Prometheus Biosciences, Inc. Stock Price, News & Analysis

Prometheus Biosciences reported promising results from the ARTEMIS-UC and APOLLO-CD Phase 2 studies of PRA023. In ARTEMIS-UC, 26.5% of patients achieved clinical remission compared to 1.5% on placebo (p<0.0001). All secondary endpoints were met, with 100% of patients completing the study. The APOLLO-CD study showed 26.0% endoscopic response and 49.1% clinical remission rates. PRA023 demonstrated favorable safety profiles, with no significant adverse events reported. Prometheus plans to advance PRA023 into Phase 3 studies for ulcerative colitis and Crohn’s disease in 2023.

Prometheus Biosciences, Inc. (Nasdaq: RXDX) reported its Q3 2022 financial results and significant progress in its clinical trials. The company is on track to release topline results for its ARTEMIS-UC Phase 2 study and full APOLLO-CD Phase 2a results concurrently in 4Q 2022. Prometheus has a strong cash position of $260.2 million, anticipated to fund operations into mid-2024. The FDA cleared the IND for PRA052, a first-in-class monoclonal antibody, and a Phase 1 trial has started. R&D expenses increased to $29.1 million in Q3 2022 due to advancements in clinical trials.

Prometheus Biosciences, Inc. (Nasdaq: RXDX), a clinical-stage biotechnology company focused on precision medicine for immune-mediated diseases, will present at three upcoming healthcare conferences. Management will conduct fireside chats at the Credit Suisse Annual Healthcare Conference on November 8, the Guggenheim 4th Annual Immunology and Neurology Conference on November 15, and the Jefferies London Healthcare Conference on November 17. Webcast access will be available through the Prometheus Biosciences Investor Relations page.

Prometheus Biosciences announced FDA clearance for the IND of PRA052, a monoclonal antibody targeting CD30 ligand for ulcerative colitis, marking a significant milestone. The Phase 1 study is expected to begin in 4Q 2022. PRA052 is the second candidate from the Prometheus360™ platform, showing strong genetic ties to inflammatory bowel disease (IBD) and potential efficacy in various immune-mediated conditions. The company aims to leverage its platform to enhance patient selection and treatment outcomes.

Prometheus Biosciences, Inc. (Nasdaq: RXDX) has announced its participation in upcoming healthcare conferences, where management will host fireside chats. The conferences include the Wells Fargo Healthcare Conference on September 7, 2022, at 11:00 am EST, and the Morgan Stanley 20th Annual Global Healthcare Conference on September 13, 2022, at 7:20 am EST. A live and archived webcast of these presentations will be available on their Events & Webcasts page.

Prometheus Biosciences (RXDX) reported Q2 2022 results, highlighting significant progress in clinical trials for PRA023 and the unveiling of PRA052, a new monoclonal antibody candidate. The company completed enrollment for both ARTEMIS-UC and APOLLO-CD Phase 2 studies ahead of schedule, with topline results expected in Q4 2022. Financially, Prometheus had $211.8 million in cash and equivalents, bolstered by $51.5 million raised from an ATM facility, providing a runway into mid-2024. Despite increased R&D and G&A expenses, collaboration revenue rose to $1.3 million from $0.3 million year-over-year.

Prometheus Biosciences (Nasdaq: RXDX) announced a virtual R&D Day on July 26, 2022, starting at 9:00 am ET. The event will present the novel therapeutic candidate PRA052, a first-in-class monoclonal antibody targeting a significant genetic link to inflammatory bowel diseases (IBD). Key insights will include the unveiling of the PR600 target and its scientific rationale. The company plans to submit an IND in Q3 2022 and initiate Phase 1 trials in Q4 2022. Dr. Marla Dubinsky will also provide insights into the unmet needs in precision medicine for IBD.

Prometheus Biosciences (NASDAQ: RXDX) has completed enrollment for Cohort 1 of the ARTEMIS-UC global Phase 2 study evaluating PRA023 in patients with moderate-to-severe ulcerative colitis (UC). This milestone comes alongside the completion of enrollment for APOLLO-CD, a study for Crohn's Disease (CD). Both studies are set to deliver topline results in 4Q 2022. The trial's rapid enrollment pace indicates substantial demand for new UC therapies, as noted by CEO Mark McKenna and CMO Allison Luo.

Prometheus Biosciences (Nasdaq: RXDX) has completed enrollment ahead of schedule for its APOLLO-CD Phase 2a study of PRA023 in Crohn’s disease patients. Enrollment for the ARTEMIS-UC Phase 2 study is on track to conclude in 3Q 2022. Both studies are expected to deliver topline results in 4Q 2022. The company highlights strong investigator interest and rapid trial execution as crucial milestones. Prometheus is advancing a global trial network and utilizing its Enroll360 platform to enhance patient enrollment, while also implementing a subcutaneous formulation for upcoming registrational studies.