| Ticker | Status | Jurisdiction | Filing Date | CP Start | CP End | CP Loss | Deadline |
|---|
| Ticker | Case Name | Status | CP Start | CP End | Deadline | Settlement Amt |
|---|
| Ticker | Name | Date | Analyst Firm | Up/Down | Target ($) | Rating Change | Rating Current |
|---|
Piper Sandler downgraded Iovance Biotherapeutics Inc (NASDAQ:IOVA), citing the slow launch of Amtagvi (lifileucel), a prescription medicine used to treat adults with a type of skin cancer that cannot be removed surgically or has spread to other parts of the body called unresectable or metastatic melanoma.
The FDA approved the one-time, individualized T-cell therapy in February.
Amtagvi is made from surgically removed tumor. Tumor-derived T cells are grown in a manufacturing center.
Tumor tissue is sent to a manufacturing center to make Amtagvi. It takes about 34 days from the time tumor tissue is received at the manufacturing center until Amtagvi is available to be shipped back to the healthcare provider, but the time may vary.
Piper Sandler spoke with six authorized treatment centers (ATCs) to gauge the early utilization of Amtagvi.
Despite the demand for Amtagvi based on the number of enrolled patients, initial metrics point to very few patients infused in the second quarter of 2024.
While the 6 ATCs had “enrolled” 43 patients, they had only infused 5-6 patients (13% infusion rate in 2Q24).
The challenges largely seem to stem from extended treatment timelines, with potentially a six-week wait to obtain a manufacturing slot. ATCs view this as a major issue for a patient population with progressive disease.
Piper Sandler has now lowered the estimate of $12 million for Amtagvi revenues for the second quarter (vs. consensus of $24 million) and trimmed the fiscal year 2024 Amtagvi revenue estimates to $84 million (vs. consensus of $131 million).
The analyst downgraded Iovance from Overweight to Neutral and cut the price target from $19 to $10.
In June, Iovance Biotherapeutics submitted a marketing authorization application to the European Medicines Agency for lifileucel for unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
Price Action: IOVA stock is down 2.83% at $8.98 at last check Monday.
Photo via Shutterstock
Read Next:
Posted In: IOVA
