Rezdiffra definition
Rezdiffra means any product that contains the pharmaceutical compound known by the name resmetirom[***] in all forms (including salts, solvates, polymorphs, stereoisomers, prodrugs, conjugates or complex of resmetirom), presentations, doses, and formulations. “Roche Agreement” means that certain Research, Development and Commercialization Agreement, dated as of December 18, 2008, by and between ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇-▇▇ ▇▇▇▇▇ Inc. and ▇. ▇▇▇▇▇▇▇▇-▇▇ ▇▇▇▇▇ Ltd, as in effect on the Closing Date and as amended form time to time in accordance with the terms of this Agreement. “Royalty Monetization Transaction” means any monetization or financing transaction involving (a) the sale, transfer, option or collateralization of (i) any monetary payments (contingent or otherwise) payable to Borrower or its Subsidiaries by a counterparty under a Product Agreement, or (ii) any revenues generated through the commercial sale of the Product to third parties, in each case whether in whole or in part or (b) the provision of financing for the development, manufacture and/or Commercialization of any Product in exchange for the future payment of royalties, milestones and other amounts (whether or not contingent), including but not limited to sales of royalty streams, royalty bonds and other royalty financings, synthetic royalty, development financing, and revenue interest transactions (including but not limited to clinical trial funding arrangements), and hybrid monetization transactions. “S&P” means Standard & Poor’s Ratings Group, a division of The McGraw Hill Corporation. “Sanctioned Entity” means (a) a country or territory or a government of a country or territory, (b) an agency of the government of a country or territory, (c) an organization directly or indirectly controlled by the government of a country or territory, or (d) a Person ordinarily resident in a country or territory, in each case of clauses (a) through (d) that is a Sanctioned Jurisdiction. “Sanctioned Jurisdiction” means, at any time, each country or territory that is or has since April 24, 2019, been subject to a comprehensive OFAC Sanctions Program. As of the Closing Date, the
Rezdiffra refers to resmetirom approved by the FDA for the treatment of adults with ▇▇▇▇ with moderate to advanced liver fibrosis, and “remetirom” refers to, where applicable, Rezdiffra as well as resmetirom for the treatment of indications beyond ▇▇▇▇ with moderate to advanced liver fibrosis. Rezdiffra is a once-daily, oral THR-ß agonist designed to target key underlying causes of ▇▇▇▇. ▇▇▇▇ is a more advanced form of nonalcoholic fatty liver disease (“NAFLD”). ▇▇▇▇ is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally. Additionally, patients with ▇▇▇▇, especially those with more advanced metabolic risk factors (hypertension, concomitant type 2 diabetes), are at increased risk for adverse cardiovascular events and increased morbidity and mortality. Once patients progress to ▇▇▇▇ with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), the risk of adverse liver outcomes increases dramatically. ▇▇▇▇ is rapidly becoming the leading cause of liver transplantation in the U.S. ▇▇▇▇ is also known as MASH following a change in disease nomenclature introduced by hepatology medical societies in 2023. We were incorporated in Delaware in September 2011. Our principal executive offices are located at ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇ Drive, Suite 200, West Conshohocken, Pennsylvania 19428. Our telephone number is (▇▇▇) ▇▇▇-▇▇▇▇. Our website address is ▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇. The contents of our website are not incorporated into, and do not form a part of, this prospectus supplement or the registration statement of which it forms a part. The following summary contains basic information about our common stock and the offering and is not intended to be complete. It does not contain all of the information that may be important to you. For a more complete understanding of our common stock, you should read the section entitled “Description of Capital Stock” in the accompanying prospectus. Up to 22,073,230 shares, assuming sales of 1,388,567 shares of our common stock in the offering at a price of $216.05 per share, which was the closing price of our common stock on The Nasdaq Global Select Market on May 2, 2024. The actual number of shares issued will vary depending on the sales price under this offering.
Examples of Rezdiffra in a sentence
Borrower shall take all commercially reasonable steps to obtain traditional approval from the FDA of REZDIFFRA for the treatment of patients with non-alcoholic steatohepatitis (or metabolic dysfunction-associated steatohepatitis) with labeling that is generally consistent with the label approved in connection with accelerated approval by satisfying the post-marketing commitments associated with the accelerated approval of REZDIFFRA.
If ▇▇▇▇▇▇▇▇ becomes aware of a third party patent with claims that covers REZDIFFRA or any other Product, Borrower will use its best efforts to challenge the validity of said third party patent or to obtain a license to said third party patent.