What happened
Veru (VERU -8.33%), an oncology-focused biotech, saw its share price leap by over 20% on Tuesday, crushing not only the top stock market indexes, but also many peers in its sector. The reason why was clear: The company received an important regulatory nod for one of its key pipeline projects.
So what
In a press release published on Monday, Veru announced that the Food and Drug Administration (FDA) has granted Fast Track designation for the phase 3 registration program of its enobosarm. This is a selective androgen receptor agonist, administered orally, that targets certain forms of breast cancer.
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Veru quoted its CEO, Mitchell Steiner, as saying the regulator's move "underscores the urgent need for new, novel, targeted therapies for this important patient population suffering from this aggressive disease."
The FDA grants Fast Track designation to pipeline treatments that target serious illnesses, and/or could potentially "fill an unmet medical need," in the agency's words.
Now what
Breast cancer certainly falls into these categories. As Veru notes pointedly, it's the most common form of cancer diagnosed in women; the company quoted a statistic that an estimated one in eight women will develop it at some point in their lives. It's little wonder, then, that investors are getting sharply more bullish on the stock.
Zooming out a bit, Veru isn't just a one-trick biotech. The company does good business with its one commercialized product, the FC2 women's condom from its Female Health Company unit. It's also attracted notice for its VERU-111, an experimental antiviral that has done well in clinical trials targeting COVID-19.
