Shares of Mesoblast more than doubled and set a new 52-week high price after the company reported that it achieved a 83% survival rate in New York ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome who were treated with its allogeneic cell therapy remestemcel-L.
Mesoblast Ltd. (MESO:NASDAQ; MSB:ASX) today announced that it had achieved an "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." The company stated that of the 12 patients treated, 75% (9/12) successfully came off ventilator support after a median timeframe of 10 days. The firm advised that all of the patients were treated under an emergency Investigational New Drug (IDA) application or expanded access protocol at Mt. Sinai hospital in New York City and so far seven of the patients have been discharged from the hospital. The company noted that each of the patients had received a variety of experimental agents prior to being treated with remestemcel-L.
The firm explained that until now only about 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 existing standard of care treatments during March and April 2020. The company reported that at a second major referral hospital network in New York City over the same period, there was 88% mortality with only 12% survival (38/320) among ventilator-dependent COVID-19 patients.
The company's CEO Dr. Silviu Itescu commented, "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."
Dr. Fred Grossman, Mesoblast's Chief Medical Officer, added, "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 COVID-19 ARDS."
Mesoblast Ltd. is headquartered in Melbourne, Australia, and is a developer of industrial-scale, cryopreserved, off-the-shelf allogeneic cellular medicines. The company utilizes its proprietary mesenchymal lineage cell therapy technology platform in order to create a wide portfolio of commercial products and late-stage product candidates. The firm indicated that "the Biologics License Application to seek approval of its product candidate RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease has been accepted for priority review by the U.S. Food and Drug Administration." The company has offices in Australia, the U.S. and Singapore.
Mesoblast began the day with a market capitalization of around $687.9 million with approximately 106.7 million shares outstanding. MESO shares opened nearly 142% higher today at $15.59 (+$9.14, +141.71%) over yesterday's $6.45 closing price and reached a new 52-week high price this morning of $20.57. The stock has traded today between $13.01 and $20.57 per share and is presently trading at $14.76 (+$8.30, +128.76%).
Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.