The stock of Mesoblast decreases by 20% following approval by the FDA.
Mesoblast (ASX:MSB)stock price increased by 25% this morning following the announcement that the company US FDA has granted its allogeneic cell therapy Revascor (rexlemestrocel-L) a Designation for Rare Pediatric Disease (RPD) .
The FDA grants an RPD Designation for specific diseases that primarily impact children and are serious or life-threatening.
The choice comes after the announcement of findings from the scientific study involving children that was conducted using random assignment and a controlled approach.HLHS refers to a condition known as hypoplastic left heart syndrome., a congenital heart condition that has the potential to be life-threatening.
Earlier, results from the REVASCOR The results of a study carried out in America on children with HLHS were released in the December 2023 edition of the peer-reviewed journal called “The Journal of Thoracic and Cardiovascular Surgery Open (JTCVS Open).”
In the trial involving 19 children, the desired outcome was achieved by administering REVASCOR intramyocardially.
This involved much bigger rises in the volumes of both the left ventricle at the end of systole and at the end of diastole over a period of 12 months, in comparison to the control group.
As noted earlier by Mesoblast:
The author suggests that the results indicate REVASCOR treatment may improve the potential for the left ventricle (LV) in children with HLHS to grow after LV recruitment surgery. This is supported by the finding that all REVASCOR-treated children, in contrast to only 57% of controls, had LVs that were spacious enough for a complete BiV conversion.
Today, the CEO of Mesoblast, Silviu Itescu, stated
Based on the notable growth of the left chamber in the children who received REVASCOR in the controlled trial, as well as their improved ability to undergo life-saving surgery, we intend to have a meeting with the FDA to explore the possibility of using this trial to expedite approval for this specific purpose.
Upon approval of a A Biologics Licensing Application (BLA) is a document submitted for approval of a biologic drug by regulatory authorities.In regard to REVASCOR, Mesoblast states that they might be qualified to obtain aThe FDA Priority Review Voucher (PRV) is a voucher that is given priority by the FDA.These points can be exchanged for any future marketing purpose, or they can be sold or given to a different person.
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VTI releases one-year study results
Visioneering Technologies (ASX:VTI)The company disclosed the complete findings of a year-long study that was conducted across multiple centers. This study was a randomized controlled trial and was conducted with participants who were unaware of the treatment they received.
product through a series of rigorous tests. These tests were conducted on a sample group of participants and the results were analyzed by a panel of experts. The trial aimed to determine whether the product met the necessary standards for safety and if it had a positive impact on the participants’ health. The findings of the trial will play a crucial role in determining the future of VTI’s product and whether it will be approved for public use.The NVMC is a type of contact lens with multifocal capabilities that is designed to mimic natural vision. lenses for controlling the progression of nearsightedness in children .
According to the data collected over a year, it was found that 45% of the participants in the experimental group did not experience any further development of myopia. Additionally, almost 64% of the subjects in the experimental group had no significant progression of myopia, which means their condition worsened by 0.25D or less per year.
Additionally, a decrease of 71% (equivalent to a reduction of 0.41D) in the progression of refractive error was observed compared to the control group.
The group of children who wore NVMC lenses experienced a significant improvement in their refractive error, with an average reduction of 61% (0.17mm) in axial elongation compared to the control group.
Children who wore NaturalVue Multifocal Contact lenses experienced an average change in axial length of 0.11mm.
VTI states that the ongoing PROTECT study will continue to evaluate and analyze data, and will also share any available findings.
