Analysts at Berenberg Bank provided their views on bluebird bio, Inc. (NASDAQ:BLUE), which saw its stock decline more than 60% in the last 12 months, stating that they see significant hurdles ahead and limited upside to the stock, despite the company intending to bring three products to the U.S. market in the next two years.

Despite two BLA submissions for bluebird bio’s lead programs (eli-cel and beti-cel) having been completed, the analysts remain cautious regarding their approval and commercial prospects. While eli-cel is already approved in the EU, the company is still working to lift the clinical hold that the U.S. FDA placed in mid-2021 and awaits a potential approval in mid- 2022. While Beti-cel will likely become the first gene therapy for this indication approved in the U.S., the analysts believe regulatory uncertainties persist.

The brokerage views the sales potential of these two products, even if they are approved, as particularly limited.