KENILWORTH (NJ) (dpa-AFX) - 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%.



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