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SAN FRANCISCO/BOSTON - Apogee Therapeutics, Inc. (NASDAQ:APGE), a $2.77 billion biotech company, announced Monday that its experimental atopic dermatitis treatment APG777 met all primary and key secondary endpoints in Part A of its Phase 2 APEX clinical trial. The news sparked investor interest, with the stock gaining over 9% in the past week. According to InvestingPro analysis, the company appears fairly valued at current levels.
The anti-IL-13 antibody demonstrated a 71.0% reduction in the Eczema Area Severity Index (EASI) score from baseline at Week 16 compared to 33.8% for placebo. The drug achieved an EASI-75 response rate of 66.9% versus 24.6% for placebo, which the company described as the highest response rate for any biologic in a global atopic dermatitis study to date.
The trial enrolled 123 adult patients with moderate-to-severe atopic dermatitis who received an induction regimen of APG777 or placebo. Researchers observed an exposure-response relationship, with patients in the highest exposure quartile achieving 89.5% EASI-75 response. Wall Street appears optimistic about these results, with InvestingPro data showing analyst price targets ranging from $78 to $116, suggesting significant upside potential. Four analysts have recently revised their earnings expectations upward for the upcoming period.
"APG777 demonstrated promising efficacy results from only four injection days over the initial 16-week induction period," said Emma Guttman-Yassky, Health System Chair of Dermatology at the Icahn School of Medicine at Mount Sinai, in the press release.
The drug was well tolerated with a safety profile consistent with other agents in its class. Serious treatment-emergent adverse events were rare (1.2% vs. 2.4% in placebo), and the most common side effects included non-infective conjunctivitis, upper respiratory tract infection, and nasopharyngitis.
Based on these results, Apogee has accelerated the readout timeline for APEX Part B, which is testing higher doses, to mid-2026. The company also expects 52-week maintenance data from Part A in the first half of 2026, which is evaluating 3- or 6-month maintenance dosing intervals.
Additionally, Apogee announced that dosing has begun in a Phase 1b head-to-head trial of its dual-targeting antibody APG279 (IL-13 + OX40L) versus Dupixent, with results expected in the second half of 2026.
The company plans to initiate Phase 3 trials of APG777 in 2026, according to the announcement.
In other recent news, Apogee Therapeutics has garnered attention as several research firms reiterated their Buy ratings on the company’s stock. Canaccord Genuity maintained its Buy rating with a price target of $89, expressing confidence in Apogee’s financial position and ongoing clinical trials. The company reported cash reserves of $681.4 million, suggesting strong financial health to support operations until 2028. Stifel also reiterated its Buy rating, highlighting Apogee’s confidence in its leading drug candidate, APG777, which targets atopic dermatitis. The firm emphasized the drug’s unique formulation and potential market dominance due to its differentiated dosing regimen. Guggenheim and TD Cowen also maintained Buy ratings, citing the upcoming Phase II trial results for APG777 as a significant catalyst for the company. Guggenheim noted the potential for substantial market share if trial results meet expectations. Stifel and TD Cowen both expressed optimism about APG777’s efficacy, comparing it favorably to existing treatments. These developments underscore Apogee’s strategic positioning in the biotechnology sector.
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