LEVERKUSEN (dpa-AFX) - November, a month best known for Thanksgiving and harvest festivals, is also an important month for raising awareness about various health issues. Some of the key health observances in November include National Diabetes Month, National Healthy Skin Month, Stomach Cancer Awareness Month, Lung Cancer Awareness Month, and COPD Awareness Month, among others.
As we shift our focus to the regulatory front, promising new therapies are awaiting the FDA's verdict this November. So far this year (January-October), the U.S. regulatory agency has greenlighted 34 novel drugs compared to 38 approved during the same time frame last year.
Listed below are biotech stocks to keep an eye on as they approach a key regulatory catalyst.
Arrowhead Pharmaceuticals Inc. (ARWR)
Arrowhead Pharma's New Drug Application for Plozasiran, seeking approval in the indication of familial chylomicronemia syndrome, is under FDA review, with a decision due on November 18, 2025.
Familial chylomicronemia syndrome refers to a condition of having extremely high triglyceride levels, typically over 880 mg/dL, and is associated with a substantially higher risk of developing acute pancreatitis and associated long-term complications, including poor quality of life.
In clinical trials, Plozasiran demonstrated statistically significant reductions in triglycerides (TGs), apolipoprotein C-III (APOC3), and the incidence of acute pancreatitis (AP).
If approved, Plozasiran would represent an additional therapeutic option for Familial Chylomicronemia Syndrome (FCS), joining Ioni's Pharma's Tryngolza - currently the first and only FDA-approved prescription medicine for adults with this condition.
Approved in December 2024, Tryngolza generated net product sales of $26 million in the first half of 2025.
ARWR closed Friday's (Oct.31, 2025) trading at $42.39, up 0.19%.
Otsuka Holdings Co. Ltd. (OTSKF)
Otsuka Pharmaceutical, a wholly owned subsidiary of Otsuka Holdings, awaits the U.S. regulatory agency's decision on Sibeprenlimab on November 28, 2025.
Sibeprenlimab, an investigational monoclonal antibody that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand), is proposed for the treatment of adults with immunoglobulin A nephropathy (IgAN).
IgAN is a progressive, autoimmune, chronic kidney disease that can lead to end-stage kidney disease (ESKD) despite optimized standard care.
In clinical trials, Sibeprenlimab, administered as a single-dose prefilled syringe for subcutaneous injection every four weeks, with the convenience of self-administration, demonstrated a statistically significant and clinically meaningful reduction in 24-hour urine protein-to-creatinine ratio (uPCR) after nine months of treatment compared to placebo.
According to analysts, if approved, Sibeprenlimab has the potential to become a blockbuster drug due to its novel mechanism of targeting APRIL, which plays a crucial role in the pathogenesis of IgAN.
OTSKF closed Friday's trading at $57.36.
Bayer (BAYRY)
Bayer's new drug application for the investigational compound Sevabertinib is under priority review by the FDA, with a decision expected on November 28, 2025.
Sevabertinib, an oral, small-molecule tyrosine kinase inhibitor (TKI), is proposed for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptors 2 (HER2) (ERBB2) mutations and who have received a prior systemic therapy.
If approved, Sevabertinib will provide an additional treatment option for previously treated patients with advanced NSCLC harboring a HER2-activating mutation. Daiichi Sankyo's Enhertu and Boehringer Ingelheim Pharma's Hernexeos are the approved drugs specifically for treating HER2-mutant non-small cell lung cancer.
BAYRY closed Friday's trading at $7.75, up 0.52%.
Ascendis Pharma A/S (ASND)
The FDA decision on Ascendis Pharma's Navepegritide, proposed for the treatment of children with achondroplasia, is due on November 30, 2025.
Achondroplasia is a rare genetic condition arising from a systemic fibroblast growth factor receptor 3 (FGFR3) variant that leads to an imbalance in the effects of the FGFR3 and C-type natriuretic peptide (CNP) signaling pathways. It not only leads to skeletal dysplasia characterised by disproportionate short stature, but also causes serious muscular, neurological, and cardiorespiratory complications. More than 250,000 people worldwide are affected by this condition.
Navepegritide, also known as TransCon CNP, is an investigational prodrug of C-type natriuretic peptide (CNP), which is designed to be administered by subcutaneous injection once weekly to provide sustained exposure to CNP, resulting in continuous inhibition of the fibroblast growth factor receptor 3 (FGFR3) pathway that is overactive in achondroplasia. FGFR3 is a negative regulator of bone growth.
Voxzogo, developed by BioMarin Pharmaceutical Inc. (BMRN), is the first and only FDA-approved treatment for pediatric patients with achondroplasia. It is administered as a once-daily subcutaneous injection. The drug generated total revenue of $221 million in Q2, 2025, up 20% over the year-ago quarter.
ASND closed Friday's trading at $201.60, down 1.04%.
Kura Oncology Inc. (KURA)
On November 30, 2025, Kura Oncology is expected to learn whether the FDA will approve its investigational drug Ziftomenib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) harbouring a nucleophosmin 1 (NPM1) mutation.
In a clinical trial setting, a significant number of patients treated with Ziftomenib achieved complete remission and complete remission with partial blood count recovery.
Acute myeloid leukemia (AML) is the most common acute leukemia in adults and begins when the bone marrow makes abnormal myeloblasts (white blood cells), red blood cells or platelets. The menin pathway is considered a driver for multiple genetic alterations of the disease, of which NPM1 mutations are among the most common, representing approximately 30% of AML cases. There are currently no FDA-approved therapies targeting NPM1-mutant AML.
The company sees a market opportunity of $350 million to $400 million per year in the U.S. for Ziftomenib in relapsed or refractory NPM1-mutant AML, if approved.
Kura has a strategic collaboration with Japan-based Kyowa Kirin to develop and commercialize Ziftomenib.
KURA closed Friday's (Oct.31, 2025) trading at $10.27, down 1.63%.
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