What happened
Shares of UroGen Pharma (URGN -2.74%) were up more than 25% as of 1:20 p.m. ET on Friday. The biotech company announced positive phase 3 trial news for a bladder cancer therapy. The stock is up more than 152% this year.
So what
UroGen focuses on urothelial and specialty cancers. On Thursday, the company announced positive top-line data from two phase 3 trials for UGN-102 (mitomycin), an intravesical (within the bladder) solution to treat patients with low-grade, intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC).
Both trials met their primary endpoints. In the first, UGN-102 showed a 64.8% complete response rate at three months in patients, compared to a 63.6% complete response rate with patients who only received a transurethral resection of a bladder tumor (TURBT).
In the other trial, the Envision trial, the therapy met its primary endpoint in treating LG-IR-NMIBC by showing a 79.2% complete response after three months. The company said it expects additional data from the trial next year, as well as the submission of a New Drug Application for UGN-102 with the Food and Drug Administration (FDA).
The company also said it was raising $120 million as part of a private placement with investors to help fund operations. The placement includes nearly 12.6 million ordinary shares or prefunded warrants priced at $9.54 per share.
Now what
The possibility of a nonsurgical solution for bladder cancer should continue to drive the company's stock higher. The company said the therapy could help 80,000 people in the U.S. and has the potential of a $3 billion annual market. If approved, UGN-102 would be the company's second marketed therapy. The other is Jelmyto, designed to treat low-grade upper-tract urothelial cancer. Both involve the company's sustained release platform of RTGel reverse-thermal hydrogel.
In the first quarter, UroGen reported revenue, all from Jelmyto, of $17.2 million, up 27% year over year. It also had a net loss of $30.2 million, or $1.30 in earnings per share (EPS), compared to a net loss of $28.4 million and EPS loss of $1.25 in the same period last year.