FDA grants priority review for Nefecon, for patients with IgA nephropathy
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ( Calliditas ) today announced that
the U.S. Food and Drug Administration (FDA) has accepted the submission and granted Priority Review for the New Drug Application (NDA) for Nefecon, a down regulator of IgA1 for the treatment of IgA nephropathy (IgAN.) The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. We are very excited about being granted priority review, which reflects the unmet medical need of IgAN. We look forward to engaging with the agency and work towards an accelerated approval later this year so that we will be in a position to provide the first approved medication for IgAN patients, said CEO Renée Aguiar-Lucander.
FDA grants priority review for Nefecon, for patients with IgA nephropathy
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FDA grants priority review for Nefecon, for patients with IgA nephropathy
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Pomerantz LLP announces that a class action lawsuit has been filed against Kadmon Holdings, Inc. ("Kadmon" or the "Company") (NASDAQ: KDMN) and certain of its officers. The class action, filed in the United States District Court for the Eastern District of New York, and docketed under 21-cv-01797, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Kadmon securities between October 1, 2020 and March 10, 2021, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
16%
Certain financial information for 2021 and 2020 is presented on both a reported and a non-GAAP basis. Some numbers in this press release may not add due to rounding. Reported results were prepared in accordance with U.S. generally accepted accounting principles (GAAP) and include all revenue and expenses recognized during the periods. Non-GAAP measures reflect adjustments for the items described in the reconciliation tables later in the release. Beginning in 2021, non-GAAP measures exclude gains and losses on investments in equity securities and 2020 amounts have been reclassified for comparability. The company s 2021 financial guidance is being provided on both a reported and a non-GAAP basis. The non-GAAP measures are presented to provide additional insights into the underlying trends in the company s business.