Welcome to our dedicated page for PRNB news (Ticker: PRNB), a resource for investors and traders seeking the latest updates and insights on PRNB stock.
Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect PRNB's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.
Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of PRNB's position in the market.
Principia Biopharma has successfully completed patient enrollment for the Phase 3 PEGASUS trial of rilzabrutinib, a Bruton tyrosine kinase (BTK) inhibitor, ahead of schedule despite challenges posed by the COVID-19 pandemic. This pivotal trial aims to evaluate the drug's efficacy in achieving durable complete remission in pemphigus patients. Approximately 120 participants will receive treatment alongside corticosteroids, and results are expected within 37 weeks. Rilzabrutinib is designated as an orphan drug by the FDA and European Commission.
On September 17, 2020, Principia Biopharma (Nasdaq: PRNB) announced the dosing of the first patient in a Phase 2A trial evaluating rilzabrutinib for IgG4-related disease (RD). This multicenter trial plans to enroll 25 patients to assess the drug’s efficacy compared to glucocorticoids. IgG4-RD is a serious condition often requiring long-term steroid treatment, indicating strong demand for safer, effective alternatives like rilzabrutinib. The trial's primary endpoint is complete remission without glucocorticoids, highlighting the potential for significant therapeutic advances.
Principia Biopharma (Nasdaq: PRNB) announced the enrollment of the first patient in Sanofi's Phase 3 clinical trial of SAR442168 for relapsing multiple sclerosis (RMS). Principia is set to receive a $50 million milestone upon dosing. This trial compares SAR442168, a Bruton’s tyrosine kinase (BTK) inhibitor, with teriflunomide in 900 participants, focusing on relapse rates and secondary objectives including disability progression and cognitive performance. The partnership with Sanofi aims to advance treatment options for CNS diseases.
Principia Biopharma (PRNB) announced promising results from its Phase 2 Part B trial for rilzabrutinib in pemphigus, showing a 40% complete remission rate after 24 weeks and significant reduction in corticosteroid use. The median corticosteroid dose fell from 18 mg/day at baseline to 6 mg/day at 24 weeks, demonstrating a clear dose-response relationship. The drug exhibited a favorable safety profile, with only mild-to-moderate side effects reported. A Phase 3 trial is ongoing, targeting durable complete remission after 36 weeks.
Principia Biopharma Inc. (Nasdaq: PRNB) announced promising results from a Phase 1/2 trial of its oral BTK inhibitor, rilzabrutinib, for treating immune thrombocytopenia (ITP). In the trial, 50% of patients receiving 400 mg twice daily for over 12 weeks achieved the primary endpoint of sustained platelet counts. The treatment demonstrated rapid response, with significant improvements seen as early as day eight. The company plans to initiate a pivotal Phase 3 trial for ITP by the end of 2020, barring any COVID-19 disruptions. Rilzabrutinib was also well tolerated with no serious side effects reported.
Principia Biopharma Inc. (Nasdaq: PRNB) announced a virtual analyst event on June 16, 2020, to discuss its precision bonding technology platform and the role of BTK in immune-mediated diseases. The event will cover clinical observations related to BTK inhibition and recent data from prominent medical conferences. The company's ongoing pipeline includes Rilzabrutinib, PRN2246/SAR442168 for multiple sclerosis, and PRN473 Topical for immune-mediated skin diseases. The presentation will be available via live webcast.
Principia Biopharma (Nasdaq: PRNB) announced its upcoming presentations at the European Hematology Association and International Society on Thrombosis and Haemostasis congresses. The focus will be on rilzabrutinib, an oral treatment for immune thrombocytopenia (ITP), a serious autoimmune condition. Dr. David Kuter will discuss clinical trial results, including efficacy and safety updates. Presentations are scheduled for June and July 2020. Rilzabrutinib targets underlying disease mechanisms to improve patient outcomes, representing a significant advancement in treating ITP.
Principia Biopharma (Nasdaq: PRNB) has announced a full data set presentation from the Phase 2 Part B pemphigus trial of its investigational drug, rilzabrutinib, to be held during the American Academy of Dermatology (AAD) meeting from June 12-14, 2020. Rilzabrutinib is designed to treat immune-mediated diseases as a reversible covalent inhibitor of Bruton’s tyrosine kinase (BTK). This presentation will be led by Dr. Dedee Murrell and will be available on-demand. The company aims to present significant findings supporting rilzabrutinib's safety and efficacy.
Principia Biopharma (Nasdaq: PRNB) reported its Q1 2020 financial results, highlighting a net loss of $32.5 million, compared to a loss of $13.7 million in Q1 2019. Cash and cash equivalents decreased to $341.1 million from $367.8 million in the previous quarter. R&D expenses surged to $26.7 million, driven by the growth of the rilzabrutinib program. Although no collaboration revenue was recognized this quarter, the company is optimistic about ongoing clinical trials, including a Phase 2 study for rilzabrutinib, now expected to start in H2 2020. Positive data from a partnered Phase 2 trial in multiple sclerosis was noted.
Principia Biopharma (Nasdaq: PRNB) has announced its participation in the 2020 Bank of America Health Care Conference on May 12, 2020, at 3:00 PM EDT. The presentation will be accessible via a live webcast on the company's website, with a replay available afterward. Principia is focused on developing treatments for immune-mediated diseases using its proprietary Tailored Covalency platform. Current key projects include Rilzabrutinib in clinical trials for pemphigus and immune thrombocytopenia, and PRN2246/SAR442168 for multiple sclerosis.
