Blueprint Medicines Corporation’s BPMC lead drug, Ayvakit (avapritinib), was approved by the FDA for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (“GIST”), harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations, in January 2020. The European Commission has granted conditional marketing authorization to Ayvakyt 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. In the first nine months of 2021, the drug generated sales worth $32.9 million, reflecting a significant year-over-year increase. Label expansion of the drug is driving sales too.
Ayvakit received label expansion nod from the FDA in June 2021 to treat advanced systemic mastocytosis (“SM”), a rare and debilitating disease. Ayvakit is being evaluated in the phase II PIONEER study for treating non-advanced SM. Top-line data from the same is anticipated in mid-2022.
Shares of Blueprint Medicines have declined 12.2% so far this year compared with the industry’s decrease of 18.1%.
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We note that Blueprint Medicines is co-developing another cancer drug, Gavreto (pralsetinib), with Roche RHHBY for treating patients with various types of RET-altered thyroid cancers and other solid tumors.
In July 2021, Blueprint Medicines transferred the responsibilities of booking U.S. product sales of Gavreto to Roche. The company only records the share of profit and loss for Gavreto in financial results and does not record any net product revenues from Gavreto sales.
The FDA approved Gavreto for the treatment of patients with advanced/metastatic rearranged during transfection RET-mutant and RET fusion-positive thyroid cancer in December 2020. Gavretois also approved for the treatment of adults with metastatic RET fusion-positive non-small-cell lung cancer.
This apart, Blueprint Medicines has other promising pipeline candidates that are progressing well, targeting various cancer indications.
Blueprint Medicines is riding on the success of Ayvakit. The company’s current product revenues solely comprise sales from Ayvakit, which narrows its revenues stream. Hence, any regulatory setback for Ayvakit could hurt the stock in the days ahead.
Also, Ayvakit faces competition from Deciphera Pharmaceuticals' DCPH Qinlock (ripretinib), which is approved for the treatment of fourth-line GIST. In November 2021, the European Commission approved Qinlock for the same indication.
Please note that Deciphera is looking to streamline commercial operations for Qinlock in the United States and focus on commercialization efforts on a select number of key European markets for the medicine.
Zacks Rank & Stock to Consider
Blueprint Medicines currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Sarepta Therapeutics, Inc. SRPT, which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sarepta Therapeutics’ loss per share estimates have narrowed 31.3% for 2021 and 26% for 2022, over the past 60 days.
Earnings of Sarepta Therapeutics have surpassed estimates in two of the trailing four quarters, and missed the same on the other two occasions.
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