Advaxis, Inc. (ADXS) Stock is Up Big After FDA Lifts Clinical Hold on Their Drugs & Europe Gives Orphan Drug Status


Advaxis, Inc. (NASDAQ:ADXS) shares are soaring in early morning trading, upon two positive updates from the company. One update came early yesterday as it was announced that the European Union has granted the company’s axalimogene filolisbac drug “Orphan” status. Then, early this morning the company announced that the US FDA has lifted a previous “clinical hold” tha was applied to their investigational New Drug (ND) application for three of their drugs, including the aforementioned axalimogene filolisbac, as well as ADXS-PSA and ADXS-HER2.

This means that Advaxis, Inc. (NASDAQ:ADXS) can now continue with their clinical trials for all three of these potential cancer treatments.

“We appreciate the FDA’s review of this matter. We are grateful that our clinical trials will now resume so that we may continue investigating new treatments for unmet medical needs. We thank both the patients and their physicians for their participation in our clinical trials,” said Daniel J. O’Connor, President and Chief Executive Officer of Advaxis.

The stock is up 28.91% or $2.4 following the news, hitting $10.7 per share. About 432,578 shares traded hands. ADXS has declined 56.20% since May 13, 2015 and is downtrending. It has underperformed the S&P500 by 52.52%.

From a total of 2 analysts covering Advaxis (NASDAQ:ADXS) stock, 2 rate it a “Buy”, 0 a “Sell”, and 0 a “Hold”. This means that 100% of the ratings are positive. The highest target price is $40 while the lowest target price is $30.0. The mean of all analyst targets is $35 which is 227.10% above today’s ($10.7) stock price. Advaxis was the topic of 2 analyst reports since September 11, 2015 according to the firm StockzIntelligence Inc. Barclays Capital initiated shares on September 22 with a “Overweight” rating.

The institutional sentiment decreased to 2 in Q2 2015. It’s down 0.79, from 2.79 in 2015Q2. The ratio worsened, as 16 funds sold all their Advaxis, Inc. shares they owned while 18 reduced their positions. 31 funds bought stakes while 37 increased their total positions. Institutions now own 32.44 million shares which is 53.71% more than the previous share count of 21.10 million in 2015Q2.

Cormorant Asset Management Llc holds 1.31% of its total portfolio in Advaxis, Inc., equating to 800,000 shares. Knoll Capital Management Lp owns 275,000 shares representing 1.19% of their total US portfolio. Moreover, Broadfin Capital Llc has 0.99% of their total portfolio invested in the company, equating to 1.74 million shares. The Quebec – Canada-based Sectoral Asset Management Inc has a total of 0.59% of their portfolio invested in the stock. Birchview Capital Lp, a Vermont-based fund reported 35,600 shares owned.

Since August 4, 2015, the stock had 1 buying transaction, and 4 selling transactions for a total of $3.60 million in net activity. Mayes – Gregory T. sold 19,231 shares worth $223,657. Mauro David J sold 24,586 shares worth $247,827. Adage Capital Partners Gp Llc bought 300,000 shares worth $4.25M. O’connor Daniel sold 8,449 shares worth $130,453. The insider Petit Robert sold 2,943 shares worth $45,440.

Advaxis, Inc. is a United States-based clinical-stage biotechnology company. The company has a market cap of $357.01 million. The Firm is focused on developing various cancer immunotherapies that use the body’s natural immune system to redirect the immune response to kill cancer. It currently has negative earnings. The Company’s Lm Technology is a cancer immunotherapy agent shown in preclinical studies to both generate cancer fighting T-cells directed against a cancer antigen, and neutralizes regulatory T cells and myeloid-derived suppressor cells that protect the tumor microenvironment from immunologic attack and contribute to tumor growth.