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EKSO Leaps, FDA Nod For DRIO, CRVS Up 38% This Month, VTL To Report Data In Sep.

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

1. Ekso Bionics Holdings Inc. (EKSO)

Ekso is a robotic exoskeleton company offering technologies that help those with paralysis to stand up and walk.

Gained 34.42% to close Monday's (Mar.26) trading at $2.07.

News: No news

Recent event:

-- On Mar.13, 2018, the Company reported financial results for the three and twelve months ended December 31, 2017.

Net loss applicable to common stockholders for the recent fourth quarter was $9.0 million or $0.15 per share, compared to $5.6 million, or $0.34 per share for the three months ended December 31, 2016.

Revenue was $2.5 million for the recent fourth quarter ended December 31, 2017, compared to $2.6 million for the quarter ended December 31, 2016.

The Company ended the year 2017 with cash of $27.8 million.

2. DarioHealth Corp. (DRIO)

Gained 27.86% to close Monday's trading at $1.79.

News: The FDA has cleared the Company's Lightning-enabled version of Dario Blood Glucose Monitoring System which enables the use of the Dario app on iPhone 7, 8 and X smart mobile devices.

DarioHealth has been marketing the product in the U.S. exclusively for Apple iOS 6.1 platform and higher since the FDA first granted clearance for the Dario Blood Glucose Monitoring System in December 2015, and certain leading Android SMD's including Samsung Galaxy S series, Samsung Galaxy Note series, and LG G series, since September 2017.

With the Lightning-enabled Version also getting FDA clearance, DarioHealth plans to expand U.S. sales in the coming weeks.

3. ArQule Inc. (ARQL)

Gained 18.28% to close Monday's trading at $3.17.

News: No news

Clinical Trials:

-- ARQ 087 (Derazantinib), under phase III trial in Intrahepatic Cholangiocarcinoma (iCCA), is ongoing.
-- ARQ 531, proposed for heme malignancies, is under phase 1a/b testing.
-- Miransertib (ARQ 092), for Proteus syndrome, is under Phase I/II trial.
-- ARQ 751, for solid tumors, is under Phase 1a study.

Upcoming event:

-- The Company will make a presentation at the 17th Annual Needham Healthcare Conference on March 27th, 2018, at 3:30 p.m. ET at the Westin Grand Central Hotel in New York.

Near-term Catalysts:

-- Data from a phase 1b trial for Miransertib in combination with Anastrozole in PIK3CA or AKT1-mutant endometrial and ovarian cancers will be presented on April 15, 2018.
-- Results of a phase I dose escalation study of ARQ 751 in adult subjects with advanced solid tumors will be presented on April 15, 2018.

4. Bellerophon Therapeutics Inc. (BLPH)

Gained 14.85% to close Monday's trading at $2.32.

News: No news

Clinical Trials & Near-term Catalysts:

-- A phase III INOvation-1 study evaluating INOpulse in patients with pulmonary arterial hypertension is underway. Readout of the interim analysis of this trial is expected in mid-2018, with top-line data from the full study anticipated around the end of 2018.
-- A phase 2b study evaluating INOpulse to assess the safety and efficacy of pulsed, inhaled nitric oxide versus placebo in patients with pulmonary hypertension associated with Interstitial Lung Disease (PH-ILD) is also ongoing. Top-line results from this study are expected to be available by the end of 2018.
-- The Company announced positive results from its phase 2 study for INOpulse in pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD) last September. The next clinical program is being planned.

5. OncoMed Pharmaceuticals Inc. (OMED)

Gained 13.70% to close Monday's trading at $3.32.

News: No news

Clinical Trials & Near-term Catalysts:

--A phase Ia single agent study of OMP-313M32 in advanced or metastatic solid tumors continues to enroll patients. Data from this trial is expected in the 4th quarter of 2018.
-- The Phase 1b portion of this trial, which will evaluate OMP-313M32 in combination with anti-PD1, is expected to begin in the first half of 2018.
-- A phase 1a single agent study of OMP-336B11 in patients with advanced or metastatic solid tumors. Enrollment in this study is ongoing. The presentation of data from this Phase 1 study is currently planned for 2019.
-- Two phase 1b dose escalation and expansion studies of Navicixizumab in combination with standard-of-care chemotherapies - one in patients with platinum-resistant ovarian cancer who have failed more than two prior therapies or prior Avastin and a second in patients with 2nd line metastatic colorectal cancer. Enrollment is continuing in both the studies, and interim data are expected in the 2nd half of 2018.

6. AcelRx Pharmaceuticals Inc. (ACRX)

Gained 13.25% to close Monday's trading at $2.35.

News: No news

Near-term Catalysts:

-- Resubmit NDA for DSUVIA in the second quarter of this year.

DSUVIA, known as known as DZUVEO outside the United States, is designed to reduce moderate-to-severe acute pain and dosing errors associated with IV administration via its non-invasive single-dose applicator in medically supervised settings. DSUVIA was denied FDA approval last October.

-- An FDA panel is expected to review the DSUVIA NDA in the third quarter of this year.
-- The EMA's Committee for Medicinal Products for Human Use is expected to announce its opinion on the Marketing Authorization Application for DZUVEO in the first half of this year.
-- Resubmit Zalviso NDA in the second half of 2018.

Zalviso is a patient-activated, non-invasive analgesic system for the management of moderate-to-severe acute pain in adult patients in the hospital setting. It was turned down by the FDA in July 2014.

7. Vital Therapies Inc. (VTL)

Gained 11.21% to close Monday's trading at $6.45.

News: No news

Pipeline:

The Company's lead investigational product is ELAD, a cell-based therapy for the treatment of acute forms of liver failure.

Recent event:

-- On Mar.22, 2018, the Company announced that its phase III trial designed to evaluate the ELAD System in subjects with severe alcoholic hepatitis, dubbed VTL-308, reached its enrollment target of 150 subjects.

Near-term Catalyst:

-- Report top line results for VTL-308 in the third quarter, likely in September.

8. Soligenix Inc. (SNGX)

Gained 10.42% to close Monday's trading at $2.12.

News: No news

Clinical Trials & Near-term Catalysts:

-- A phase III study of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer receiving chemoradiation therapy is underway. Final results from this study are expected in the second half of 2019.

-- A pivotal phase III study of SGX301 in cutaneous T-cell lymphoma is ongoing. Results from this study are anticipated in the first half of 2019.

9. Corvus Pharmaceuticals Inc. (CRVS)

Gained 9.90% to close Monday's trading at $11.21.

News: No news

Recent event:

-- On March 12, 2018, the Company completed its previously announced underwritten public offering of 8.11 million shares of its common stock at a price to the public of $8.50 per share. The gross proceeds to Corvus from this offering were $69.0 million and net proceeds were roughly $64.8 million.

Clinical Trials & Near-term Catalysts:

-- A phase 1/1b study of CPI-444 both as a single agent and in combination with Roche's Tecentriq in renal cell cancer (RCC) and non-small cell lung cancer (NSCLC) is underway.
-- A phase 1b/2 clinical trial of CPI-444 in combination with Tecentriq as second- or third-line therapy in patients with NSCLC who are resistant or refractory to prior anti-PD-(L)1 antibody therapy is ongoing.
-- Enrollment in a Phase 1/1b clinical trial with CPI-006 in patients with advanced cancers is expected to be initiated in the first quarter of 2018.

10. INSYS Therapeutics Inc. (INSY)

Gained 9.03% to close Monday's trading at $6.28.

News: No news

Recent event:

On Mar.2, 2018, the Company initiated a phase III study of CBD oral solution for infantile spasms.

Near-term Catalysts:

-- 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 December. Data read for this proof-of-concept study is anticipated in the first half of 2018.
-- A phase III study of CBD oral solution for Prader-Willi Syndrome is expected to be initiated in the first half of 2018.
-- 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.
-- The data read for phase II study of CBD oral solution for childhood absence epilepsy is expected in the second half of 2018.

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