II trial of its remestemcel-L product in treating lung disease.
Under the trial, 60 patients with chronic obstructive pulmonary disease (COPD) were tested against a placebo control group to monitor the efficacy of remestemcel-L.
COPD refers to a group of lung diseases that all block airflow and make it difficult to breathe. Conditions such as emphysema and chronic bronchitis fall under the COPD umbrella.
Remestemcel-L was proven to bring about "improved respiratory and functional outcomes" to patients tested under the trial.
Stem cell speciality
Mesoblast's product is based on mesenchymal stem cells, or MSCs. These are an adult stem cell generally extracted from bone marrow.
The treatment was initially developed to treat a rare condition known as acute graft-versus-host disease (GVHD) in which the body rejects bone marrow transplants.
The product is already for sale under the brand name Ryoncil in Japan.
In March, Mesoblast told shareholders it would be testing the product against COVID-19 patients with acute respiratory distress syndrome (ARDS) based on its previously-proven ability to treat COPD.
Today, this was further reaffirmed.
According to Mesoblast, the Phase II trial showed that remestemcel-L significantly improved respiratory and functional clinical outcomes in patients with high levels of C-reactive protein (CRP).
This is a type of protein made by the liver and secreted into the blood and is often the first sign of inflammation or infection in the body.
Mesoblast said significantly higher levels of CRP can result in hospitalisation and even death in patients with COPD. High CRP levels are common with many different types of lung diseases.
Mesoblast's study showed that the greater the degree of inflammation from heightened CRP levels, the better remestemcel-L was at improving lung condition.
Importantly, patients with the highest level of CRP in their bodies were able to walk 55 metres further in a six-minute walk test after being treated with remestemcel-L than those treated with the placebo.
Further, no toxicity or safety concerns were revealed using the treatment.
COVID-19 treatment support
Mesoblast Chief Medical Officer Dr Fred Grossman said today's results provide a "compelling rationale" for the evaluation of a current Phase III trial in the US for treating patients with COVID-19 ARDS.
"The correlation between highest CRP levels and greatest degree of response to remestemcel-L suggests that the inflammatory component of the lung disease may trigger and be amenable to the immunomodulatory effects of treatment with remestemcel-L in patients with acute inflammatory conditions," Dr Fred explained.
"Since recurrent hospitalization rates and mortality in COPD are associated with both high levels of CRP and progressive decline in the six-minute walk test, these results suggest that remestemcel-L could provide longer-term benefits for COPD patients with high levels of inflammation," he said.
Shares in Mesoblast have had a rollercoaster of a day, dancing between red and green several times within the first hour of trade. As at 11:50 am AEST, company shares are down 0.63 per cent and trading for $3.98 each.