Apellis Pharmaceuticals gains 6.66% as investors bet on Q2 trial update and long-term pipeline potential

Apellis Pharmaceuticals, Inc. (NASDAQ: APLS) saw its stock price surge by 6.66% to close at $17.45 on May 16, 2025, marking a rare upward move in what has otherwise been a difficult year for the biotech company. The rally, fueled largely by speculative accumulation among value-focused investors, came despite the stock being down nearly 60% over the past twelve months. Investors appear to be repositioning in anticipation of pivotal trial updates expected in the second quarter of 2025, sparking renewed interest in the beleaguered $2.19 billion biotech firm.

The day’s gains were accompanied by higher-than-average trading volumes and an uptick in retail investor chatter around Apellis, with sentiment driven by the approaching catalyst and the company’s broader rare disease pipeline. In after-hours trading, the stock edged lower to $17.24, suggesting a modest cooldown following the intraday jump. Still, the move reflects a strategic shift among investors seeking potential upside in undervalued biotechnology names that have already priced in much of their downside risk.

What Is Driving the Renewed Interest in Apellis Pharmaceuticals?

Apellis Pharmaceuticals’ recent rally appears to be linked to expectations surrounding upcoming clinical trial data, particularly updates concerning its flagship products SYFOVRE and EMPAVELI. In its Q1 2025 financial results, Apellis reaffirmed that two pivotal trials for EMPAVELI—targeting focal segmental glomerulosclerosis (FSGS) and delayed graft function (DGF)—are set to initiate in the second half of the year. These trials represent key expansion opportunities in the company’s complement-inhibition strategy, which has long been the backbone of Apellis’ scientific identity.

Furthermore, the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for EMPAVELI in the treatment of C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). The FDA has granted Priority Review status, with a decision anticipated by July 2025. This regulatory milestone introduces a high-stakes binary event that could significantly reshape market expectations for Apellis, either validating its research trajectory or raising further scrutiny over its drug development strategy.

The market’s speculative accumulation reflects a belief among some biotech-focused institutional investors that Apellis is oversold and undervalued in the context of its near-term catalysts. Given the historically high volatility around such inflection points in the biotech sector, many see asymmetric risk-reward in the current price range.

How Did Apellis Perform Financially in Q1 2025?

Apellis reported total revenues of $166.8 million for the first quarter of 2025, including $149.9 million in U.S. net product sales. Its leading product SYFOVRE® (pegcetacoplan injection), indicated for geographic atrophy (GA) secondary to age-related macular degeneration, contributed $130.2 million in net U.S. revenue. Notably, while the number of injections administered increased 4% quarter-on-quarter, revenue growth was somewhat muted due to channel inventory adjustments and temporary disruptions in co-pay assistance funding.

The company posted a net loss of $92.2 million during the quarter, wider than the $66.4 million loss reported in the same period a year earlier. Research and development expenses totaled $88.1 million, reflecting continued investment in late-stage trials. The general and administrative spend remained elevated at $86.4 million, underscoring the cost base associated with maintaining commercial operations across multiple therapeutic areas.

Management stated that ongoing operational and capital expenditures would be funded through a combination of U.S. product sales and ex-U.S. royalties from partners. However, analysts have raised concerns about Apellis’ cash burn rate and the need for efficient capital deployment, particularly in light of potential revenue plateaus for SYFOVRE in GA and a lack of near-term approvals beyond EMPAVELI.

What Are Analysts Saying About Apellis Pharmaceuticals Stock Outlook?

Market sentiment on Apellis Pharmaceuticals remains divided. According to industry forecasts compiled by financial data services, the stock carries a median 12-month price target of $41, with the lowest estimate at $18 and the highest at $60. While this implies considerable upside from current levels, the wide spread of estimates underscores uncertainty around the company’s clinical trial outcomes, regulatory timelines, and commercial scalability.

Analysts at firms focused on healthcare equities have characterized Apellis as a “speculative buy,” with the caveat that its high short interest—standing at approximately 24.8% of its public float—indicates elevated bearish bets by hedge funds and quant-driven portfolios. This may also contribute to short-covering rallies during catalyst anticipation phases, such as the one seen on May 16.

Several investment research notes have flagged SYFOVRE’s market performance as a mixed signal. Although patient uptake remains stable, the commercial trajectory is being watched closely for signs of stagnation or erosion from emerging competitors. Meanwhile, EMPAVELI’s positioning in rare nephrology indications could provide longer-term growth if regulatory milestones are achieved.

Is Apellis Pharmaceuticals Positioned for a Biotech Rebound in 2025?

Apellis is one of several mid-cap biotech companies currently trading at significant discounts to peak valuations, a trend common across the sector since late 2023. While broader investor sentiment toward biotech remains cautious, there is growing interest in names with pipeline optionality and upcoming catalysts, particularly where revenue from marketed products can help offset R&D risks.

In Apellis’ case, its dual revenue-generating portfolio and late-stage pipeline may allow it to participate in any biotech sector recovery, especially if upcoming trial updates and regulatory decisions skew positively. Still, the company faces notable execution risk and will need to manage investor expectations carefully over the coming quarters.

From a financial standpoint, Apellis is not yet profitable, and its cash runway depends on maintaining consistent product sales while advancing multiple late-stage programs. The company’s strategic decision to double down on complement-related indications places it in a unique niche but also raises concerns about therapeutic concentration and scientific redundancy if trial results disappoint.

What Is the Future Outlook for Apellis Pharmaceuticals?

Looking ahead, Apellis Pharmaceuticals’ trajectory will be shaped by three critical developments in the near term. First, the anticipated FDA decision on EMPAVELI’s sNDA for C3G and IC-MPGN, expected by July 2025, will provide a litmus test for regulatory confidence in the platform. Second, the launch of pivotal trials in FSGS and DGF later this year will determine investor sentiment on the scalability of EMPAVELI into additional renal indications. Third, continued commercial performance of SYFOVRE will be closely monitored to assess whether the GA market is maturing or plateauing.

If Apellis successfully executes on these fronts, the company could reestablish its credibility with long-term investors and biotech funds. However, any missteps in clinical outcomes, regulatory interactions, or commercial performance could exacerbate downside risk and increase pressure to restructure or partner further.

In summary, Apellis’ recent share price rebound may mark the beginning of a speculative turnaround, but it is grounded in high-stakes clinical and regulatory events that remain unresolved. The path forward for the company will depend on its ability to deliver consistent scientific and commercial wins in a highly competitive biotechnology landscape.