March 2025 FDA Approval Calendar

 

As March 2025 approaches, the FDA is set to review several highly anticipated therapies that could bring groundbreaking advancements in healthcare. This month features innovative treatments targeting serious and underserved conditions, including heart failure, rare eye diseases, amyloidosis, antibiotic-resistant infections, and emergency heart care.

1. scPharmaceuticals (SCPH): FUROSCIX for Decompensated Heart Failure

FUROSCIX is a novel subcutaneous formulation of furosemide designed to help patients with worsening heart failure manage fluid overload at home, potentially reducing hospitalizations.

  • Approval Probability: 85%

  • Potential Stock Price Boost: 15%

  • Why It Matters: Provides an alternative to IV diuretics, offering a convenient at-home treatment for heart failure patients.

2. Roivant (ROIV): VTAMA (Tapinarof) Cream for Plaque Psoriasis

VTAMA cream is a non-steroidal topical treatment for plaque psoriasis, showing strong efficacy in clinical trials. If approved, it could be a major advancement in dermatology.

  • Approval Probability: 88%

  • Potential Stock Price Boost: 12%

  • Why It Matters: Offers a new steroid-free option for psoriasis patients, improving long-term safety and adherence.

3. Neurotech Pharmaceuticals: NT-501 for Macular Telangiectasia Type 2

NT-501 is a sustained-release intravitreal implant designed to treat macular telangiectasia type 2, a rare but progressive retinal disorder with no current FDA-approved therapies.

  • Approval Probability: 80%

  • Potential Stock Price Boost: 20%

  • Why It Matters: Addresses an unmet need for patients suffering from vision loss due to macular telangiectasia type 2.

4. Alnylam Pharmaceuticals (ALNY): Vutrisiran for ATTR-CM

Vutrisiran is an RNA interference (RNAi) therapy for transthyretin amyloidosis with cardiomyopathy (ATTR-CM), a life-threatening disease affecting the heart.

  • Approval Probability: 92%

  • Potential Stock Price Boost: 22%

  • Why It Matters: A potential game-changer in the treatment of ATTR-CM, improving survival and quality of life.

5. GSK (GSK): Gepotidacin for Uncomplicated Urinary Tract Infections (UTIs)

Gepotidacin is a first-in-class, novel antibiotic developed to treat UTIs, addressing the growing concern of antibiotic resistance.

  • Approval Probability: 87%

  • Potential Stock Price Boost: 10%

  • Why It Matters: A critical advancement in fighting antibiotic-resistant infections, particularly UTIs affecting millions annually.

6. Milestone Pharmaceuticals (MIST): Etripamil for PSVT

Etripamil is a nasal spray treatment for paroxysmal supraventricular tachycardia (PSVT), allowing patients to self-administer treatment during sudden episodes.

  • Approval Probability: 86%

  • Potential Stock Price Boost: 18%

  • Why It Matters: A convenient, fast-acting alternative to hospital-based interventions for PSVT, empowering patients with self-care options.

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 ðŸŒ±


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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