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OGEN Plays It Safe, MOTS Awaits Data In Q4, EXAS Soars On ACS New Guideline


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

1. Oragenics Inc. (OGEN)

Gained 66.67% to close Wednesday's (May 30) trading at $2.00.

News: The Company has reported positive interim safety analysis results from its phase II trial of AG013 for oral mucositis.

The data analysis, which involved 19 patients, indicated that the distribution of adverse events were similar between AG013 and placebo. There were no reports of bacteremia or sepsis.

The phase II trial is designed to enroll about 200 patients, and the purpose of the study is to evaluate the efficacy, safety and tolerability of topically administered AG013 compared to placebo for reducing the incidence and severity of oral mucositis in patients undergoing traditional chemoradiation for the treatment of head and neck cancer.

2. TapImmune Inc. (TPIV)

Gained 24.15% to close Wednesday's trading at $5.09.

News: The Company President and CEO, Peter Hoang, will make a presentation at the 2018 Sachs Associates Immuno-Oncology BD&L and Investment Forum on June 1, 2018, at the Waldorf Astoria Chicago Hotel.

Recent event:

On May 15, 2018, the Company entered into a merger agreement to acquire Marker Therapeutics Inc., a privately-held clinical-stage developer of a transformative, non-genetically engineered, multi-antigen T cell therapy platform.

The transaction adds to TapImmune's product pipeline a synergistic portfolio of highly-differentiated T cell therapies that has demonstrated potentially groundbreaking results in early clinical trials in lymphoma, acute myeloid leukemia (AML), and multiple myeloma.

3. Motus GI Holdings Inc. (MOTS)

Gained 17.14% to close Wednesday's trading at $5.40.

News: No news

Recent event:

On May 23, 2018, the Company announced that it has enrolled the first patient in its REDUCE (Reliable Endoscopic Diagnosis Utilizing Cleansing Enhancement) study.

The REDUCE study is a single-arm multi-center, prospective study that will utilize the Pure-Vu System to facilitate bowel cleansing in approximately 100 hospitalized patients who are indicated for a diagnostic colonoscopy procedure.

The Pure-Vu System is FDA-cleared and CE-Marked in the indication of cleaning of a poorly prepared colon during the colonoscopy procedure.

Near-term Catalyst:

-- Data from the REDUCE study are expected in the fourth quarter of this year.

4. Oramed Pharmaceuticals Inc. (ORMP)

Gained 15.61% to close Wednesday's trading at $8.22.

News: The Company's patent for its invention, titled "Methods and Compositions for Oral Administrations of Proteins," has been allowed by the United States Patent and Trademark Office.

Commenting on the news, Nadav Kidron, CEO of Oramed, stated, "This is an important milestone which allows for additional patent protection for our proprietary POD Technology and which we believe will help pave our entrance into the U.S. diabetes market, which is one of the largest single diabetes markets worldwide."

Recent event:

On May 16, 2018, the Company announced the launch of a pivotal clinical study of oral insulin.

The trial involves 240 patients with type 2 diabetes in multiple centers throughout the U.S., including the CHEAR Center in the Bronx.

Near-term Catalyst:

-- Data from the U.S.-based clinical trial of oral Insulin will be available early next year.

5. Invuity Inc. (IVTY)

Gained 13.56% to close Wednesday's trading at $3.35.

News: No news

Invuity is a medical technology company focused on minimal access surgery.

Recent event:

On May 3, 2018, the Company announced financial results for the three months ended March 31, 2018.

The net loss for the first quarter of 2018 narrowed to $11.2 million or $0.62 per share from $13.2 million or $0.78 per share for the first quarter of 2017. Revenue was $9.5 million in the recent first quarter, up 5.3% from $9.0 million in the first quarter of 2017 driven primarily by strong market acceptance of PhotonBlade.

Looking ahead to 2018, Invuity continues to expect revenue to exceed $46 million. Full year 2017 revenue was $39.6 million.

6. ZIOPHARM Oncology Inc. (ZIOP)

Gained 11.76% to close Wednesday's trading at $4.94.

News: No news

7. Exact Sciences Corporation (EXAS)

Gained 11.12% to close Wednesday's trading at $58.58.

Exact Sciences is the maker of Cologuard, a noninvasive colon cancer screening test.

News: The American Cancer Society has now recommended that colorectal cancer screening should begin at age 45 for people at average risk of the disease, which is down from the long recommended age of 50.

Cologuard is currently available to individuals age 50 and older who are at average risk for colorectal cancer. Exact Sciences will seek to expand the product's current indication to people age 45 and older who are at an average risk for colorectal cancer.

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