![]() MAA under review with European Medicines Agency (EMA) with anticipated approval in second half of 2022.Marketing Authorization Application (J-MAA) under review with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) with anticipated approval in first quarter of 2022.Food and Drug Administration (FDA) with target action date of Decemunder Prescription Drug User Fee Act (PDUFA) Biologics License Application (BLA) under review with U.S.Three global regulatory reviews ongoing for FcRn antagonist efgartigimod for the treatment of gMG THIRD QUARTER 2021 AND RECENT BUSINESS UPDATE Our growing commercial infrastructure along with our expanding pipeline ambitions provide considerable opportunity for argenx to deliver long-term, sustainable growth,” concluded Mr. This includes a first-in-class C2 inhibitor, ARGX-117, which is on track to begin the first Phase 2 trial in multifocal motor neuropathy patients by the end of this year. “As part of our commitment to becoming a fully-integrated, global immunology company, we are expanding our efgartigimod development plan to be in at least 15 indications by 2025 while also advancing a series of additional high-potential programs emerging from our Immunology Innovation Program. In order to optimize our strategy to make efgartigimod available to patients in need across the world, we are pursuing innovative partnerships, such as the strategic partnership with Zai Lab in China and the agreement with Medison in Israel which we are excited to announce today,” said Tim Van Hauwermeiren, Chief Executive Officer of argenx. “With three parallel regulatory reviews in our key priority territories of the U.S., Japan and the EU and the simultaneous build-out of our respective commercial organizations, we are well-positioned for the planned global launch of efgartigimod for the treatment of generalized myasthenia gravis. Argenx (Euronext & Nasdaq: ARGX), a global immunology companycommitted to improving the lives of people suffering from severe autoimmune diseases and cancer, today announced its third quarter 2021 financial results and provided a business update and outlook for the remainder of the year.
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Their sophomore album Tearing at the Seams debuted in March 2018 to widespread critical acclaim and included three singles which hit No. Now certified gold in the U.S., it has sold over a million records worldwide. The band’s self-titled debut album was a breakout success. ![]() Nathaniel Rateliff & The Night Sweats are Rateliff (vocals, guitar), Joseph Pope III (bass), Meese (drums, percussion, keys), Luke Mossman (guitar), Mark Shusterman (organ, keys), Andreas Wild (saxophone), Daniel Hardaway (trumpet) and Jeff Dazey (saxophone). Additional production was added by musician, engineer and producer Elijah Thompson ( Father John Misty, Richard Swift) while Jenny Lewis, Jess Wolfe ( Lucius) and Amelia Meath ( Sylvan Esso) contributed backing vocals. the production trio of Rateliff, Patrick Meese of The Night Sweats and James Barone ( Beach House), the team behind Rateliff’s acclaimed 2020 solo album And It’s Still Alright. The Future was produced by Bradley Cook ( Bon Iver, Kevin Morby, The War On Drugs) and R.M.B. The Future’s lead single Survivor sums up Rateliff’s perspective as he sings, “I’m afraid that the weight of the world is catching up to you / I’m afraid to admit that it’s catching up to me too / Does the weight continue to grow until it finally buries you?” Photo by Danny Clinch. There is this constant back-and-forth battle in me personally and I am sure that comes out in my writing.” Then my own neurosis, and maybe being a Libra gets in the way, and I can’t make up my mind. I just continue to try to write from a place of hope. “When I was writing the record, we were in the middle of a pandemic and our future looked pretty bleak. “I look at the album overall as a big question,” notes Rateliff. While recognizable, the new work has evolved and pushes the band to a new level. 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The only way the screening could be more complete, he joked, is if it had its own themed meal. Now not only does the film get its Austin debut, but it will also be the first time he and Petersen will be in the same room since the Attack of the Demons premiere, having made When You Get to the Forest remotely across the pandemic. He recalled Saucedo telling him, "'I really like this, can I show this?' Well, I'm not going to stop you." Power had got to know series programmer Robert Saucedo after screenings of Attack of the Demon>, and so showed him his next project. Power and Petersen's own long strange trip began last July when the film premiered at the Maine International Film Festival (see " Into the Woods", July 8, 2022), and continues next month when Power flies to Japan as a guest of the inaugural Niigata International Animation Film Festival.īut before then the film screens at Alamo Drafthouses across the nation as part of the chain's World of Animation series, a program that has previously screened classics like Millennium Actress and Song of the Sea. "It always had a mystical element to it, and I went, 'maybe it's the afterlife.' but I'm an atheist, so when I thought about it that wasn't what I wanted to do." After he wrote Attack of the Demon with Petersen, he reopened that folder for their next collaboration, and with Petersen's collaboration it evolved into "a quasi-survivalist story with a philosophical bent." The script started over a decade ago as a folder on Power's desktop marked "Forest Project." He was unsure what he would do with it, even considering it as an art installation. Power called it "a coming of age story for young adults, where Dana's in her mid-20s and been crapped on by the world, and I think most people have been there." The pacing may be different to his earlier work, but Power noted that the film forms part of an informal trilogy of "forest-centric movies." This time, the forest is everything and everywhere, as the recently orphaned Dana (voiced by the filmmaker's wife, Alicia Power) finds herself deep in the woods with a talking cat, Lakris (Marcella Campos), as her sole companion. "We wanted static shots of trees laying for minutes on end," Power said. That tone, he said, was extremely important to both him and screenwriter Andreas Petersen when creating their mythical arborial fantasy, When You Get to the Forest, which gets its Austin premiere this Monday at the Alamo Lakeline. 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