Blueprint Medicines Corporation BPMC announced that it has accelerated the regulatory filling plans of its two key pipeline candidates — avapritinib and BLU-667 — and expedited the development of another mid-stage candidate, BLU-782. The company now expects to submit regulatory applications and initiate pivotal studies on the same, much earlier than expected following interactions with the regulatory authorities.
Blueprint Medicines’ lead candidate avapritinib is currently being evaluated in several mid-to-late-stage studies for various oncological indications. The company remains on course to petition a new drug application (NDA) for avapritinib for PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST) and the fourth-line GIST during the second quarter of 2019 as scheduled. However, in the latest press release, the company stated that it will now also apply for a marketing authorization (MAA) in favor of avapritinib in the EU for the same indication in the third quarter.
The candidate is also investigated for the third-line GIST and in second-line setting. The company plans to file a supplemental NDA for avapritinib to treat the third-line GIST in 2020.
Additionally, avapritinib is being analyzed under two ongoing programs — the phase I EXPLORER clinical study and the registration-enabling phase II PATHFINDER probe for the advanced systemic mastocytosis (SM). Blueprint Medicines plans to submit an NDA to the FDA under its breakthrough therapy program for avapritinib to address the condition of advanced SM in the first quarter of 2020, which was previously expected at any time next year.
BLU-667 in being examined in the phase I ARROW study on previously-treated patients with receptor tyrosine RET-fusion non-small cell lung cancer (NSCLC) and RET-mutant medullary thyroid carcinoma (MTC). The company plans to complete enrollment in the NSCLC and MTC cohorts in the ARROW assessment during second-quarter 2019.
Blueprint Medicines now decides to file an NDA for BLU-667 for the NSCLC indication in the first quarter of 2020, which was earlier expected in the first half of 2020. Meanwhile, the company looks to submit an NDA for the MTC indication in the first half of 2020.
The before-time achievement of the enrollment targets in the ARROW study instigated the quickened filing timelines.
By 2020, the company expects to have a couple of marketed products in the United States, such as avapritinib and BLU-667.
Notably, BLU-782 is being examined in phase I study for the treatment of fibrodysplasia ossificans progressive (FOP). The company aims to begin a phase IIa study on the same in the fourth quarter of 2019, which was earlier expected in the first half of 2020.
Shares of Blueprint Medicines have surged 48.1% so far this year, outperforming the industry’s rally of 11.1%.
In a separate press release, Blueprint Medicines announced that it has launched a public offering of worth $300 million shares of its common stock. The company intends to use the net proceeds from this proposition to build its commercial infrastructure and fund the pipeline development of its candidates. Plus, it looks to gear up for the potential launch of avapritinib in the United States and Europe upon approval.
Zacks Rank & Stocks to Consider
Blueprint Medicines currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Celgene Corporation CELG, Kamada Ltd. KMDA and PDL BioPharma, Inc. PDLI, all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Celgene’s earnings estimates have been revised 3.5% upward for 2019 and 3.3% for 2020 over the past 60 days. The stock has soared 38.5% in the year so far.
Kamada’s earnings estimates have moved 34.3% north for 2019 and 5% for 2020 over the past 60 days. The stock has risen 15.8% so far this year.
PDL BioPharma’s earnings estimates have been raised 92.3% for 2019 and 25% for 2020 over the past 60 days. The stock has ascended 25.8% year to date.
Zacks' Top 10 Stocks for 2019
In addition to the stocks discussed above, would you like to know about our 10 finest buy-and-holds for the year?
Who wouldn't? Our annual Top 10s have beaten the market with amazing regularity. In 2018, while the market dropped -5.2%, the portfolio scored well into double-digits overall with individual stocks rising as high as +61.5%. And from 2012-2017, while the market boomed +126.3, Zacks' Top 10s reached an even more sensational +181.9%.
See Latest Stocks Today >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
PDL BioPharma, Inc. (PDLI) : Free Stock Analysis Report
Celgene Corporation (CELG) : Free Stock Analysis Report
Kamada Ltd. (KMDA) : Free Stock Analysis Report
Blueprint Medicines Corporation (BPMC) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research