GSK Announces Extension of FDA Review for Rare Blood Therapy
GSK plc GSK announced that the FDA has extended the review period of its new drug application (NDA) for momelotinib to treat myelofibrosis patients with anemia by three months. This decision to extend the review duration was taken by the regulatory body to provide time to review recently submitted data.
A decision regarding the potential approval of momelotinib is now expected on Sep 16, 2023 (previously, Jun 16, 2023).
Momelotinib is a novel, investigational JAK1/JAK2 inhibitor, which was added to GSK’s portfolio, following the acquisition of Sierra Oncology. Particularly, momelotinib complements GSK’s new drug, Blenrep/belantamab mafatotin, which was approved for fourth-line multiple myeloma in 2020.
Year to date, shares of GSK have gained 0.1% against the industry’s 6.1% fall.
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We would like to remind the investors that in July 2022, GSK completed the acquisition of Sierra Oncology for $55 per share of common stock in cash representing an approximate total equity value of $1.9 billion.
The NDA application for momelotinib, in August 2022, was based on data from key phase III studies, including the pivotal MOMENTUM study. The MOMENTUM study evaluated momelotinib versus danazol for treating anemic myelofibrosis patients previously treated with an approved JAK inhibitor. In the MOMENTUM study, momelotinib achieved statistical significance in the primary and all pre-specified secondary endpoints, reporting a statistically significant benefit on symptoms, anemia and splenic size.
Myelofibrosis is a rare and fatal cancer of the bone marrow, which often leads to anemia that causes fatigue, increased risk of infection and bleeding or bruising due to reduced platelet count in patients.
A marketing authorization application by GSK is simultaneously being reviewed by the European Medicine Agency for approval in the EU. Currently, momelotinib is not approved in any market.
GSK PLC Sponsored ADR Price and Consensus
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Zacks Rank and Stocks to Consider
GSK currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Adaptimmune Therapeutics ADAP, Akero Therapeutics AKRO and ADMA Biologics, Inc. ADMA, each 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 Zacks Consensus Estimate for Adaptimmune Therapeutics’ 2023 loss per share has narrowed from 63 cents to 46 cents. During the same period, the estimate for Adaptimmune Therapeutics’ 2024 loss per share has narrowed from 59 cents to 56 cents. Year to date, shares of ADAP have fallen by 30.2%.
ADAP beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 36.89%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $3.22 to $2.80. During the same period, the estimate for Akero Therapeutics’ 2024 loss per share has narrowed from $3.44 to $3.27. Year to date, shares of AKRO have lost 0.4%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 9 cents. The consensus estimate for 2024 earnings is currently pegged at 7 cents per share. Year to date, shares of ADMA have gained by 1.3%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.
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