|Over a week ago|
Apellis price target raised to $67 from $55 at Wedbush » 07:4109/1209/12/22
Wedbush analyst Laura…
Wedbush analyst Laura Chico raised the firm's price target on Apellis to $67 from $55 and keeps a Neutral rating on the shares. Following management commentary last week surrounding the completion of an FDA mid-cycle review, the analyst is lowering her valuation discount rate to 20%, previously 25%. The commentary reinforced the low likelihood of an Advisory Committee meeting prior to the pegcetacoplan November PDUFA. While Chico continues to have questions around the data, she sees an increased probability of approval on the heels of this commentary.
JPMorgan healthcare analysts to hold an analyst/industry conference call » 10:4009/0909/09/22
Healthcare Analysts, along with Key Opinion Leader Dr. Roger Goldberg, provide a perspective on recent updates in Geographic Atrophy and other retinal diseases (Apellis Pharmaceuticals APLS and Kodiak Sciences KOD) on an Analyst/Industry conference call to be held on September 9 at 11 am. Webcast Link
Apellis price target raised to $65 from $60 at Stifel » 07:3609/0809/08/22
Stifel analyst Annabel…
Stifel analyst Annabel Samimy raised the firm's price target on Apellis (APLS) to $65 from $60 and keeps a Buy rating on the shares after having hosted a panel with retinal specialists to discuss the evolving GA treatment landscape and Iveric bio's (ISEE) Zimura along with Apellis' pegcetacoplan. The biggest takeaways were the high level of comfort physicians now have with complement inhibition, their view on both compounds' clinical meaningfulness, safety and overall views on approvability as likely, said Samimy, who thinks the event reflects positively on the broader GA treatment landscape and each drug respectively.
Iveric bio price target raised to $35 from $28 at Stifel » 07:3609/0809/08/22
Stifel analyst Annabel…
Stifel analyst Annabel Samimy raised the firm's price target on Iveric bio (ISEE) to $35 from $28 and keeps a Buy rating on the shares after having hosted a panel with retinal specialists to discuss the evolving geographic atrophy, or GA, treatment landscape and Iveric bio's Zimura along with Apellis' (APLS) pegcetacoplan. The biggest takeaways were the high level of comfort physicians now have with complement inhibition, their view on both compounds' clinical meaningfulness, safety and overall views on approvability as likely, said Samimy, who thinks the event reflects positively on the broader GA treatment landscape and each drug respectively.
Apellis says FDA won't convene AdCom for pegcetacoplan in GA, says Citi » 14:4609/0709/07/22
Citi analyst Yigal…
Citi analyst Yigal Nochomovitz said Apellis' CEO stated during a fireside chat at the firm's BioPharma conference that the FDA has confirmed to the company that the agency will not be convening an Advisory Committee meeting, or AdCom, to review pegcetacoplan for use in geographic atrophy, or GA. The CEO also said the FDA considers the 18-month slope analysis in the Phase 3 DERBY and OAKS studies as the primary efficacy analysis, according to Nochomovitz, who calls both disclosures "very, very positive." The analyst, who continues to see a 95% chance of FDA approval on or before November 26, has a Buy rating and $86 price target on Apellis shares.
B. Riley cuts Iveric bio to Sell, says data affirms 'me-too profile' of Zimura » 11:0909/0609/06/22
ISEE, APLS, NGM
B. Riley analyst Yuan Zhi…
B. Riley analyst Yuan Zhi downgraded Iveric bio (ISEE) to Sell from Neutral with a price target of $8, down from $12, after the company announced topline results from GATHER2, the second Phase 3 clinical trial of Zimura, for the treatment of geographic atrophy. The "highly anticipated, yet disappointing" data reaffirm Zimura's "me-too profile" versus Apellis' (APLS) pegcetacoplan, according to Zhi, who also contends that Iveric bio's Phase 3 data "represents the best case scenario" for NGM Biopharmaceuticals' (NGM) Phase 2 CATALINA study thesis.
|Over a month ago|
Apellis announces 24-month results from Phase 3 DERBY, OAKS studies » 08:1008/2408/24/22
Apellis Pharmaceuticals announced top-line data at 24 months showing increased effects over time with intravitreal pegcetacoplan, an investigational, targeted C3 therapy, in the Phase 3 DERBY and OAKS studies in geographic atrophy, GA, secondary to age-related macular degeneration, AMD. In a pre-specified analysis of GA lesion growth over 24 months, both monthly and every-other-month pegcetacoplan showed a clinically meaningful reduction in GA lesion growth from baseline compared to sham. Between months 18-24, the pegcetacoplan treatment effect accelerated compared to previous six-month periods, with robust reductions of GA lesion growth versus sham. The increased effects were driven by a greater slowing of lesion growth by pegcetacoplan and not by an increase in the lesion growth rate in the sham group, which was highly consistent over each of the four six-month intervals. Additionally, the reduction of GA lesion growth in patients with extrafoveal lesions was comparable to the reduction in patients with foveal lesions in the combined studies between months 18-24. Consistent with expectations, no clinically meaningful difference was observed between pegcetacoplan and sham in the key secondary endpoints measuring visual function at 24 months. Studies show that GA lesion growth is correlated with loss of visual function over longer periods of time. The visual function outcomes at 24 months are believed to be due to the limitations of the endpoints when used for GA and the relatively early assessment timeframe. Patients will be treated with pegcetacoplan in the GALE extension study for an additional three years. Pegcetacoplan continued to demonstrate a favorable safety profile, consistent with safety data to date and longer-term exposure to intravitreal injections. No cases of endophthalmitis were reported between months 18 and 24. Over 24 months, the rate of infectious endophthalmitis was 0.034% per injection and the rate of intraocular inflammation was 0.24% per injection, which continue to be generally in line with reported rates in studies of other intravitreal therapies. No events of occlusive vasculitis or retinitis were observed over 24 months, and no serious adverse events of ischemic optic neuropathy were reported between months 18 and 24. The combined rate of new-onset exudations at month 24 was 11.9%, 6.7%, and 3.1% in the pegcetacoplan monthly, every-other-month, and sham groups, respectively. The results at 24 months will be included in the marketing authorization application that the company plans to submit to the European Medicines Agency by the end of this year. The U.S. marketing application is under Priority Review with a Prescription Drug User Fee Act target action date of Nov. 26, 2022.
Apellis price target raised to $78 from $68 at Oppenheimer » 07:4408/1808/18/22
Oppenheimer analyst Justin Kim raised the firm's price target on Apellis to $78 from $68 and keeps an Outperform rating on the shares following quarterly results. With upcoming focus on clinical data, the analyst sees the dominoes lined up for the ultimate PDUFA date on November 26. Based on 18-month results, Kim remains encouraged approaching the near-term readout of 24-month data from the DERBY and OAKS studies and the upcoming PDUFA date for GA.
Apellis price target raised to $113 from $102 at Raymond James » 07:5208/0908/09/22
APLS, ISEE, NGM
Raymond James analyst…
Raymond James analyst Steven Seedhouse raised the firm's price target on Apellis (APLS) to $113 from $102 and keeps a Strong Buy rating on the shares. Several key catalysts come either before or around the same time as the November 26 PDUFA date for Apellis' C3 inhibitor pegcetacoplan in geographic atrophy, including competitor Iveric's (ISEE) Phase 3 GATHER2 data for C5 aptamer Zimura in September, 24-month data from DERBY/OAKS including functional data in September, and competitor NGM Bio's (NGM) Phase 2 CATALINA study of C5 antibody NGM621 in 4Q22, Seedhouse tells investors in a research note.
Iveric bio initiated with a Buy at UBS » 07:5608/0208/02/22
UBS analyst Eliana Merle…
UBS analyst Eliana Merle initiated coverage of Iveric bio (ISEE) with a Buy rating and $20 price target. The analyst sees significant upside for the shares if Zimura is successful in upcoming GATHER2 Phase 3 topline in geographic atrophy expected in September. Geographic atrophy is a significant market opportunity with room for multiple players, including both Apellis's (APLS) pegcetacoplan and Iveric's Zimura, Merle tells investors in a research note. She sees "many reasons" for why Zimura will be successful in GATHER2, but also notes there is meaningful downside potential to the stock of up to 80% on a missed primary endpoint.