Day: November 14, 2020

IRVINE, Calif., Nov. 13, 2020 (GLOBE NEWSWIRE) — Tarsus Pharmaceuticals, Inc. (“Tarsus” NASDAQ: TARS), a late clinical-stage biopharmaceutical company whose mission is to discover and deliver breakthrough treatments to transform the lives of patients with common and poorly treated diseases, starting with the eye, today announced that Bobak Azamian, M.D., Ph.D., CEO of Tarsus, will present an overview of the company at the Jefferies Virtual London Healthcare Conference, being held November 17-19.Presentation DetailsDate: Thursday, November 19Time: 11:10 AM GMT/ 6:10 AM EST/ 3:10 AM PSTWebcast: https://wsw.com/webcast/jeff141/tars/1861050The live webcast will be hosted on ir.tarsusrx.com and available for replay for a period of 90 days.In addition to the presentation, the management team will host investor meetings at the conference....

ROAD TOWN, British Virgin Islands, Nov. 13, 2020 (GLOBE NEWSWIRE) — Aura Minerals, Inc. (“Aura Minerals” or the “Company”) announces that the Company has filed today its interim financial statements for the third quarter of 2020, its associated management’s discussion and analysis and related certification filings for the third quarter of 2020 (collectively, the “Third Quarter Results”).Rodrigo Barbosa, CEO of Aura, comments: “We at Aura are very pleased with both our quarterly results and the new trajectory for the company. Not only did we start this quarter with a successful IPO in Brazil, significantly strengthening our balance sheet and our support base, but also we delivered on our promises: Stronger production, lower cost and continued profit growth. Today, we published another record high result for Aura. Our team was able...

FDA issues Complete Response Letter for sutimlimab, an investigational treatment for hemolysis in adults with cold agglutinin disease                                                                                                                                                           *     Complete Response Letter refers to deficiencies from a pre-license inspection of a third-party manufacturing facilityPARIS – November 14, 2020 – The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sutimlimab, an investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease.The CRL refers to certain deficiencies identified by the agency during a pre-license inspection of a third-party facility responsible for manufacturing....

La FDA publie une lettre de réponse complète au sujet du sutimlimab, un médicament expérimental pour le traitement de l’hémolyse chez l’adulte atteint de la maladie des agglutinines froides*     La lettre de réponse complète se rapporte aux carences issues d’une inspection préalable à l’approbation de la demande de licence menée auprès d’une installation tierce responsable de la fabrication.PARIS – Le 14 novembre 2020 – La Food and Drug Administration des États-Unis a publié une lettre de réponse complète (CRL, Complete Response Letter) au sujet de la demande de licence de produit biologique (BLA, Biologics License Application) relative au sutimlimab, un anticorps monoclonal expérimental pour le traitement de l’hémolyse chez l’adulte atteint de la maladie des agglutinines froides (MAF).  Cette lettre se rapporte à certaines...

NEW YORK, Nov. 13, 2020 (GLOBE NEWSWIRE) — Fiduciary/Claymore Energy Infrastructure Fund (“FMO” or the “Fund”) today announced a change in the estimate of the accrual of federal and state income tax expense caused by sales of investments. The Fund’s net asset value per share (“NAV”), which was impacted on November 13, 2020, is $6.20, which takes into account such accrual. The accrual is estimated, and the Fund’s actual tax liability could vary.The Fund is generally subject to U.S. federal income tax on its taxable income at the 21% rate applicable to corporations and, in addition, is subject to various state income taxes. The Fund accrues estimated current federal and state income tax expense based on current income and gains generated from its underlying investments and trading activity. Any net current or deferred income tax expense...