Mesoblast Limited Initiated The Rolling Submission Of BLA For GvHD

  • May 30, 2019 AEST
  • Team Kalkine
Mesoblast Limited Initiated The Rolling Submission Of BLA For GvHD

Cellular medicines developer, Mesoblast Limited (ASX: MSB) has achieved a major corporate milestone by filing the first component of a rolling submission for a Biologics License Application to U.S. Food and Drug Administration for its lead product candidate, Remestemcel-L. This product candidate is going to be used for the treatment of children who are suffering from aGVHD.

The FDA has agreed to a rolling review of the BLA, and during this review, the company will be addressing any substantial matters raised by the FDA.

The company’s share were down by 2.055% during the intraday trade as on 30 May 2019.

aGVHD is a life-threatening complication of an allogeneic bone marrow transplant, and currently, there are 30,000 allogeneic bone marrow transplants performed annually worldwide, 50% of which develops aGVHD.

In the company’s Phase 3 trial of 55 children with aGVHD, treatment with Remestemcel-L resulted in a six-month survival of 69%, which is encouraging news for the company and its shareholders.

In the first half FY2019, the company reported a loss after tax of US$44.1 million compared to a profit after tax of US$6.7 million in the previous corresponding period (pcp). Increase in loss was primarily due to the increased investment in commercial manufacturing by US$8.0 mn. The loss was also driven by US$5.1 million of increased finance costs.

Further, the company reported revenues of US$13.5 million as compared to US$14.6 million in pcp, a decrease of US$1.1 million.

During the half-year period, the company completed its transaction with Tasly Pharmaceutical Group (Tasly) to establish a strategic cardiovascular partnership in China and also expanded its partnership with Japan’s JCR Pharmaceuticals Co. Ltd. (JCR) for the treatment of wound healing in epidermolysis bullosa (EB).

As at 31st December 2018, the company had pro forma cash of US$92.0 million which includes-

  • US$15.0 million received in January 2019 from Hercules Capital, Inc. (Hercules) after having successfully achieved the clinical milestone of reduction in major GI bleeding events and related hospitalizations in the NIH trial of Revascor in end-stage heart failure patients with LVADs;
  • Additional non-dilutive capital of US$35.0 million may be available under existing arrangements with Hercules and NovaQuest Capital Management, L.L.C. (NovaQuest), subject to certain milestones.

Pro Forma Cash Position (Source: Company Reports)

In the past six months, the share price of the company increased by 8.68% as on 27th May 2019. At market close on 30th May 2019, the stock of the company was trading at a price of A$1.430, down 2.055% during the day’s trade with a market capitalisation of ~$727.99 million. The counter opened the day at $1.425 and reached the day’s high of $1.465 and touched the day’s low of $1.415 with a daily volume of ~ 896,682. Its 52 weeks high price is set at $2.470, and its 52 weeks low price is set at $1.015 with an average volume of ~952,681.


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