- Regeneron Pharmaceuticals said the Food and Drug Administration could approve a much-anticipated new version of its top-selling eye drug during the third quarter, a quicker-than-expected turnaround after the regulator rejected the therapy in June.
- The FDA turned back a high-dose form of Eylea over inspection findings at a Catalent facility that fills vials of the drug. In an earnings call Thursday, CEO Leonard Schleifer said required manufacturing data will be submitted by mid-August, and the agency plans to work “expeditiously” to complete a review before Aug. 20. The evaluation could also be extended if it’s not finished by then.
- The news caused Regeneron shares to climb and recoup some of the value they lost after news of the FDA rejection. But the stock price gains also helped “mask” some setbacks to Regeneron’s development pipeline, wrote RBC Capital Markets analyst Brian Abrahams.
When the FDA surprised Wall Street and rejected Regeneron’s application for high-dose Eylea, analysts expected the worst.
At the time, some said that companies in similar situations faced delays as long as nine months — something Regeneron could ill afford with biosimilar competitors looming and a new Roche drug, Vabysmo, grabbing market share from its long-dominant medicine.
Regeneron’s announcement Thursday provided what RBC’s Abrahams called “much-needed partial clarity” on the path forward for high-dose Eylea. It’s still unclear exactly when the FDA might make a decision, as another manufacturing inspection may be necessary. But the “potential worst case scenario of [a] long delay” is less likely, he wrote.
That news was delivered alongside quarterly sales of $1.5 billion for Eylea, which beat analyst expectations. The drug, which still accounts for the bulk of Regeneron’s revenue, delivered “despite Roche’s commentary around Vabysmo’s share gains,” added Piper Sandler analyst Christopher Raymond. Roche’s drug generated more than $1 billion in the first half of the year.
“Rumors of Eylea’s demise have been greatly exaggerated,” Raymond wrote.
Yet Regeneron stumbled elsewhere. The FDA is requiring a second, positive Phase 3 result before the company can seek approval of its inflammatory disease drug Dupixent in a common lung disease, which is seen as a multibillion-dollar market opportunity. Regeneron previously discussed the possibility of an early approval in the condition, known as COPD, but will now have to wait for study results expected next year.
Regeneron also reported a setback in its cancer drug portfolio. A second patient died in a study testing a prostate cancer medicine that has shown promise in early testing. Regeneron is changing its development plan for that drug, named REGN-5678, as a result.
The company has several other prospects in development, among them the blood cancer drug odronextamab and linvoseltimab and the melanoma treatment fianlimab. It’s also exploring a variety of drug combinations meant to help the company stand out from its peers.
Still, Regeneron is behind competitors with similar drugs, and analysts have been skeptical as to whether it can succeed. “It will take time and developmental nuance for these efforts ... to play out,” Abrahams wrote.