UroGen Pharma Ltd. (URGN) has seen an increase of 8.64% in aftermarket. However, the last trading session concluded at $10.99 with a decrease of 4.18%.
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Third Quarter 2021 Results – Updated!
URGN announced third quarter 2021 results on 15th November 2021. The company reported $11.4 million in Jelmyto net product revenue. Moreover, research and development costs came out to be $11.9 million, and selling, general, and administrative expenditures totaled $21.6 million. Not only this, but the company stated the cash and cash equivalents of $110.3 million and the net loss was $30.2 million. The company is lowering its full-year operating costs projection for 2021 from $155 million to $165. The revised guidance includes a non-cash share-based compensation expense of $22 to $25 million. Last but not least, the company expects that sales will go up from $47 million to $51 million for the entire year of 2021.
URGN continued to make progress in both clinical and commercial areas in the third quarter of 2021. Moreover, the company is trying to give UGN-102 a better chance of regulatory approval in patients with low-grade IR-NMIBC, while keeping on target for a 2024 NDA filing. Furthermore, as the company approaches the end of 2021, they are encouraged by the robust demand for Jelmyto. Lastly, both new patient enrollment forms and new patient starts were at an all-time high in September and October.
Phase 3 Development Plan for UGN-102 – What’s it all about?
On 10th November 2021, URGN announced the new phase 3 development plan at the Spotlight event. URGN thanks the investigators and patients who took part in the ATLAS research and feels the results will be a key element of the anticipated UGN-102 NDA application in 2024. Moreover, URGN will halt enrolling in the ATLAS study due to the new Phase 3 trial being prepared. Patients who have already joined ATLAS will be able to stay in the trial until it is finished.
URGN is now performing nonhuman primate toxicity studies in order to allow the start of a multi-arm Phase 1 investigation of UGN-301 in early 2022. It will be followed by a study of UGN-301 in combination with additional medicines. This strategy makes use of URGN’s proprietary drug delivery technology. This allows researchers to test the anti-CTLA4 monoclonal antibody’s intravesical administration in conjunction with various immunomodulators, chemotherapies, gene therapy, and innate immune stimulators, such as UGN-201.