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INSY On Fast Track, GTXI's ASTRID On The Way, EOLS Makes Investors Smile

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

1. INSYS Therapeutics Inc. (INSY)

Gained 34.05% to close Thursday's (Aug.30) trading at $10.67.

News: The FDA has granted Fast Track designation to the Company's Epinephrine Nasal Spray as an investigational treatment for anaphylaxis, an acute, life-threatening allergic reaction requiring urgent treatment.

According to the preliminary results announced in June of this year, in a pharmacokinetics study involving 60 people with seasonal allergies, the bioavailability of INSYS' Epinephrine Nasal Spray was similar to that of Mylan's intramuscular injection with EpiPen (0.3 mg). The study also demonstrated rapid drug absorption with the epinephrine nasal spray.

Recent events:

-- On August 8, the Company reached an agreement in principle with the Department of Justice (DOJ) to settle the DOJ's civil and criminal investigation into inappropriate sales and commercial practices by some former company employees.
-- On July 27, the FDA turned down the Company's New Drug Application for a buprenorphine sublingual spray as a treatment for moderate-to-severe acute pain.

Clinical Trials:

-- A phase II clinical trial of cannabidiol (CBD) oral solution as potential treatment for Prader-Willi syndrome is enrolling patients.
-- A phase III clinical trial of CBD oral solution as potential treatment for infantile spasms is underway.
-- A phase II clinical trial of CBD oral solution as potential treatment for childhood absence epilepsy is ongoing.

2. K2M Group Holdings Inc. (KTWO)

Gained 26.03% to close Thursday's trading at $27.50.

News: The Company is all set to be acquired by Stryker (SYK) for $27.50 per share, or a total equity value of approximately $1.4 billion.

The acquisition of K2M is slated to close late in the fourth quarter of this year and is expected to have an immaterial dilutive impact to Stryker's net earnings per diluted share and adjusted net earnings per share in 2018.

3. Adverum Biotechnologies Inc. (ADVM)

Gained 16.73% to close Thursday's trading at $7.15.

News: The Company expects to initiate a phase I, dose-escalation study of ADVM-022, a novel gene therapy candidate for the treatment of wet age-related macular degeneration in the fourth quarter of 2018.

Clinical Trials & Near-term Catalysts:

-- Report preliminary data from patients in Cohorts 1 through 3 in a Phase I/II clinical trial of ADVM-043 in A1AT deficiency patients, dubbed ADVANCE, by the end of this year.
-- Submit an IND application to the FDA for ADVM-053 in hereditary angioedema in the fourth quarter of 2018.

4. CEL-SCI Corporation (CVM)

Gained 15.29% to close Thursday's trading at $2.94.

News: No news

Near-term Catalyst:

-- The top line results from a phase III trial of its investigational immunotherapy Multikine in the treatment of head and neck cancer may be available as soon as early 2019.

5. GTx Inc. (GTXI)

Gained 14.81% to close Thursday's trading at $23.41.

News: No news

Clinical Trial & Near-term Catalyst:

-- A phase II trial of Enobosarm in postmenopausal women with stress urinary incontinence, dubbed ASTRID, is underway, with top-line results expected early in the fourth quarter of 2018.

Upcoming Event:

An overview of the company is scheduled to be presented at the Baird 2018 Global Healthcare Conference on Thursday, September 6, 2018 at 9:05 am ET in New York.

6. electroCore Inc. (ECOR)

electroCore is a commercial-stage bioelectronic medicine company.

Gained 14.66% to close Thursday's trading at $16.19.

News: No news

Recent Event:

-- On August 13, the Company announced financial results for the second quarter ended June 30, 2018.

The net loss in the recent second quarter was $17.78 million compared to a net loss of $11.57 million in the year-earlier quarter. Net sales rose to $393 thousand in Q2, 2018, up from $177 thousand in Q2, 2017.

The Company ended June 30, 2018, with cash of $95.8 million.

7. Biocept Inc. (BIOC)

Gained 13.16% to close Thursday's trading at $3.87.

News: No news:

Recent Events:

-- On August 23, Highmark Health, an integrated health care delivery and financing network, announced that through its VITAL Innovation Program, it is testing Biocept's Target Selector liquid biopsy platform designed to help oncologists improve the diagnosis and treatment of patients with non-small cell lung cancer.

The goals of the collaboration are to improve health outcomes by using liquid biopsy to more rapidly assess a patient's molecular status and select appropriate therapy, while reducing the overall cost of care.

-- On August 14, the Company reported financial results for the second quarter ended June 30, 2018.

The net loss for the second quarter of 2018 was $6.2 million or $2.70 per share on 2.3 million weighted-average shares outstanding. This compares with a net loss for the second quarter of 2017 of $5.7 million or $6.32 per share on 901,000 weighted-average shares outstanding. Revenues for the second quarter of 2018 declined to $822,000 from $1.3 million for the second quarter of 2017.

-- On July 10, 2018, the Company implemented a 1 for 30 reverse stock split.

8. Evolus Inc. (EOLS)

Gained 12.56% to close Thursday's trading at $26.79.

News: No news

Recent event:

-- On August 29, the Company's resubmitted Biologics License Application for its lead product candidate, prabotulinumtoxinA (DWP-450) was accepted for review by the FDA, with a decision date set for February 2, 2019.

PrabotulinumtoxinA is being developed for the treatment of glabellar lines, also known as frown lines, in adult patients, a rival to Allergan's (AGN) Botox.

In May of this year, the FDA rejected the Company's Biologics License Application for prabotulinumtoxinA citing the deficiencies in items related to Chemistry, Manufacturing, and Controls ("CMC") processes. The deficiencies were not related to clinical or non-clinical matters.

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