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Galena (GALE) Stock Falls on Discontinuation of NeuVax Study
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Galena Biopharma, Inc’s shares plunged 82.8% after the company announced that it has discontinued the phase III PRESENT study on its lead candidate, NeuVax (nelipepimut-S).
The decision followed the recommendation of an Independent Data Monitoring Committee (IDMC), which stated that the study should be stopped due to futility. The planned safety and futility interim analysis was triggered after 70 qualifying disease-free survival events were reached and a total of 71 events were reviewed by the IDMC.
NeuVax was being evaluated for the prevention of breast cancer recurrence following the standard-of-care treatment in the adjuvant setting.
The company stated that it will host a conference call next week to offer a preliminary review of the study. It will also provide an update on its immunotherapy and hematology clinical development programs.
Meanwhile, NeuVax, in combination with Roche Holding AG’s (RHHBY - Free Report) Herceptin (trastuzumab), is being evaluated in two breast cancer studies – a phase IIb study in node-positive and triple-negative HER2 IHC 1+/2+ and a phase II study in high-risk, node-positive or negative HER2 IHC 3+ patients. The company also plans to evaluate the candidate in phase II studies for the treatment of ductal carcinoma in situ (DCIS) and gastric cancer.
Breast cancer is estimated to affect over 230,000 women in the U.S. annually. An approximate 75%–80% of breast cancer patients are tissue test-positive for some increased amount of the HER2 receptor, which is associated with disease progression and decreased survival.
The decision to stop evaluating NeuVax in the PRESENT study, which was being conducted under a Special Protocol Assessment (SPA) granted by the FDA, is a huge setback for Galena Biopharma, considering that it was the only late-stage study on the candidate. The company is highly dependent on NeuVax for growth. A positive interim analysis would have enabled the company to file regulatory application and gear up for the launch of its first drug in the market.
Going ahead, we expect investor focus to remain on further details pertaining to the development of NeuVax in ongoing studies.
Galena Biopharma currently carries a Zacks Rank #4 (Sell). Investors interested in the health care sector may consider Bristol-Myers Squibb Company (BMY - Free Report) and Pfizer Inc. (PFE - Free Report) . Both stocks sport a Zacks Rank #1 (Strong Buy).
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Galena (GALE) Stock Falls on Discontinuation of NeuVax Study
Galena Biopharma, Inc’s shares plunged 82.8% after the company announced that it has discontinued the phase III PRESENT study on its lead candidate, NeuVax (nelipepimut-S).
The decision followed the recommendation of an Independent Data Monitoring Committee (IDMC), which stated that the study should be stopped due to futility. The planned safety and futility interim analysis was triggered after 70 qualifying disease-free survival events were reached and a total of 71 events were reviewed by the IDMC.
NeuVax was being evaluated for the prevention of breast cancer recurrence following the standard-of-care treatment in the adjuvant setting.
The company stated that it will host a conference call next week to offer a preliminary review of the study. It will also provide an update on its immunotherapy and hematology clinical development programs.
Meanwhile, NeuVax, in combination with Roche Holding AG’s (RHHBY - Free Report) Herceptin (trastuzumab), is being evaluated in two breast cancer studies – a phase IIb study in node-positive and triple-negative HER2 IHC 1+/2+ and a phase II study in high-risk, node-positive or negative HER2 IHC 3+ patients. The company also plans to evaluate the candidate in phase II studies for the treatment of ductal carcinoma in situ (DCIS) and gastric cancer.
Breast cancer is estimated to affect over 230,000 women in the U.S. annually. An approximate 75%–80% of breast cancer patients are tissue test-positive for some increased amount of the HER2 receptor, which is associated with disease progression and decreased survival.
The decision to stop evaluating NeuVax in the PRESENT study, which was being conducted under a Special Protocol Assessment (SPA) granted by the FDA, is a huge setback for Galena Biopharma, considering that it was the only late-stage study on the candidate. The company is highly dependent on NeuVax for growth. A positive interim analysis would have enabled the company to file regulatory application and gear up for the launch of its first drug in the market.
Going ahead, we expect investor focus to remain on further details pertaining to the development of NeuVax in ongoing studies.
Galena Biopharma currently carries a Zacks Rank #4 (Sell). Investors interested in the health care sector may consider Bristol-Myers Squibb Company (BMY - Free Report) and Pfizer Inc. (PFE - Free Report) . Both stocks sport a Zacks Rank #1 (Strong Buy).
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 >>