Just days after Hifibio Therapeutics Inc. closed a $75 million series D financing, Fibrogen Inc. has agreed to pay the antibody specialist $25 million up front and as much as $1.1 billion in milestones for rights to multiple preclinical programs for autoimmune diseases and cancer. The deal includes exclusive rights to Galectin-9 programs, in which the lead asset is expected to enter clinical development in the first quarter of 2023, and options to license all assets in Hifibio's CXCR5 and CCR8 programs.
It has been a challenging opening first quarter for companies developing new therapeutics, with the BioWorld Drug Developers index recording a 9% drop in value, representing a stark contrast to its more than 35% growth last year.
Fibrogen Inc. said senior management’s prep for an upcoming FDA advisory committee meeting included a surprise. The internal review unearthed a primary cardiovascular safety analysis of roxadustat for treating anemia of chronic kidney disease (CKD) that included post-hoc changes to the phase III study’s stratification factors.
Although U.S. President Joe Biden has yet to nominate his choice to lead the FDA, his nomination of Xavier Becerra as the next Health and Human Services (HHS) secretary – and Becerra’s Senate confirmation March 18 – could signal a shift to a more conservative approach at the FDA when it comes to approving new drugs and devices.
The Institute for Clinical and Economic Review (ICER) took Fibrogen Inc., of San Francisco, to task for not disclosing data from completed roxadustat trials.
The latest global regulatory news, changes and updates affecting biopharma, including: HIV trial networks streamlined; Grants to advance use of RWD, RWE; GAO, National Academies, report on AI in health care; ICER not sold on roxadustat; Teva, Cephalon latest EC targets; Hungary looks to Russian vaccine.
As the world awaits more phase III data due any day from Akebia Therapeutics Inc. with vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), in chronic kidney disease (CKD), the company is basking in the approval of the product in Japan as Vafseo as a once-daily treatment for CKD anemia.
Although investors’ enthusiasm has cooled toward the biopharma sector, particularly large cap companies, over the past couple of months, they haven’t neglected it entirely and have been willing to reward those companies reporting positive news about their pipeline progress. As a result, a number of companies returned significant gains in their share valuations in August, contributing to the BioWorld Drug Developers index pushing more than 4% higher in the period and up 6% year-to-date.
Marking a key advance for Akebia Therapeutics Inc. in the global race to establish a new class of medicines for chronic kidney disease-associated anemia, the first of its two pivotal phase III programs proved its lead candidate, vadadustat, noninferior to darbepoetin alfa in adults on dialysis.
As the industry looks forward to 2020 at the 38th Annual J.P. Morgan Healthcare Conference next week, BioWorld is looking backward to those we lost in the past year.
