![]() The changes are being made based on a written recommendation by the FDA on statistical considerations ahead of the planned database lock, Blueprint said in a June 9 press release.īlueprint noted that it continues to plan to report data from the PIONEER study in late summer 2022 and file a supplemental new drug application with the FDA for Ayvakit for non-advanced SM by the end of the year. The company said that the mean absolute change in total symptom score (TSS), which was previously a key secondary goal, will be the main goal, while the proportion of patients with a 30% or greater decrease in TSS, previously the main objective, will now become a key secondary endpoint. SM is a rare disorder which occurs due to build of large number of mast cells, a a type of white blood cell, in the body. The company is evaluating Ayvakit (avapritinib) in a trial called PIONEER to treat patients with non-advanced systemic mastocytosis (SM). No cash balance or cash flow is included in the calculation.Grandbrothers/iStock Editorial via Getty Imagesīlueprint Medicines ( NASDAQ: BPMC) stock fell ~9% on June 9 after the company said that it will swap the objectives of a key study of its medicine Ayvakit after recommendation from the U.S. ![]() Please note all regulatory considerations regarding the presentation of fees must be taken into account. Backtested results are adjusted to reflect the reinvestment of dividends and other income and, except where otherwise indicated, are presented gross-of fees and do not include the effect of backtested transaction costs, management fees, performance fees or expenses, if applicable. Actual performance may differ significantly from backtested performance. Further, backtesting allows the security selection methodology to be adjusted until past returns are maximized. Since trades have not actually been executed, results may have under- or over-compensated for the impact, if any, of certain market factors, such as lack of liquidity, and may not reflect the impact that certain economic or market factors may have had on the decision-making process. Specifically, backtested results do not reflect actual trading or the effect of material economic and market factors on the decision-making process. Backtested performance is developed with the benefit of hindsight and has inherent limitations. This information is provided for illustrative purposes only. No representations and warranties are made as to the reasonableness of the assumptions. Certain assumptions have been made for modeling purposes and are unlikely to be realized. Changes in these assumptions may have a material impact on the backtested returns presented. General assumptions include: XYZ firm would have been able to purchase the securities recommended by the model and the markets were sufficiently liquid to permit all trading. ![]() Backtested results are calculated by the retroactive application of a model constructed on the basis of historical data and based on assumptions integral to the model which may or may not be testable and are subject to losses. The results reflect performance of a strategy not historically offered to investors and does not represent returns that any investor actually attained. Backtested performance is not an indicator of future actual results. Disclaimer: The TipRanks Smart Score performance is based on backtested results.
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