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Galena Biopharma Reveals Regulatory Pathway for GALE-401
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Galena Biopharma, Inc.’s shares surged 21.4% after the company confirmed the regulatory pathway to advance GALE-401 (anagrelide CR) into a pivotal phase III study.
Galena’s year-to-date share price movement shows that the company has underperformed the Zacks classified Medical-Biomedical/Genetics industry. Specifically, the stock plunged almost 92% during this period, while the industry declined 25.4%.
Note that GALE-401 is being developed for the treatment of patients with essential thrombocythemia (ET). Following a meeting with the FDA, the company said that the proposed study is appropriate for filing a New Drug Application (NDA) using the 505(b)(2) regulatory pathway.
The study will evaluate GALE-401, in comparison to the best available therapy (BAT), in patients with ET who have either failed or are intolerant to hydroxyurea, including a sizable subpopulation of patients treated with anagrelide immediate release.
Galena expects to finalize the phase III protocol and initiate the study in the second quarter of 2017.
We note that GALE-401 is a controlled release (CR) version of Agrylin (an immediate release formulation of anagrelide). Currently, Agrylin is the only FDA approved drug for the treatment of ET. This indicates significant market opportunity for GALE-401, if approved.
Successful development and commercialization of the controlled release version of Agrylin will significantly boost the company’s top line.
According to information provided by the company in its press release, ET affects 135,000–175,000 individuals in the U.S. of which approximately 75% receive treatment.
Vanda’s loss estimates for 2016 narrowed from 62 cents to 45 cents over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%.
MannKind’s estimates narrowed from loss of 24 cents to earnings of 12 cents for 2016 over the last 60 days. For 2017, its loss estimates narrowed from 14 cents to 9 cents over this period. The company posted a positive surprise in two of the four trailing quarters with an average beat of 103.33%.
Arbutus’ loss estimates narrowed from $2.15 to $1.71 for 2016 and from $1.96 to $1.52 for 2017 over the last 60 days. The company posted a positive surprise thrice in the four trailing quarters with an average beat of 59.31%.
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Galena Biopharma Reveals Regulatory Pathway for GALE-401
Galena Biopharma, Inc.’s shares surged 21.4% after the company confirmed the regulatory pathway to advance GALE-401 (anagrelide CR) into a pivotal phase III study.
Galena’s year-to-date share price movement shows that the company has underperformed the Zacks classified Medical-Biomedical/Genetics industry. Specifically, the stock plunged almost 92% during this period, while the industry declined 25.4%.
Note that GALE-401 is being developed for the treatment of patients with essential thrombocythemia (ET). Following a meeting with the FDA, the company said that the proposed study is appropriate for filing a New Drug Application (NDA) using the 505(b)(2) regulatory pathway.
The study will evaluate GALE-401, in comparison to the best available therapy (BAT), in patients with ET who have either failed or are intolerant to hydroxyurea, including a sizable subpopulation of patients treated with anagrelide immediate release.
Galena expects to finalize the phase III protocol and initiate the study in the second quarter of 2017.
We note that GALE-401 is a controlled release (CR) version of Agrylin (an immediate release formulation of anagrelide). Currently, Agrylin is the only FDA approved drug for the treatment of ET. This indicates significant market opportunity for GALE-401, if approved.
Successful development and commercialization of the controlled release version of Agrylin will significantly boost the company’s top line.
According to information provided by the company in its press release, ET affects 135,000–175,000 individuals in the U.S. of which approximately 75% receive treatment.
GALENA BIOPHARM Price and Consensus
GALENA BIOPHARM Price and Consensus | GALENA BIOPHARM Quote
Galena currently carries a Zacks Rank #3 (Hold).
Key Picks in the Sector
Some better-ranked stocks in the health care sector include Vanda Pharmaceuticals Inc. (VNDA - Free Report) , MannKind Corporation (MNKD - Free Report) and Arbutus Biopharma Corporation (ABUS - Free Report) . Each of them sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Vanda’s loss estimates for 2016 narrowed from 62 cents to 45 cents over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%.
MannKind’s estimates narrowed from loss of 24 cents to earnings of 12 cents for 2016 over the last 60 days. For 2017, its loss estimates narrowed from 14 cents to 9 cents over this period. The company posted a positive surprise in two of the four trailing quarters with an average beat of 103.33%.
Arbutus’ loss estimates narrowed from $2.15 to $1.71 for 2016 and from $1.96 to $1.52 for 2017 over the last 60 days. The company posted a positive surprise thrice in the four trailing quarters with an average beat of 59.31%.
The Best Place to Start Your Stock Search
Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>