Latest news with #KiniksaPharmaceuticalsInternational
Yahoo
05-06-2025
- Business
- Yahoo
Kiniksa Pharmaceuticals Announces Trial Design of Planned Phase 2/3 Clinical Trial of KPL-387 in Recurrent Pericarditis
– KPL-387 Phase 2/3 trial on track to initiate in mid-2025; Phase 2 data expected in 2H 2026 –– KPL-387 Phase 1 single ascending dose data support profile for monthly dosing –– Presentation and webcast at Jefferies 2025 Global Healthcare Conference scheduled for 12:50 pm ET today– LONDON, June 05, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications, today announced details for its planned Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis, expected to initiate in the middle of 2025. KPL-387 is an independently developed monoclonal antibody that binds human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling activity of the cytokines interleukin-1α (IL-1α) and interleukin-1β (IL-1β). 'We leveraged our expertise in this indication and experience with the RHAPSODY study design to plan this pivotal phase 2/3 study. We believe KPL-387 could provide a meaningful addition to the therapeutic options available to patients,' said John F. Paolini, M.D., Ph.D., FACC, Chief Medical Officer of Kiniksa. 'We are eager to advance KPL-387, with its target profile of monthly dosing in a single subcutaneous injection in a liquid formulation, through this pivotal Phase 2/3 clinical trial and to patients in need. We expect to initiate the study in the middle of this year, with data from the dose-focusing portion expected in the second half of 2026.' Phase 2/3 Clinical Trial of KPL-387 in Recurrent PericarditisKiniksa is on track to initiate a Phase 2/3 clinical trial designed to evaluate the efficacy and safety of KPL-387 administered subcutaneously (SC) in patients with recurrent pericarditis. The trial will consist of three overlapping parts combined into a single protocol: a dose-focusing portion (Phase 2), a pivotal portion (Phase 3), and long-term extensions (LTE). The dose-focusing portion of the trial will enroll up to approximately 80 participants with recurrent pericarditis randomized in a 1:1:1:1 ratio to receive KPL-387 300 mg SC biweekly, 300 mg SC monthly, 100 mg SC biweekly, and 100 mg SC monthly. The primary efficacy endpoint is time to treatment response at Week 24. Subsequently, active, enrolled participants may be eligible to enter an LTE. Following the dose-focusing portion, enrollment of up to approximately 85 patients with recurrent pericarditis into the pivotal portion of the clinical trial will commence. In the first period, a single-blind run-in (RI), all participants will receive KPL-387 while conventional oral pericarditis medications are weaned and discontinued. Participants achieving Clinical Response in the RI period will then be randomized in a 1:1 ratio to receive either KPL-387 or placebo in an event-driven, double-blind, randomized withdrawal (RW) period. The primary efficacy endpoint is time to first-adjudicated pericarditis recurrence during the RW period. Participants in the RW period may be eligible to enter an LTE. The Phase 2/3 clinical trial design is supported by data from the Phase 1 first-in-human single ascending dose study. Presentation Information Ross Moat, Chief Commercial Officer, and Dr. John Paolini, Chief Medical Officer, will provide a corporate presentation at the Jefferies 2025 Global Healthcare Conference at 12:50 p.m. Eastern Time on Thursday, June 5, 2025. A live webcast of Kiniksa's presentation will be accessible through the Investors & Media section of the company's website at A replay of the event will also be available on Kiniksa's website within approximately 48 hours after the event. About KiniksaKiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa's portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. For more information, please visit About KPL-387KPL-387 is an independently developed, investigational, fully human immunoglobulin G2 (IgG2) monoclonal antibody that binds human interleukin-1 receptor 1 (IL-1R1), inhibiting the signaling of the cytokines IL-1α and IL-1β. Kiniksa believes KPL-387 could expand the treatment options for recurrent pericarditis patients by enabling dosing with a single monthly SC injection in a liquid formulation. Forward-Looking StatementsThis press release contains forward-looking statements. In some cases, you can identify forward looking statements by terms such as 'may,' 'will,' 'should,' 'expect,' 'plan,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'potential' or 'continue' or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: our plan to initiate a Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis in mid-2025, with Phase 2 data expected in the second half of 2026, and that we remain on track to meeting such plan; our target profile of monthly dosing via a single subcutaneous injection in a liquid formulation for KPL-387; our belief that KPL-387 could provide a meaningful addition to therapeutic options available to patients; the design of our Phase 2/3 clinical trial of KPL-387, including the number of participants expected to enroll and our belief that the Phase 3 portion is pivotal; our beliefs about the mechanisms of our assets and potential impact of their approach; and our belief that our portfolio of assets offers the potential for differentiation. These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including without limitation, the following: delays or difficulty in enrollment of patients in, and activation or continuation of sites for, our clinical trials; delays or difficulty in completing our clinical trials as originally designed; potential for changes between final data and any preliminary, interim, top-line or other data from clinical trials; our inability to replicate results from our earlier clinical trials or studies; impact of additional data from us or other companies, including the potential for our data to produce negative, inconclusive or commercially uncompetitive results; potential undesirable side effects caused by our products and product candidates; our inability to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities; potential for applicable regulatory authorities to not accept our filings, delay or deny approval of any of our product candidates or require additional data or trials to support approval; our reliance on third parties as the sole source of supply of the drug substance and drug product used in our products and product candidates; raw material, important ancillary product and drug substance and/or drug product shortages; our reliance on third parties to conduct research, clinical trials, and/or certain regulatory activities for our product candidates; complications in coordinating requirements, regulations and guidelines of regulatory authorities across jurisdictions for our clinical trials; business development activities and their impact on our financial performance and strategy; changes in our operating plan, business development strategy or funding requirements; existing or new competition; and the impact of global economic policy, including any uncertainty in national and international markets. These and other important factors discussed in our filings with the U.S. Securities and Exchange Commission, including under the caption 'Risk Factors' contained therein, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press Investor & Media ContactJonathan Kirshenbaum(781) 829-3949jkirshenbaum@ in to access your portfolio
Yahoo
29-05-2025
- Business
- Yahoo
Kiniksa Pharmaceuticals to Present at Upcoming Investor Conferences
LONDON, May 29, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) today announced that management will present at the following investor conferences in June: Jefferies 2025 Global Healthcare Conference on Thursday, June 5 at 12:50 p.m. Eastern Time Goldman Sachs 46th Annual Global Healthcare Conference on Tuesday, June 10 at 8:00 a.m. Eastern Time – Fireside Chat A live webcast of Kiniksa's presentations will be accessible through the Investors & Media section of the company's website at A replay of the events will also be available on Kiniksa's website within approximately 48 hours after the event. About KiniksaKiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa's portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. For more information, please visit Kiniksa Investor & Media ContactJonathan Kirshenbaum (781) 829-3949jkirshenbaum@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
01-05-2025
- Business
- Yahoo
3 Stocks Including Kiniksa Pharmaceuticals International That May Be Priced Below Intrinsic Value Estimates
The United States market has experienced a positive trajectory, climbing 2.7% in the last 7 days and showing a 9.6% increase over the past year, with earnings forecasted to grow by 14% annually. In such an environment, identifying stocks that are potentially priced below their intrinsic value can be key for investors seeking opportunities that align with these promising growth trends. Name Current Price Fair Value (Est) Discount (Est) Trade Desk (NasdaqGM:TTD) $53.63 $106.20 49.5% Lantheus Holdings (NasdaqGM:LNTH) $104.34 $204.26 48.9% First Bancorp (NasdaqGS:FBNC) $40.46 $79.05 48.8% SharkNinja (NYSE:SN) $80.50 $160.80 49.9% Curbline Properties (NYSE:CURB) $22.89 $45.17 49.3% Tenable Holdings (NasdaqGS:TENB) $30.57 $60.24 49.3% BigCommerce Holdings (NasdaqGM:BIGC) $5.18 $10.35 49.9% Verra Mobility (NasdaqCM:VRRM) $21.80 $43.13 49.5% CBIZ (NYSE:CBZ) $68.10 $133.65 49% Roku (NasdaqGS:ROKU) $68.18 $135.82 49.8% Click here to see the full list of 189 stocks from our Undervalued US Stocks Based On Cash Flows screener. Let's take a closer look at a couple of our picks from the screened companies. Overview: Kiniksa Pharmaceuticals International, plc is a biopharmaceutical company that develops and commercializes novel therapies for diseases with unmet needs, focusing on cardiovascular indications globally, with a market cap of approximately $1.89 billion. Operations: Kiniksa Pharmaceuticals International generates its revenue from developing and delivering therapeutic medicines, amounting to $481.17 million. Estimated Discount To Fair Value: 38.6% Kiniksa Pharmaceuticals International is trading at US$26.97, significantly below its estimated fair value of US$43.96, suggesting it may be undervalued based on cash flows. The company recently raised its 2025 revenue guidance to between US$590 million and US$605 million, reflecting strong financial performance with Q1 2025 revenue at US$137.79 million compared to US$79.86 million a year ago, and a net income turnaround from a loss of USD 17.7 million to an income of USD 8.54 million. Our expertly prepared growth report on Kiniksa Pharmaceuticals International implies its future financial outlook may be stronger than recent results. Click here to discover the nuances of Kiniksa Pharmaceuticals International with our detailed financial health report. Overview: AngloGold Ashanti plc is a gold mining company with operations across Africa, Australia, and the Americas, and it has a market cap of approximately $20.48 billion. Operations: The company's revenue primarily comes from its Metals & Mining segment, specifically Gold & Other Precious Metals, totaling $5.79 billion. Estimated Discount To Fair Value: 19.7% AngloGold Ashanti, trading at US$42.16, is below its estimated fair value of US$52.49, indicating potential undervaluation based on cash flows. The company's earnings are projected to grow faster than the market average at 19.9% annually. Recent strategic alliances, such as the expanded joint venture with Kincora Copper in Australia, enhance exploration opportunities and may bolster future revenue streams despite an unstable dividend history and past shareholder dilution concerns. Upon reviewing our latest growth report, AngloGold Ashanti's projected financial performance appears quite optimistic. Delve into the full analysis health report here for a deeper understanding of AngloGold Ashanti. Overview: Equifax Inc. is a data, analytics, and technology company with a market cap of $32.13 billion. Operations: The company's revenue is derived from three primary segments: International ($1.36 billion), Workforce Solutions ($2.45 billion), and U.S. Information Solutions ($1.93 billion). Estimated Discount To Fair Value: 39.8% Equifax, currently trading at US$260.13, is significantly undervalued based on cash flows with an estimated fair value of US$432.42. Despite high debt levels, its earnings are expected to grow at 21.3% annually, outpacing the market average. Recent developments include a new share buyback program worth US$3 billion and a 28% dividend increase to US$0.50 per share for Q2 2025, reflecting robust financial strategies amidst moderate revenue growth forecasts. In light of our recent growth report, it seems possible that Equifax's financial performance will exceed current levels. Take a closer look at Equifax's balance sheet health here in our report. Investigate our full lineup of 189 Undervalued US Stocks Based On Cash Flows right here. Already own these companies? Link your portfolio to Simply Wall St and get alerts on any new warning signs to your stocks. Discover a world of investment opportunities with Simply Wall St's free app and access unparalleled stock analysis across all markets. Explore high-performing small cap companies that haven't yet garnered significant analyst attention. Diversify your portfolio with solid dividend payers offering reliable income streams to weather potential market turbulence. Fuel your portfolio with companies showing strong growth potential, backed by optimistic outlooks both from analysts and management. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NasdaqGS:KNSA NYSE:AU and NYSE:EFX. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
Yahoo
24-04-2025
- Business
- Yahoo
Kiniksa Pharmaceuticals to Report First Quarter 2025 Financial Results on April 29, 2025
LONDON, April 24, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) announced today that it will host a conference call and live webcast on Tuesday, April 29, 2025 at 8:30 a.m. Eastern Time to report its first quarter 2025 financial results and recent portfolio execution. A live webcast will be accessible through the Investors & Media section of the company's website at Individuals interested in participating in the call via telephone may register here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the event will also be available on Kiniksa's website within approximately 48 hours after the event. About KiniksaKiniksa is a biopharmaceutical company dedicated to improving the lives of patients suffering from debilitating diseases by discovering, acquiring, developing, and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. Kiniksa's portfolio of assets is based on strong biologic rationale or validated mechanisms and offers the potential for differentiation. For more information, please visit Investor ContactJonathan Kirshenbaum(781) 829-3949jkirshenbaum@ Kiniksa Media ContactTyler Gagnon (781) 431-9100tgagnon@ in to access your portfolio
