Aptevo Therapeutics Reports 2020 Financial Results and Provides Business Update phoenixherald.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from phoenixherald.com Daily Mail and Mail on Sunday newspapers.
Pivotal Program for RGX-314 for the Treatment of Wet Age-related Macular Degeneration (wet AMD)
REGENXBIO announced in January 2021 that it completed an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss the details of a pivotal program to support a Biologics License Application (BLA). REGENXBIO plans to conduct two randomized, well-controlled clinical trials to evaluate the efficacy and safety of RGX-314 in patients with wet AMD, enrolling approximately 700 patients total. REGENXBIO expects to submit a BLA based on these trials in 2024.
ATMOSPHERE™, the first of two planned pivotal trials, is active and enrolling patients. The trial will enroll approximately 300 patients across two RGX-314 dose arms versus ranibizumab. The primary endpoint of the trial is non-inferiority to ranibizumab based on change from baseline in Best Corrected Visual Acuity (BCVA) at one year.
Nektar Therapeutics Reports Fourth Quarter and Year-End 2020 Financial Results prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.
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CAMBRIDGE, Mass., Feb. 25, 2021 /PRNewswire/
Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, today reported financial results for the fourth quarter and full-year ended December 31, 2020 and provided business updates. The Company will host a conference call today, Thursday, February 25, 2021, at 9:00 a.m. Eastern Time.
Akebia also announced a $60 million non-dilutive transaction with an entity managed by HealthCare Royalty Management, LLC (HCR), to monetize the Company s rights to receive royalties and sales milestones on vadadustat net sales under its collaboration agreement with Mitsubishi Tanabe Pharma Corporation (MTPC). MTPC has the exclusive rights to commercialize vadadustat in Japan, where it is currently marketed under the trade name Vafseo™ (vadadustat), and certain other Asian countries. Under the terms of the agreement with HCR, Akebia receive
Expansion of West Coast Presence:
HCR has appointed Matthew H. Bullard as a Managing Director based in San Francisco, CA.
“We are very pleased to welcome Matt to the HCR team,” said Clarke B. Futch, Chief Executive Officer and Chairman at HCR. “With over two decades of healthcare experience, Matt brings a wealth of knowledge and relationships to HCR. Matt will round out HCR’s team on the West Coast, which has been one of our most important markets. Matt’s addition along with HCR’s existing professionals on the West Coast, Sean Mansoory, Mardi Dier (Senior Advisor) and Gary Lyons (Senior Advisor), demonstrates HCR’s commitment to its regional model and provides the firm with more scale and depth to better serve the needs of biopharmaceutical companies in that region.”