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On Wednesday, Prometheus Biosciences Inc. (NASDAQ:RXDX) reported positive results from its ARTEMIS-UC Phase 2 and APOLLO-CD Phase 2a studies of PRA023.
The company said in a press release that the drug showed strong efficacy and favorable safety results in both studies, and based on the data in the studies, it intends to advance PRA023 into Phase 3 trials for ulcerative colitis and Crohn’s disease in 2023.
RXDX shares surged over 165% on the news Wednesday, while it is up a further 13% so far on Thursday.
Reacting to the announcement, Credit Suisse analysts, who have an Outperform rating and $59 price target on the stock, said in a research note that the results “exceed both sell/buy side expectations for the readout.”
They added that they also “provide substantial optionality to RXDX’s PRA023 development in IBD, with potential for all-comers and/or CDx+ positioning. We believe the data should also support potential upside to current peak sales estimates given the robust efficacy/safety profile to date.”
Meanwhile, Oppenheimer analysts said in a note: “Both studies met primary and secondary endpoints along with demonstrating a clean safety profile for RXDX’s TL1A targeting MAb PRA023.”
“In the case of the single arm CD study the results were positive, with 26% of patients achieving endoscopic response vs. a historical placebo rate of 12% (p=0.002). However, this missed our target of 30-40%, based on competing products. The secondary endpoint of clinical remission was 49% (p0.001), in range with other recent data of 45-55%. We view the top-line results in UC as among the best for any product in a Phase 2 study to date,” wrote the analysts, who have an Outperform rating on the stock.
