Shares of Immunomedics, Inc. (NASDAQ:IMMU) are up huge this morning after it was announced that the company has received FDA Breakthrough Therapy Designation for its investigational drug IMMU-132. The drug is designed for the treatment of individuals with triple-negative breast cancer (TNBC) whom have failed two or more previous therapies for metastatic disease. It was because of a successful Phase 2 study that the FDA decided to grant this much sought after designation.
“We believe Breakthrough Therapy Designation for IMMU-132 further validates this potential therapeutic for patients with TNBC, and we are delighted to receive this important recognition,” stated Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics, Inc.. “We continue to assess partnering opportunities while completing the scale-up manufacturing and regulatory activities for an international, randomized, controlled, registration trial in TNBC, based on the Special Protocol Assessment agreement that was already granted by the FDA. “IMMU-132 is also in Phase 2 trials in patients with advanced, heavily-pretreated, non-small-cell lung cancer, small-cell lung cancer, and urothelial cancers, where encouraging results have been observed. The Trop-2 receptor targeted by this antibody-drug conjugate has increased expression in a large number of solid cancers. To date, we have enrolled about 300 patients with diverse cancer types.”
The stock is up 33.51% or $0.61 following the news, hitting $2.43 per share. About 1.34 million shares traded hands or up 79.08% from the average. IMMU has declined 53.92% since July 1, 2015 and is currently downtrending. It has underperformed the S&P500 by 46.63%.
From a total of 2 analysts covering Immunomedics (NASDAQ:IMMU) stock, 0 rate it a “Buy”, 0 a “Sell”, and 2 a “Hold”. This means that 0 of the ratings are positive. Immunomedics was the topic of 2 analyst reports since July 29, 2015 according to the firm StockzIntelligence Inc. Wells Fargo downgraded shares on December 4 to a “Market Perform” rating.
The institutional sentiment decreased to 0.93 in Q2 2015. It’s down 0.46, from 1.39 in 2015Q2. The ratio dived, as 19 funds sold all their Immunomedics, Inc. shares they owned while 23 reduced their positions. 13 funds bought stakes while 26 increased their total positions. Institutions now own 50.39 million shares which is 25.38% more than the previous share count of 40.19 million in 2015Q2.
Longwood Capital Partners Llc holds 1.7% of its total portfolio in Immunomedics, Inc., equating to 1.71 million shares. J.P. Turner & Co Capital Mnagement Llc owns 4.29 million shares representing 0.14% of their total US portfolio. Moreover, Orbimed Advisors Llc has 0.06% of their total portfolio invested in the company, equating to 3.32 million shares. The Illinois-based Balyasny Asset Management Llc has a total of 0.03% of their portfolio invested in the stock. Krasney Financial Llc, a New Jersey-based fund reported 44,675 shares owned.
Immunomedics, Inc. is a clinical-stage biopharmaceutical firm developing monoclonal antibody products for the targeted treatment of cancer, autoimmune disorders and other serious diseases. The company has a market cap of $230.21 million. The Company’s technologies allow it to create humanized antibodies in unlabeled or naked form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins. It currently has negative earnings. The Company’s product candidates include 90Y-clivatuzumab tetraxetan.