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id: 433, Created by Stan Vick, Scout
Apellis (APLS) SYFOVRE Safety Case
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28 Jan 2021Class period Start
28 Jul 2023Class period End
- Apellis (APLS) confirmed a seventh case of eye inflammation resulting from SYFOVRE treatment.
- $APLS declined 19.6%, damaging investors.
- Investors suspect Apellis of misconduct and failing to disclose that the design of SYFOVRE's clinical trials was insufficient to avoid safety issues.
On July 29, 2023, Apellis (APLS) provided an update on the Company’s review of the six events of retinal vasculitis reported by the ASRS concerning SYFOVRE treatments.
- Apellis confirmed a seventh event of retinal vasculitis resulting from SYFOVRE treatment as determined by Apellis’ internal safety committee and external retina/uveitis specialists.
- Apellis also stated that the Company is evaluating an eighth reported event of retinal vasculitis, which the Company had not yet confirmed.
On this news, $APLS declined 19.6%, damaging investors.
- On July 15, 2023, the American Society of Retina Specialists published a letter highlighting concerns with SYFOVRE. Specifically, the ASRS indicated that physicians have reported cases of eye inflammation in patients treated with SYFOVRE, including six instances of occlusive retinal vasculitis, a type of inflammation that blocks blood flow through the vessels that feed the retina and potentially results in blindness.
- On July 17, 2023, Apellis issued a statement addressing the concerns raised by ASRS regarding vasculitis and SYFOVRE, explaining that, of the six occurrences of vasculitis following SYFOVRE treatment, “two of the events were confirmed as occlusive, one was confirmed as non-occlusive, and the remaining three were undetermined based on limited information and lack of imaging.”
- Wedbush downgraded Apellis’s price target by more than 50%,
Taking the representations and appeared facts into account, Investors have reasons to suspect Apellis & its Leaders of misleading and failing to disclose that the design of SYFOVRE's clinical trials was insufficient to identify incidents of retinal vasculitis in patients receiving SYFOVRE injections and the commercial adoption of SYFOVRE was subject to significant unknown risk factors.
Failure to Disclose,
Breach of Fiduciary duty,
Shock Event Date
29 July 2023
02 August 2023
Lead Plaintiff Deadline
08 October 2023