Iveric bio (ISEE): APLS Data As Good As Possible for Iveric, Buy Here - Analyst

Late Thursday, Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) reported top-line results from the Phase 3 DERBY and OAKS studies evaluating intravitreal pegcetacoplan, an investigational targeted C3 therapy, in 1,258 adults with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

OAKS study met the primary endpoint for both monthly and every-other-month treatment with pegcetacoplan, demonstrating a significant reduction in GA lesion growth of 22% (p=0.0003) and 16% (p=0.0052), respectively, compared to pooled sham at 12 months

DERBY did not meet the primary endpoint of GA lesion growth, showing a reduction of 12% (p=0.0528) and 11% (p=0.0750) with monthly and every-other-month treatment, respectively, compared to pooled sham at 12 months In a prespecified analysis of the combined studies.

Commenting on the APLS data, Cowen analyst Ken Cacciatore highlights the company’s key competitor in the GA space – IVERIC bio (NASDAQ: ISEE). He keeps a highly optimistic tone on ISEE and believes the “results have both de-risked Iveric, while also potentially clearing the competitive playing field.”

The analyst’s report underscores that the APLS data readout has:

1. Confirmed the complement pathway thesis.

2. Confirmed Iveric has properly enriched their Phase III study via analyzing only extrafoveal lesions, which means it has the maximum chance of success.

3. Called into question whether the FDA will accept these mixed results from Apellis or require another study.

4. Whether pegcetocoplan is approved or not, the safety profile is clearly troubling, meaning Zimura would likely still have a distinct commercial advantage.

Cowen now assumes “Iveric is in possession of a potentially greater than $1B+ product”, as they maintain “Outperform” rating on the shares and increase price target to $25 from $15.

Stifel also initiated coverage of the shares, noting “Iveric bio is positioned to be one of the top industry leaders within the Geographic Atrophy (GA) sector.” Its analyst Annabel Samimy believes that Zimura “could very well be the leading treatment for this indication” and sees ISEE “as building the most unique platform for untapped retinal diseases.”

Stifel puts a “Buy” rating on the shares with $22 price target.

ISEE is moving over 65% higher in the pre-market; Shares of APLS are down nearly 30%.

Written by Vlad Schepkov | [email protected]

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