Join My Distribution List - Get My Articles Emailed To Your Inbox - FREE!!

Thursday, November 26, 2015

Update From InVivo Should Help Investors Return To The Story

InVivo Therapeutics (NVIV) has been stuck in a narrow  trading range between $7 and $8 per share since September, putting a much-needed floor in the stock that traded as high as $17 over the summer. Despite what remains encouraging news from the company over the past few months, investors have fled the story based on a new disclosure policy with respect to the ongoing pilot study and poor visibility on just what will be necessary to gain approval for the Neuro-Spinal Scaffold (NSS) device. Next week, on December 3, 2015, the company will host an "Analyst & Investor Day" in New York City at the Palace Hotel. An update from the pilot study and improved visibility provided by management on the pivotal registration program may be just what investors need to return to the story.

Monday, November 23, 2015

Can-Fite Advances CF102 Into NASH Market

On November 23, 2015, Can-Fite BioPharma (NYSEMKT:CANF) announced development of CF102 will be expanded into non-alcoholic steatohepatitis (NASH) based on compelling preclinical data.  The drug is currently being investigated in a Phase 2 program for hepatocellular carcinoma (HCC), the most common form of liver cancer, an indication for which the drug has granted both Orphan Drug designation and Fast Track development status. Can-Fite has filed a method-of-use patent for CF102 in the treatment NASH and expects to begin initial human clinical studies under the current active Investigational New Drug (IND) application in 2016.

I was able to obtain from management some additional information about the "compelling" preclinical data cited in the company's press release. Below are the data from the preclinical study, along with some background information on CF102 and the NASH market.

Thursday, November 19, 2015

Immune Making Progress, Despite Share Price Declines

Immune Pharmaceuticals (NASDAQ:IMNP) has released some positive news over the past few weeks, but you would not know that based on the stock price. Immune shares are down 64% over the past year despite what is meaningful progress on the pipeline. Below I highlight the recent progress and provide a brief update on the story following some recent developments.

Wednesday, November 18, 2015

Bekinda™ Development Continues In Phase 3 Gastroenteritis Study; Expands to IBS-D

Please see the BioNap, Inc. Disclaimer

I am continuing my analysis of RedHill Biopharma Ltd (RDHL), a specialty biopharmaceutical company with several orally-administered drug candidates in late-stage clinical development for the treatment of various gastrointestinal and inflammatory diseases. The company is highly intriguing to me because of the depth of their pipeline in GI disorders with unmet medical needs, including inflammatory bowel disease and gastroenteritis, and the strength of the balance sheet relative to the current market capitalization. Specifically, the company exited September 2015 with $64 million in cash and investments, representing almost 40% of the total market value. The product pipeline includes three Phase 3 assets, several Phase 2 assets, an interesting mid-stage oncology pipeline, another mid-stage asset at partner Salix Pharmaceuticals, and one approved drug in Europe.

RedHill's clinical-stage pipeline (shown below) is impressive. I encourage investors to view my previous work on the company, which covers Phase 3 RHB-104 for the treatment of Crohn's Disease >> HERE << and Phase 3 RHB-105 for the treatment of H. pylori infection >> HERE <<.

Monday, November 16, 2015

Actinium Pharmaceuticals: An Impressive Platform Targeting Leukemia

Acute Leukemia - A Quick Overview

Leukemias are cancers of the blood and involve bone marrow, circulating white blood cells, and organs such as the spleen and lymph nodes. The cancer usually manifests in the bone marrow and results in a high number of abnormal white blood cells called blasts (also called leukemia cells). The presence of these immature (not fully developed) blast cells can lead to a number of physiological symptoms such as bleeding, bruising, anemia, fatigue, and an increased risk of infection. The symptoms get worse as the number of blast cells increase and subsequently reduce the number of healthy normal blood cells through a crowding out effect.