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Last Updated: February 12, 2025

DANYELZA Drug Profile


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Summary for Tradename: DANYELZA
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for DANYELZA
Recent Clinical Trials for DANYELZA

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Margaret Gatti-MaysPhase 1/Phase 2
Wake Forest University Health SciencesPhase 2

See all DANYELZA clinical trials

Pharmacology for DANYELZA
Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for DANYELZA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for DANYELZA Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for DANYELZA Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: DANYELZA

Introduction to DANYELZA

DANYELZA, developed by Y-mAbs Therapeutics, is a biologic drug approved by the U.S. FDA for the treatment of relapsed or refractory high-risk neuroblastoma in bone or bone marrow. This drug has been making significant strides in the market, driven by its efficacy and the company's strategic expansion plans.

Market Approval and Indications

DANYELZA is specifically designed for patients who have demonstrated a partial response, minor response, or stable disease with prior therapies. Neuroblastoma, the most common cancer in infants and the third most common cancer in children, presents a critical need for effective treatments, making DANYELZA a vital option[4].

Financial Performance: Q4 and Full Year 2023

Y-mAbs Therapeutics reported robust financial results for the fourth quarter and full year of 2023. DANYELZA net product sales for Q4 2023 were $23.4 million, representing a 42% year-over-year (YoY) increase. For the full year, net product revenues reached $84.3 million, a 71% increase from 2022[1][5].

Geographic Expansion

The company is expanding DANYELZA's geographic footprint, with plans to enter Brazil and Mexico in Q2 2024. This expansion is part of Y-mAbs' strategy to increase global access to the drug, further boosting its revenue potential[1].

Clinical Programs and Updates

Y-mAbs has provided positive updates on its clinical programs, particularly the SADA PRIT platform. The SADA PRIT clinical trials have shown promising results, with no dose-limiting toxicities observed. This platform, which targets CD38 for radiosensitive tumors, is a key area of focus for the company and is expected to enhance its therapeutic offerings[1][4].

Regulatory Milestones

A significant regulatory milestone was achieved with the conditional approval of DANYELZA in China, resulting in a $15 million payment from SciClone Pharmaceuticals. This approval opens up new markets and reinforces the drug's global potential[1].

Financial Outlook for 2024

Y-mAbs has a positive financial outlook for 2024. The company projects DANYELZA net product revenues to be between $95 million and $100 million. Operating expenses are expected to range between $115 million and $120 million, with a total annual cash burn anticipated to be between $15 million and $20 million. The company's cash reserves, currently at $78.6 million, are expected to support operations until 2027[1][5].

Q1 2024 Performance

In the first quarter of 2024, Y-mAbs reported an 11% increase in U.S. net product revenues for DANYELZA, reaching $18.6 million. However, global net product sales decreased by 4% due to lower international demand. Despite this, the company remains confident in meeting its full-year revenue guidance[4].

Cash Position and Operational Runway

As of March 31, 2024, Y-mAbs had approximately $75.7 million in cash and cash equivalents. This strong cash position is expected to fund operations into 2027, providing a stable financial foundation for the company's ongoing activities[2][4].

Collaboration and Licensing

Y-mAbs collaborates with renowned institutions such as Memorial Sloan Kettering Cancer Center (MSK), holding exclusive licenses for technologies developed by MSK researchers. These partnerships enhance the company's capabilities in advancing its therapeutic platforms and contribute to its innovative pipeline[2].

Competitive Landscape

Y-mAbs views competition as an opportunity to provide more treatment options to patients and physicians. The company is confident in its SADA approach, which targets CD38 for radiosensitive tumors, positioning DANYELZA as a unique and valuable treatment option in the market[1].

Operational Efficiency

The company has successfully decreased its operational expenses, with selling, general, and administrative expenses reduced to $11.4 million in Q1 2024. This efficiency is expected to contribute to the company's overall financial health and sustainability[4].

Challenges and Misses

Despite the strong performance, Y-mAbs faced some challenges, including a 4% decline in global net product sales in Q1 2024 due to lower international demand. Additionally, the company reported a net loss of $6.6 million for the quarter, although this was an improvement from previous periods[4].

Key Takeaways

  • Robust Sales Growth: DANYELZA net product sales increased by 42% in Q4 2023 and 71% for the full year, reaching $84.3 million.
  • Geographic Expansion: Plans to expand into Brazil and Mexico in Q2 2024.
  • Positive Clinical Updates: No dose-limiting toxicities observed in SADA PRIT clinical trials.
  • Regulatory Milestones: $15 million payment from SciClone Pharmaceuticals for DANYELZA's conditional approval in China.
  • Financial Outlook: Projected DANYELZA revenues between $95 million and $100 million for 2024.
  • Strong Cash Position: Cash reserves expected to support operations until 2027.

FAQs

What is DANYELZA used for?

DANYELZA is used for the treatment of relapsed or refractory high-risk neuroblastoma in bone or bone marrow for patients who have demonstrated a partial response, minor response, or stable disease with prior therapies.

How has DANYELZA performed financially in 2023?

DANYELZA net product sales for Q4 2023 were $23.4 million, a 42% YoY increase, and $84.3 million for the full year, a 71% increase from 2022.

What are Y-mAbs' plans for geographic expansion?

Y-mAbs plans to expand DANYELZA's geographic footprint to Brazil and Mexico in Q2 2024.

How is Y-mAbs' cash position?

As of March 31, 2024, Y-mAbs had approximately $75.7 million in cash and cash equivalents, expected to support operations until 2027.

What are the key clinical updates for DANYELZA?

The SADA PRIT clinical trials have shown promising results with no dose-limiting toxicities observed, targeting CD38 for radiosensitive tumors.

Sources

  1. Investing.com: Earnings call: Y-mAbs Therapeutics reports robust 2023 financials.
  2. Stocktitan.net: YMAB - Y-mAbs Therapeutics, Inc. Latest Stock News & Market.
  3. ResearchGate: Trends and Perspectives of Biological Drug Approvals by the FDA.
  4. Investing.com: Earnings call: Y-mAbs Therapeutics reports mixed Q1 results, growth in DANYELZA sales.
  5. Y-mAbs IR: Y-mAbs Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Corporate Developments.

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