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FDA Lifts Clinical Hold on Bellicum’s (BLCM) T Cell Therapy


Bellicum Pharmaceuticals, Inc.’s BLCM announced that FDA has lifted clinical hold on studies conducted in the United States evaluating its T cell therapy, BPX-501. The company consulted with regulatory body and agreed to make amendments to the study protocols, which include guidance on monitoring and management of neurologic adverse events.

Shares of the company have rallied more than 25% in the after-market hours on Apr 11, following the announcement. However, Bellicum’s shares fell 18.6% so far this year, compared with the industry’s decline of 2.4%.

The FDA placed the studies on clinical hold on Jan 30, 2018, after three cases of encephalopathy (brain disease, damage, or malfunction) were reported. Treatment with BPX-501 was held as the possible reason for the adverse events.

Bellicum will resume patient enrolment in the studies after implementing the amended protocols in the clinical study sites.

BPX-501 is being developed as an adjunct T cell therapy for the treatment of patients with hematologic cancers and inherited blood diseases, who have undergone haploidentical (partial match) hematopoietic stem cell transplant.

However, Bellicum claims the clinical hold did not have any impact on the ongoing registrational study, BP-004, in Europe, which was evaluating BPX-501 in pediatric patients with acute myeloid leukemia (AML) and primary immunodeficiencies. Per interim data announced in March, BPX-501 has demonstrated anti-leukemic effect in patients with AML in the study.

Apart from BPX-501, Bellicum is developing a CAR-T candidate, the most advanced form of treating cancer which cures by strengthening the body’s immune system.

Zacks Rank & Stocks to Consider

Bellicum carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the pharma sector include Protagonist Therapeutics, Inc. PTGX, Ligand Pharmaceuticals Incorporated LGND and Catabasis Pharmaceuticals, Inc. CATB. While Protagonist and Ligand sport a Zacks Rank #1 (Strong Buy), Catabasis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Protagonist’s loss estimates narrowed from $1.30 to 66 cents for 2018 and from $1.99 to $1.26 for 2019, in the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 24.95%.

Ligand’s earnings per share estimates have moved up from $3.78 to $4.20 and from $4.75 to $5.32 for 2018 and 2019, respectively, over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 24.88%. The company’s shares have rallied 20.7% so far this year.

Catabasis’ loss estimates narrowed from $1.09 to 92 cents for 2018 and from $1.76 to $1.48 for 2019, in the last 30 days. The company came up with a positive earnings surprise in all the preceding four quarters, with an average beat of 14.56%. The stock has rallied 20.2% so far this year.

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