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Key FDA Decisions Approaching in April 2025 (PDUFA Date Calendar)

BiopharmaWatch Research3 min read

April 2025 is shaping up to be a significant month for several biotechnology and pharmaceutical companies as the U.S. Food and Drug Administration (FDA) has target action dates set for a variety of important applications. Let's take a look at some of the key decisions anticipated next spring.

  • argenx SE

    • Ticker: ARGX

    • Drug Catalyst: VYVGART SC (efgartigimod alfa and hyaluronidase-qvfc)

    • Event Type: PDUFA Date

    • PDUFA Date: April 10, 2025

    • Indication: Generalized Myasthenia Gravis (gMG) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

    • argenx SE is awaiting the FDA's decision on its pre-filled syringe (PFS) version of VYVGART SC, a subcutaneous formulation of their already approved intravenous treatment.

    • The subcutaneous formulation offers the advantage of easier administration, potentially supporting earlier intervention and expanding patient access.

    • Having already seen success with the intravenous version of VYVGART for gMG, the probability of FDA approval for this subcutaneous version is estimated at 90%.

    • Following a potential U.S. approval, argenx plans to submit additional regulatory applications in Europe, Japan, and Canada in 2025.

  • Theratechnologies Inc.

    • Ticker: THTX

    • Drug Catalyst: EGRIFTA SV® (tesamorelin for injection)

    • Event Type: PDUFA Date

    • PDUFA Date: April 18, 2025

    • Indication: HIV (to reduce excess abdominal fat in HIV-infected patients with lipodystrophy)

    • Theratechnologies Inc. has a PDUFA date for its Prior Approval Supplement (PAS) for EGRIFTA SV®.

    • The FDA review is focused on proposed manufacturing or formulation changes for this approved treatment.

    • Given that this is a review of a supplement to an already approved drug, with a focus on manufacturing rather than new clinical concerns, the probability of FDA approval is estimated at 85%.

  • Regeneron Pharmaceuticals, Inc.

    • Ticker: REGN

    • Drug Catalyst: EYLEA HD (aflibercept 8 mg)

    • Event Type: PDUFA Date

    • PDUFA Date: April 20, 2025

    • Indication: Wet Age-Related Macular Degeneration (wAMD) and Diabetic Macular Edema (DME)

    • Regeneron Pharmaceuticals, Inc. has a supplemental Biologics License Application (sBLA) under review to extend the dosing intervals of EYLEA HD up to every 24 weeks.

    • This application is supported by positive data from the Phase 3 PHOTON and PULSAR trials.

    • The probability of approval for these extended dosing intervals is estimated at 75%.

  • Bristol-Myers Squibb Company

    • Ticker: BMY

    • Drug Catalyst: Opdivo® (nivolumab) plus Yervoy® (ipilimumab)

    • Event Type: PDUFA Date

    • PDUFA Date: April 21, 2025

    • Indication: Unresectable hepatocellular carcinoma (HCC)

    • Bristol-Myers Squibb Company has an sBLA under review for the combination of Opdivo® plus Yervoy® as a first-line treatment for HCC.

    • This combination of well-established immunotherapies has shown promising survival outcomes in clinical trials for HCC patients.

    • Considering the PDUFA stage, previous approvals of both drugs for other cancers, and strong clinical evidence, the likelihood of approval is high.

  • Telix Pharmaceuticals Limited

    • Ticker: TLX

    • Drug Catalyst: TLX101-CDx (Pixclara®)

    • Event Type: PDUFA Date

    • PDUFA Date: April 26, 2025

    • Indication: Characterization of progressive or recurrent glioma from treatment-related changes in adult and pediatric patients

    • Telix Pharmaceuticals Limited has a New Drug Application (NDA) under priority review for TLX101-CDx.

    • This PET imaging agent is designed to differentiate between progressive or recurrent glioma and treatment-related changes.

    • The FDA granted priority review, highlighting the unmet medical need for an approved targeted amino acid PET agent for brain cancer imaging in the U.S..

    • The probability of approval is estimated at 75%.

  • Abeona Therapeutics Inc.

    • Ticker: ABEO

    • Drug Catalyst: Prademagene zamikeracel (pz-cel)

    • Event Type: PDUFA Date

    • PDUFA Date: April 29, 2025

    • Indication: Recessive dystrophic epidermolysis bullosa (RDEB)

    • Abeona Therapeutics Inc. has resubmitted its Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), an investigational autologous cell-based gene therapy.

    • If approved, pz-cel would be the first autologous, cell-based gene therapy for RDEB, designed to provide collagen VII expression at wound sites.

    • The probability of regulatory approval is estimated at 75%.

Looking Ahead

April 2025 promises to be an eventful month in the biopharmaceutical landscape. The potential approvals of new formulations, extended dosing regimens, a novel imaging agent, and a gene therapy could have significant impacts on patient care across various conditions. Investors and patients alike will be closely watching these FDA decisions.

Frequently asked questions

What are the key FDA decisions approaching in April 2025?
April 2025 is set to be significant for biotech and pharma companies, with several key FDA decisions on PDUFA dates. Notable drugs under review include argenx's VYVGART SC for generalized myasthenia gravis, Theratechnologies' EGRIFTA SV® for HIV-related lipodystrophy, and Bristol-Myers Squibb's Opdivo® plus Yervoy® for hepatocellular carcinoma.
How does the PDUFA date impact biotech investments?
The PDUFA date is crucial for biotech investments as it indicates when the FDA will decide on drug approvals. A positive decision can lead to significant stock price increases, while negative outcomes can result in declines. Investors closely monitor these dates to assess the probability of approval and potential market impact.
What is the probability of FDA approval for the drugs reviewed in April 2025?
The probability of FDA approval varies among the drugs under review. For instance, argenx's VYVGART SC has a high approval probability of 90%, while Theratechnologies' EGRIFTA SV® stands at 85%. Other drugs, like Bristol-Myers Squibb's combination therapy, also show strong likelihoods due to previous successes and clinical evidence.
What is the significance of priority review for FDA applications?
Priority review by the FDA signifies that a drug addresses an unmet medical need, allowing for faster review times. For example, Telix Pharmaceuticals' TLX101-CDx received priority review, highlighting its importance in brain cancer imaging. This expedited process can lead to quicker access for patients needing new therapies.
What are the implications of FDA decisions for patients and healthcare?
FDA decisions can significantly impact patient care by introducing new therapies and improving treatment options. The anticipated approvals in April 2025, such as gene therapies and novel formulations, may enhance patient access to effective treatments, ultimately improving health outcomes and quality of life.