Immunomedics' Veltuzumab Receives Orphan Drug Status

Immunomedics Inc. (IMMU) announced that the FDA has granted orphan drug status to its anti-CD20 antibody, veltuzumab, for the treatment of pemphigus.

We note that orphan drug designation is usually granted to novel drugs or biologics targeting rare diseases or conditions upon the request of a sponsor. This designation makes Immunomedics eligible for certain benefits for developing veltuzumab including tax credits on costs related to such studies and exemption from paying fees under the Prescription Drug User Fee Act (:PDUFA). Moreover, the status makes the drug eligible for seven years of marketing exclusivity in the U.S. following approval.

We are encouraged by the FDA granting orphan drug designation to veltuzumab. Immunomedics mentioned that in a compassion-use case study report, it was found that a pemphigus vulgaris patient refractory to multiple agents including Biogen (BIIB)/Roche’s (RHHBY) Rituxan was successfully treated with veltuzumab.

Presently, the two most advanced candidates at Immunomedics are epratuzumab and Y-clivatuzumab tetraxetan. While epratuzumab is being evaluated in two phase III studies for the treatment of systemic lupus erythematosus, Immunomedics commenced a phase III study on Y-clivatuzumab tetraxetan in January this year for the treatment of advanced pancreatic cancer. Immunomedics has a collaboration agreement with UCB (UCBJF) for epratuzumab.

Moreover, Immunomedics’ antibody-drug conjugates (ADCs) portfolio consists of IMMU-132 and IMMU-130 which are in phase II studies for solid tumors and metastatic colorectal cancer, respectively. Meanwhile, Immunomedics has several early- and mid-stage candidates in its pipeline, which are being evaluated for different types of cancer.

We expect investor focus to remain on pipeline updates from the company.

Immunomedics currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Biogen carrying a Zacks Rank #1 (Strong Buy).

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