Ladenburg Thalmann initiated coverage of UroGen Pharma (NASDAQ:URGN) with a “buy” rating and $50 price target. The stock closed at $37.21 on Dec. 29.
UroGen is developing RTGel, a reverse, thermally-triggered hydrogel platform technology, which is liquid at lower temperatures and converts into gel form at body temperature to deliver therapeutics. RTGel works to facilitate the delivery of a drug into body cavities and prevent the rapid excretion and clearance of the gel/drug.
UroGen formulates RTGel with mytomicin C in the case of MitoGel and VesiGel, and botulinum toxin in the case of BotuGel.
UroGen’s MitoGel is currently in Phase 3 development for the treatment of low- grade upper tract urothelial carcinoma. The Phase 3 OLYMPUS study is a pivotal, open-label, single-arm study, with anticipated enrollment of about 70 patients.
“We expect the top-line data to be announced in mid-2018,” writes analyst Matthew Kaplan. “We believe the program is on track for an NDA filing in the U.S. by the fourth quarter of 2018, with approval expected in the second half of 2019.
“We are encouraged by the Phase 2 results and believe there is strong likelihood for a positive readout for the study based on the strength of the Phase 2 data in this patient population,” he added.
VesiGel, UroGen’s second product, is currently on track to enter Phase 3 development for the treatment of low-grade non-muscle invasive bladder cancer (NMIBC) in the first half of 2018. Mr. Kaplan expects top-line data from the study in the first half of 2020.
To date, 86%, of the patients with low-grade NMIBC evaluated in the Phase 2a study in the VesiGel high dose group achieved a complete response, he added.
