Blueprint Medicines Corporation ( BPMC Quick Quote BPMC - Free Report) have rallied 68.2% in the past three months compared with the industry’s rise of 10.2%.
The company has made steady progress with its lead drug, Ayvakit (avapritinib), approved by the FDA for treating adult patients with unresectable or metastatic gastrointestinal stromal tumors (“GIST”), harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations during this period. The European Commission has granted conditional marketing authorization to Ayvakyt (brand name of Ayvakit in Europe) as a monotherapy for the treatment of adult patients with unresectable/metastatic GIST, harboring the PDGFRA D842V mutation.
Ayvakit/Ayvakyt has witnessed strong uptake since its launch.
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Ayvakit was approved by the FDA for treating advanced systemic mastocytosis (“SM”), a rare and debilitating disease in June 2021.
In March 2022, the European Commission approved Ayvakyt as a monotherapy for the treatment of adult patients with aggressive SM, including SM with an associated hematological neoplasm as well as mast cell leukemia, after at least one systemic therapy.
Last month, BPMC announced top-line data from part 2 of the PIONEER study, which evaluated Ayvakit for treating patients with non-advanced SM.
Data from the registrational part 2 of the PIONEER study showed that treatment with Ayvakit led to clinically meaningful and highly significant improvements across the primary and all key secondary endpoints, including patient-reported symptoms and measures of mast cell burden.
Blueprint Medicines plans to submit a supplemental new drug application (sNDA) for Ayvakit for treating non-advanced SM in the fourth quarter of 2022.
A type II variation marketing authorization application for Ayvakit in non-advanced SM is expected to be filed with the European Medicines Agency next year.
In the first six months of 2022, Ayvakit/Ayvakyt generated sales worth $52.3 million, reflecting a significant year-over-year increase. Potential label expansion into additional indications will make Ayvakit eligible to treat a broader patient population and is likely to drive sales further in the days ahead.
This apart, the company has other promising pipeline candidates targeting various cancer indications that are progressing well.
Blueprint Medicines’ current product revenues solely comprise sales from Ayvakit. Hence, any regulatory setback for the drug could hurt the stock in the days ahead.
Moreover, Ayvakit faces competition from
Deciphera Pharmaceuticals' ( DCPH Quick Quote DCPH - Free Report) Qinlock (ripretinib), which is approved for the treatment of fourth-line GIST. In November 2021, the European Commission approved Qinlock for the same indication.
Deciphera’s sole-marketed drug Qinlock holds great potential. DCPH is also working to expand the label of Qinlock for the larger commercial opportunity in GIST.
Zacks Rank & Stocks to Consider
Blueprint Medicines currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are
Achilles Therapeutics plc ( ACHL Quick Quote ACHL - Free Report) and ORIC Pharmaceuticals, Inc. ( ORIC Quick Quote ORIC - Free Report) , 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
Achilles Therapeutics’ loss per share estimates narrowed 6.4% for 2022 and 9.6% for 2023 in the past 60 days.
Earnings of Achilles Therapeutics surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ACHL delivered an earnings surprise of 12.45%, on average.
ORIC Pharmaceuticals’ loss per share estimates narrowed 8.6% for 2022 and 22% for 2023 in the past 60 days.
Earnings of ORIC Pharmaceuticals surpassed estimates in three of the trailing four quarters and missed on the remaining occasion. ORIC delivered an earnings surprise of 8.85%, on average.