Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of human cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its lead proprietary drug candidate, CUDC-907 for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL).
"We are pleased to receive Orphan Drug Designation for CUDC-907 in DLBCL, which represents an area of significant unmet need, especially in the relapsed/ refractory setting," said Ali Fattaey, Ph.D., President and Chief Executive Officer of Curis. "We are continuing to treat DLBCL patients with CUDC-907 in the expansion stage of our Phase 1 study and anticipate initiating a Phase 2 trial in this indication in the second half of the year."
CUDC-907 is an oral, dual inhibitor of histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K) enzymes that is currently under investigation in Phase 1 clinical studies in patients with relapsed or refractory lymphomas or multiple myeloma as well as in patients with advanced/ relapsed solid tumors, including hormone receptor positive (HR+)/ HER2-negative breast cancer or midline carcinoma with certain NUT gene rearrangements.
The FDA's Orphan Drug Designation program grants orphan status to drugs and biologics that are intended for use in rare diseases/ or disorders, defined as those that affect fewer than 200,000 people in the U.S. or that affect more than 200,000 people in the U.S. where there is no reasonable expectation that the cost of developing and making the drug or biological product for the specific disease or condition will be recovered from sales in the U.S. Orphan drug designation may qualify the sponsor for financial incentives such as tax credits for qualified trials, the ability to apply for annual grant funding, clinical trial research design assistance and waiver of application fees associated with the approval of new drug under the Prescription Drug User Fee Act. In addition, if a product receives the first FDA approval for the indication for which it has orphan designation, the product is entitled to orphan drug exclusivity, which means the FDA may not approve any other application to market the same drug or biological product for the same indication for a period of 7 years, except in limited circumstances, such as a showing of clinical superiority over the product with orphan exclusivity or if the product with orphan exclusivity experiences a shortage. Orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process.
About Diffuse Large B-cell Lymphoma (DLBCL)
Non-Hodgkin lymphoma (NHL) is a clinically and pathologically heterogeneous group of lymphoproliferative malignancies that are predominantly of B-cell origin and have diverse patterns of behavior and responses to treatment. DLBCL is an aggressive form and the largest subtype of NHL, accounting for approximately 30% to 35% of all NHL diagnoses1,2. The American Cancer Society estimates that in 2015 there will be 71,850 new cases of NHL in the United States and 19,790 people will die of this disease3. In Europe, the estimated numbers of new cases of NHL and number of deaths due to the disease in 2012 was 93,400 and 37,900, respectively4.
1Crit Rev Oncol Hematol. 2013 Aug;87(2):146-71.
2Non-Hodgkin's Lymphoma Classification Project, 1997
3CA Cancer J Clin 2015;65:5-29
4European Journal of Cancer 49 (2013) 1374-1403 (Original Source)
Shares of Curis Inc. closed last Thursday at $2.35 . CRIS has a 1-year high of $3.50 and a 1-year low of $1.09. The stock's 50-day moving average is $2.93 and it's 200-day moving average is $1.83.
On the ratings front, Curis Inc. has been the subject of a number of recent research reports. In a report issued on January 28, Roth Capital analyst Joseph Pantginis reiterated a Buy rating on CRIS, with a price target of $6, which represents a potential upside of 155.3% from where the stock is currently trading. Separately, on January 21, Cowen's Boris Peaker reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joseph Pantginis and Boris Peaker have a total average return of 10.9% and 34.1% respectively. Pantginis has a success rate of 54.1% and is ranked #158 out of 3568 analysts, while Peaker has a success rate of 63.6% and is ranked #31.
Curis Inc is abiotechnology company engaged in developing and commercializing drug candidates for the treatment of human cancers. Its products includeCUDC-907,phosphatidylinositol-3-kinase andsmall molecule inhibitor of histone deacetylase.