Biotech Stocks Facing FDA Decision In February 2024

(RTTNews) - The year 2024 has begun on a muted note in terms of FDA approvals, with only one novel drug getting endorsed in January. This is in stark contrast to the four drugs that got the regulatory nod during the same month last year.

Let's take a look at the biotech companies that are awaiting FDA word on their drug candidates in February.

Ipsen (IPSEY.OB)

Ipsen has sought FDA approval to expand the use of its cancer medicine Onivyde plus combination chemotherapy regimen NALIRIFOX as a potential first-line treatment for metastatic pancreatic ductal adenocarcinoma and a decision is due on February 13. 2024.

The NALIRIFOX regimen is a combination of fluorouracil/leucovorin and oxaliplatin.

Onivyde received its initial approval in October 2015, in combination with fluorouracil and leucovorin, for the treatment of patients with advanced (metastatic) pancreatic ductal adenocarcinoma who have been previously treated with gemcitabine-based chemotherapy.

Pancreatic ductal adenocarcinoma, commonly known as PDAC, ranks as the most prevalent form of pancreatic cancer, with around 60,000 cases diagnosed annually in the United States and nearly 500,000 cases globally. Currently, less than 20% of individuals diagnosed with PDAC manage to survive beyond one year.

IPSEY.OB closed Tuesday's trading at $29.09.

Iovance Biotherapeutics Inc. (IOVA)

Iovance's one-time tumor infiltrating lymphocyte (TIL) therapy Lifileucel is at the FDA altar, with a decision due on February 24, 2024.

Lifileucel, an individualized therapy, is proposed for the treatment of patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, where applicable. There are no FDA approved therapies in this treatment setting.

If approved, Lifileucel will be the first and only TIL therapy for patients with advanced melanoma, as well as the first one-time cell therapy for a solid tumor cancer.

According to GlobalData, Lifileucel could achieve worldwide sales amounting to $959 million in the year 2029.

IOVA closed Tuesday's trading at $7.84, down 5.54%.

Alvotech (ALVO)

Alvotech's AVT02, the interchangeable biosimilar to AbbVie's Humira, is under FDA review, with a decision expected on February 24, 2024.

This is the company's second attempt to secure FDA approval for AVT02.

If approved, AVT02 could be the first interchangeable high-concentration biosimilar to Humira in the U.S. market. Humira is used to treat a range of certain inflammatory conditions.

AVT02 is currently marketed in multiple European countries and in Canada.

ALVO closed Tuesday's trading at $15.13, down 0.79%.

Minerva Neurosciences Inc. (NERV)

The FDA decision on Minerva Neurosciences' New Drug Application for Roluperidone for the treatment of negative symptoms of schizophrenia is due on February 26, 2024.

Schizophrenia, a chronic, severe, and debilitating type of mental illness, is characterized by distortions in thinking, perception, emotions, language, sense of self and behaviour. About 20 million people worldwide are said to be affected by this condition.

Negative symptoms can cause individuals with schizophrenia to withdraw from society, become disinterested or unable to complete tasks or feel pleasure. There are currently no treatments approved for negative symptoms of schizophrenia in the US.

NERV closed Tuesday's trading at $8.85, up 4.12%.