April 2025 FDA Approval Calendar

As we move into the spring of 2025, the pharmaceutical industry is buzzing with anticipation as several companies await decisions from the U.S. Food and Drug Administration (FDA) on their New Drug Applications (NDAs) and Biologics License Applications (BLAs). The Prescription Drug User Fee Act (PDUFA) dates in April 2025 are critical milestones that could shape the future of these companies and their innovative treatments. In this blog post, we’ll dive into the details of the companies with PDUFA dates in April 2025, including their drugs, approval probabilities, potential stock boosts, and why these developments matter. Let’s explore each one!

 

Aldeyra Therapeutics Inc. (ALDX)

• Drug: Small-molecule modulator of RASP
• PDUFA Date: April 2, 2025
• Approval Probability: High (85%)
• Potential Stock Boost: 20-25%
• Why It Matters: Aldeyra Therapeutics is targeting a novel approach with its small-molecule modulator of RASP, which could address unmet needs in certain cancer treatments. A successful approval would not only validate Aldeyra’s research but also position it as a contender in the competitive oncology market. The stock could see a significant uptick if the FDA greenlights this application, given the company’s relatively small market cap and the potential for expanded indications.

 

Exelixis Inc. (EXEL)

• Drug: Cabozantinib (CABOMETYX) for Differentiated Thyroid Cancer (DTC)
• PDUFA Date: April 3, 2025
• Approval Probability: High (88%)
• Potential Stock Boost: 15-20%
• Why It Matters: Exelixis is seeking to expand the use of Cabozantinib, an established tyrosine kinase inhibitor, into differentiated thyroid cancer. This supplemental New Drug Application (sNDA) builds on the drug’s existing success in other cancer types, such as renal cell carcinoma. Approval could strengthen Exelixis’ revenue stream and reinforce its reputation in precision oncology, potentially driving a moderate but meaningful stock increase.
• Drug: Cabozantinib for neuroendocrine tumors
• PDUFA Date: April 3, 2025
• Approval Probability: High (87%)
• Potential Stock Boost: 15-20%
• Why It Matters: Another sNDA for Cabozantinib targets neuroendocrine tumors, a rare but challenging condition. If approved, this would diversify Exelixis’ portfolio further, appealing to a niche market with limited treatment options. The dual PDUFA dates in early April could create a cumulative positive effect on the stock, especially if both applications succeed.

 

Bristol-Myers Squibb Company (BMY, BMYMP)

• Drug: Opdivo (nivolumab) for resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting
• PDUFA Date: April 21, 2025
• Approval Probability: Very High (92%)
• Potential Stock Boost: 10-15%
• Why It Matters: Opdivo, a leading immunotherapy drug, is already a cornerstone of Bristol-Myers Squibb’s oncology lineup. Expanding its use into the adjuvant setting for esophageal and GEJ cancers could capture a new patient population and solidify the company’s dominance in immuno-oncology. While the stock boost might be modest due to the company’s large size, the long-term revenue potential is substantial.

 

Abeona Therapeutics Inc. (ABEO)

• Drug: pz-cel for the treatment of patients with recessive dystrophic epidermolysis bullosa
• PDUFA Date: April 29, 2025
• Approval Probability: High (85%)
• Potential Stock Boost: 25-30%
• Why It Matters: Abeona’s pz-cel targets a rare genetic skin disorder with few effective treatments. A successful BLA approval could be a game-changer for the company, which has been working to establish itself in gene therapy. Given Abeona’s smaller market presence, a positive FDA decision could lead to a significant stock surge, attracting investor attention to this innovative therapy.

 Summary Table

Company	Symbol	Current Price	% Upside?	Drug	Phase	Chances of Approval	Disease Targeted	FDA Approval Date
Aldeyra Therapeutics Inc.	ALDX	N/A	20-25%	Small-molecule modulator of RASP	NDA	High (85%)	Cancer	April 2, 2025
Exelixis Inc.	EXEL	N/A	15-20%	Cabozantinib (CABOMETYX) for DTC	sNDA	High (88%)	Differentiated Thyroid Cancer (DTC)	April 3, 2025
Bristol-Myers Squibb Company	BMY	N/A	10-15%	Opdivo (nivolumab)	sBLA	Very High (92%)	Resected Esophageal or GEJ Cancer (Adjuvant)	April 21, 2025
Abeona Therapeutics Inc.	ABEO	N/A	25-30%	pz-cel	BLA	High (85%)	Recessive Dystrophic Epidermolysis Bullosa	April 29, 2025

 

Final Thoughts

The April 2025 PDUFA calendar features a diverse range of therapies, from cancer treatments to rare genetic disease interventions. Companies like Aldeyra and Abeona, with significant upside potential, could see dramatic stock movements if their drugs gain approval, reflecting their growth-stage status. Meanwhile, established players like Exelixis and Bristol-Myers Squibb stand to enhance their market positions with expanded indications. Investors and healthcare professionals alike will be watching these dates closely, as they could herald new treatment options and reshape the biotech landscape. Stay tuned for updates as these decisions unfold!

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."