Kiniksa Pharmaceuticals International, plc Stock Price, News & Analysis

Kiniksa Pharmaceuticals has announced results from a Phase 2 clinical trial of mavrilimumab for treating giant cell arteritis (GCA). The trial achieved statistical significance in both primary and secondary efficacy endpoints, showing a 62% lower risk of flare and 33.3 percentage points higher sustained remission rate in mavrilimumab recipients compared to placebo. No drug-related serious adverse events were reported. The FDA granted Orphan Drug designation for mavrilimumab, and the company plans to present these findings at the ACR Convergence on November 9, 2020.

Kiniksa Pharmaceuticals announced positive results from the Phase 2 trial of mavrilimumab for treating giant cell arteritis (GCA). Both primary and secondary efficacy endpoints were statistically significant, indicating mavrilimumab may provide a viable treatment option. The trial involved 70 patients aged 50-85, with mavrilimumab showing a 62% lower risk of flare compared to placebo. The safety profile was favorable, with no serious drug-related adverse events noted. The company anticipates further discussions with the FDA to guide next steps in the development program.

Kiniksa Pharmaceuticals (KNSA) announced its virtual Rilonacept Analyst Day scheduled for September 29, 2020. The event will include discussions on the market potential for rilonacept in treating recurrent pericarditis and the company's commercial launch strategy. Key presentations will feature insights from Kiniksa's management and Dr. Paul Cremer from Cleveland Clinic. Notably, there are currently no FDA-approved treatments for recurrent pericarditis, highlighting a significant market opportunity for rilonacept, which has received Breakthrough Therapy designation from the FDA.

Kiniksa (Nasdaq: KNSA) will host a virtual Rilonacept Analyst Day on September 28, 2020, focusing on the market opportunity for rilonacept in recurrent pericarditis. The event will include insights from Kiniksa's management and guest speaker Paul Cremer from the Cleveland Clinic. Rilonacept, originally developed by Regeneron, is FDA-approved for Cryopyrin-Associated Periodic Syndromes but aims to address recurrent pericarditis, a condition with no current FDA-approved treatments. Kiniksa plans to submit a supplemental Biologic License Application for rilonacept later this year.

Kiniksa Pharmaceuticals (Nasdaq: KNSA) will present at the Morgan Stanley 18th Annual Global Healthcare Conference on September 16, 2020, at 2:00 p.m. ET. A live webcast of the presentation will be available on Kiniksa's website. A replay will be accessible for 14 days post-conference. Kiniksa focuses on developing therapeutic medicines for debilitating diseases and has several clinical-stage product candidates, including rilonacept and mavrilimumab, which aim to address unmet medical needs through innovative approaches.

Kiniksa Pharmaceuticals (KNSA) presented findings at ESC Congress 2020 on the impact of recurrent pericarditis on patients' quality of life. The survey revealed significant physical and mental health burdens, emphasizing the need for effective treatment. Their pivotal Phase 3 trial of rilonacept demonstrated a 96% reduction in pericarditis recurrence risk, leading to plans for an sBLA submission to the FDA. Kiniksa aims to commercialize rilonacept, with existing FDA designations supporting its use in recurrent pericarditis. The company continues to generate evidence on the disease's burden.

Kiniksa Pharmaceuticals (Nasdaq: KNSA) announced its participation at the 2020 Wedbush PacGrow Healthcare Conference, scheduled for August 11, 2020, at 1:10 p.m. Eastern Time. A live webcast of the presentation will be available on the company's website, and a replay will be accessible for 14 days post-conference. Kiniksa focuses on developing therapeutic medicines for patients with unmet medical needs, with clinical-stage candidates targeting various immunological pathways.

Kiniksa Pharmaceuticals (KNSA) reported significant advancements in its pipeline, with the pivotal Phase 3 trial of rilonacept in recurrent pericarditis achieving a 96% risk reduction in event recurrence. The company plans to submit a supplemental Biologics License Application (sBLA) to the FDA this year. A recent capital raise of ~$220 million will extend cash reserves into 2023. Moreover, mavrilimumab is in global trials for COVID-19 pneumonia, and vixarelimab's Phase 2 is set for prurigo nodularis. Despite a net loss of $37.5 million, operating expenses decreased from 2019, indicating financial discipline.

Kiniksa Pharmaceuticals has announced a public offering of 5,952,381 Class A common shares at $21.00 each, aiming for gross proceeds of approximately $155 million, including a concurrent private placement of 1,428,572 shares. The offering is set to close on July 24, 2020. Proceeds will support the development and commercialization of its product candidates, alongside working capital needs. Joint book-running managers for the offering include Goldman Sachs, BofA Securities, and J.P. Morgan.