The Mesoblast Limited (ASX: MSB) share price has started the week on a very positive note.
In morning trade the global leader in cellular medicines for inflammatory diseases saw its shares zoom 7% higher to $1.47.
Why is the Mesoblast share price charging higher?
This morning Mesoblast announced that the United States Food and Drug Administration (FDA) has granted its product candidate, rexlemestrocel-L, Orphan Drug Designation for prevention of post-implantation mucosal bleeding in end-stage chronic heart failure (CHF) patients who require a left ventricular assist device (LVAD).
The FDA's Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the United States.
The release explains that the designation qualifies the sponsor of the drug for various development incentives, including eligibility for seven years of market exclusivity upon regulatory approval, exemption from FDA application fees, tax credits for qualified clinical trials, and other potential assistance in the drug development process.
Mesoblast's chief executive, Dr Silviu Itescu, said: "We are very pleased that the FDA has granted our heart failure cell therapy product candidate, Revascor, Orphan Drug designation for use in patients with LVADs to prevent mucosal bleeding, including from the gastrointestinal tract. We look forward to our upcoming meeting with the FDA to discuss a potential approval pathway under the product's existing Regenerative Medicine Advanced Therapy (RMAT) designation for this life-threatening condition."
Mesoblast's investigational cell therapy Revascor consists of 150 million allogeneic mesenchymal precursor cells (MPCs) and is being developed for injection into heart muscle of patients with moderate-advanced or end-stage chronic heart failure.
Recent studies have been very promising. According to the release, in a 30-patient placebo-controlled pilot trial in end-stage heart failure patients with LVADs, a single intra-myocardial dose of Revascor resulted in a 70% reduction in gastrointestinal bleeding and associated hospitalisations.
Elsewhere in the sector today, the CSL Limited (ASX: CSL) share price is trading flat after a mixed response to Friday's China update from brokers and the Mayne Pharma Group Ltd (ASX: MYX) share price is trading within a whisker of a multi-year low due to concerns over the performance of its generic drugs.
