What happened
Veru (VERU 4.96%), a biopharmaceutical company that looks for novel cancer therapies, particularly in breast cancer or prostate cancer, saw its shares drop 10.33% on Monday. The stock closed on Friday at $6, then opened on Monday at $5.89. It fell to a low of $5.33 before closing on Monday at $5.38. The stock is down more than 8% so far this year, and has a 52-week high of $24.55 and a 52-week low of $4.34.
So what
The company's stock already lost $10 a share two weeks ago when a Food and Drug Administration (FDA) advisory panel voted 8-5 against approving sabizabulin, Veru's COVID-19 oral therapy, via the Emergency Use Authorization route.
It's not the last word, but the FDA usually agrees with advisory panels' votes. In its discussions regarding the drug, the panel noted the phase 3 trial for sabizabulin had too small a sample size and recommended additional studies before the FDA approved the drug. The company is also expecting the European Medicines Agency's Emergency Task Force review of the drug. Monday's fall reflects continued concerns about the potential FDA decision.
Now what
Veru is struggling financially, so potential bad news regarding sabizabulin is compounded. In the third quarter, the company reported revenue of $9.6 million, down 46% year over year, while it reported a net loss of $22.2 million, or $0.28 in earnings per share (EPS), compared to a net loss in the third quarter of 2021 of $2.7 million, or a loss of $0.03 in EPS.
Veru does have some therapies in late-stage trials, including enobosarm to treat metastatic breast cancer and the combination of enobosarm and abemaciclib, a therapy developed by Eli Lilly (LLY 1.19%) to treat metastatic breast cancer. The FDA granted the combination therapy Fast Track designation.
