Biotech Stocks Facing
Biotech Stocks Facing FDA Decision In October 2025
September was marked by a couple of notable firsts on the regulatory front.
On September 25, the FDA authorized the marketing of Essilor Stellest eyeglass lenses - the first approved to slow the progression of myopia in children aged 6 to 12. Myopia, or near-sightedness, is a chronic condition affecting roughly 40% of the U.S. population, with rates rising rapidly among children and adolescents.
Just days earlier, on September 19, the FDA granted accelerated approval to Stealth Biotherapeutics' Forzinity, which becomes the first-ever treatment for the life-threatening mitochondrial disorder, Barth syndrome.
Meanwhile, the most commonly used analgesic, acetaminophen (Tylenol), found itself under renewed scrutiny, as the FDA, on September 22, initiated the process of updating its labeling to warn of the potential association between acetaminophen use during pregnancy and an increased risk of autism and ADHD in children.
Let us now shift our attention to take a look at the drugs currently awaiting FDA approval decisions in October.
Regeneron Pharmaceuticals Inc. is seeking to expand the label of Libtayo (cemiplimab or cemiplimab-rwlc) as adjuvant therapy in patients with high-risk cutaneous squamous cell carcinoma after surgery, and a decision is expected in October 2025. Cutaneous Squamous Cell Carcinoma (CSCC) is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1.8 million cases according to the Skin Cancer Foundation.
In a phase III trial, Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death in patients with high-risk cutaneous squamous cell carcinoma after surgery compared to placebo. The drug is already approved in the U.S. for the treatment of certain adult patients with cutaneous squamous cell carcinoma, basal cell carcinoma, and non-small cell lung cancer.
For cutaneous squamous cell carcinoma (CSCC) in particular, the current indication covers patients with either metastatic CSCC (mCSCC) or locally advanced CSCC (laCSCC) who are not suitable candidates for curative surgery or radiation.
Libtayo, approved in more than 30 countries for one or more indications, generated global net sales of $1.22 billion in full-year 2024 and $662 million in the first half of 2025. REGN closed Friday’s (September 26, 2025) trading at $563.90, up 1.51%.
