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CHEK Explodes, ATOS Scripts History, CDMO Working On A Facelift, EYPT In Focus

pharma daily 041918

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

1. Check-Cap Ltd. (CHEK)

Gained 104.82% to close Tuesday's (Apr.24) trading at $14.87.

News: No news

Check-Cap is a clinical stage medical diagnostics company developing a capsule-based system for preparation-free, colorectal cancer screening.

Recent events:

-- On January 10, 2018, the Company received CE Mark approval for the C-Scan system.

The C-Scan system, an ingestible capsule, offers an alternative to current colon cancer screening methods that require laxative preparation and invasive endoscopic procedures.

-- On March 12, 2018, the Company initiated an EU post approval study using its Advanced C-Scan system.
-- On April 4, 2018, the Company implemented a 1-for-12 reverse stock split of its outstanding ordinary shares.
-- On April 19, 2018, the Company regained compliance with Nasdaq Listing Rule 5550(a)(2), which concerns minimum bid price listing requirements.

Near-term Catalyst:

-- The Company is expected to initiate the US pilot trial for advanced C-Scan Version in the second half of 2018.

2. Atossa Genetics Inc. (ATOS)

Gained 27.09% to close Tuesday's trading at $3.80.

News: The Company has received positive interim review from independent safety committee in the first cohort of its phase I topical Endoxifen dose escalation study in men, which is being developed to address gynecomastia (or male breast enlargement).

The next level of the study is to escalate the dosage in a new cohort of subjects as the Company continues to monitor safety and tolerability in the first cohort of the study.

Gynecomastia affects 25% of men ages 50-69, and there are no approved drugs, either topical or oral, for this condition.

Atossa is the first to conduct a clinical trial of a topical pharmaceutical for the treatment of gynecomastia.

3. EyePoint Pharmaceuticals Inc. (EYPT)

Gained 20.61% to close Tuesday's trading at $1.99. The stock is up nearly 66% so far this month.

News: No news

Recent events:

-- On March 28, 2018, pSivida Corp. (PSDV) acquired specialty biopharmaceutical company Icon Bioscience Inc.
-- pSivida Corp. rebranded and changed its name to EyePoint Pharmaceuticals Inc., with ticker EYPT, effective April 2, 2018.

Near-term Catalysts:

-- DEXYCU, a dropless, long-acting therapeutic, which was approved by the FDA for the treatment of inflammation in post cataract surgery on February 9, 2018, is expected to be launched in the U.S. in the first half of 2019 following the successful scale up of commercial supplies.
-- The NDA for YUTIQ micro-insert, proposed for treatment of non-infectious posterior segment uveitis, is under FDA review - with a decision expected on November 5, 2018.

4. Avid Bioservices Inc. (CDMO)

Gained 12.72% to close Tuesday's trading at $3.81.

Avid Bioservices is a contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies.

News: The Company has provided an update on its ongoing expansion of process development capabilities and laboratory infrastructure.

New agreements with three additional undisclosed international drug development companies have been signed in recent weeks, which takes the number of Master Service Agreements with new clients to 4 in calendar 2018 compared with four similar agreements during the entire 2017 calendar year.

Efforts are being taken to expand the Company's total available process development laboratory space to more than 6,000 square feet, upgrade the infrastructure and equipment within its existing process development laboratories, and implement new state-of-the-art technologies and equipment. The first new laboratories are expected to be operational during the third quarter of calendar 2018.

5. Obalon Therapeutics Inc. (OBLN)

Gained 12.39% to close Tuesday's trading at $3.72.

Obalon is the maker of the first and only FDA approved swallowable, gas-filled balloon for weight loss.

News: No news

Recent event:

On March 5, 2018, the Company reported Q4, and full-year 2017 financial results.

The annual net loss in 2017 was $34.8 million or $2.08 per share compared to a net loss of $20.5 million or $4.85 for the full year 2016. Total annual revenue in 2017 was $9.9 million, a 192% increase from $3.4 million for the full year 2016.

As of December 31, 2017, cash, cash equivalents and short-term investments were $44.4 million and total debt was $10.0 million.

6. Genprex Inc. (GNPX)

Gained 12.61% to close Tuesday's trading at $5.00.

News: No news

Clinical Trial:

The Company's initial product candidate is Oncoprex for non-small cell lung cancer, under phase II trial.

Recent event:

The Company went public on the Nasdaq Capital Market on March 29, 2018, offering its shares at a price of $5.00 each.

7. Innovate Biopharmaceuticals Inc. (INNT)

Gained 10.43% to close Tuesday's trading at $19.48.

News: No news

Pipeline:

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.

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