Today, a brief rundown of news involving Amgen and Erasca, as well as updates from Rocket Pharma and Janux Therapeutics that you may have missed.
The Food and Drug Administration has officially proposed that Amgen withdraw from market Tavneos, a drug the company acquired in a nearly $4 billion deal in 2022. Amgen disclosed in February that it intended to keep selling Tavneos despite FDA concerns about the drug's clinical results and safety. The FDA stepped up its campaign Monday, publishing a letter to Amgen arguing Tavneos should be pulled because of "new information" showing the drug's approval submissions from former developer ChemoCentryx "contained untrue statements of material fact." According to the agency, "unblinded study personnel manipulated [Tavneos'] results" to make the drug look effective when the original analysis "did not support that conclusion." That initial analysis wasn't disclosed, violating agency regulations, the FDA claimed. Tavneos will remain on the market until Amgen chooses to remove it or is forced to do so by Commissioner Martin Makary. Amgen could also request a public hearing, the FDA said.
Shares of Erasca lost nearly half their value despite early clinical data for a drug that, to multiple Wall Street analysts, may be competitive with Revolution Medicines' closely watched pancreatic cancer medicine. Erasca's therapy ERAS-0015 targets "RAS" mutations, as Revolution's does, but was designed to have potentially superior characteristics. Data disclosed Monday showed a 62% unconfirmed response rate in people with second-line, non-small cell lung cancer and a 40% response rate in previously treated pancreatic cancer patients. Erasca said both figures were double-digit percentage points higher than previously reported results from Revolution, and analysts at Evercore ISI and Stifel described the findings as a "home run" and "promising signals of differentiation." Yet Erasca also disclosed that Revolution has accused it of patent infringement and, in a slide presentation, revealed that a treatment recipient who'd experienced a kind of lung tissue inflammation voluntarily withdrew from supportive care and later died. Stifel's Laura Prendergast claimed in a Tuesday note that those factors weighed down shares, as did sky-high expectations and findings that were "sliced in many different ways” — a "red flag for investors."
Rocket Pharmaceuticals has sold for $180 million a regulatory fast pass it received upon winning U.S. approval of a gene therapy for a rare immune disorder. Rocket didn't reveal which firm had agreed to acquire the "priority review voucher" it was awarded in May, but said Tuesday the sale proceeds will help progress its pipeline of gene therapies for heart conditions, among them a program for Danon disease that's currently in advanced testing. Rocket now expects to be able to operate into the second quarter of 2028, compared to mid-2027 previously.
Janux Therapeutics has trimmed its pipeline, announcing Monday it scrapped an experimental cancer drug called JANX008 that targets the well-known cancer-driving protein EGFR. Janux said that, while “durable responses” were observed in early clinical testing, the “overall magnitude and consistency of activity” for JANX008 didn’t warrant further development. Janux shares have lost more than half their value since late last year, following the release of prostate cancer drug results that disappointed investors. The latest update will “raise more questions,” wrote Stifel’s Stephen Wiley, though the company claimed JANX008’s issues were “program-specific” and don’t impact its broader pipeline.
