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2025/11/05
The U.S. FDA has announced plans to streamline the approval process for gene-editing therapies. The agency's director emphasized the need for flexibility and speed in bringing these treatments to patients. Detailed plans are expected in early November, a move anticipated to attract more investment into the gene-editing sector.
The FDA has placed a formal clinical hold on two of Intellia Therapeutics' late-stage gene therapy trials after a participant experienced severe liver stress. This event continues to impact the entire CRISPR industry, sparking widespread discussion about the safety of gene editing.
CRISPR Therapeutics is expected to release its third-quarter financial results later this week. Analysts anticipate quarterly sales of $6.71 million and a loss of $1.32 per share. The company's stock has declined by 16.1% over the past month.
A STAT News in-depth report reveals Moderna is facing the most severe crisis in its 15-year history, with Wall Street demanding spending cuts amid declining COVID vaccine sales and no new blockbuster products on the horizon. However, the company's stock surged 17% on rumors that at least one major pharmaceutical company is in talks with Moderna about a "significant transaction."
Moderna announced that the first patient has been dosed in the Phase 1/2 study of its investigational mRNA-based T-cell engager (TCE), mRNA-2808, for relapsed or refractory multiple myeloma. This marks a step forward in the company's diversification strategy into oncology.
Moderna reported third-quarter revenue of $1.9 billion, down from the previous year, with product sales showing a significant decline. The company updated its 2025 expected revenue range to
1.5−1.5−
2.2 billion and plans to reduce cash costs to $4.2 billion by 2027.
QIAGEN reported Q3 net sales of $533 million, with core sales growing 6% at constant exchange rates, and adjusted EPS of $0.61, beating the outlook of $0.58. The company also announced it will acquire Parse Biosciences for approximately $225 million in cash and has launched a $500 million share repurchase program.
QIAGEN has entered into a definitive agreement to fully acquire Parse Biosciences for an upfront cash payment of about $225 million, with Parse shareholders eligible for up to $55 million in additional milestone payments. The transaction is expected to be completed in December 2025.
Vertex reported third-quarter total revenue of $3.08 billion, an 11% increase year-over-year, surpassing Wall Street expectations. The performance was driven by strong demand for its cystic fibrosis therapies and early contributions from new drugs. The company raised its full-year 2025 revenue guidance to
11.9−11.9−
12.0 billion.
The gene-editing therapy CASGEVY saw its number of first cell collections double year-over-year to 110 in the first three quarters of 2025, with the company expecting full-year revenues to exceed $100 million. The non-opioid painkiller JOURNAVX has already seen over 300,000 prescriptions written as of mid-October.
Following Illumina's raised revenue guidance for 2025, investors are watching to see if this reinforces long-term growth confidence. While Q3 revenue was flat, the slight upward revision to the full-year forecast provides short-term assurance. The company also announced the acquisition of SomaLogic to accelerate its proteomics and multi-omics capabilities.
The FDA issued a Complete Response Letter to Regeneron, rejecting its application for the Eylea HD pre-filled syringe formulation. The rejection was due to issues at a third-party manufacturer's filling plant in Bloomington, Indiana, operated by Novo Nordisk, where ongoing contamination problems were found during an August inspection.
Interim results from Regeneron's Phase 2 COURAGE trial showed that a combination of semaglutide and trevogrumab significantly enhanced fat loss while preserving lean body mass in patients with obesity. This addresses the common issue of muscle loss associated with GLP-1 monotherapy.
Moderna's acquisition rumors and QIAGEN's official acquisition of Parse Biosciences indicate an accelerating trend of industry consolidation, with large pharma and life science tool companies seeking to expand their portfolios and market share through M&A.
The FDA's announcement to streamline the approval process for gene-editing therapies is a positive signal for CRISPR companies, but the hold on Intellia's trial serves as a reminder that safety remains the top priority.
The FDA's rejection of Regeneron's Eylea HD highlights the stringent requirements for manufacturing quality. This puts pressure on pharmaceutical companies to strengthen supply chain management and quality control.
QIAGEN's acquisition of Parse and 10x Genomics' launch of a new platform demonstrate fierce competition in the single-cell analysis market, where automation and scalability are becoming key competitive advantages.
The strong performance of Vertex in cystic fibrosis and new therapies, contrasted with Moderna's challenges, shows that post-pandemic, biotech companies need diversified product pipelines to sustain growth.
The small Cas12l nuclease has been recognized in The Scientist's 2025 Top 10 Innovations in the biotechnology category as a versatile and high-performance tool for genome editing. Cas12l's compact design supports multiple delivery strategies while maintaining high editing efficiency, making it suitable for advanced therapeutic development.
