Immunomedics' IMMU-132 Gets Orphan Drug Status - Analyst Blog

Immunomedics, Inc. IMMU announced that the FDA has granted orphan drug status to its oncology candidate, IMMU-132, for the treatment of pancreatic cancer.

Orphan drug designation is usually granted to novel drugs or biologics targeting rare diseases or conditions that affect less than 0.2 million patients in the U.S. Under this status, the company developing the orphan drug enjoys a seven-year period of marketing exclusivity, receives assistance on studies conducted on the candidate and tax credits on costs related to such studies. In addition, the company can apply for annual grant funding and is exempted from paying fees under the Prescription Drug User Fee Act.

Last month, the company had reported encouraging data from an ongoing phase I/II study on IMMU-132. In the study, IMMU-132 showed a median time-to-progression of 12.7 weeks in patients with advanced pancreatic cancer who failed one to five prior therapies. The median time-to-progression associated with IMMU-132 was impressive considering an estimated median of 8.0 weeks on the most recent therapy prior to IMMU-132.

We note that IMMU-132 also has orphan drug status in the U.S. for the treatment of patients with small-cell lung cancer. Apart from pancreatic and small-cell lung cancer, Immunomedics is evaluating IMMU-132 for other oncology indications including triple-negative breast cancer (phase I/II study) and colorectal cancer (phase I/II study).

Immunomedics carries a Zacks Rank #3 (Hold). Some better-ranked biotech stocks include Gilead Sciences Inc. GILD, Regeneron Pharmaceuticals, Inc. REGN and Alexion Pharmaceuticals, Inc. ALXN. While Gilead and Regeneron are Zacks Rank #1 (Strong Buy) stocks, Alexion holds a Zacks Rank #2 (Buy).