Seres Therapeutics, Inc. MCRB announced that its lead candidate, SER-109, received orphan drug status from the FDA for the prevention of recurrent Clostridium difficile infection (CDI) in adults. The company’s shares were up 3.2% following the announcement.

We note that the FDA usually grants orphan drug status to novel candidates or biologics being developed for the treatment, diagnosis or prevention of rare diseases/conditions that affect less than 200,000 people in the U.S., and which are not expected to recover the expenses related to its development and commercialization in the U.S. This designation allows the product to enjoy a seven-year period of marketing exclusivity in the U.S., upon approval.

Additionally, Seres is now eligible to receive tax credits for the research and development costs incurred in the U.S. as well as to be exempt from FDA application user fees.

Currently, efficacy and safety of SER-109 is being evaluated in a multi-center, randomized, placebo-controlled phase II study for the prevention of recurrent CDI. The primary outcome of the study will measure the absence of CDI through eight weeks following treatment with SER-109 versus placebo. Results should be out by mid-2016. SER-109 also enjoys Breakthrough Therapy status in the U.S.

According to the company, CDI is considered one of the top-three most-urgent antibiotic-resistant bacterial threats by the U.S. Centers for Disease Control and is the leading cause of hospital-acquired infection in the U.S. Roughly, 29,000 patients in America die from the disease every year. On an annual basis, 85,000 – 110,000 patients in the U.S. suffer from recurrent CDI.

The receipt of orphan status for SER-109 is not only an important event for Seres, but it also marks the first microbiome candidate to achieve it.

Seres carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Gilead Sciences Inc. GILD and Regeneron Pharmaceuticals, Inc. REGN and Actelion Ltd. ALIOF. While Gilead and Regeneron carry a Zacks Rank #1 (Strong Buy), Actelion carries a Zacks Rank #2 (Buy).

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
REGENERON PHARM (REGN): Free Stock Analysis Report
 
GILEAD SCIENCES (GILD): Free Stock Analysis Report
 
ACTELION LTD (ALIOF): Free Stock Analysis Report
 
SERES THERAPEUT (MCRB): Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research