Cathie Wood-led Ark Investment Management is betting that despite recent setbacks Iovance Biotherapeutics Inc IOVA 3.73% will benefit from its compelling tumor-infiltrating lymphocyte (TIL) immunotherapy.
What Happened: IOVA shares have declined 32% since Tuesday after the California-based biotech startup delayedits Biologics License Application (BLA) until the first half of 2022 because of FDA feedback on its potency tests.
The delay in the program is attributed to the FDA’s second request for additional data regarding potency assays, which are a series of tests that prove the company can consistently manufacture the product in question.
Soon after, IOVA announced CEO Maria Fardis is leaving the company after five years in the role and that General Counsel Frederick Vogt would be stepping in as interim CEO. Shares fell 39% on Wednesday after the announcement.
The New York-based investment firm started piling up shares in the company last week and holds 18.26 million IOVA shares, worth about $450.64 million, according to Ark’s data as of Friday’s trade.
The Ark Genomic Revolution ETF (BATS:ARKG) and theArk Innovation ETF ARKK 0.75% carry the stake in IOVA.
“We believe that Iovance’s TILs will continue to be the most compelling therapy for solid tumors in the market and that Iovance has the most robust TIL data set,” the Cathie Wood-led firm said in a note to investors.
“Furthermore, in our view, Iovance is trail-blazing the FDA regulatory process and likely will get FDA approval for its TIL therapy to treat melanoma, a very difficult-to-treat disease with high unmet need.”
Price Action: IOVA shares closed 3.73% lower at $18.05 on Friday.