February 2025 FDA Approval Calendar

February 2025 has  several highly anticipated therapies awaiting FDA decisions. These upcoming approvals have the potential to address significant unmet medical needs in conditions such as Parkinson's disease, PTSD, and chikungunya virus. This list highlights five promising drugs and vaccines set for review, analyzing their chances of approval, market potential, and projected impact on stock performance.

1. Valneva (VALN): CHIKV VLP Vaccine for Chikungunya Virus

Valneva’s CHIKV VLP vaccine could become the first widely available solution for chikungunya, a disease with no current vaccine. Phase 3 results showed 98% immunogenicity, making approval highly likely.

• Approval Probability: 90%
• Potential Stock Price Boost: 18%
• Why It Matters: Targets a pressing global need in regions prone to chikungunya outbreaks.

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2. Pfizer (PFE): MenABCWY Vaccine for Meningococcal Disease

Pfizer is simplifying immunization with its MenABCWY vaccine, which provides protection against five meningococcal serogroups in one shot. Phase 3 trials met all primary endpoints, ensuring a strong case for approval.

• Approval Probability: 85%
• Potential Stock Price Boost: 20%
• Why It Matters: Reduces the number of shots required, improving convenience and compliance.

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3. Supernus Pharmaceuticals (SUPN): SPN-830 for Parkinson’s Disease

SPN-830 is a resubmitted NDA for an apomorphine infusion device to manage motor fluctuations in Parkinson’s patients. Clinical trials demonstrated significant efficacy, addressing an unmet need.

• Approval Probability: 80%
• Potential Stock Price Boost: 20%
• Why It Matters: A novel treatment option for Parkinson’s patients experiencing “off” episodes.

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4. SpringWorks Therapeutics (SWTX): Mirdametinib for NF1-PN

Mirdametinib, a MEK inhibitor, targets neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), a rare and debilitating disease. Phase 2b trials showed promising efficacy and quality-of-life improvements.

• Approval Probability: 80%
• Potential Stock Price Boost: 25%
• Why It Matters: Offers relief for an underserved population with limited treatment options.

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5. Otsuka & Lundbeck (OTSKY): Brexpiprazole + Sertraline for PTSD

This combination therapy for PTSD pairs an antipsychotic with an SSRI. While two out of three Phase 3 trials were successful, the mixed results slightly temper expectations.

• Approval Probability: 65%
• Potential Stock Price Boost: 10%
• Why It Matters: Could serve a large market, but additional data may be needed for widespread confidence.

 

Summarized view is as follows - 

Company	Symbol	Current Price	% Upside?	Drug	Phase	Chances of Approval	Disease Targeted	FDA Approval Date
Supernus Pharmaceuticals	SUPN	37.74	20	SPN-830 (Apomorphine Infusion Device)	Phase 3 (Resubmitted NDA)	High (80%)	Parkinson's Disease (Motor Fluctuations)	01-Feb-25
Otsuka & Lundbeck	OTSKY	25.58	10	Brexpiprazole + Sertraline	Phase 3 (sNDA)	Moderate (65%)	Post-Traumatic Stress Disorder (PTSD)	08-Feb-25
Pfizer	PFE	26.3	20	MenABCWY Vaccine	Phase 3	High (85%)	Meningococcal Disease (All Serogroups)	14-Feb-25
Valneva	VALN	4.36	18	CHIKV VLP Vaccine	Phase 3	High (90%)	Chikungunya Virus	14-Feb-25
SpringWorks Therapeutics	SWTX	34.63	25	Mirdametinib	Phase 2b	High (80%)	Neurofibromatosis Type 1 (NF1-PN)	28-Feb-25

It is important to note that the probabilities and projections presented here are based on probabilistic models and publicly available data. They are not intended to be professional, financial, or medical advice. Investors and stakeholders are encouraged to conduct their own research or consult experts before making decisions.

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."