Prometheus Biosciences, Inc. Stock Price, News & Analysis

Prometheus Biosciences (RXDX), a clinical-stage biotech company, reported its Q1 2022 financial results with a strong cash position of $227 million. The company is advancing PRA023 across three immune-mediated disease indications, with topline results from ARTEMIS-UC and APOLLO-CD Phase 2 studies expected in Q4 2022. Recent key appointments include Marla Hochfeld and Deepti Garg to strengthen clinical development and diagnostics. Collaboration revenue increased to $3.9 million from $0.8 million year-over-year.

Prometheus Biosciences (Nasdaq: RXDX) has initiated the ATHENA-SSc-ILD trial, a Phase 2 study evaluating PRA023 for the treatment of Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD). This trial, focused on the dual action against fibrosis and inflammation, marks the first indication for PRA023 outside inflammatory bowel disease. The FDA has granted Fast Track Designation for PRA023, with topline results expected in H1 2024. The study plans to enroll approximately 100 patients and assess various clinical endpoints, including forced vital capacity changes.

Prometheus Biosciences (RXDX) reported strong financial results for 2021, ending the year with cash of $257.3 million. The company is advancing its lead candidate PRA023 for ulcerative colitis and Crohn's disease, with top-line data expected in Q4 2022. They have initiated Phase 2 trials and received Fast Track Designation for PRA023 in treating systemic sclerosis-associated interstitial lung disease (SSc-ILD). Prometheus also completed a successful IPO and secured $20 million from Dr. Falk Pharma for its PR600 program, indicating robust growth prospects.

On March 1, 2022, Prometheus Biosciences (Nasdaq: RXDX) announced that CEO Mark McKenna and management will participate in a virtual fireside chat at the Cowen 42nd Annual Healthcare Conference on March 7, 2022, at 12:50 PM ET. The company focuses on precision medicine for immune-mediated diseases, utilizing its Prometheus360™ platform. Its lead candidate, PRA023, targets conditions like ulcerative colitis and Crohn’s disease, with ongoing Phase 2 trials. A live and archived webcast of the chat will be available on their Investor section web page.

Prometheus Biosciences (Nasdaq: RXDX) announced that CEO Mark McKenna will participate in a virtual fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on February 16, 2022, at 3:40 PM ET. The event will be accessible via a live and archived webcast on the company's investor relations page. Prometheus is focused on precision medicine for immune-mediated diseases, with its lead candidate, PRA023, currently in Phase 2 trials for Ulcerative Colitis and Crohn's disease, and plans to initiate a trial for systemic sclerosis-associated interstitial lung disease.

Prometheus Biosciences (RXDX) announced that the U.S. FDA granted Fast Track Designation for its lead candidate, PRA023, targeting Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD). This designation aims to expedite the development and review process due to the unmet medical need. Additionally, a new patent for the PRA023 companion diagnostic technology has been granted, extending coverage until 2040. The company plans to begin Phase 2 trials for PRA023 in early 2022.

Prometheus Biosciences (Nasdaq: RXDX) will present at the 40th Annual J.P. Morgan Virtual Healthcare Conference on January 12 at 1:30 p.m. EST. Mark McKenna, Chairman and CEO, will provide an overview of the company, which focuses on precision medicine for immune-mediated diseases. The presentation will be available via webcast on Prometheus’ website for 30 days after the event. The company is advancing its lead candidate, PRA023, an IgG1 monoclonal antibody currently in Phase 2 trials for ulcerative colitis and Crohn's disease, with plans for additional trials in systemic sclerosis-associated interstitial lung disease.

Prometheus Biosciences (Nasdaq: RXDX) announced the receipt of a final preclinical milestone payment from Dr. Falk Pharma for its PR600 program, which is aimed at developing a companion diagnostic for immune-mediated diseases, particularly inflammatory bowel disease (IBD). This milestone supports Prometheus' goal of initiating clinical trials for PR600 in 2022, with an Investigational New Drug Application (IND) expected to be submitted in the third quarter. The collaboration will see shared responsibilities for global development, with both companies focusing on precision treatments for IBD.

Prometheus Biosciences reported positive topline results from its Phase 1 trial of PRA023, a monoclonal antibody targeting TL1A, achieving its primary objective of safety and tolerability. The trial, involving 69 healthy volunteers, showed no significant safety concerns and <20% immunogenicity rate. The company is expanding its pipeline by adding a Phase 2 trial for Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD), expected to begin in Q1 2022. This marks a potential new indication for PRA023, which showed strong target engagement, suggesting the potential for improved treatment outcomes in immune-mediated diseases.