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Blueprint Medicines Files NDA to FDA for Pralsetinib in MTC

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Blueprint Medicines Corporation (BPMC - Free Report) announced that it has submitted a new drug application (NDA) to the FDA for its precision therapy pralsetinib to address patients with advanced or metastatic RET mutant medullary thyroid cancer (MTC) as well as RET fusion-positive thyroid cancers.

The NDA submission was made under the FDA’s Real-Time Oncology Review pilot program, which aims to explore a more efficient review process to ensure safe and effective treatments for patients.

In May 2020, Blueprint Medicines submitted an NDA to the FDA and marketing applications in the EU for pralsetinib to address RET fusion-positive non-small-cell lung carcinoma (NSCLC).

Shares of Blueprint Medicines were up 1.3% following the above announcement on Wednesday. However, the stock has lost 1.3% so far this year against the industry’s rally of 12.1%.


By the end of 2020, Blueprint Medicines anticipates having a couple of marketed products in the United States, one being the already approved Ayvakit (avapritinib) while the other is pralsetinib.

We remind investors that in January 2020, Blueprint Medicines’ lead product Ayvakit was approved by the FDA for treating unresectable or metastatic GIST, harboring a PDGFRA exon 18 mutation including PDGFRA D842V mutations in adults.

Following this, Ayvakit became the first precision therapy to have won the FDA nod for treating genomically-defined patients with GIST, a rare form of cancer.

In the first quarter of 2020, which marks the initial partial quarter of Ayvakit since its launch in January, the drug generated sales worth $3.5 million. The product is also under review in Europe with a decision pending in the third quarter 2020. A potential approval should boost Ayvakit’s sales in the quarters ahead.

Notably, the medicine is also being studied for the advanced, indolent and smoldering forms of systemic mastocytosis (SM).

Zacks Rank & Stocks to Consider

Blueprint Medicines currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Ligand Pharmaceuticals Incorporated (LGND - Free Report) , NuCana PLC (NCNA - Free Report) and Emergent BioSolutions Inc. (EBS - Free Report) , all flaunting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Ligand’s earnings estimates have been revised 7.2% upward for 2020 and 10% for 2021 over the past 60 days. The stock has gained 7.3% year to date.

NuCana’s loss per share estimates have narrowed 17% for 2020 and 19.8% for 2021 over the past 60 days.

Emergent’s earnings estimates have moved 22.5% north for 2020 and 3.3% for 2021 over the past 60 days. The stock has surged 51.8% year to date.

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