Comeback For Juno (JUNO) Stock? FDA Lifts Clinical Hold

Is immuno-oncology focused Juno Therapeutics, Inc. (NASDAQ:JUNO) , set for a comeback? The company, which saw its shares falling 31.9% last week, looks poised for a recovery with the FDA removing the clinical hold on its pivotal phase II study (ROCKET) on JCAR015.

Why Was ROCKET on Clinical Hold?

The FDA had placed the ROCKET study on clinical hold last week after two patients died within a week due to severe neurotoxicity following the recent addition of fludarabine to the pre-conditioning regimen (Read more: Juno Suffers Setback, Pivotal Study on Clinical Hold).

Juno had proposed the continuation of the study using JCAR015 with cyclophosphamide pre-conditioning alone. The study is being conducted in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL).

Shares Up in After-Hours Trading

Juno’s shares were up 24.2% in after-hours trading following the company’s announcement that the FDA has lifted the clinical hold on the study which will continue under a revised protocol – the study will continue enrollment using JCAR015 with cyclophosphamide pre-conditioning alone.

JUNO THERAPEUTC Price

JUNO THERAPEUTC Price | JUNO THERAPEUTC Quote

While the lifting of the clinical hold is a huge boost for the stock, investors will have to wait for the company’s earnings call to get more details on expected regulatory filing timelines for the candidate. Juno was earlier looking to gain accelerated FDA approval in 2017 but timelines were pushed back with the clinical hold being announced. However, now that the study has resumed, we await more clarity on the company’s plans for filing for approval.

Meanwhile, the lifting of the clinical hold has boosted the stock of other immuno-oncology focused companies like Kite Pharma, Inc. (NASDAQ:KITE) and bluebird bio, Inc. (NASDAQ:BLUE) as well, which were up in after-hours trading.

Juno is a Zacks Rank #4 (Sell) stock. Merrimack Pharmaceuticals, Inc. (NASDAQ:MACK) is a better-ranked stock in the healthcare sector with a Zacks Rank #1 (Strong Buy).