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Blueprint Medicines' (BPMC) Ayvakit Aids Growth Amid Rivalry

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Blueprint Medicines Corporation (BPMC - Free Report) has made steady progress with its lead drug, Ayvakit (avapritinib), which is approved 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 the United States. 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.

In June 2021, the FDA approved Ayvakit for a new indication — advanced systemic mastocytosis (“SM”) — a rare and debilitating disease.

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.

Ayvakit is being evaluated in the phase II PIONEER study for treating non-advanced SM. Blueprint Medicines plans to submit a supplemental new drug application for Ayvakit in non-advanced SM to the FDA in the second half of 2022. Currently, there is no approved therapy for non-advanced SM.

Per the company, Ayvakit has the potential to be the first and only treatment approved for non-advanced SM.

Shares of Blueprint Medicines have plunged 56.4% so far this year compared with the industry’s decrease of 28.8%.

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Blueprint Medicines is co-developing another cancer drug, Gavreto (pralsetinib), with Roche (RHHBY - Free Report) 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 RHHBY. The company only records the share of profit and loss for Gavreto in its financial results and does not record any net product revenues from Gavreto sales.

Gavreto is approved in the United States for treating advanced/metastatic RET-mutant and RET fusion-positive thyroid cancer. The drug is 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 currently being evaluated in various early-to-mid-stage studies, targeting various cancer indications.

Successful development and potential approval of the candidates will boost the company’s growth prospects in the future ahead.

Blueprint Medicines is riding on the success of Ayvakit. The company’s current product revenues solely comprise sales from Ayvakit, which narrows its revenue stream. Hence, any regulatory setback for Ayvakit could hurt the stock in the days ahead.

Moreover, Ayvakit faces competition from Deciphera Pharmaceuticals' (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 is also working to expand the label of Qinlock for the larger commercial opportunity in GIST.

Zacks Rank & Stock to Consider

Blueprint Medicines currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Leap Therapeutics, Inc. (LPTX - Free Report) , 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.

The Zacks Consensus Estimate for Leap Therapeutics’ loss per share has narrowed 11.1% for 2022 and 5.9% for 2023 in the past 60 days.

Earnings of Leap Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. LPTX delivered an earnings surprise of 1.92%, on average.

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