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Harpoon's (HARP) Multiple Myeloma Candidate Gets Orphan Drug Tag

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Zacks Equity Research
·2 min read
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Harpoon Therapeutics, Inc. HARP announced that the FDA has granted Orphan Drug designation toHPN217 for the treatment of multiple myeloma. 

Notably, the Orphan Drug designation is granted to drugs that are capable of treating rare diseases that affect less than 200,000 people in the United States. This tag also makes the company entitled to certain other benefits, including tax credits related to clinical trial expenses, an exemption from the FDA user fee and seven-year marketing exclusivity following approval.

Shares of the company have surged 44.2% in the past year against the industry’s decline of 2.6%.

HPN217, a tri-specific T cell activating recombinant protein construct (TriTAC), targets B-cell maturation antigen (BCMA), a well-validated antigen expressed on malignant multiple myeloma cells. The candidate is in a phase I/II dose-escalation study for the potential treatment of relapsed/refractory multiple myeloma (RRMM). It expects to present interim data from the study later in 2021.

There are many other companies developing candidates for the treatment of RRMM. In December 2020, Johnson & Johnson JNJ initiated the rolling submission of its biologics license application (BLA) to the FDA for its BCMA CAR-T therapy, ciltacabtagene autoleucel (cilta-cel), being developed for the treatment of adult patients with RRMM.

bluebird bio BLUE and Bristol Myers’ BMY investigational BCMA-directed CAR-T therapy, idecabtagene vicleucel (ide-cel), has also been developed for RRMM. The The FDA has set an action date of Mar 27, 2021 for the candidate.

Harpoon currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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Johnson & Johnson (JNJ) : Free Stock Analysis Report
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