Kiniksa Pharmaceuticals Ltd

Kiniksa Pharmaceuticals Ltd. is a biopharmaceutical company, which engages in discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Its products include Rilonacept, Mavrilimumab, Vixarelimab, and KPL-404. The company was founded by Sanj K. Patel, Stephen Frank Mahoney, Krisha S. Mahoney, Thomas W. Beetham, Christopher Heberlig, Carsten Boess, Rasmus Holm-Jorgensen, Gregory Alex Grabowksi, Aaron Isadore Young, Eben P. Tessari, Jennifer Lynne Mason and Mickenzie Elizabeth Gallagher in July 2015 and is headquartered in Lexington, MA.

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Kiniksa Pharmaceuticals reports robust Q2 growth and strategic initiatives

Kiniksa Pharmaceuticals delivered a strong Q2 performance with significant revenue growth driven by ARCALYST sales and strategic initiatives. The company's focus on disease awareness and patient base expansion bodes well for future growth.
While challenges such as managing expenses and addressing operational complexities persist, Kiniksa's solid financial position and market opportunities position it favorably for sustained growth and value creation.
Overall, Kiniksa Pharmaceuticals' Q2 earnings call highlights a mix of strong performance, strategic strengths, operational challenges, and growth opportunities, signaling a dynamic and evolving landscape for the company.

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Kiniksa Pharmaceuticals International Plc is a commercial-stage biopharmaceutical company. It engages in discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. The company was founded on April 9, 2024 and is headquartered in London, United Kingdom.

- Defined regulatory pathway for Phase 3 clinical development of mavrilimumab in multiple indications -

Kiniksa Outlines Next Steps for the Development of Mavrilimumab

HAMILTON, Bermuda, June 01, 2021 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) announced today that it will present at the Goldman Sachs 42nd Annual Global Healthcare Conference on Tuesday, June 8, 2021 at 9:40 a.m. Eastern Time.

Kiniksa Pharmaceuticals to Present at Goldman Sachs 42nd Annual Global Healthcare Conference

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- ARCALYST ® (rilonacept) launched as the first and only FDA-approved therapy for recurrent pericarditis - - Mavrilimumab Phase 2 severe COVID-19 data demonstrated a reduction in mechanical ventilation and death at Day 29; Phase 3 enrollment ongoing - - Final KPL-404 Phase 1 data support further development in patients; Phase 2 proof-of-concept trial initiation planned for 2H 2021 - - Cash reserves of approximately $264 million -

Kiniksa Reports First Quarter 2021 Financial Results and Recent Corporate and Portfolio Activity

- Highest dose cohorts confirm and extend previously-reported 3 mg/kg IV cohort data - - 10 mg/kg IV dose provides full receptor occupancy through Day 71 and complete suppression of TDAR after KLH challenge and re-challenge through at least Day 57 - - 5 mg/kg SC dose provides full receptor occupancy through Day 43 and complete suppression of TDAR after KLH challenge through at least Day 29 - - Plan to initiate Phase 2 proof-of-concept trial in patients in 2H 2021 -

Kiniksa Announces Positive Final Data from Phase 1 Trial of KPL-404

Kiniksa is testing Mavrilimumab in giant cell arteritis and COVID-19. It has produced strong data in either indication.

Kiniksa: A Look At Mavrilimumab

– P rimary endpoint achieved: the proportion of patients alive and free of mechanical ventilation at Day 29 was 12.3 percentage points higher with mavrilimumab versus placebo (p=0.1224 met predefined statistical threshold of p

Kiniksa Announces Positive Results for Mavrilimumab Phase 2 Trial in Non-Mechanically Ventilated Severe COVID-19 Patients

- ARCALYST is the first and only FDA-approved therapy for recurrent pericarditis – - ARCALYST now available on prescription basis in the U.S. – - Kiniksa One Connect™ program provides ongoing patient access and support services –

Kiniksa Announces Commercial Availability of ARCALYST ® (rilonacept) for Recurrent Pericarditis

- ARCALYST is the first and only FDA-approved therapy for recurrent pericarditis - - Commercial launch expected in April 2021 - - Kiniksa launches Kiniksa One Connect™ patient support program - - Conference call and webcast scheduled for  5:30 p.m. EDT today -

Kiniksa Announces FDA Approval of ARCALYST ® (rilonacept) for Recurrent Pericarditis

- Strong execution across pipeline of immune-modulating assets throughout 2020 enables multiple milestones in 2021 - - Rilonacept in recurrent pericarditis granted priority review, with PDUFA goal date of March 21, 2021 - - Clinical data expected in 1H 2021 from KPL-404 (anti-CD40) Phase 1 clinical trial and mavrilimumab Phase 2 clinical trial in severe COVID-19 - - Year-end 2020 cash reserves of approximately $323 million -

Kiniksa Reports Fourth Quarter and Full-Year 2020 Financial Results and Corporate and Pipeline Activity

HAMILTON, Bermuda, Jan. 04, 2021 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) announced today that it will present at the 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2021 at 4:30 p.m. Eastern Time.

Kiniksa Pharmaceuticals to Present at 39th Annual J.P. Morgan Healthcare Conference

- Early signal of efficacy with trends toward lower mortality and shorter duration of mechanical ventilation in patients treated with mavrilimumab –

Kiniksa Announces Data from U.S. Investigator-Initiated Study of Mavrilimumab in Severe COVID-19 Pneumonia and Hyperinflammation

– Evaluating vixarelimab across a range of once-monthly dose regimens injected subcutaneously – – Evaluating vixarelimab across a range of once-monthly dose regimens injected subcutaneously –

Kiniksa Commences Dosing of Vixarelimab Phase 2b Clinical Trial in Prurigo Nodularis

- R eceptor occupancy and TDAR suppression shown through Day 29 at 3 mg/kg intravenous –

Kiniksa Announces Preliminary Data from Phase 1 Trial of KPL-404

HAMILTON, Bermuda, Nov. 24, 2020 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) announced today that it will present at the Evercore ISI 3rd Annual HealthCONx Conference on Tuesday, December 1st, 2020 at 8:50 a.m. Eastern Time.

Kiniksa Pharmaceuticals to Present at the Evercore ISI 3rd Annual HealthCONx Conference

- PDUFA goal date of March 21, 2021 - - Filing based on positive data from RHAPSODY , which achieved its primary  and all major secondary endpoints - - Rilonacept BLA for CAPS transferred to Kiniksa from Regeneron -

Kiniksa Announces U.S. FDA Acceptance of sBLA and Priority Review for Rilonacept in Recurrent Pericarditis

Primary and secondary efficacy endpoints achieved statistical significance; mavrilimumab reduced risk of flare and increased sustained remission Primary and secondary efficacy endpoints achieved statistical significance; mavrilimumab reduced risk of flare and increased sustained remission

Kiniksa Announces American College of Rheumatology Convergence 2020 Late-Breaking Abstracts Presentation of Mavrilimumab Phase 2 Giant Cell Arteritis Data

HAMILTON, Bermuda, Nov. 05, 2020 (GLOBE NEWSWIRE) --  Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company with a pipeline of assets designed to modulate immunological pathways across a spectrum of diseases, today reported third quarter 2020 financial results and highlighted recent pipeline and corporate activity.

Kiniksa Reports Third Quarter 2020 Financial Results and Highlights Recent Pipeline and Corporate Activity

Kiniksa expects to initiate a dose-ranging Phase 2b clinical trial of vixarelimab in prurigo nodularis in the fourth quarter of 2020 Kiniksa expects to initiate a dose-ranging Phase 2b clinical trial of vixarelimab in prurigo nodularis in the fourth quarter of 2020

Kiniksa Announces Phase 2 Clinical Data from Vixarelimab in Prurigo Nodularis to be Presented at European Academy of Dermatology and Venereology Virtual Congress

- Mavrilimumab r educe d t ime - to - f lare and i ncrease d s ustained r emission in Phase 2 giant cell arteritis clinical t rial - - Primary and secondary efficacy endpoints achieved statistical significan ce - - Results were consistent across new onset and relapsing / refractory cohorts - 

Kiniksa Announces New Data from Phase 2 Trial of Mavrilimumab in Giant Cell Arteritis to be Presented at Late-Breaking Abstracts Session of American College of Rheumatology Convergence 2020

- Primary and secondary efficacy endpoints statistically significant - - Primary and secondary efficacy endpoints statistically significant -

Kiniksa Announces Positive Data from Phase 2 Trial of Mavrilimumab in Giant Cell Arteritis

- Virtual e vent to take place from  8:00 a.m. to 9: 3 0 a.m.  E D T -

Kiniksa Announces Rilonacept Analyst Day Now Tuesday, September 29th

- Virtual event scheduled for Monday, September 28th, 2020 from 8:00 a.m. to 9:30 a.m. EDT- - Virtual event scheduled for Monday, September 28th, 2020 from 8:00 a.m. to 9:30 a.m. EDT-

Kiniksa Announces Upcoming Rilonacept Analyst Day

HAMILTON, Bermuda , Sept.  09, 2020  (GLOBE NEWSWIRE) --  Kiniksa Pharmaceuticals, Ltd.  (Nasdaq: KNSA) announced today that it will present at the Morgan Stanley 18th Annual Global Healthcare Conference on Wednesday, September 16th, 2020 at 2:00 p.m. Eastern Time.

Kiniksa Pharmaceuticals to Present at the Morgan Stanley 18th Annual Global Healthcare Conference

HAMILTON, Bermuda, Aug.  31, 2020  (GLOBE NEWSWIRE) --  Kiniksa Pharmaceuticals, Ltd.  (Nasdaq: KNSA) (“Kiniksa”), a biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutic medicines for patients with significant unmet medical need, presented findings from a real-world patient survey assessing the substantial impact of recurrent pericarditis on health-related quality of life at ESC Congress 2020, the annual meeting of the European Society of Cardiology.

News for Kiniksa Pharmaceuticals Ltd Stock (KNSA)