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News Alert: Citius Pharmaceuticals Receives FDA Approval For LYMPHIR™ (Denileukin Diftitox-Cxdl) Immunotherapy For The Treatment Of Adults With Relapsed Or Refractory Cutaneous T-Cell Lymphoma. Click to Read More.

One area where speculators can continue to expect big things this cycle is in Biotech, where a number of major new deals and research projects are beginning to come to a head in more speculative names that have yet to fall into the embrace of big institutional hands.

We are going to look at a few such names today, including Athenex Inc (NASDAQ:ATNX), NUTRIBAND ORD (OTCMKTS:NTRB), and Crispr Therapeutics AG (NASDAQ: CRSP).

Athenex Inc (NASDAQ:ATNX) is a global clinical stage biopharmaceutical company dedicated to “becoming a leader in the discovery and development of next generation drugs for the treatment of cancer.”

Athenex is organized around three platforms, including an Oncology Innovation Platform, a Commercial Platform and a Global Supply Chain Platform.

The company recently announced that both Phase 3 studies, KX-AK-003 and KX-AK-004, had achieved their primary endpoint of 100% clearance of actinic keratosis (AK) lesions at Day 57 within the face or scalp treatment areas, with each study achieving statistical significance (p<0.0001). According to the release, “Statistical significance (p<0.001) was achieved for both face and scalp subgroups as well.”

Athenex’s Oncology Innovation Platform generates clinical candidates through an extensive understanding of kinases, including novel binding sites and human absorption biology, as well as through the application of Athenex’s proprietary research and selection processes in the lab. The Company’s current clinical pipeline is derived from two different platform technologies Athenex calls Orascovery and Src Kinase Inhibition.

The Orascovery platform is based on the novel oral P-glycoprotein pump inhibitor molecule HM30181A, through which Athenex is able to facilitate oral absorption of traditional cytotoxics, which Athenex believes may offer improved patient tolerability and efficacy as compared to IV administration of the same cytotoxics. The Orascovery platform was developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi. The Src Kinase Inhibition platform refers to novel small molecule compounds that have multiple mechanisms of action, including the inhibition of the activity of Src Kinase and the inhibition of tubulin polymerization during cell division.

Shares of the stock have been pulling back since a sharp spike higher from March to early June of this year that peaked at around $3/share. Since that peak, we have seen some distribution taking shares down to test key support at the stock’s 20-day simple moving average. We continue to monitor this stock for technical signals and further updates on its progress in these key twin phase 3 studies.


NUTRIBAND ORD (OTCMKTS:NTRB) is perhaps the most interesting name we see right now simply because the float is so small (under 2.5 million shares) and the company recently pushed to acquire a company that recently got some very good news from the FDA. In addition, the stock has been trading in an unambiguously rising trend on the chart, and is now pulling back to test the support outlined by that trend.

This transdermal patch name has recently signed a Letter of Intent to acquire 100% of Carmel Biosciences, a pharmaceutical company that addresses critical needs in new drug and liquid reformulation for cardiovascular and metabolic therapies.  Nutriband plans to complete the deal, valued at approximately $3.8 million, through payment of 450,000 restricted common shares of the Company’s stock.

As noted above, in December 2017, Carmel Biosciences received FDA approval for PREXXARTAN™, the first and only approved oral liquid dosage form of the angiotensin receptor blocker (ARB) valsartan in the United States.

“The Carmel Biosciences team combines a deep understanding of lipid biochemistry and clinical expertise in the cardiovascular and metabolic space,” stated Gareth Sheridan, CEO of Nutriband. “Carmel’s focus in the reformulation of drugs with a high degree of safety and efficacy allows improved access to patients who have difficulty swallowing tablets or capsules and provides enhanced usage of these widely acclaimed products.”

As noted above, the stock has been steadily trading in a rising trend over the past few months as volume starts to grow day by day. The stock has an extremely tight float – sitting at just a tiny 2.3 million shares. That can often augment the upward potential in a stock that starts to see new and growing interest. It’s very basic supply and demand economics as applied to the floating share market.

Crispr Therapeutics AG (NASDAQ:CRSP) is a gene editing company that focuses on developing transformative gene-based medicines for the treatment of serious human diseases using its regularly interspaced short palindromic repeats associated protein-9 (CRISPR/Cas9) gene-editing platform in Switzerland.

The company’s lead product candidate is CTX001, which targets sickle cell disease and beta-thalassemia with an ex vivo approach whereby cells are harvested from a patient, treated with a CRISPR/Cas9-based therapeutic and reintroduced into the patient.

The company is also developing CTX101, a donor-derived gene-edited allogeneic CAR-T therapy targeting CD19-positive malignancies. In addition, it is developing earlier stage allogeneic CAR-T programs targeting B-Cell maturation antigen and CD70; hemoglobinopathies to treat other diseases, including Hurler Syndrome and severe combined immunodeficiency disease; programs that are in preclinical development for indications, including glycogen storage disease 1-a and hemophilia; and programs targeting diseases of organ systems outside the liver, such as Duchenne muscular dystrophy and cystic fibrosis.

It has a collaboration agreement with Vertex Pharmaceuticals, Incorporated Vertex Pharmaceuticals (Europe) Limited to develop, manufacture, commercialize, sell, and use therapeutics. The company also has research collaboration agreements with Neon Therapeutics for developing neoantigen-based therapeutic vaccines and T cell therapies; and Massachusetts General Hospital Cancer Center to develop T cell therapies for cancer. CRISPR Therapeutics AG is headquartered in Zug, Switzerland.

CRSP shares have been pulling back to test some pretty important support zones on the chart in recent action. The key level to watch at this point is likely to be in the low 40’s as we home in a possible test of the 200-day simple moving average, which now intersects the chart at about $42/share.

Ultimately, the most important level will focused around the $40 area where the stock made an important pivot low inflection in early April before launching over 75% higher in a sharp two-month rally.