Biotech Q2 2026: REGENXBIO Hits Trial Endpoint, Compass NDA on Track, Puma Lifts Guidance

Several biopharmaceutical companies reported second quarter 2026 financial results and operational updates, with REGENXBIO announcing that its Phase III AFFINITY DUCHENNE trial met its primary endpoint, Compass Pathways advancing its rolling COMP360 NDA submission, Puma Biotechnology raising full-year 2026 revenue and net income guidance on increased NERLYNX demand, and Evotec updating its full-year outlook downward.

REGENXBIO reported that the Phase III AFFINITY DUCHENNE trial of its gene therapy RGX-202 for Duchenne muscular dystrophy met its primary endpoint with high statistical significance (p<0.0001). The confirmatory study of RGX-202 completed enrollment in June 2026 ahead of schedule. The company is on track to initiate a BLA submission in Q3 2026 under the accelerated approval pathway, supporting potential approval in 2H 2027. Topline data from the pivotal subretinal wet AMD studies, ATMOSPHERE and ASCENT, are expected in Q4 2026, with global regulatory submissions expected in 2027. REGENXBIO also reaffirmed the path forward for RGX-121 for Hunter syndrome with the FDA during a productive July Type A meeting, with resubmission on track for Q3 2026. The company received over $200 million in July 2026, including a $100 million milestone payment from AbbVie for dosing the first patient in the Phase IIb/III NAAVIGATE study for diabetic retinopathy, and approximately $108 million in net proceeds from an underwritten public offering. Pro forma ending Q2 2026 cash, cash equivalents and marketable securities were in excess of $310 million, extending the expected cash runway into Q4 2027.

Compass Pathways reported that data from two positive Phase 3 trials of COMP360 psilocybin in treatment-resistant depression demonstrated rapid onset of effect and durable benefit through at least 6 months. A rolling NDA submission is underway, with the final submission expected to be completed in Q4, and a commercial launch is expected in the first half of 2027. The company ended the second quarter with a cash position of $433 million, providing cash well beyond launch and into 2028. COMP360 has Breakthrough Therapy designation from the FDA and Innovative Licensing and Access Pathway designation in the UK for TRD.

Puma Biotechnology reported second quarter 2026 financial results and raised its 2026 revenue and net income guidance based on increased demand for NERLYNX. For the third quarter of 2026, the company guided net product revenue of $54–$56 million, royalty revenue of $2–$3 million, total revenue of $56–$59 million, and net income of $2–$3.5 million. For the full year 2026, the new guidance is net product revenue of $202–$206 million, royalty revenue of $19–$22 million, total revenue of $222–$229 million, and net income of $16–$19 million. NERLYNX was approved by the U.S. FDA in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, and in February 2020 in combination with capecitabine for advanced or metastatic HER2-positive breast cancer. It was granted marketing authorization by the European Commission in 2018.

Evotec announced preliminary unaudited results for the second quarter and first half of 2026, with Group revenues of approximately €300.1 million and adjusted Group EBITDA of approximately -€42.7 million for H1 2026. The company updated its full-year 2026 outlook, now expecting Group revenues of approximately €570 to 610 million (€595 to 635 million CER) and adjusted Group EBITDA of approximately -€70 to -105 million (-€60 to -90 million CER), compared with previous guidance of €700-780 million for revenues and €0-40 million for adjusted EBITDA. Approximately 40% of the revenue difference was shifted to 2027 due to revised phasing and milestone schedules in existing partnerships, ~45% shifted beyond Q4 2026 due to delays in strategic partnerships under negotiation, and ~15% was attributable to lower-than-expected sales to revenue conversion. Net sales in D&PD ex-strategic partnerships increased by approximately 28% year-on-year in H1 2026, and Just – Evotec Biologics continued to benefit from high capacity utilization and expansion of its customer base. The company remains on track to deliver approximately 20-30% of cost savings in 2026 as part of its previously announced target of €75 million in annual run-rate savings by the end of 2027.