May 2025 FDA Approval Calendar

As we head into the summer stretch, May 2025 is shaping up to be another pivotal month for the pharmaceutical sector. With several major FDA decisions slated, the potential for market movement—and medical milestones—is high. From game-changing respiratory vaccines to rare disease therapies, here’s what investors and healthcare watchers should keep on their radar.

Let’s dive into the details.

 🧬 Moderna, Inc. (MRNA)

Drug: mRNA-1283
Application Type: Biologics License Application (BLA)
PDUFA Date: May 31, 2025
Approval Probability: High (90%)
Potential Stock Boost: 12–18%
Why It Matters:

Moderna aims to follow up on its pandemic-era success with mRNA-1283, a next-generation COVID-19 vaccine designed for easier storage and potentially fewer side effects. With public health agencies calling for updated vaccine tech, this approval could reaffirm Moderna’s leadership in respiratory mRNA vaccines—just in time for fall vaccination campaigns.

 

💊 Eton Pharmaceuticals, Inc. (ETON)

Drug: ET-400
Application Type: New Drug Application (NDA)
PDUFA Date: May 28, 2025
Approval Probability: Moderate to High (80%)
Potential Stock Boost: 20–30%
Why It Matters:

ET-400 represents a strategic move to broaden treatment options for adrenal insufficiency. As an oral hydrocortisone alternative, it could simplify regimens for patients and create a fresh revenue stream for Eton. For a small-cap company, FDA approval might be a major catalyst.

 

🧪 Merck & Co. Inc. (MRK)

Drug: WELIREG (belzutifan)
Application Type: Supplemental NDA (sNDA)
PDUFA Date: May 26, 2025
Approval Probability: High (88%)
Potential Stock Boost: 6–10%
Why It Matters:

Merck’s push to expand WELIREG into treatment for advanced Pheochromocytoma and Paraganglioma (PPGL) highlights the company’s oncology strength. These rare but aggressive tumors have limited options—approval would further diversify Merck’s cancer portfolio.

 

Liquidia Corporation (LQDA)

Drug: YUTREPIA
Application Type: Resubmitted NDA
PDUFA Date: May 24, 2025
Approval Probability: Moderate (75%)
Potential Stock Boost: 30–40%
Why It Matters:

After previous regulatory hurdles, Liquidia returns to the FDA with YUTREPIA, an inhaled dry powder therapy for pulmonary hypertension. The potential green light could be a pivotal moment—validating its proprietary PRINT technology and positioning Liquidia against industry giant United Therapeutics.

 

Sanofi (SNYNF, SNY)

Drug: MenQuadfi
Application Type: Supplemental BLA (sBLA)
PDUFA Date: May 23, 2025
Approval Probability: High (85%)
Potential Stock Boost: 5–7%
Why It Matters:

MenQuadfi could soon be approved for children as young as 6 weeks, expanding its reach in pediatric meningococcal disease prevention. This move strengthens Sanofi’s vaccine franchise and meets a crucial need in infant immunization programs globally.

 

Arcutis Biotherapeutics Inc. (ARQT)

Drug: ZORYVE (roflumilast) foam 0.3%
Application Type: Supplemental NDA (sNDA)
PDUFA Date: May 22, 2025
Approval Probability: High (87%)
Potential Stock Boost: 15–20%
Why It Matters:

ZORYVE’s foam formulation targets scalp and body psoriasis—a particularly stubborn area for topical treatments. If approved, Arcutis could corner a lucrative market segment within dermatology, driving revenue growth from an already FDA-cleared compound.

GSK plc (GSK.L, GSK)

Drug: Nucala (mepolizumab)
Application Type: BLA
PDUFA Date: May 7, 2025
Approval Probability: High (89%)
Potential Stock Boost: 7–10%
Why It Matters:

GSK seeks to extend Nucala’s use into COPD patients with an eosinophilic phenotype. With biologics gaining traction in respiratory care, this could be a meaningful label expansion for a drug already thriving in the asthma space.

 

📊 Summary Table

Company	Drug	FDA Date	Application Type	Indication	Approval Odds	Stock Impact
Moderna (MRNA)	mRNA-1283	May 31, 2025	BLA	COVID-19 Vaccine	High (90%)	12–18%
Eton Pharma (ETON)	ET-400	May 28, 2025	NDA	Oral Hydrocortisone	Moderate-High	20–30%
Merck (MRK)	WELIREG	May 26, 2025	sNDA	PPGL (rare tumor types)	High (88%)	6–10%
Liquidia (LQDA)	YUTREPIA	May 24, 2025	Resub. NDA	Pulmonary hypertension	Moderate (75%)	30–40%
Sanofi (SNY)	MenQuadfi	May 23, 2025	sBLA	Pediatric Meningococcal Vaccine	High (85%)	5–7%
Arcutis (ARQT)	ZORYVE Foam	May 22, 2025	sNDA	Scalp & Body Psoriasis	High (87%)	15–20%
GSK (GSK)	Nucala	May 7, 2025	BLA	COPD with eosinophilic phenotype	High (89%)	7–10%

  💭 Final Thoughts

May 2025 offers a mix of heavyweight contenders and upstart biotech hopefuls. Moderna and GSK continue to evolve respiratory therapeutics, while companies like Eton and Liquidia aim to prove that smaller players can punch above their weight. Whether it’s rare diseases, chronic conditions, or public health initiatives, this month’s decisions could shape future pipelines and portfolios.

Please keep in mind that I’m not a biotechnology or medical professional—just an enthusiast sharing my thoughts and curiosity about what’s ahead!

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."