FOSTER CITY (dpa-AFX) - As May draws to a close, it's time to turn our attention to the FDA's upcoming slate of decisions. From January through May 2025, the U.S. regulatory agency has approved 13 novel drugs, a modest decline from the 16 approvals recorded during the same period in 2024.
The following biotech companies are awaiting potential FDA approvals in June 2025.
Merck & Co. Inc. (MRK)
The FDA is set to decide by June 10, 2025, on Merck's Clesrovimab, a long-acting monoclonal antibody developed to protect infants from respiratory syncytial virus (RSV) during their first RSV season.
Respiratory syncytial virus is a contagious virus that causes widespread seasonal infections like the flu in infants and older adults. There is a high unmet need for preventative options in both healthy and high-risk infants. RSV can lead to serious respiratory conditions like bronchiolitis and pneumonia, causing an estimated 3.6 million hospitalizations and 101,000 deaths a year worldwide in children under five.
According to the CDC, RSV season starts in the fall and peaks in the winter in most regions of the United States, but timing and severity in a given community or region can vary year to year.
AstraZeneca and Sanofi's Beyfortus, a monoclonal antibody approved in July 2023, is the first preventive option specifically designed to protect the broad infant population through its first RSV season. The dosage of Beyfortus depends on the child's age and body weight, among others.
Merck's Clesrovimab, if approved, would be the first and only single-dose immunization for infants, regardless of weight, designed to protect them for the duration of their first RSV season.
MRK closed Thursday's (May 29, 2025) trading at $76.40, up 0.30%.
Moderna Inc. (MRNA)
Moderna is another company waiting to hear back from the FDA about its RSV vaccine.
The company's RSV vaccine, proposed for high-risk adults aged 18-59, is under priority regulatory review, with a decision expected on June 12, 2025.
Each year in the US, about 60,000 to 120,000 older adults are hospitalized, and 6,000 to 10,000 of them die due to RSV infection. In the U.S., the burden of illness caused by RSV in older adults (60 years or older) results in approximately $3 billion in direct medical costs per year.
The company already has one approved RSV vaccine, named mRESVIA, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. It was approved by the FDA last May.
In October 2024, the FDA approved Pfizer's Abrysvo to treat adults 18 to 59 years of age at increased risk for RSV.
MRNA closed Thursday's trading at $26.93, up 3.38%.
UroGen Pharma Ltd. (URGN)
UroGen Pharma, which faced a setback in May after an FDA advisory panel narrowly voted against its investigational therapy UGN-102, is now approaching a critical regulatory milestone. The FDA is expected to issue its final decision on the drug by June 13, 2025.
UGN-102 (mitomycin) for intravesical solution is proposed for the treatment of low-grade intermediate risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
In the U.S., bladder cancer is the second most common urologic cancer in men and primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. More specifically, LG-IR-NMIBC represents approximately 23,000 newly diagnosed bladder cancer patients each year and an estimated 59,000 recurrences annually among patients diagnosed in previous years.
Trans-urethral resection of bladder tumor (TURBT) is considered the standard of care for the management of NMIBC. However, up to 70% of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures.
According to the company, UGN-102 represents a meaningful advancement for patients facing the recurrent and challenging nature of LG-IR-NMIBC.
On May 21, 2025, an FDA advisory panel narrowly voted 4 to 5 that the benefit-risk profile of UGN-102 for intravesical use is favorable for the treatment of recurrent low-grade, intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC).
The regulatory agency usually follows the panel's recommendations, although it is not mandatory to do so.
URGN closed Thursday's trading at $3.97, down 1.98%.
KalVista Pharmaceuticals Inc. (KALV)
Come June 17, 2025, KalVista Pharma will learn whether Sebetralstat, its investigational therapy, will gain FDA approval. If approved, Sebetralstat would become the first oral, on-demand treatment for hereditary angioedema (HAE), offering a significant shift from current standard therapies, which are primarily injectable or infused.
Sebetralstat works by targeting the kallikrein-kinin system (KKS) cascade, selectively inhibiting plasma kallikrein and the uncontrolled activity that drives hereditary angioedema (HAE) attacks.
Hereditary angioedema is a rare genetic condition characterized by painful, often severe swelling in various parts of the body. It is primarily caused by a deficiency or dysfunction of C1 inhibitor, leading to excessive plasma kallikrein activity and bradykinin release.
According to KalVista, Sebetralstat is designed to offer people living with HAE a medication that can be taken as a discreet oral dose to readily treat HAE attacks on-demand, including at the earliest signs before the attack fully develops.
In clinical trials, Sebetralstat demonstrated a significantly faster onset of symptom relief, greater reduction in attack severity, and quicker achievement of complete resolution compared to placebo.
According to analysts at TD Cowen, the drug has the potential to reach peak annual sales of $750 million.
KALV closed Thursday's trading at $11.89, up 4.30%.
Gilead Sciences Inc. (GILD)
Gilead Sciences' twice-yearly injectable HIV-1 capsid inhibitor, Lenacapavir, is currently under priority review by the FDA for its proposed use as pre-exposure prophylaxis (PrEP) to prevent HIV infection. A regulatory decision is expected by June 19, 2025.
In clinical trials, Lenacapavir demonstrated superior efficacy in preventing HIV infections compared to once-daily oral Truvada. The treatment was also generally well-tolerated, with no significant or new safety concerns reported.
If approved, Lenacapavir would become the first and only twice-yearly HIV prevention option, offering a potentially transformative alternative for individuals at risk of HIV.
GILD closed Thursday's trading at $111.11, up 2.46%.
Sanofi (SNY)
Sanofi and Regeneron are seeking FDA approval for Dupixent in yet another indication - this time, for the treatment of adults with bullous pemphigoid. The U.S. regulatory agency is expected to make a decision by June 20, 2025.
Bullous pemphigoid (BP) is a chronic, debilitating, and relapsing skin disease with underlying type-2 inflammation affecting mostly the elderly population. It is characterized by intense itch and blisters, reddening of the skin, and painful lesions. Approximately 27,000 adults in the US live with BP that is uncontrolled by systemic corticosteroids.
Dupixent (dupilumab), a fully human monoclonal antibody, is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. In the U.S., Dupixent is already approved for multiple conditions, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease (COPD), and chronic spontaneous urticaria. Globally, the drug has received approval in over 60 countries for one or more of the above indications.
Global net sales of Dupixent reached $14.15 billion in full-year 2024, reflecting a 22% year-over-year increase.
SNY closed Thursday's trading at $52.35, up 0.69%.
GSK plc (GSK)
The FDA decision on GSK's prefilled syringe presentation of Shingrix vaccine for the prevention of shingles is expected on June 20, 2025.
Shingrix vaccine, approved in the U.S. in October 2017 for adults aged 50 and older, currently comes as two separate components: a freeze-dried (lyophilized) antigen powder and a liquid adjuvant that healthcare providers must mix before giving the vaccine.
The new prefilled syringe would eliminate the need for this mixing step, providing a more convenient option for pharmacists, doctors, and other healthcare workers who administer the vaccine.
Shingles is caused by the reactivation of the varicella-zoster virus (VZV), the same virus that causes chickenpox. It causes a painful rash with blisters that can last several weeks. While about 99% of U.S. adults over 50 carry the virus, not everyone will develop shingles. An estimated one million people develop shingles annually in the US.
GSK closed Thursday's trading at $40, up 2.09%.
Nuvation Bio Inc. (NUVB)
Nuvation Bio's lead drug candidate, Taletrectinib, proposed for the treatment of advanced ROS1-positive non-small cell lung cancer, is under priority review by the FDA, with a decision due on June 23, 2025.
When the ROS1 gene combines with a segment of another gene, leading to lung cancer, the patient is described as ROS1-positive. This genetic alteration occurs in approximately 1-2% of lung cancer cases, typically in adenocarcinoma, a type of non-small cell lung cancer. ROS1-positive patients are often younger than the typical lung cancer patient and usually have little or no history of smoking. (Source: American Lung Association).
Taletrectinib received regulatory approval in China for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) who either have or have not been previously treated with ROS1 tyrosine kinase inhibitors (TKI) in January of this year. The drug is marketed in China under the brand name DOVBLERON, by Innovent Biologics.
Pfizer's Xalkori, Roche's Rozlytrek, and Bristol-Myers Squibb Co.'s Augtyro are the FDA-approved medications for ROS1-positive non-small cell lung cancer.
NUVB closed Thursday's trading at $2.26, up 2.72%.
Merck & Co. Inc. (MRK)
Merck is seeking to expand the approved use of its blockbuster drug Keytruda in yet another indication - this time for the treatment of patients with resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, then continued as adjuvant treatment in combination with standard of care radiotherapy with or without cisplatin and then as a single agent.
Keytruda is currently approved as monotherapy and in combination regimens for appropriate patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) in the U.S., Europe, China, Japan, and other countries worldwide.
The FDA's decision on the proposed new indication is expected on June 23, 2025.
Melanoma, endometrial cancer, Hodgkin's lymphoma, urothelial carcinoma, gastric cancer, cervical cancer, biliary tract tumor, hepatocellular carcinoma, renal cell carcinoma, Merkel cell carcinoma, esophageal carcinoma, metastatic, non-small cell lung cancer, squamous cell carcinoma, hepatocellular carcinoma, breast cancer, and malignant pleural mesothelioma are the other FDA-approved indications of Keytruda.
MRK closed Thursday's trading at $76.40, up 0.30%.
Unicycive Therapeutics Inc. (UNCY)
Unicycive Therapeutics' Oxylanthanum Carbonate, proposed for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis, awaits the FDA decision on June 28, 2025.
Hyperphosphatemia, characterized by elevated phosphate levels in the blood, is a common and serious condition in nearly all patients with End Stage Renal Disease (ESRD). If not treated, it can lead to secondary hyperparathyroidism, which may result in renal osteodystrophy, a bone disease resembling osteoporosis. Additionally, hyperphosphatemia is associated with cardiovascular complications, including hardening of arteries and atherosclerosis.
Although there are several FDA-cleared medications for Hyperphosphatemia, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.
According to the company, if approved, Oxylanthanum Carbonate could improve patient adherence compared to current treatments because it requires fewer and smaller pills per dose, and the pills can be swallowed instead of chewed, making them more convenient.
UNCY closed Thursday's trading at $0.58, down 3.93%.
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