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30.03.2017 04:46:05

Gainers & Losers Of Mar.29: ATHX, VRTX, ACHN, SSH, RTTR...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of March 29, 2017.

GAINERS

1. Athersys Inc. (ATHX)

Gained 22.03% to close Wednesday's (Mar.29) trading at $1.44.

News: William Blair & Co. analyst Katherine Xu initiated coverage on shares of Athersys and has set an Outperform rating.

Anticipated event:

The Company will be presenting a corporate overview at the 16th Annual Needham Healthcare Conference at The Westin New York Grand Central Hotel in New York City on April 4, 2017.

The lead product candidate of Athersys is MultiStem, a proprietary stem cell product for multiple disease indications in the areas of neurological, cardiovascular and inflammatory & immune disease areas.

In April 2015, the Company reported interim results from its exploratory phase II clinical study of intravenous administration of MultiStem cell therapy to treat patients who have suffered an ischemic stroke, dubbed MASTERS-1.

Although the study results demonstrated favorable safety and tolerability for MultiStem, the primary endpoint of global stroke recovery at day 90, which assesses disability neurological deficit and activities of daily living, and secondary endpoints evaluating elements of recovery and dysfunction were not met.

However, the 1 year follow-up data from its phase II study of the intravenous administration of MultiStem cell therapy to treat patients who have suffered an ischemic stroke, reported last February, demonstrated a significantly higher rate of complete or nearly full recovery.

Last September, the Company reached an agreement with the FDA under Special Protocol Assessment for the design and analysis of its phase III study of MultiStem treatment for ischemic stroke.

2. Vertex Pharmaceuticals Inc. (VRTX)

Gained 20.45% to close Wednesday's trading at $108.01.

News: The Company's phase III studies of Tezacaftor/Ivacaftor combination treatment, dubbed EVOLVE and EXPAND, met the primary endpoints with statistically significant improvements in Lung Function (FEV1) in people with Cystic Fibrosis.

The EVOLVE study evaluated the combination of Tezacaftor/Ivacaftor in people who have two copies of the F508del mutation. The second study, EXPAND, evaluated the combination treatment in people who have one mutation that results in residual CFTR function and one F508del mutation.

3. CombiMatrix Corp. (CBMX)

Gained 17.71% to close Wednesday's trading at $5.65.

News: No news

CombiMatrix is a clinical diagnostic laboratory serving the IVF, prenatal, miscarriage analysis and pediatric markets.

Recent event:

On Feb.22nd, the Company reported Q4 and full-year 2016 financial results.

The net loss attributable to common stockholders for the fourth quarter of 2016 narrowed to $558,000 or $0.22 per share on total revenue of $3.5 million. This compared with a net loss attributable to common stockholders of $1.7 million or $2.02 per share and revenue of $2.7 million in the fourth quarter of 2015.

The Company is confident of reaching positive cash flow from operations by the fourth quarter of 2017.

4. TearLab Corp. (TEAR)

Gained 15.45% to close Wednesday's trading at $3.17.

News: No news

Recent event: On Mar.9th, the Company reported Q4 and full-year 2016 financial results.

The net loss for the fourth quarter of 2016 was $4.3 million or $0.81 per share on revenue of $7.1 million. This compared with a net loss of $8.9 million or $2.64 per share and revenue of $6.8 million in the year-ago quarter.

5. Achillion Pharmaceuticals Inc. (ACHN)

Gained 12.66% to close Wednesday's trading at $4.27.

News: No news

Near-term catalysts:

- Advance ACH-4471 into phase II study for treatment-naive paroxysmal nocturnal hemoglobinuria (PNH) patients during the first half of 2017. - Initiate a phase II trial with ACH-4471 for patients with C3 glomerulopathy (C3G) during the second half of 2017.

LOSERS

1. Catalyst Biosciences Inc. (CBIO)

Lost 29.98% to close Wednesday's trading at $10.51. A pullback after yesterday's gain of over 190%.

Recent event:

On Mar.28th, the Company announced that it has been given permission by the Korean Ministry of Food and Drug Safety to conduct a clinical trial with CB 2679d/ISU30, a next-generation Factor IX drug for the treatment of patients with hemophilia B.

Accordingly, Catalyst's collaborator, ISU Abxis, plans to initiate a phase 1/2 proof-of-concept study in individuals with severe hemophilia B in the second quarter of 2017.

2. Atossa Genetics Inc. (ATOS)

Lost 27.52% to close Wednesday's trading at $0.79.

News: The Company said it intends to raise gross proceeds of $4 million in an underwritten public offering.

The offering is expected to close April 3, 2017.

3. Diffusion Pharmaceuticals Inc. (DFFN)

Lost 26.51% to close Wednesday's trading at $3.66. A pullback after yesterday's gain of over 81%.

News: No news

Anticipated event:

The company's lead investigational drug is Trans Sodium Crocetinate or TCS, which is being investigated to enhance the efficacy of radiation and chemotherapy.

TSC is designed to work by safely re-oxygenating oxygen deprived (hypoxic) tissue. Hypoxia is an especially critical obstacle in the treatment of cardiovascular and respiratory diseases, as well as in cancer.

A phase II study of TCS in Glioblastoma produced encouraging results - with overall survival increasing by 37% at 2 years. An end of phase II meeting with the FDA was held in May 2015 and the company was informed that a single phase III study could serve as the basis for approval.

Diffusion Pharma expects to begin enrollment in the phase III study of TSC in Glioblastoma in the first half of this year.

The company's shares were uplisted from OTC to the NASDAQ on November 9, 2016.

4. Sunshine Heart Inc. (SSH)

Lost 20.78% to close Wednesday's trading at $1.83.

News: The Nasdaq Hearings Panel has granted the Company time until May 10, 2017 to evidence full compliance with all applicable criteria for continued listing on The Nasdaq Capital Market, including the $2.5 million stockholders' equity requirement.

On Feb.10, 2017, the Company received a formal notice from The NASDAQ Stock Market LLC indicating that it has evidenced compliance with the minimum $1.00 bid price requirement.

A 1-for-30 reverse split of common stock came into effect on January 13, 2017.

5. Ritter Pharmaceuticals, Inc. (RTTR)

Lost 17.95% to close Wednesday's trading at $1.60.

News: The Company reported positive results from its phase 2b/3 study of RP-G28 in subjects with lactose intolerance. However, there were irregularities at one study center, and the data from this center were excluded from the primary analysis population.

The primary endpoint of the trial, i.e., a clinically meaningful benefit to patients suffering from lactose intolerance, met statistical significance, and no significant adverse events (SAEs) were reported from treatment, said the Company.

Based on the trial results, Ritter believes that the successful completion of a confirmatory phase III program could be adequate to support a New Drug Application submission and therefore has requested an end-of-Phase II meeting with the FDA.

6. Akers Biosciences Inc. (AKER)

Lost 17.02% to close Wednesday's trading at $1.95. A pullback after yesterday's gain of more than 67%.

News: No news

Recent event: On Mar.28th, the Company announced that it has received an initial order for its Tri-Cholesterol "Check" test from First Check Diagnostics LLC.

The Tri-Cholesterol "Check" test is disposable, uses just a finger-stick blood sample and gives a result in only 5 minutes. The test has FDA 510(k) clearance in the United States as well as a CE mark for the European Economic Area.

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