Apellis Pharmaceuticals Inc. (APLS) is starting to make waves in a small but significant market, and Wall Street is taking notice. The biotech company just scored an upgrade from Bank of America Securities, which argues that investors are missing the bigger picture on Empaveli's potential in rare kidney diseases.
Analyst Tazeen Ahmad moved the stock from Neutral to Buy on Wednesday, saying the current valuation doesn't fully appreciate what Empaveli could do in C3 glomerulopathy and immune complex membranoproliferative glomerulonephritis. Those are mouthfuls, so the industry shorthand is C3G and IC-MPGN.
The FDA gave Empaveli the green light in July 2025 as the first treatment for these conditions in patients 12 and older, specifically to reduce proteinuria (excess protein in urine, a key disease marker). The drug is also already approved for paroxysmal nocturnal hemoglobinuria, or PNH, in adults.
The Numbers Are Looking Good Early
Here's what caught BofA's attention: Since the late July approval, Apellis has logged 267 new patient start forms for Empaveli in the C3G/IC-MPGN indication. That represents about 5% penetration of what the company estimates is a 5,000-patient market in the United States. And we're only talking about a few months of commercialization here.
Third quarter results showed Empaveli generated $27 million in U.S. net product revenue. Management also highlighted something critical for any new drug launch: payer coverage is cooperating. The company noted it hasn't seen any full coverage denials yet, which removes a major hurdle for patient access.
Why Apellis Might Have an Edge
Empaveli's label is broader than the competition, covering IC-MPGN patients, pediatric cases, and post-transplant situations. Apellis believes the drug shows stronger efficacy compared to Novartis AG (NVS) Fabhalta (iptacopan), which gives it a competitive positioning advantage in the market.
BofA is modeling $508 million in peak U.S. sales by 2033, assuming the drug reaches 20% market penetration. That alone contributes $10 per share to the firm's $28 price target. Ahmad says the continued momentum from the Empaveli launch in C3G could deliver further upside beyond current estimates.
The Syfovre Situation and What's Next
It's not all smooth sailing, though. Ahmad noted that Syfovre, Apellis's geographic atrophy treatment, took a hit in 2025 when charitable foundation funding dried up. Geographic atrophy is a form of advanced age-related macular degeneration, and the loss of those funds made a dent in the business.
Management expects modest growth in 2026, but there's a potential catalyst on the horizon: a prefilled syringe version of Syfovre. The company plans to file for approval in the first half of 2026, and BofA thinks this could be a meaningful competitive advantage. Prefilled syringes are easier for physicians to use and could help expand market share while growing the overall market over time.
The impact from the prefilled syringe should materialize in 2027, and any signs of renewed momentum could push results above current projections. Syfovre currently accounts for $16 per share of BofA's price forecast.
APLS Price Action: Apellis Pharmaceuticals shares were up 2.37% at $21.52 at the time of publication on Wednesday.
