Immune Design Corp (NASDAQ:IMDZ)
Immune Design Corp (NASDAQ:IMDZ) shares fell 16% after the clinical stage company announced that the European Medicine Agency had granted its immunotherapy, G100, for non-Hodgkin’s lymphoma Orphan Drug Designation. The EMA designation is normally assigned to products targeting the treatment of rare medical conditions with prevalence of not more than 5 in 10,000 people.
The designation accords Immune Design Corp (NASDAQ:IMDZ) a string of benefits not limited to reduced fees for regulatory activities. The company also stands to enjoy protocol assistance when it comes to clinical trials. In addition, the clinical stage immunotherapy company will be granted 10 years of market exclusivity upon approval by regulators in the Union.
The company’s lead drug for the treatment of non-Hodgkin’s lymphoma has also been granted Orphan Drug Designation in the U.S by the Food and Drug Administration. Developed from Immune Design Corp (NASDAQ:IMDZ)’s GLAAS discovery platform, the candidate product is designed to activate innate and adaptive immunity in the tumor microenvironment.
IMDZ Stock Performance
Immune Design Corp (NASDAQ:IMDZ) free fall in the market shows no signs of slowing down as the stock has shed more than 40% in market value since the start of the month. The stock is currently trading at levels last seen at the start of the year.
Declining investor’s sentiments on the stock follows reports that the company plans to initiate a Phase 3 study of cancer vaccine candidate CMB305 in NY-ESO-1. The timing of the study, slated for mid-2018, appears to have spooked investors. The stock has also been downgraded by analysts at Wells Fargo to a ‘Neutral’ – seen as another cause for alarm among investors.
Immune Design Pipeline
CMB305 is one of Immune Design primary candidates currently in multiple clinical trials in patients with soft tissue sarcoma. The product is being investigated as a monotherapy and in combination with Roche Holding Ltd. (ADR) (OTCMKTS:RHHBY)’s RHHBY Tecentriq.
“The trial will have progression-free survival (PFS) followed by overall survival (OS) as co-primary endpoints. If the PFS endpoint is successful, the FDA offered that it may support full approval of CMB305. Depending on the rate of events, final PFS analysis may occur as early as 24 months from the first patient dosed,” Immune Design in a statement.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Monica has an undergraduate degree in Accounting and an MBA she earned – with Honors. She has six years of experience in the financial markets and has been an analyst for the past two years.