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HAIR Grows, OMED Up 45% In 2 Days, AXSM Braces For Busy Q4

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

1. vTv Therapeutics Inc. (VTVT)

Gained 28.42% to close Wednesday's (Oct.17) trading at $3.66.

News: No news

Pipeline:

-- A Phase I/II study of TTP399 as an add-on to insulin therapy in patients with type 1 diabetes, dubbed SimplicT-1, is underway. TTP399 has previously demonstrated statistically significant reductions in HbA1c levels in the AGATA Study, a phase 2 study in type 2 diabetes.
-- In June of this year, the Company announced disappointing results from Part B of STEADFAST Study. The results from Part A of the STEADFAST study, announced in April 2018, were also disappointing.

The STEADFAST is a phase III trial that evaluated Azeliragon in patients with mild Alzheimer's disease. The STEADFAST trial had 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.

Cash position:

At June 30, 2018, the Company had cash of $1.2 million.

2. Restoration Robotics Inc. (HAIR)

Restoration Robotics is a medical device company developing and commercializing ARTAS and ARTAS iX Robotic Hair Restoration Systems.

Gained 21.11% to close Wednesday's trading at $2.18.

News: The Company announced results from a real-world evaluation study of the new ARTAS iX Robotic Hair Restoration System demonstrating clinical efficiency in hair harvesting and implantation.

According to the Company, the results suggest that the robotic, image-guided ARTAS iX System provides a practical alternative to manual *FUE procedures, whose limitations include human fatigue, pain and discomfort associated with long, repetitive procedures and capricious human vision that can potentially lead to human error during manual hair transplant procedures.

*Manual FUE (Follicular Unit Extraction) is a widely-used and clinically proven technique of hair transplantation.

3. OncoMed Pharmaceuticals Inc. (OMED)

OncoMed is a clinical-stage biopharmaceutical company focused on developing novel anti-cancer therapeutics.

Gained 20.52% to close Wednesday's trading at $2.76.

News: No news

Pipeline:

-- Navicixizumab in combination with paclitaxel for the treatment of heavily pretreated, platinum-resistant ovarian cancer patients under phase Ib clinical trial.
-- Etigilimab in combination with Opdivo in patients with advanced or metastatic solid tumors, under phase Ia/b study.
-- OMP-336B11, under phase Ia study, in patients with advanced or metastatic solid tumors.

Near-term Catalyst:

Interim results of the ongoing phase Ib study of Navicixizumab in combination with paclitaxel in patients with platinum-resistant ovarian cancer are scheduled to be presented on October 20, 2018.

4. SELLAS Life Sciences Group Inc. (SLS)

Gained 20.24% to close Wednesday's trading at $2.02.

News: No news

Near-term Catalyst:

On October 22, 2018, the Company will be presenting interim (median follow-up of 18.8 months) and updated and final (median follow-up of 26.1 months) clinical data from its phase IIb trial of the combination of NeuVax and Herceptin to prevent breast cancer recurrence.

5. ENDRA Life Sciences Inc. (NDRA)

ENDRA is developing a next generation Thermo-Acoustic Enhanced UltraSound (TAEUS) system that will help clinicians to visualize tissue function, composition, and monitor a variety of therapeutic interventions at the point of care. The first TAEUS application will focus on the quantification of fat in the liver, for early detection and monitoring of Non-Alcoholic Fatty Liver Disease.

Gained 12.77% to close Wednesday's trading at $3.18.

News: The Company has received approval from Health Canada for an Investigational Testing Authorization to commence human studies with its TAEUS clinical system targeting Non-Alcoholic Fatty Liver Disease.

Near-term Catalyst:

The first human studies with the TAEUS clinical system targeting Non-Alcoholic Fatty Liver Disease are expected to yield results in the fourth quarter of 2018.

6. Axsome Therapeutics Inc. (AXSM)

Axsome is a clinical-stage biopharmaceutical company developing novel medicines for the management of central nervous system disorders.

Gained 11.36% to close Wednesday's trading at $3.92.

News: The Company's drug candidate AXS-12 has been granted Orphan Drug Designation by the FDA for the treatment of narcolepsy.

Narcolepsy is a serious, debilitating, neurological condition characterized by excessive daytime sleepiness.

Near-Term Catalysts:

* Initiate a Phase 2 trial of AXS-12 for the treatment of the symptoms of narcolepsy this quarter (Q4). Top-line results from this study are anticipated in the first half of 2019.
* Results from final interim analysis of phase III trial of AXS-05 in treatment resistant depression, or TRD (STRIDE-1) are expected in the fourth quarter of 2018. Top-line results from this study are anticipated in the first half of 2019.
* Results of the first interim analysis of Phase 2/3 trial of AXS-05 in patients with agitation associated with Alzheimer's disease (ADVANCE-1) are expected in the fourth quarter of 2018.
* Top line results from a phase II trial of AXS-05 in patients with major depressive disorder (ASCEND) are anticipated in the fourth quarter of 2018.
* Top line results from a phase II trial of AXS-05 for smoking cessation treatment are anticipated in first quarter of 2019.
* Initiation of a phase III trial of AXS-07 for the acute treatment of migraine in the fourth quarter of 2018.

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