In June 2025, the FDA’s PDUFA calendar features a diverse slate of decision dates spanning vaccines, rare diseases, oncology, and more. Below is a snapshot of each scheduled action, complete with our estimated approval probabilities, potential market impact, and a highlight of those therapies designated as breakthrough treatments.
Merck & Co., Inc. (NYSE: MRK)
Drug: Clesrovimab
Application Type: BLA
PDUFA Date: June 10, 2025
Approval Probability: High (78%)
Potential Stock Boost: 8–12%
Why It Matters: Clesrovimab is a long‐acting monoclonal antibody
designed to protect infants from severe RSV disease. If approved, it could
complement existing pediatric RSV prophylaxis options and address an ongoing
unmet need in infant respiratory care.
Moderna, Inc. (NASDAQ: MRNA)
Drug: mRNA-1345
Application Type: BLA
PDUFA Date: June 12, 2025
Approval Probability: Very High (90%)
Potential Stock Boost: 8–12%
Breakthrough Treatment: Granted Breakthrough Therapy Designation in
January 2023
Why It Matters: mRNA-1345 represents the first mRNA RSV vaccine candidate for high-risk adults aged 18–59, with the potential to significantly reduce hospitalizations from RSV-related lower respiratory tract disease.
UroGen Pharma Ltd. (NASDAQ: URGN)
Drug: UGN-102
Application Type: NDA
PDUFA Date: June 13, 2025
Approval Probability: Moderate (60%)
Potential Stock Boost: 15–20%
Why It Matters: UGN-102 is an innovative hydrogel formulation of
mitomycin for low-grade, intermediate-risk non-muscle invasive bladder cancer.
Approval would offer the first non-surgical, office-based treatment
alternative, reducing the need for repeated TURBT procedures under general
anesthesia.
KalVista Pharmaceuticals, Inc. (NASDAQ: KALV)
Drug: Sebetralstat
Application Type: NDA
PDUFA Date: June 17, 2025
Approval Probability: High (70%)
Potential Stock Boost: 10–15%
Why It Matters: Sebetralstat is the first oral on-demand therapy for
hereditary angioedema (HAE). If approved, it would allow patients to treat
acute HAE attacks without injections, improving convenience and potentially
increasing timely therapy use
Gilead Sciences, Inc.
(NASDAQ: GILD)
Drug: Lenacapavir
Application Type: NDA
PDUFA Date: June 19, 2025
Approval Probability: Very High (95%)
Potential Stock Boost: 5–8%
Breakthrough Treatment: Received Breakthrough Therapy Designation for
PrEP in October 2024
Why It Matters: Lenacapavir is a twice-yearly injectable for HIV
prevention (PrEP). Its extended-release profile could greatly improve adherence
compared with daily oral regimens, marking a potential paradigm shift in HIV
prophylaxis.
Regeneron Pharmaceuticals (NASDAQ: REGN) & Sanofi
(NASDAQ: SNY)
Drug: Dupixent (dupilumab)
Application Type: sBLA
PDUFA Date: June 20, 2025
Approval Probability: Moderate (75%)
Potential Stock Boost: 3–5%
Why It Matters: This sBLA seeks to expand Dupixent’s use into bullous pemphigoid, a debilitating autoimmune blistering disease. Approval would represent the first targeted biologic therapy for this condition, reducing reliance on systemic steroids.
GSK plc (LSE/NYSE: GSK)
Drug: Shingrix (recombinant zoster vaccine)
Application Type: sBLA
PDUFA Date: June 20, 2025
Approval Probability: Very High (99%)
Potential Stock Boost: 1–2%
Why It Matters: GSK’s sBLA covers a new prefilled syringe presentation of Shingrix, eliminating the need for reconstitution and streamlining administration of the leading shingles vaccine in adults.
Nuvation Bio Inc. (NYSE: NUVB)
Drug: Taletrectinib
Application Type: NDA
PDUFA Date: June 23, 2025
Approval Probability: High (80%)
Potential Stock Boost: 20–25%
Breakthrough Treatment: Granted Breakthrough Therapy Designation for
ROS1+ NSCLC
Why It Matters: Taletrectinib is a next-generation
oral ROS1 inhibitor for advanced ROS1-positive non-small cell lung cancer,
including patients with brain metastases. Approval would address resistance to
first-line ROS1 TKIs.
Merck & Co., Inc. (NYSE: MRK)
Drug: Keytruda (pembrolizumab)
Application Type: sBLA
PDUFA Date: June 23, 2025
Approval Probability: High (85%)
Potential Stock Boost: 5–7%
Why It Matters: The KEYNOTE-689 trial demonstrated a 27% reduction in
event-free survival events when Keytruda was added perioperatively in
resectable, locally advanced head and neck squamous cell carcinoma—the first
positive trial in over two decades for this setting
Unicycive Therapeutics, Inc. (NASDAQ: UCVT)
Drug: Oxylanthanum Carbonate
Application Type: NDA
PDUFA Date: June 28, 2025
Approval Probability: Moderate (65%)
Potential Stock Boost: 20–30%
Why It Matters: Oxylanthanum carbonate is a novel phosphate binder
designed for dialysis patients. Approval could reduce pill burden and improve
treatment adherence and outcomes in hyperphosphatemia associated with chronic
kidney disease
Verastem, Inc. (NASDAQ: VSTM)
Drug: Avutometinib + Defactinib
Application Type: NDA
PDUFA Date: June 30, 2025
Approval Probability: High (85%)
Potential Stock Boost: 25–30%
Breakthrough Treatment: Granted Breakthrough Therapy Designation for
recurrent low-grade serous ovarian cancer
Why It Matters: This combination would be the first
FDA-approved therapy for KRAS-mutant low-grade serous ovarian cancer, a rare
subtype with limited options, offering a precision-medicine approach.
|
Company |
Drug |
FDA Date |
Application Type |
Indication |
Approval Odds |
Stock Impact |
|
Merck & Co., Inc. |
Clesrovimab |
10-Jun-25 |
BLA |
Long-acting monoclonal
antibody for RSV prophylaxis in infants |
High (78%) |
8–12% |
|
Moderna, Inc. |
mRNA-1345 |
12-Jun-25 |
BLA |
RSV vaccine in high-risk
adults (18–59 years) |
Very High (90%) |
8–12% |
|
UroGen Pharma Ltd. |
UGN-102 |
13-Jun-25 |
NDA |
Low-grade, intermediate-risk
non-muscle invasive bladder cancer |
Moderate (60%) |
15–20% |
|
KalVista Pharmaceuticals, Inc. |
Sebetralstat |
17-Jun-25 |
NDA |
Oral on-demand therapy for
hereditary angioedema (≥ 12 years) |
High (70%) |
10–15% |
|
Gilead Sciences, Inc. |
Lenacapavir |
19-Jun-25 |
NDA |
Twice-yearly injectable for
HIV PrEP |
Very High (95%) |
5–8% |
|
Regeneron Pharma & Sanofi |
Dupixent (dupilumab) |
20-Jun-25 |
sBLA |
Treatment of bullous
pemphigoid in adults |
Moderate (75%) |
3–5% |
|
GSK plc |
Shingrix |
20-Jun-25 |
sBLA |
Prefilled-syringe presentation
for shingles prevention |
Very High (99%) |
1–2% |
|
Nuvation Bio Inc. |
Taletrectinib |
23-Jun-25 |
NDA |
Advanced ROS1-positive non-small
cell lung cancer |
High (80%) |
20–25% |
|
Merck & Co., Inc. |
Keytruda (pembrolizumab) |
23-Jun-25 |
sBLA |
Perioperative treatment of
resectable, locally advanced head and neck squamous cell carcinoma |
High (85%) |
5–7% |
|
Unicycive Therapeutics, Inc. |
Oxylanthanum Carbonate |
28-Jun-25 |
NDA |
Treatment of hyperphosphatemia
in CKD patients on dialysis |
Moderate (65%) |
20–30% |
|
Verastem, Inc. |
Avutometinib + Defactinib |
30-Jun-25 |
NDA |
Recurrent KRAS-mutant
low-grade serous ovarian cancer |
High (85%) |
25–30% |
Stay figgy,
The Figured Figs Team 🌱
Disclaimer: “This article is for informational purposes only and does not constitute financial, investment, legal, or tax advice. Readers are encouraged to consult a licensed professional before making any financial decisions."
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