I’m not sure if this is something, but I think it is something to be aware of.
Biopharmaceutical oncology company VERU just announced that they will be reporting Q4 earnings before market opens on December 2nd. They also happen to have an unspecified December PDUFA for their combo drug TADFIN, which combines 5 mg of Tadalafil [Eli Lilly’s Cialis] and 5 mg of Finasteride [Merck’s Propecia] in one capsule for the treatment of benign prostatic hyperplasia, which apparently affects men with lower urinary tract symptoms and enlarged prostates. Yay.
It’s probably just a coincidence, as it seems highly unlikely that they set up the earnings report date to match up with a PDUFA announcement.
A few things to be aware of:
- according to a press release, this is the company’s first New Drug Application (NDA) submission. I’m unclear if this means the first NDA for this particular drug, or an NDA for any drug of theirs.
- according to this image on the TADFIN page, they see the Market Potential (US and global) to be greater than $200 million
- they also just had a press release touting their inclusion on Deloitte’s “Technology Fast 500”, a ranking of the 500 fastest-growing tech, media, telecom, life siciences, fintech and energy tech companies in North America.
- they were trading at a high of almost $25 back in February on news that one of their drugs had positive Phase 2 results in treating hospitalized Covid-19 patients at high risk for acute respiratory distress syndrome. Phase 3 began enrollment in May, and enrollment was targeted to be completed by year-end, so that might be part of the earnings announcement as well.
Over the past month, VERU had been trading in the low to mid $8 area, but climbed up to $10 last week (probably because Jim Cramer shilled it) before dropping sharply back to $8.14 at the end of today. Dec and Jan options don’t look too shabby with Dec $10 having 1,257 OI, and there being 14k OI for Jan across all strikes.
Feel free to take a deeper look to see if this is a worthwhile play.