Biotech Stocks Facing FDA Decision In January 2024

(RTTNews) - As the year draws to a close, it's time to assess the current status regarding the approval of novel drugs, also referred to as new molecular entities.

The highest number of novel drugs was approved in 2018 - with 59 getting the FDA nod, and this record still remains unbeaten.

As of this writing, 55 novel drugs have been greenlighted by the U.S. regulatory agency this year, making it the second-highest tally. This number compares favorably with the 37 novel drugs approved in 2022.

Will 2024 mark a fresh record for novel drug approvals? While we await the answer, let's take a look at the biotech companies awaiting the FDA decision in January 2024.

Ligand Pharmaceuticals Inc. (LGND)

The FDA decision on Berdazimer gel, proposed for the treatment of molluscum contagiosum, is expected on January 5, 2024.

Berdazimer, a topical antiviral gel, came under Ligand's fold when it acquired all the assets of Novan Inc. (NOVN) in September of this year.

Molluscum contagiosum is a highly infectious viral skin disease that affects around six million individuals, mainly children, in the United States. It results from a pox virus, leading to raised lesions with a skin-toned to pink hue, which may induce pain, inflammation, itching, and bacterial infection.

Verrica Pharmaceuticals Inc.'s (VRCA) YCANTH, approved in the U.S. in July of this year, is the first FDA-approved treatment for molluscum contagiosum.

LGND closed Wednesday's (Dec.27, 2023) trading at $72.28, down 0.48%.

Astellas Pharma Inc. (ALPMY.OB)

The FDA decision on Astellas Pharma's Zolbetuximab, a first-in-class chimeric IgG1 monoclonal antibody that targets and binds to Claudin 18.2 (CLDN18.2), a transmembrane protein, is due on January 12, 2024.

Zolbetuximab is proposed for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive.

Gastric cancer, commonly referred to as stomach cancer, ranks as the fifth most frequently diagnosed cancer globally. In the United States, it is projected that around 26,500 individuals will be diagnosed with gastric cancer, with approximately 11,130 succumbing to the disease in 2023.

If approved, Zolbetuximab would offer a new treatment option for patients with advanced gastric and gastroesophageal cancers and would be the first CLDN18.2-targeted therapy available in the U.S. for these patients.

ALPMY.OB closed Wednesday's trading at $11.74, up 0.56%.

Merck & Co. Inc. (MRK)

Merck has sought FDA approval for its blockbuster cancer drug Keytruda in yet another indication and a decision is expected on January 20, 2024.

This time, the company is seeking approval for the drug's use in combination with concurrent chemoradiotherapy as treatment for patients with newly diagnosed high-risk locally advanced cervical cancer.

In the indication of cervical cancer, Keytruda is already approved as a single agent for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1. The drug is also approved in combination with chemotherapy, with or without Avastin, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1.

MRK closed Wednesday's trading at $107.98, up 0.33%.

Sanofi (SNY)

Sanofi has sought to expand the approved use of Dupixent in the treatment of eosinophilic esophagitis in children aged 1 to 11 years, and a decision is due on January 31, 2024.

Eosinophilic esophagitis (EoE) is characterized by type 2 inflammation, causing harm to the esophagus and impairing its normal function. In children, typical symptoms of EoE encompass heartburn, vomiting, abdominal discomfort, difficulty swallowing, food rejection, and failure to thrive.

Dupilumab is being jointly developed by Sanofi and Regeneron Pharmaceuticals Inc. (REGN) under a global collaboration agreement. The drug is already approved for the treatment of adult and pediatric patients aged 12 years and older with eosinophilic esophagitis.

Atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, and prurigo nodularis are the other indications for which Dupilumab is approved in the U.S. The drug is approved in more than 60 countries, including in Europe, the U.S. and Japan.

SNY closed Wednesday's trading at $49.75, up 1.37%.