Shares of APLS stock rocketed Wednesday after Apellis Pharmaceuticals identified the potential culprit behind eye inflammation following treatment with its new injection, Syfovre.
The company says it found "internal structural variations" in the 19-gauge filter needle used to withdraw Syfovre from the vial. Syfovre is a treatment for an eye disease called geographic atrophy. It's injected directly into the eye.
Apellis says it hasn't established a causal relationship between the larger needle and the eight cases of retinal vasculitis among Syfovre recipients.
But "out of an abundance of caution," doctors should toss out any injection kits that use the 19-gauge needle and instead only use kits that include the 18-gauge needle, Apellis Chief Medical Officer Caroline Baumal said in a news release. Those are already in distribution, the company said.
On the stock market today, APLS stock soared 30.2% to close at 40.04.
APLS Stock: Injection Rate Remains Unclear
Each of the eight retinal vasculitis cases occurred after the patient's first Syfovre injection. One patient remained stable at baseline vision, two patients have recovered nearly back to baseline, two have severe vision impairment and three outcomes are still pending. The company says there have been two additional, but unconfirmed, cases.
That means retinal vasculitis has occurred in 0.01% of injections, Apellis said. To date, there have been more than 100,000 vials of the eye disease drug distributed.
But Wedbush analyst Laura Chico says the math isn't that simple. Doctors are ordering Syfovre, but that doesn't mean they have used every injection. Further, Apellis has not fully established a connection between the larger needle and retinal vasculitis.
"Overall, the number of reported/suspected cases remains low," she said in a note to clients. "However, the number of first-time injections occurring is somewhat unknown."
She kept her neutral rating and 29 price target on APLS stock.
Follow Allison Gatlin on X, formerly known as Twitter, at @IBD_AGatlin.
