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Altimmune's Coronavirus Spike, And Other News: The Good, Bad, And Ugly Of Biopharma

Mar. 04, 2020 2:00 PM ETAltimmune, Inc. (ALT)ABBV, MRNA, NVAX, PFE1 Comment


  • Altimmune surges on coronavirus drug development.
  • AbbVie down on poor venetoclax data.
  • Pfizer's Advil Dual Action gets approved.
  • Looking for more stock ideas like this one? Get them exclusively at The Total Pharma Tracker. Get started today »

AbbVie Slides as Venetoclax Trial Yields Negative Results

AbbVie (ABBV) reported that its Phase VIALE-C trial failed to meet its primary endpoint. The trial tested venetoclax (VENCLEXTA®) in combination with low-dose cytarabine (LDAC) versus LDAC in combination with placebo. The endpoint of the trial was related to proving statistically significant improvement of overall survival (OS) for patients suffering from acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy.

The data showed that the venetoclax combination brought 25% reduction in the risk of death compared to LDAC with placebo. The median overall survival of the venetoclax with LDAC arm stood at 7.2 months in comparison to 4.1 months in the LDAC arm. The secondary endpoints of the trial pertained to complete remission, complete remission or complete remission with incomplete blood count recovery (CR+Cri), complete remission or complete remission with partial hematologic recovery, and complete remission or complete remission with incomplete blood count by the time of start of cycle 2.

The safety profile for the combination remained unaltered from the profile shown in the Phase 1/2 studies. Neil Gallagher, M.D., Ph.D., chief medical officer and vice president of development, AbbVie said,

"The study results, while not statistically significant, are indicative of the clinical activity of venetoclax in combination with low-dose cytarabine."

While the trial failed to prove statistically significant improvement, it still showed clinical activity in patients. The data showed that there was complete remission in 27.3 percent, while LDAC with placebo group had complete remission in 7.4 percent patients.

VENCLEXTA was granted accelerated approval in the United States in combination with LDA, decitabine, and azacitidine. AbbVie is working towards preparing a robust portfolio of AML therapies. Its VIALE-A is in Phase 3 and is designed to test the combination of venetoclax with azacitidine compared to azacitidine along with placebo in newly-diagnosed patients

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Comments (1)

NVAX will undoubtedly get $$$ funding from the $8 billion just passed for COVID-19 vaccine development imho. They were 1 of the 5 biotech /pharma companies invited to the WH a couple days ago for COVID-19 meeting. Bet on news event concerning NVAX to be released soon imho. Huge short squeeze imminent.
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