MSB is up another +21% today on the back of this announcement, on top of the +35% rise they enjoyed on Monday.
Yesterday and overnight Mesoblast's share price had another of its big recent spikes, going up 40% on the ASX and then 140% on NASDAQ. That's effectively another $1.4bn of market cap. The NASDAQ price is higher than it has been since 2015.
Like the other spikes this one followed a press release. Unlike them the press release conveyed nothing of consequence. Two samples of a dozen COVID-19 patients treated with Mesoblast's remestemcel-L had sharply different outcomes from those for two samples of a few hundred COVID-19. Mesoblast's CEO called this "remarkable". Actually the remarkable thing would have been if the outcomes were in any way similar. In statistical terms this is, to quote Arrested Development, comparing apples with some fruit no one ever heard of. Never mind that almost any mortality rate would have been better than the control group's, or that "patients received a variety of experimental agents prior to remstemcel-L". The COVID-19 results were encouraging rather than "remarkable", just as other preliminary results have been encouraging for therapies that now look like duds (remdesivir, hydroxychloroquine). Might work, might not.
I don't know if management had an obligation to disclose, but if they didn't then it makes you wonder about their mentality. And they certainly didn't have call the findings "remarkable". This is a company that should be on the cusp of at least one big catalyst. The share price can take care of itself. But you'd also think the directors would be buying, and that isn't really happening either. It's puzzling. Treating COVID-19 isn't even part of any long thesis for them, so why hype something that doesn't really demonstrate they can treat it? How will all those traders and first-level MOMO/FOMO punters who have been jumping on the bandwagon like it's January again react to any kind of blip?
Full disclosure: I bought a tiny amount of Mesoblast shares earlier this week. But that's for another post.
06-Apr-2020: FDA Clears IND for Remestemcel Use in COVID-19 ARDS
14:15 (2:15pm Sydney Time): MSB is up around +35% today on the back of that one.
83% SURVIVAL IN COVID-19 PATIENTS WITH MODERATE/SEVERE ACUTE RESPIRATORY DISTRESS SYNDROME TREATED IN NEW YORK WITH MESOBLAST’S CELL THERAPY REMESTEMCEL-L
--- click on link for more ---
MSB were up +39% on this news today. Since their $1.10 low point on March 23rd, MSB have risen +148% in 4 weeks to close at $2.73 today. However, they were even higher 3 months ago, on Jan 24th, when they closed at $3.07, so I don't think they're rediculously overpriced... yet... Quite a news-driven SP recovery, and plenty of positive news to drive it.
Disclosure: I do NOT hold MSB shares. Wouldn't be selling if I did though.
MESOBLAST PARTNERS WITH THE CARDIOTHORACIC SURGICAL TRIALS NETWORK ESTABLISHEDBY THE U.S. NATIONAL INSTITUTES OF HEALTH’S NATIONAL HEART, LUNGAND BLOOD INSTITUTE TO CONDUCT RANDOMIZED CONTROLLED TRIAL OF REMESTEMCEL-L FOR PATIENTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME DUE TO COVID-19
Melbourne, Australia; Thursday April 9, 2020; and New York, USA;
Wednesday April 8, 2020:
Mesoblast Limited (ASX:MSB; Nasdaq:MESO) today announced that its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L will be formally evaluated in a randomized, placebo-controlled trial in 240 patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19). This multi-center Phase 2/3 trial will be conducted as a public-private partnership in a collaboration with the Cardiothoracic Surgical Trials Network (CTSN), which was established by the United States National Institutes of Health’s National Heart, Lung and Blood Institute (NHLBI) as a flexible platform for conducting collaborative trials. Mesoblast holds an Investigational New Drug (IND) Application from the United States Food and Drug Administration (FDA) for use of remestemcel-L in the treatment of patients with COVID-19 ARDS, and will provide investigational product for the trial.
ARDS occurs due to an excessive immune response against the COVID-19 virus in the lungs, with the inflammatory cytokines produced by the immune cells (cytokine storm) destroying the lung tissue. These inflammatory cytokines also can cause damage to other organs such as liver, kidney, and heart.
Remestemcel-L is being developed for various inflammatory conditions, and is believed to counteract the inflammatory processes implicated in these diseases by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues. The safety and therapeutic effects of remestemcel-L intravenous infusions have been evaluated in over 1,100 patients in various clinical trials.
Remestemcel-L was successful in a Phase 3 trial for steroid-refractory acute graft versus host disease (aGVHD) in children, a potentially fatal inflammatory condition due to a similar cytokine storm process as is seen in COVID-19 ARDS. Additionally, a post-hoc analysis of a randomized, placebo-controlled study in 60 patients with chronic obstructive pulmonary disease demonstrated that remestemcel-L significantly improved respiratory function in patients with the same elevated inflammatory biomarkers that are also observed in patients with COVID-19 ARDS. Together, these outcomes provide the rationale for evaluating remestemcel-L in patients with COVID-19 ARDS.