Biotech Stocks Facing FDA Decision In February 2025

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(RTTNews) - February is observed as American Heart Month, a period dedicated to raising awareness about heart health. The first American Heart Month was officially declared by President Lyndon B. Johnson in 1964.

Heart disease remains the leading cause of death in the United States, and it caused 702,880 deaths in 2022, according to the latest data from the CDC.

Let's take a look at the biotech stocks awaiting FDA decisions in February.

Supernus Pharmaceuticals Inc. (SUPN)

The FDA decision on Supernus Pharma's SPN-830, an investigational apomorphine infusion device for the continuous treatment of motor fluctuations ("OFF" episodes) in Parkinson's disease, is expected on February 1, 2025.

SPN-830 is a continuous subcutaneous infusion formulation of the company's very own approved dopamine agonist apomorphine, administered through an infusion device.

Apomorphine, under the brand name Apokyn, received FDA approval in 2004 for the acute, intermittent treatment of OFF episodes in Parkinson's disease. Apokyn is administered by subcutaneous injection using only the multiple-dose APOKYN Pen with the supplied cartridges.

One of the hallmarks of Parkinson's disease is the gradual depletion of dopamine-producing cells in the brain, which play an important role in regulating movement and other functions.

In the early stages of Parkinson's disease, medications like Levdopa are effective at managing the symptoms. However, as the disease progresses, there will be only fewer dopamine-producing cells, and the effectiveness of levodopa begins to diminish, providing shorter durations of symptom relief. The patients may experience the return of symptoms such as muscle stiffness, tremors, and involuntary movements. These periods, when symptoms re-emerge, are known as "OFF periods."

This marks Supernus Pharma's fourth attempt to gain FDA approval for SPN-830.

In November 2020, the U.S. regulatory agency refused to accept for review the New Drug Application for SPN-830, stating that the application was not sufficiently complete to permit a substantive review. The second and third attempts were also unsuccessful, with the FDA issuing Complete Response Letters in October 2022 and April 2024, respectively.

SUPN closed Thursday's trading at $38.69, down 0.79%.

Indivior PLC (INDV)

Indivior's Prior Approval Supplement, which aims to expand the SUBLOCADE label to include alternative injection sites and support rapid induction, is under priority review by the FDA, with a decision due on February 7, 2025.

SUBLOCADE, a monthly injectable formulation of buprenorphine, received FDA approval for the treatment of moderate to severe opioid use disorder in November 2017. The current approved mode of administration is as subcutaneous (under the skin) injection in the stomach region.

The Prior Approval Supplement seeks to expand the injection sites to include the thigh, buttock, and back of the upper arm for both induction and maintenance. In addition, the company has also sought a rapid induction protocol, which would reduce treatment induction time from the current 7-day minimum on transmucosal buprenorphine (TM BUP) to a single dose of TM BUP with 1-hour observation period to confirm tolerability and allow for the second 300 mg dose to be administered as early as one week after the initial 300 mg injection, based on patient needs.

INDV closed Thursday's trading at $12.20, up 0.41%.

GSK plc (GSK)

On February 14, 2025, the FDA will decide whether to approve GSK's 5-in-1 MenABCWY vaccine, which targets the five most common strains of the Neisseria meningitidis bacteria (A, B, C, W, and Y) responsible for invasive meningococcal disease worldwide.

Invasive meningococcal disease (IMD) is a serious and unpredictable illness that can affect anyone, though individuals in their late teens and early adulthood are at higher risk. It can lead to life-threatening complications, with one in six cases resulting in death, sometimes within just 24 hours. For those who survive, the long-term consequences can include brain damage, amputations, hearing loss, and issues with the nervous system.

The 5-in-1 MenABCWY vaccine combines the antigenic components from its two approved meningococcal vaccines - Bexsero and Menveo. Bexsero is approved for preventing IMD caused by Neisseria meningitidis serogroup B in individuals from 10 through 25 years, while Menveo is approved for preventing IMD caused by serogroups A, C, W, and Y in individuals from 2 months through 55 years of age.

If approved, the 5-in-1 MenABCWY vaccine can simplify immunization, increase vaccination coverage, and help reduce the overall burden of IMD, with unvaccinated adolescents being at particular risk of infection and potential outbreaks, according to the company.

GSK closed Thursday's trading at $35.36, up 0.86%.

Ono Pharmaceutical Co., Ltd. (OPHLY.OB)

Japan-based Ono Pharma will find out on February 17, 2025, whether the FDA approves its experimental drug Vimseltinib.

Vimseltinib, a colony-stimulating factor 1 receptor (CSF1R), is proposed for the treatment of patients with tenosynovial giant cell tumor. The drug came under Ono Pharma's fold when it acquired Deciphera Pharmaceuticals Inc. (DCPH) last April for $25.60 per share, for a total equity value of $2.4 billion.

Tenosynovial Giant Cell Tumor (TGCT) is a rare, non-malignant tumor that develops inside or near joints. Although benign, these tumors can grow and cause damage to surrounding tissues and structures inducing pain, swelling, and limitation of movement of the joint.

Daiichi Sankyo's TURALIO, approved by the FDA in 2019, is the only approved therapy for TGCT in the U.S.

OPHLY.OB closed Thursday's trading at $3.47, up 1.76%.

Novartis (NVS)

An FDA panel is scheduled to review Novartis' (NVS) application seeking approval for the expanded use of its drug Fabhalta to treat adults with complement 3 glomerulopathy on February 24, 2025.

Complement 3 glomerulopathy (C3G) is an ultra-rare, progressive kidney disease that triggers the formation of C3 protein deposits in the kidneys, resulting in proteinuria (protein in urine), hematuria (blood in urine), and reduced kidney function.

In a clinical trial setting, patients treated with Fabhalta in addition to supportive care achieved a 35.1% reduction in proteinuria at 6 months when compared to placebo on top of supportive care.

The drug is already approved in the U.S. for treating paroxysmal nocturnal hemoglobinuria and primary immunoglobulin A nephropathy.

NVS closed Thursday's trading at $104.75, up 1.77%.

Astellas Pharma Inc. (ALPMY.OB)

Astellas Pharma has sought FDA approval to add positive 2-year data to the label of IZERVAY injection for the treatment of Geographic Atrophy, and a decision is anticipated by February 26, 2025.

The U.S. regulatory agency previously declined to approve the company's request in November 2024, citing concerns regarding the labeling language proposed by Astellas.

IZERVAY was approved by the FDA on August 4, 2023, for treatment for geographic atrophy (GA), caused by age-related macular degeneration.

The sales of IZERVAY for the 6 months from April 1, 2024, to September 30, 2024, totaled 28.1 billion yen.

ALPMY.OB closed Thursday's trading at $9.88, up 0.82%.

Eton Pharmaceuticals Inc (ETON)

The FDA is scheduled to announce its decision on Eton Pharma's New Drug Application seeking approval of ET-400 for pediatric adrenal insufficiency on February 28, 2025.

ET-400 is a proprietary patented formulation of hydrocortisone oral solution, and if approved, will provide an additional oral hydrocortisone treatment option.

According to the company, there is a strong demand for an FDA-approved liquid formulation of hydrocortisone, particularly among infants and young children.

ETON closed Thursday's trading at $17.32, up 1.46%.

SpringWorks Therapeutics Inc. (SWTX)

SpringWorks' investigational drug Mirdametinib is under priority review by the FDA, with a decision due on February 28, 2025.

Mirdametinib, a MEK inhibitor, is proposed for the treatment of adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN).

Neurofibromatosis type 1 (NF1) is a rare genetic disorder of the nervous system causing tumors to grow on nerves. These tumors can lead to significant disfigurement and often cause chronic, debilitating pain. Individuals with NF1 may also face a reduced life expectancy, typically 8 to 15 years shorter than that of the general population, due to the complications associated with the condition.

There is one FDA-approved treatment for pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas - AstraZeneca's Koselugo, which was approved in 2020. However, no approved treatment options exist for adult patients with this condition.

SWTX closed Thursday's trading at $37.23, up 1.94%.