Dogged for several years by an investor lawsuit accusing the company of misleading investors about the safety and efficacy of its now-approved drug Tavneos, ChemoCentryx has emerged victorious in a securities fraud complaint.
On Friday, a U.S. District Judge in California granted ChemoCentryx’s bid for summary judgment in the case, knocking out investor-led claims that the biotech—purchased by Amgen for $3.7 billion in 2022—ignored warnings from a data monitoring committee and withheld or manipulated trial results in a bid to hype up Tavneos.
Tavneos, also known as avacopan, was approved by the FDA in October 2021 as a treatment for the rare autoimmune disease antineutrophil cytoplasmic antibody-associated (ANCA-associated) vasculitis.
The rationale behind the judge’s decision remains under seal, according to court documents filed Friday in the U.S. District Court for the Northern District of California.
The judge issued his ruling on the grounds that Tavneos’ ultimate approval may undercut the plaintiffs’ argument that ChemoCentryx intentionally overstated the drug’s benefit, Law360 reports.
That train of thought largely aligns with the arguments laid out by Amgen in a May motion to toss the case.
Citing legal precedent, Amgen’s legal team argued earlier this year that “as a matter of law, FDA’s approval of a drug precludes a securities fraud plaintiff from showing that a defendant’s favorable interpretation of the drug’s clinical trial data was fraudulent.”
Further, “statements reflecting [a company’s] interpretation of trial data are opinion statements, and the fact that a plaintiff—or an advisory committee—expresses a different view cannot show the defendant’s interpretation was false or misleading,” Amgen’s lawyers contended.
ChemoCentryx’s win follows a litigious back-and-forth between the company, its new parent Amgen and a slate of plaintiffs who purchased ChemoCentryx shares between Nov. 26, 2019, and May 6, 2021.
The cutoff date for the share purchases dovetails closely with a 2021 FDA advisory committee meeting that first brought the company’s alleged misconduct to light and sent ChemoCentryx’s stock tumbling.
The investor suit was initially filed in May 2021 and amended the following year.
Amgen did not immediately respond to Fierce Pharma’s request for comment on the latest development in the case.
Amgen laid out $3.7 billion to get its hands on ChemoCentryx and its approved drug Tavneos in August of 2022. At the time, Amgen’s CEO Robert Bradway said that the deal “represents a compelling opportunity for Amgen to add to our decades-long leadership in inflammation and nephrology with Tavneos.”
In 2024, Tavneos sales grew a whopping 111% year-over-year to reach $256 million. Tavneos has carried that momentum into 2025, too. In Amgen’s most recent earnings report, the company said the drug logged sales of $110 million, a 55% jump over the sum it generated over the same period in 2024.