KENILWORTH (NJ) (dpa-AFX) - May has just begun, and it's time to turn our attention to the FDA decisions on deck for the coming weeks.
So far this year, the U.S. regulatory agency has approved only nine novel drugs - new molecular entities (NMEs) having chemical structures that have never been approved before. This number pales in comparison to 15 novel drugs approved during the same period last year (January through April).
Last month, Martin A. Makary, M.D., M.P.H., was appointed the 27th Commissioner of the FDA. Just days into his tenure, on April 10, he announced that the U.S. regulatory agency would begin reducing its reliance on traditional animal testing in the development of monoclonal antibody therapies and other pharmaceuticals. In its place, the FDA will increasingly utilize AI-based computational modeling, human organ model-based lab testing, and real-world human data.
In another significant move, Makary issued a policy directive last month to avoid potential conflicts of interest by limiting the participation of people who work for FDA-regulated companies on FDA advisory committees, where statutorily allowed.
Now, let's take a look at the biotech stocks facing FDA decisions in May 2025.
GSK plc (GSK)
The FDA decision on the expanded use of GSK's Nucala, as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease with an eosinophilic phenotype, is due on May 7, 2025.
In clinical trial settings, the addition of Nucala to inhaled maintenance therapy achieved a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations versus placebo with patients treated for 52-104 weeks.
Chronic obstructive pulmonary disease (COPD) is a progressive and heterogenous inflammatory lung disease marked by persistent respiratory symptoms such as breathlessness, cough, and sputum, along with progressive airflow obstruction due to the chronic inflammation. A COPD exacerbation is an acute episode of worsening COPD symptoms and can result in hospitalisation and irreversible lung damage that leads to progressive lung function decline.
Administered via subcutaneous injection, Nucala is already approved for the treatment of severe eosinophilic asthma, chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis, and hypereosinophilic syndrome.
The drug generated annual sales of £1.78 billion in 2024, up 12% over the prior year.
GSK closed Wednesday's trading at $39.85, up 2.26%.
Arcutis Biotherapeutics Inc. (ARQT)
Arcutis Biotherapeutics has sought FDA approval to expand the use of its ZORYVE foam 0.3% for the treatment of adults and adolescents ages 12 and over with scalp and body psoriasis, and a decision is due on May 22, 2025.
Scalp psoriasis is a type of plaque psoriasis that affects the skin on the head. It can sometimes spread to the forehead, back of the neck, or around the ears. It shows up as red, raised patches of skin with a white or silver scale on top. People with scalp psoriasis often have similar patches on other parts of their bodies, too. Almost half of the 9 million Americans with plaque psoriasis also have it on their scalp.
ZORYVE foam 0.3%, a once-daily, next-generation phosphodiesterase-4 (PDE4) inhibitor, is already approved for the treatment of seborrheic dermatitis in adult and pediatric patients 9?years of age and older.
ZORYVE is also available in cream formulation and comes in two strengths - 0.3% and 0.15%. ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older. ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.
ARQT closed Wednesday's trading at $14.91, up 1.08%.
Sanofi (SNY)
The FDA decision on Sanofi's MenQuadfi for the potential extension of the indication to include children aged six weeks to 23 months through active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y, and a decision is anticipated on May 23, 2025.
MenQuadfi, a quadrivalent meningococcal vaccine, is already approved for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y in individuals 2 years of age and older.
Meningococcal disease is a serious and potentially life-threatening infection caused by the bacterium Neisseria meningitidis. It typically presents with symptoms such as a sudden high fever, stiff neck, confusion, nausea, vomiting, extreme fatigue, and a distinctive petechial or purpuric rash. If not treated quickly and properly, the condition can worsen rapidly and may lead to death.
SNY closed Wednesday's trading at $54.95, up 2.29%.
Liquidia Corp. (LQDA)
Liquidia is currently awaiting the FDA's decision on its resubmitted New Drug Application for YUTREPIA inhalation powder, with a target action date set for May 24, 2025. The therapy is being developed for the treatment of both pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).
YUTREPIA previously faced a setback in November 2020 when the FDA declined to approve the drug for PAH, requesting additional clarification related to its chemistry, manufacturing, and controls (CMC) data. However, in November 2021, the agency granted tentative approval for YUTREPIA for the PAH indication.
Liquidia later pursued an expanded label for Yutrepia to include PH-ILD, a serious and progressive form of pulmonary hypertension. In August 2024, the FDA granted tentative approval for YUTREPIA inhalation powder for both PAH and PH-ILD in adult patients.
The upcoming FDA decision will determine whether the tentative approval for Yutrepia gets converted to final approval.
LQDA closed Wednesday's trading at $13.97, up 3.40%.
Merck (MRK)
The FDA decision on the expanded use of Merck's WELIREG for the treatment of adult and pediatric patients 12 years of age and older with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma is expected on May 26, 2025.
Pheochromocytoma and paraganglioma (PPGL) are rare adrenal tumors caused by certain genetic syndromes or mutations, and there are no FDA-approved therapies for patients with this rare disease. It is estimated that up to 2,000 new cases of PPGL are diagnosed each year in the U.S., and up to 52,800 new cases are diagnosed each year worldwide.
WELIREG is already approved by the FDA for the treatment of von Hippel-Lindau (VHL) disease and advanced renal cell carcinoma. The drug generated annual sales of $509 million in 2024, compared to $218 million in 2023.
MRK closed Wednesday's trading at $85.20, up 0.58%.
Eton Pharmaceuticals Inc (ETON)
The FDA decision on Eton Pharma's New Drug Application seeking approval for ET-400 in treating pediatric adrenal insufficiency is due on May 28, 2025.
Adrenal Insufficiency is a rare disorder in children caused when the cortex of the adrenal glands does not produce enough of the vital steroid hormone, cortisol. This life-threatening condition is usually characterised by darkened skin (hyperpigmentation), low blood sugar (hypoglycemia), prolonged jaundice, poor growth, persistent fatigue, generalized weakness, headaches, and nausea or vomiting, among others.
Oral hydrocortisone is a widely used treatment for the treatment of adrenal insufficiency.
Eton Pharma's 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 Wednesday's trading at $16.85, up 2.18%.
Moderna Inc. (MRNA)
Moderna's next-generation COVID-19 vaccine, mRNA-1283, is under priority review by the FDA, with a decision due on May 31, 2025.
In clinical trials, mRNA-1283 worked just as well as the company's approved vaccine, Spikevax (mRNA-1273), in protecting against COVID-19 in participants 12 years of age and older. Moreover, mRNA-1283 showed higher efficacy than Spikevax in adults 18 and older, with a consistent trend observed in the subset of adults aged 65 and older.
If approved, the storage stability, shelf life, and pre-filled syringe presentation of mRNA-1283 could alleviate healthcare provider burden and potentially increase access into new settings to serve public health, according to Moderna.
MRNA closed Wednesday's trading at $28.54, up 2.59%.
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