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Investing.com - Cantor Fitzgerald has reiterated an Overweight rating and $39.00 price target on Apellis Pharmaceuticals (NASDAQ:APLS) following the company’s supplemental New Drug Application (sNDA) approval for Empaveli. Currently trading at $19.06, the stock sits well below analyst targets ranging from $17 to $60, with a consensus recommendation of "Buy."
The FDA approved Empaveli for patients 12 years or older with C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), expanding the drug’s potential market.
Cantor Fitzgerald highlighted that Empaveli’s label specifically includes estimated glomerular filtration rate (eGFR) data showing stability, with a time series insert not present in competitor Fabhalta’s label.
The approved treatment offers twice-weekly subcutaneous administration via commercially approved pump or Empaveli injector, compared to competitor Fabhalta’s twice-daily oral dosing regimen.
Cantor Fitzgerald estimates C3G represents a potential $1 billion-plus opportunity for Apellis in the U.S., projecting approximately $4.5 million in revenue for 2025 and approximately $106 million for 2026 from this indication.
In other recent news, Apellis Pharmaceuticals received FDA approval for EMPAVELI® as the first treatment for C3 glomerulopathy (C3G) in patients aged 12 and older. This approval is pivotal for approximately 5,000 affected individuals in the U.S., as EMPAVELI demonstrated a 68% reduction in proteinuria and stabilization of kidney function in clinical trials. Additionally, Apellis has entered into a financing agreement with Swedish Orphan Biovitrum (Sobi), securing up to $300 million in exchange for 90% of future ex-U.S. royalties for EMPAVELI. Analyst firm H.C. Wainwright reiterated a Buy rating with a $57 price target for Apellis, following discussions with company executives about market strategies. William Blair also maintained an Outperform rating, despite competition from Astellas’s Izervay. Cantor Fitzgerald reiterated an Overweight rating with a $39 price target, noting Izervay’s revenue growth. Meanwhile, Mizuho (NYSE:MFG) kept a Neutral rating with a $20 price target, reflecting on the recent royalty deal with Sobi. These developments highlight significant progress and strategic financial moves for Apellis Pharmaceuticals.
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