Mesoblast's (MESO) BLA for Ryoncil Gets FDA Priority Review

Mesoblast Limited MESO announced that the FDA has accepted the biologics license application (BLA) for its lead product candidate Ryoncil (remestemcel-L), an allogeneic cell therapy. The company is seeking approval of the candidate for treating children with steroid-refractory acute graft versus host disease (SR-aGVHD), a life-threatening complication of an allogeneic bone marrow transplant.

With the FDA granting a priority review to the BLA, a decision from the regulatory body is expected on Sep 30, 2020.

Notably, the FDA authorities informed the company that they are planning to hold an Advisory Committee meeting to discuss its application.

Per the press release, more than 30,000 allogeneic bone marrow transplants are conducted across the world annually, primarily for patients diagnosed with blood cancer. Of this, 50% develops aGVHD.

If approved, Mesoblast plans to make this therapy available immediately in the United States to address the life-threatening disease of the given patient population.

We remind investors that in May 2019, Mesoblast initiated the rolling submission of the BLA for Ryoncil to the FDA. The rolling submission followed the FDA’s Fast Track designation, which was granted to Ryoncil for treating aGVHD in the given patient population.

Shares of Mesoblast have plunged 38.6% so far this year compared with the industry’s decrease of 11.3%.

Meanwhile, last month, Mesoblast announced plans to evaluate its allogeneic mesenchymal stem cell (MSC) product candidate, remestemcel-L, in patients with acute respiratory distress syndrome (ARDS) caused by the coronavirus (COVID-19) in the United States, Australia, China and Europe. The company is actively discussing with various government and regulatory authorities, heads of medical institutions and pharmaceutical companies to implement these activities.

Several companies are now actively exploring the development of a vaccine or a treatment to address the COVID-19 pandemic, which ravaged the world of late.

Zacks Rank & Stocks to Consider

Mesoblast currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Acorda Therapeutics, Inc. ACOR, Regeneron Pharmaceuticals, Inc. REGN and Celldex Therapeutics, Inc. CLDX, all sporting a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

Acorda’s loss per share estimates have been narrowed 8.8% for 2020 and 11.1% for 2021 over the past 60 days.

Regeneron’s earnings estimates have been revised 5.6% upward for 2020 and 7.8% upward for 2021 over the past 60 days. The stock has rallied 32.9% year to date.

Celldex’s loss per share estimates have been narrowed 12.5% for 2020 and 12.8% for 2021 over the past 60 days.

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