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Make Or Break Year Awaits VTVT, It's Advantage MRUS Now, INSY Marches On

Dec28 up 122817

The following are some of today's top gainers in the pharma/biotech sector.

1. vTv Therapeutics Inc. (VTVT)

Gained 37.28% to close Thursday's (Dec.28) trading at $5.56.

News: A SEC filing dated December 27, 2017, reveals that billionaire financier Ronald Perelman purchased 50,000 shares of vTv Therapeutic at a price of $4.03 each.

Recent events:

On December 21, 2017, the Company licensed HPP593, its drug candidate that is to begin a phase II trial for the prevention of muscle weakness associated with prolonged mechanical ventilation (PMV) and critical injury, to privately-held Reneo Pharmaceuticals.

The same day, (Dec.21, 2017), the Company also licensed its GLP-1r Agonist Diabetes Program in China and Other Pacific Rim Territories to Hangzhou Zhongmei Huadong Pharmaceutical Co. The licensing agreement includes rights to TTP273, an oral small molecule GLP-1R agonist, which met its primary endpoint and demonstrated a statistically significant reduction in HbA1c in a Phase 2 trial of type 2 diabetes.

Clinical Trials & Near-term Catalysts:

-- The Company's lead product candidate is Azeliragon, under phase III trial in patients with mild Alzheimer's disease, dubbed STEADFAST.

The STEADFAST trial has 2 parts - Part A and Part B. Part A enrolled patients in the United States and Canada. Part B included study sites in the United Kingdom, Ireland, Australia, New Zealand and South Africa.

Top-line results from Part A of the study are expected to be reported in early 2018 and that from Part B in late 2018.

-- A phase 1b/2 study of TTP399 in adult patients with type 1 diabetes, dubbed simplici-T1, was initiated last month.

2. Digirad Corp. (DRAD)

Gained 37.28% to close Thursday's (Dec.28) trading at $5.56.

News: The Company announced the sale of its Medical Device Sales and Service business unit service contracts to Philips North America. The transaction is expected to close on January 31, 2018.

Recent event:

-- On November 3, 2017, the Company reported Q3, 2017 financial results and updated 2017 financial guidance.

For fiscal 2017, the Company expects to generate revenues of approximately $115 to $120 million, and adjusted net income per share of between $0.08 and $0.10. In fiscal 2016, the Company had reported revenue of $125.5 million and adjusted net income per share of $0.36.

3. Cellular Biomedicine Group Inc. (CBMG)

Gained 10.10% to close Thursday's trading at $5.56.

News: The Company announced the closing of $14.5 million private placement offering.

The offering involved two private placement transactions pursuant to which an aggregate of 1.2 million shares of the Company's common stock, par value $0.001 per share, were sold to selected key executives and private investors at $12.00 per share, for total aggregate gross proceeds of approximately $14.5 Million.

Cellular Biomedicine is a clinical-stage biopharmaceutical firm engaged in the development of immunotherapies for cancer and stem cell therapies for degenerative diseases.


The Company currently has ongoing CAR-T Phase I clinical trials in China; CARD-1 for Diffuse Large B-cell Lymphoma (DLBCL) and Non-Hodgkin Lymphoma (NHL), CALL-1 for adult Acute Lymphoblastic Leukemia (ALL), and a phase I trial in China for AlloJoin (CBMG's "Off-the-Shelf" Allogeneic Human Adipose-derived Mesenchymal Stem Cell) for the treatment of Knee Osteoarthritis.

Near-term catalysts:

-- Top line data readout from phase I clinical trials for CARD-1 and CALL-1 Chimeric Antigen Receptor (CAR) T-cell treatment for Diffuse Large B-Cell Lymphoma (DLBCL) and Acute Lymphoblastic Leukemia (ALL) in the first half of 2018.
-- Final data readout from AlloJoin phase I clinical trial for off-the-shelf Knee Osteoarthritis (KOA) therapy in China in the first half of 2018.

4. INSYS Therapeutics Inc. (INSY)

Gained 10.94% to close Thursday's trading at $8.62.

News: No news

Recent event:

On December 26, 2017, the Company's cannabidiol (CBD) oral solution secured FDA's Fast Track designation for the treatment of Prader-Willi syndrome.

Prader-Willi syndrome is a rare and complex genetic disorder characterized by insatiable appetite in children that often leads to obesity and type 2 diabetes.

Cannabidiol (CBD) oral solution for Prader-Willi syndrome is under pre-clinical testing, and the Company plans to start the clinical development program in this indication in late first quarter of 2018.

Clinical Trials & Near-term Catalysts:

-- The Company's New Drug Application for Buprenorphine Sublingual Spray for the management of moderate-to-severe acute pain is under FDA review - with a decision expected on July 28, 2018.
-- A phase I proof-of-concept study of two formulations of epinephrine nasal spray for the treatment of anaphylaxis, or severe allergic reaction, commenced early this month. Initial results from this study are expected to be available in February.
Enrollment in the study is estimated to be complete in the first quarter of 2018.
-- On December 19, 2017, the Company announced the initiation of a phase II trial of Cannabidiol (CBD) oral solution for the treatment of refractory childhood absence epilepsy in pediatric patients. This study is expected to be completed in late 2018.

5. Axsome Therapeutics Inc. (AXSM)

Gained 9.62% to close Thursday's trading at $5.70.

News: No news

Axsome has two clinical compounds namely, AXS-05 and AXS-02.

Clinical Trials:

-- AXS-05 is currently in a phase III trial for the treatment of treatment-resistant depression, dubbed STRIDE-1, and a phase II/III trial for the treatment of agitation in patients with Alzheimer's disease. A phase II trial of AXS-05 in Smoking Cessation is expected to be initiated in the first quarter of 2018.
-- AXS-02 is currently in a phase III trial in complex regional pain syndrome, dubbed CREATE, and a phase III trial in knee osteoarthritis associated with bone marrow lesions, known as COAST-1.

Near-term Catalysts:

-- The *interim analysis for CREATE-1 and COAST-1 trials will be conducted by an independent data monitoring committee, and results of the analyses are expected to be available by late December 2017 to early January 2018.

*An interim analysis helps to evaluate the trial's success probability while controlling the overall error rates. (Source: Science Direct).

-- Top-line data from the phase III STRIDE-1 trial of AXS-05 are expected in the first half of 2018.

6. Marinus Pharmaceuticals Inc. (MRNS)

Gained 8.89% to close Thursday's trading at $8.70.

Recent event:

The Company's addition to the NASDAQ Biotechnology Index became become effective on Dec.18, 2017.

Please visit our Company Spotlight column to know more about MRNS.

7. Merus N.V. (MRUS)

Gained 8.75% to close Thursday's trading at $16.65.

News: The U.S. Court of Appeals for the federal Circuit has granted a favorable ruling for the Company in its legal fight with Regeneron Pharmaceutical Inc. (REGN) related to a patent entitled "Methods of Modifying Eukaryotic Cells."

The Appeals Court has denied Regeneron's request for a rehearing the panel's decision affirming Merus' inequitable conduct claim against Regeneron.

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