1. Scrip
  2. >>R&D
  3. >>Clinical Trials

AstraZeneca, FibroGen Plan New Roxadustat Filings, But CV Data Confuse Investors

 
• By Sten Stovall

Confusion over top-line pooled cardiovascular Phase III safety data on anemia therapy roxadustat caused shares in AstraZeneca and FibroGen to slide on 9 May, but analysts later said the negative reaction was overdone.

Data
AstraZeneca, FibroGen will start talks soon with the FDA aimed at regulatory submissions of roxadustat • Source: Shutterstock

AstraZeneca PLC and FibroGen Inc. say they are preparing a US filing of roxadustat for anemia in chronic kidney disease in the second half of the year after reporting cardiovascular outcomes data from Phase III trials which analysts said should have been seen as bullish by investors but which instead triggered a sell-off in the duo's shares.

AstraZeneca and FibroGen reported on 9 May an integrated safety analysis that found that roxadustat was less likely to be...

Welcome to Scrip

Create an account to read this article

Already a subscriber?

More from Clinical Trials

Sjögren’s Success For Ianalumab Shores Up Novartis’s Pipeline-In-A-Product Plans

 
• By Alexandra Shimmings

Novartis has strengthened its argument that ianalumab, its BAFF-R inhibitor and ADCC-mediated B-cell depletor candidate, has PIP potential with successful topline results in two Phase III Sjögren’s syndrome trials, after recently dropping the product in hidradenitis suppurativa.

Pipeline Watch: Five Approvals And Two Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

BeBetter, Trinomab Advance IPOs On China’s STAR Market In Firsts Since Policy Easing

 
• By Dexter Jie Yan

BeBetter becomes first unprofitable innovative drug maker to have application for an IPO on Shanghai's STAR Market cleared by China’s top securities regulator, while Trinomab becomes first among peers to have IPO filing accepted.

Genmab/AbbVie’s Epkinly Likely To See Label Expansion After Phase III Win

 
• By Alaric DeArment

The FDA is expected to rule on the anti-CD20xCD3 bispecific combined with rituximab/lenalidomide in second-line follicular lymphoma in November.

More from R&D

Vertex’s Pain Drug Failure Adds To Investor Doubts

 
• By Andrew McConaghie

A Phase II trial to develop a second NaV1.8 pain signal inhibitor for acute pain has failed and the US FDA has given a thumbs down on Journavx’s path to broader use in peripheral neuropathic pain.

Cardiff Pushes Towards Colorectal Cancer Phase III As Funding Questions Loom

 
• By Manas Mishra

Cardiff Oncology is open to going it alone, a partnership and even an exit as the San Diego, CA-based firm tries to push its PLK1 inhibitor through late-stage development.

Aurigene Oncology CEO On Biotech Valuations, CAR-Ts And Reimbursement Models

 
• By Anju Ghangurde

Aurigene Oncology CEO talks in this audio interview about the tough biotech funding environment, pipeline assets including a CAR-T therapy in Phase II, "hybrid" manufacturing, outcome-based reimbursement and the promise of bispecifics and multispecifics, including Akeso's PD-1/VEGF bispecific.