Fidanacogene elaparvovec is a Gene Therapy owned by Pfizer, and is involved in 5 clinical trials, of which 2 were completed, and 3 are ongoing.

Fidanacogene elaparvovec (SPK-9001; PF-06838435) acts as factor IX activator. The therapeutic candidate delivers the functional copy of human factor IX gene in an engineered adeno-associated virus vector (AAV8-hFIX19 vector) to liver cells. It increases the concentration of factor IX in blood and aids in the treatment of hemophilia B.

The revenue for Fidanacogene elaparvovec is expected to reach a total of $4.5bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Fidanacogene elaparvovec NPV Report.

Fidanacogene elaparvovec was originated by Children’s Hospital of Philadelphia and is currently owned by Pfizer.

Fidanacogene elaparvovec Overview

Fidanacogene elaparvovec (SPK-9001, PF-06838435) is under development for the treatment of hemophilia B. The therapeutic candidate is administered by intravenous route as a solution. The therapeutic candidate uses an engineered adeno-associated virus to deliver the human FIX gene (AAV8-hFIX19 vector) to liver cells, where FIX is normally made. It is a new molecular entity.

Pfizer Overview

Pfizer discovers, develops, manufactures and commercializes biopharmaceuticals. The company offers products to treat various conditions such as cardiovascular, metabolic and pain, cancer, inflammation, immune disorders and rare diseases. It also provides sterile injectable pharmaceuticals, biosimilars, active pharmaceutical ingredients (APIs) and contract manufacturing services. Pfizer sells its products through wholesalers, retailers, hospitals, clinics, government agencies and pharmacies. It has major manufacturing facilities in India, China, Japan, Ireland, Italy, Belgium, Germany, Singapore, and the US. The company provides its products in North America, South America, Asia-Pacific, Australia, Europe, Africa and the Middle East. Pfizer is headquartered in New York, the US.

The company reported revenues of (US Dollars) US$81,288 million for the fiscal year ended December 2021 (FY2021), an increase of 95.2% over FY2020. In FY2021, the company’s operating margin was 29.1%, compared to an operating margin of 18.8% in FY2020. In FY2021, the company recorded a net margin of 27%, compared to a net margin of 22% in FY2020.

Quick View – Fidanacogene elaparvovec

Report Segments
  • Innovator
Drug Name
  • Fidanacogene elaparvovec
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Hematological Disorders
Key Companies
Highest Development Stage
  • Phase III

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.