Vera Therapeutics develops treatments for serious immunological diseases, with company updates centered on atacicept, a self-administered fusion protein designed to block BAFF and APRIL activity involved in autoantibody production. News commonly covers the atacicept program in IgA nephropathy, related autoimmune kidney disease research, clinical data from the ORIGIN and PIONEER programs, FDA regulatory communications, and preparations tied to potential commercialization.
Other recurring developments include quarterly financial results, balance sheet and financing commentary, participation in health care conferences, board and executive appointments, and equity-based inducement awards under Nasdaq Listing Rule 5635(c)(4).
Innocoll Holdings Ltd. has appointed Kimball Hall as President and Chief Executive Officer, bringing over 30 years of experience in commercial operations. Hall will also lead Innocoll's subsidiaries, Syntacoll GmbH and Innocoll Biotherapeutics Inc., focusing on expanding their services and product offerings. Previously, Hall served as President and COO at Abzena, overseeing multiple manufacturing sites. Gurnet Point Capital, Innocoll's parent company, expressed confidence in Hall’s ability to drive growth, particularly in non-opioid pain management products like Xaracoll® and Posimir®.
Vera Therapeutics (Nasdaq: VERA) has announced an upcoming virtual key opinion leader (KOL) event featuring Dr. Jonathan Barratt from the University of Leicester. The event will provide updates on atacicept’s ORIGIN Phase 2b data focused on IgA nephropathy (IgAN). Atacicept is a dual inhibitor aimed at treating IgAN, a serious autoimmune kidney disease. The ORIGIN trial involves 116 patients testing the efficacy and safety of atacicept against a placebo. Primary endpoints include changes in proteinuria at 24 weeks. The company aims to address the high unmet medical need in IgAN treatment, leveraging data from this and future trials.
Vera Therapeutics announced that the Phase 2b ORIGIN clinical trial of atacicept in patients with immunoglobulin A nephropathy (IgAN) achieved its primary endpoint, showing a 31% mean reduction in proteinuria at 24 weeks, with statistical significance (p=0.037). The 150 mg dose group exhibited a 33% mean reduction (p=0.047), indicating potential for significant therapeutic benefit. The safety profile of atacicept was comparable to placebo, with plans to progress to a pivotal Phase 3 trial in the first half of 2023. An investor call is scheduled for January 4, 2023.
Vera Therapeutics, a late-stage biotechnology firm, will present at the 41st Annual J.P. Morgan Healthcare Conference in San Francisco from January 9-12, 2023. The presentation is scheduled for January 10th at 1:30 PM PT. Vera focuses on treatments for immunological diseases, with its leading candidate, atacicept, targeting autoimmune conditions like IgA nephropathy and lupus nephritis. Investors can access the webcast here, with a replay available for 90 days.
Vera Therapeutics, a late-stage biotechnology company, announced its participation in two investor conferences. The Piper Sandler 34th Annual Healthcare Conference will feature a presentation on November 29, 2022, from 9:50 to 10:10 AM ET. Additionally, a Fireside Chat is scheduled for December 1, 2022, at the 5th Annual Evercore ISI HealthCONx Conference from 12:10 to 12:30 PM ET. Both sessions will be webcasted, and replays will be accessible for 90 days. Vera is focused on treatments for immunological diseases and is advancing its lead candidate, atacicept.
Vera Therapeutics, Inc. (Nasdaq: VERA) announced a key opinion leader webinar on November 28, 2022, focusing on IgA nephropathy (IgAN), a leading cause of kidney failure. Dr. Jonathan Barratt will discuss IgAN's pathogenesis and the clinical data for atacicept, a treatment showing promise in reducing immune complex levels in patients. IgAN affects around 400,000 patients in the U.S., EU, and Japan, with many progressing to end-stage renal disease. Vera expects to present topline results from its Phase 2b ORIGIN trial in early 2023 and potentially initiate a Phase 3 trial later that year.
Vera Therapeutics reported its Q3 2022 financial results, showing a net loss of $24.7 million, or $0.91 per diluted share, a significant increase from a net loss of $7.6 million in Q3 2021. The company has a strong balance sheet with $114.4 million in cash and cash equivalents, allowing operations to be funded into Q2 2024. Vera initiated the Phase 3 COMPASS trial for atacicept in lupus nephritis and announced topline data from the Phase 2b ORIGIN trial in IgA nephropathy expected in early Q1 2023. A positive interim analysis of MAU868 demonstrated safety and effectiveness in treating kidney transplant patients.
Vera Therapeutics (Nasdaq: VERA) presented new data on its therapies atacicept and MAU868 at the ASN Kidney Week 2022. Analysis from the Phase 2a JANUS trial indicates atacicept significantly reduced immune complex levels in patients with IgA nephropathy (IgAN), marking it as the first treatment to target key factors in IgAN pathogenesis. Additionally, the Phase 2 trial of MAU868 demonstrated tolerability and clinically meaningful antiviral activity against BK virus in kidney transplant patients. Vera anticipates presenting topline results from its Phase 2b ORIGIN trial for atacicept in early 2023.
Vera Therapeutics (Nasdaq: VERA) announced the presentation of new clinical data on two product candidates, MAU868 and atacicept, at the American Society of Nephrology Kidney Week 2022 Annual Meeting, held November 3-6, 2022. The oral presentation on MAU868 will detail final results from its Phase 2 trial addressing BK Viremia in kidney transplant recipients, scheduled for November 5, while the poster presentation on atacicept will analyze data from the Phase 2a JANUS clinical trial for IgA nephropathy on the same day.
Vera Therapeutics, a late-stage biotechnology company focused on immunological diseases, announced participation in two key conferences: the Morgan Stanley Global Healthcare Conference and the HC Wainwright 24th Annual Global Investment Conference. Both events will feature management presentations as well as one-on-one meetings. The Morgan Stanley conference is scheduled for September 12-14, 2022, with a presentation at 3:40 PM EDT on September 12. The HC Wainwright conference will also take place on September 12-14, with a presentation on September 13 at 3:00 PM EDT. Replays will be available for 90 days on their website.