NVIV Inspired By Data, COOL Is Hot, OCX Braces For Busy Year, ARCT Turns Heads

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

1. InVivo Therapeutics Holdings Corp. (NVIV)

Gained 70.76% to close Wednesday's (May 2) trading at $13.49.

News: The Company presented complete 6-month primary endpoint results from INSPIRE Study of investigational Neuro-Spinal Scaffold in acute thoracic complete spinal cord injury. The results were reported in January of this year.

As previously announced, 7 of 16 (43.8%) study patients who reached the six-month primary endpoint regained some neurologic function versus the Objective Performance Criterion (study success definition) of 25%. Altogether, 19 patients have been implanted with the Neuro-Spinal Scaffold.

Enrollment in the INSPIRE trial was placed on hold in July 2017 following three patient deaths. However, these deaths were deemed unrelated to the investigational device by the principal investigators.

The INSPIRE trial has been officially closed, and the Company's proposed clinical trial designed to enhance the existing clinical evidence for the Neuro-Spinal Scaffold and support potential product approval, dubbed INSPIRE 2.0, has been given the go-ahead by the FDA.

2. Community Health Systems Inc. (CYH)

Gained 28.21% to close Wednesday's trading at $5.09.

News: The Company reported better-than expected revenue in the first quarter.

Net loss attributable to common stockholders narrowed to $25 million or $0.22 per share in the first quarter of 2018 from $199 million or $1.79 per share for the same period in 2017. Net operating revenues for the recent first totaled $3.689 billion, a 17.8 percent decrease, compared with $4.486 billion for the same period in 2017.

Analysts polled by Thomson Reuters were expecting a loss of $0.22 per share on revenue of $3.65 billion in the first quarter of 2018.

3. PolarityTE Inc. (COOL)

Gained 16.54% to close Wednesday's trading at $20.36.

News: The Company's autologous bone product in development, OsteoTE, regenerated complex, hierarchically-organized, corticocancellous bone within critically-sized bone defects in standard preclinical large animal models.

The OsteoTE product, which utilizes the subject's own bone, is prepared and used to treat the defect in less than 24 hours.

You can find more about COOL in our premium stock report page.

4. OpGen Inc. (OPGN)

Gained 15.22% to close Wednesday's trading at $2.12.

News: No news

Near-term Catalyst:

The Company is slated to report financial results for the three months ended March 31, 2018 after close of the U.S. financial markets on Tuesday, May 8, 2018.

The net loss available to common stockholders for the fourth quarter of 2017 was $2.9 million or $1.33 per share on revenue of $1.0 million.

5. OncoCyte Corp. (OCX)

Gained 14.63% to close Wednesday's trading at $2.35.

News: No news

Near-term Catalysts:

-- Complete DetermaVu confirmation study in the first half of 2018. DetermaVu is OncoCyte's diagnostic test for lung cancer.
-- Select final commercial platform for DetermaVu in the second half of 2018.
-- Conduct R&D Validation Study of DetermaVu in the second half of 2018.
-- Conduct and report results of Analytical Validation Study of DetermaVu in the second half of 2018.
-- Conduct CLIA Validation Study of DetermaVu in the second half of 2018.
-- Conduct and report results of Clinical Validation Study of DetermaV in the second half of 2018.

6. Innovate Biopharmaceuticals Inc. (INNT)

Gained 12.70% to close Wednesday's trading at $19.70.

News: No news


The lead drug candidate is Larazotide acetate (INN-202), which has successfully met its primary endpoint in a phase 2b efficacy clinical trial for celiac disease. Also in the pipeline is INN-108, indicated for mild to moderate ulcerative colitis, which is entering Phase II trials this year, and INN-329, entering phase III trial for Magnetic Resonance Cholangiopancreatography (MRCP).

Near-term Catalyst:

-- Larazotide acetate is expected to move into phase III clinical trials in celiac disease in Q2 2018.

7. Arcturus Therapeutics Ltd. (ARCT)

Gained 11.65% to close Wednesday's trading at $5.56.

News: The Company founder Joseph Payne has successfully prevented the Board's attempt to dilute shareholders through sale of 24.9% of Arcturus share capital.

Payne owns about 13.7% of the issued and outstanding shares in the Company.

Certain directors were attempting to sell 24.9% of Arcturus' share capital to a single purchaser at a purchase price that is more than 40% below the trading price of Arcturus common shares prior to the termination of Payne. On February 2, 2018, the Company announced its decision to terminate Joseph Payne as President and Chief Executive Officer.

Payne had sought Court's intervention to prohibit the attempt of the Arcturus board of directors to undertake a highly dilutive equity financing.

Now, the Court has also found that the board's decision to sell shares was not being undertaken to raise necessary working capital, and that the members of the Arcturus board are motivated by their own self-interests instead of the interests of Arcturus and its shareholders.

8. CASI Pharmaceuticals Inc. (CASI)

Gained 11.62% to close Wednesday's trading at $7.97.

News: No news

The last we heard from CASI was on April 5, 2018, and it was about the receipt of Advisory Meeting Notice from China Center for Drug Evaluation indicating that EVOMELA has been scheduled for review between April 25-26, 2018.

The Advisory Committee review of the EVOMELA (melphalan) application marks a significant milestone toward addressing an unmet medical need for patients with multiple myeloma in China, as there are no versions of melphalan commercially available, according to the Company.

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