Nucor earnings beat by $0.08, revenue fell short of estimates
On Thursday, Mesoblast (NASDAQ:MESO) Limited (MSB:AU) (NASDAQ: MESO) stock received an upgrade in its rating from a major financial firm. The biopharmaceutical company's shares were raised from Hold to Buy, with a new price target set at AUD1.10.
The adjustment comes as Mesoblast continues engaging with the U.S. Food and Drug Administration (FDA) regarding a possible approval of its product, with a Prescription Drug User Fee Act (PDUFA) date anticipated in early January 2025.
The company has made significant progress in the 2024 fiscal year, developing new potency assay data. Additionally, plans are in place to conduct an externally controlled single-arm registration trial for both adults and children over the age of 12 suffering from steroid-refractory acute graft versus host disease (SR-aGVHD). This trial design is a critical step in the process of seeking FDA approval.
The firm's decision to upgrade the stock reflects recent developments within Mesoblast, which include advancements in its discussions with the FDA and the company's operational progress. The analyst noted that after evaluating the updates for fiscal years 2024 and beyond, coupled with Mesoblast's recent share price performance, it was appropriate to shift their recommendation to Buy from the previous Hold status.
Mesoblast's ongoing efforts to secure FDA approval appear to be a pivotal factor in the firm's optimistic outlook. The company's engagement with the regulatory body and its strategic moves in clinical trial development have been highlighted as key drivers for the upgraded rating and price target.
The new price target of AUD1.10 represents a significant milestone for Mesoblast, as it continues to navigate the regulatory landscape and advance its clinical programs. The upgrade to a Buy rating suggests confidence in the company's potential for growth and its ability to successfully bring its therapies to market.
In other recent news, Mesoblast Ltd has updated the market with significant developments. The company filed its quarterly report to the Australian Securities Exchange, providing financial and operational updates.
Although specific financial figures were not disclosed, such reports usually include details on cash reserves, expenditures, and revenue. This routine filing is part of Mesoblast's commitment to transparency, adhering to Australian and U.S. financial authorities' reporting standards.
In addition to its financial report, Mesoblast has made strides in the development of its Ryoncil treatment. The U.S. Food and Drug Administration (FDA) has accepted the company's resubmission of its Biologics License Application (BLA) for Ryoncil, a treatment intended for children suffering from steroid-refractory acute graft versus host disease (SR-aGVHD). The FDA has set a goal date of January 7, 2025, for making a decision regarding the application.
Ryoncil, a culture-expanded mesenchymal stromal cell therapy, has been granted Fast Track and Priority Review designations by the FDA. The Phase 3 trial of Ryoncil showed promising results, with a 70.4% Overall Response at Day 28, predictive of improved survival through Day 100. These are the latest developments for Mesoblast, known for its proprietary technology in developing off-the-shelf cellular medicines.
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