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Mesoblast (MESO) Up on Rare Pediatric Disease Tag for Heart Drug
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Mesoblast Limited (MESO - Free Report) recently announced that the FDA has granted a Rare Pediatric Disease (RPD) designation to its allogeneic cell therapy, Revascor (rexlemestrocel-L), for treating children with congenital heart disease. Shares of the company were up 20.9% in after-hours trading on Jan 18, following the announcement of the news.
The RPD designation is granted by the FDA to medicines that treat serious or life-threatening diseases, which usually affect children of all ages. Upon potential approval for Revascor by the FDA, the company may become eligible to receive a priority review voucher (“PRV”). This PRV can be used either by MESO in a subsequent marketing application filed with the FDA for a different product or may even be sold to any other third party to boost cash reserves.
The FDA granted the RPD tag to Revascor after the company submitted data from a randomized controlled study. The study investigated Revascor in children with hypoplastic left heart syndrome (HLHS), a potentially life-threatening congenital heart condition. The study was conducted on 19 children with HLHS.
Shares of Mesoblast have plunged 73.5% in the past year compared with the industry’s decline of 13.8%.
Image Source: Zacks Investment Research
Data from the study showed that a single intramyocardial administration of Revascor improved surgical outcomes and led to a significantly larger increase in left ventricular (LV) end-systolic and end-diastolic volumes in children with HLHS over a period of 12 months versus controls.
In November 2023, MESO submitted regulatory filings to the FDA seeking an orphan drug designation and rare pediatric disease designation for Revascor for the treatment of congenital heart disease HLHS.
Revascor is currently not approved in the United States. The company is also developing rexlemestrocel-L for treating chronic low back pain.
In the past 60 days, estimates for Regeneron’s 2024 earnings per share have improved from $41.57 to $43.96. In the past year, shares of REGN have rallied 28.8%.
Earnings of Regeneron beat estimates in each of the trailing last four quarters. REGN delivered a four-quarter average earnings surprise of 12.34%.
In the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 22 cents to 6 cents. In the past year, shares of CTMX have plunged 33.3%.
CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter earnings surprise of 45.44%, on average.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 62 cents to 69 cents. In the past year, shares of PBYI have risen 16.7%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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Mesoblast (MESO) Up on Rare Pediatric Disease Tag for Heart Drug
Mesoblast Limited (MESO - Free Report) recently announced that the FDA has granted a Rare Pediatric Disease (RPD) designation to its allogeneic cell therapy, Revascor (rexlemestrocel-L), for treating children with congenital heart disease. Shares of the company were up 20.9% in after-hours trading on Jan 18, following the announcement of the news.
The RPD designation is granted by the FDA to medicines that treat serious or life-threatening diseases, which usually affect children of all ages. Upon potential approval for Revascor by the FDA, the company may become eligible to receive a priority review voucher (“PRV”). This PRV can be used either by MESO in a subsequent marketing application filed with the FDA for a different product or may even be sold to any other third party to boost cash reserves.
The FDA granted the RPD tag to Revascor after the company submitted data from a randomized controlled study. The study investigated Revascor in children with hypoplastic left heart syndrome (HLHS), a potentially life-threatening congenital heart condition. The study was conducted on 19 children with HLHS.
Shares of Mesoblast have plunged 73.5% in the past year compared with the industry’s decline of 13.8%.
Data from the study showed that a single intramyocardial administration of Revascor improved surgical outcomes and led to a significantly larger increase in left ventricular (LV) end-systolic and end-diastolic volumes in children with HLHS over a period of 12 months versus controls.
In November 2023, MESO submitted regulatory filings to the FDA seeking an orphan drug designation and rare pediatric disease designation for Revascor for the treatment of congenital heart disease HLHS.
Revascor is currently not approved in the United States. The company is also developing rexlemestrocel-L for treating chronic low back pain.
Zacks Rank & Other Stocks to Consider
Mesoblast currently has a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the healthcare sector are Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , CytomX Therapeutics, Inc. (CTMX - Free Report) and Puma Biotechnology, Inc. (PBYI - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Regeneron’s 2024 earnings per share have improved from $41.57 to $43.96. In the past year, shares of REGN have rallied 28.8%.
Earnings of Regeneron beat estimates in each of the trailing last four quarters. REGN delivered a four-quarter average earnings surprise of 12.34%.
In the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 22 cents to 6 cents. In the past year, shares of CTMX have plunged 33.3%.
CytomX Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. CTMX delivered a four-quarter earnings surprise of 45.44%, on average.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 62 cents to 69 cents. In the past year, shares of PBYI have risen 16.7%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.