Yahoo Finance Mesoblast's (MESO) GVHD Drug BLA Gets FDA Priority Tag, Stock Up
Melbourne-based biotech, Mesoblast Limited MESO announced the FDA acceptance of the resubmission of its biological license application (BLA) for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD). The FDA considered the resubmission of a complete response and granted priority review designation to the BLA. The FDA’s decision is expected on Aug 2, 2023. Shares of the company were up 24% on Wednesday, following the news.
In the past year, the shares of Mesoblast have lost 15.9% compared with the industry’s decline of 9.2%.
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Remestemcel-L, the company’s lead product candidate is an investigational therapy having immunomodulatory properties that counteract by suppressing the proliferative activity of allogenic T lymphocytes.
Back in October 2020, the FDA issued a complete response letter to Mesoblast’s BLA for remestemcel-L for the treatment of pediatric (children under 12) SR-aGVHD. The FDA recommended Mesoblastto conduct at least one additional study in adults and/or children to further reaffirm the effectiveness of the candidate in the absence of any approved treatments for the same indication. This recommendation was made despite the FDA’s Oncologic Drugs Advisory Committee’s voting 9:1 in favor of the candidate, stating that the available data support the efficacy of remestemcel-L in pediatric patients with SR-aGVH.
The current BLA resubmission is now equipped with additional clinical and biomarker data, which includes data from a propensity-matched study of children with high-risk disease, which compared 25 children from Mesoblast’s phase III study treated with remestemcel-L, with 27 children treated with various other biologics, including Incyte Corporation’s INCY ruxolitinib, taken at random, from the Mount Sinai Acute GvHD International Consortium (MAGIC) database. Results from the study showed that 67% of the high-risk children, administered with remestemcel-L, responded positively to the treatment within 28 days and were alive after 180 days, compared with just 10% in the MAGIC group. The resubmitted application also included data from a four-year survival study conducted by the Center for International Blood and Marrow Transplant Research on 51 evaluable patients with SR-aGVHD. Results showed a statistically significant survival rate compared to treatment with the best available therapy.
Incyte’s lead drug, Jakafi (ruxolitinib), is a first-in-class JAK1/JAK2 inhibitor, approved in the United States for the treatment of patients with polycythemia vera (PV), who have had an inadequate response to or are intolerant to hydroxyurea. It is also approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-PV MF and post-essential thrombocythemia MF. The drug is also approved in the United States for the treatment of SR-aGVH in adult and pediatric patients aged 12 years or older. While Incyte markets the drug in the United States, it is marketed by Novartis as Jakavi outside the country.
Acute GVHD is observed in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Annually, more than 30,000 patients go through BMT worldwide, primarily during treatment for blood cancers, 20% of whom are pediatric patients. SR-aGVHD has a mortality rate of 90% with no FDA-approved treatments in the United States for children under 12 with SR-aGVHD, at present. This represents a clear unmet medical need. Per management, if approved, remestemcel-L will become the first allogenic “off-the-shelf” cellular medicine in the United States and the first therapy for children under 12 years of age with SR-aGVHD.
Mesoblast Limited Price and Consensus
Mesoblast Limited price-consensus-chart | Mesoblast Limited Quote
Zacks Rank and Stocks to Consider
Mesoblast currently has a Zacks Rank #4 (Sell).
A couple of better-ranked stocks in the same industry are Allogene Therapeutics, Inc. ALLO and ADMA Biologics, Inc. ADMA, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the estimate for Allogene’s 2023 loss per share has narrowed from $2.86 to $2.57. In the past year, the shares of Allogene have fallen 30.4%.
ALLO’s earnings witnessed an average earnings surprise of 8.33%, beating all four estimates in the trailing four reported quarters.
In the past 90 days, the consensus estimate for ADMA Biologics’ 2023 loss per share has narrowed from 20 cents to 19 cents. In the past year, the shares of ADMA Biologics have increased by 91.5%.
ADMA’s earnings beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 1.81%.
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Incyte Corporation (INCY) : Free Stock Analysis Report
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