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Shares of Iovance Biotherapeutics (NASDAQ:IOVA) dropped in the morning hours Friday after Goldman Sachs downgraded the clinical-stage biotech to Neutral from Buy, citing concerns about the company’s lead asset lifileucel.
The downgrade follows a ~17% gain in Iovance (IOVA) shares on Monday after the company director Wayne Rothbaum disclosed the acquisition of $65M worth of shares as an insider buy.
Goldman’s concerns on lifileucel are linked to the clinical, regulatory, financing, competitive, and commercial path for the cancer treatment in metastatic melanoma.
“While lifileucel has shown promising efficacy in post-PD-1 MM (for which the firm estimates $2.6B of peak risk-adjusted sales), we see the potential for multiple headwinds for the drug’s commercialization,” the analysts wrote, slashing the IOVA price target to $6 from $20 per share.
While highlighting the potential of lifileucel in post-PD-1/chemo cervical cancer and Iovance’s (IOVA) tumor-infiltrating lymphocyte therapy LN-145 in post-PD-1 non-small cell lung cancer, the analysts argue that these programs lack a clear catalyst path.
In November, Iovance (IOVA) announced a delayed timeline to complete its rolling submission for lifileucel in melanoma after the FDA requested additional information.