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Gainers & Losers Of Mar.30: XBIO, PRAN, AKER, TNXP, HALO...

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The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of March 30, 2017.

GAINERS

1. Xenetic Biosciences Inc. (XBIO)

Gained 44.18% to close Thursday's trading at $5.44.

News: No news

Xenetic's lead program is XBIO-101 (Virexxa), under phase II testing for treatment of progesterone resistant endometrial cancer. The Company also has an out-license agreement with Shire for SHP656, which is under phase I/II trial for the treatment of hemophilia A.

Near-term catalysts:

- Patient recruitment in the phase II trial of XBIO-101 is expected to commence next quarter.
- Data from phase I/II clinical trial for treatment of hemophilia A is expected in Q2 2017.

2. Prana Biotechnology Limited (PRAN)

Gained 37.10% to close Thursday's trading at $3.40.

News: The pre-clinical evidence of the Company's investigational drug PBT434 for the treatment of Parkinsonian movement disorders was presented at the 13th International Conference on Alzheimer's and Parkinson's Diseases and Related Neurological Disorders.

In preclinical models, PBT434 prevented the loss of neurons, motor function and cognitive impairment by preventing metal mediated degenerative processes that lead to neuronal death, said the Company.

3. Athersys Inc. (ATHX)

Gained 31.94% to close Thursday's trading at $1.90, continuing its rally for the second straight day.

News: No news

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, dubbed MASTERS-2.

4. Celyad SA (CYAD)

Gained 24.31% to close Thursday's trading at $25.50.

News: No news

The company's most advanced product candidate is CAR-T NKR-2.

Near-term catalyst:

- A Belgian phase Ib study to assess the safety and clinical activity of multiple administrations of autologous CAR-T NKR-2 cells in seven refractory cancers, including five solid and two hematological tumors, dubbed THINK, is ongoing. Results from this study are expected this year.
- A U.S.THINK trial is expected to be initiated soon.

5. Conatus Pharmaceuticals Inc. (CNAT)

Gained 17.93% to close Thursday's trading at $5.92.

News: No news

The Company's lead compound is Emricasan, for the treatment of patients with chronic liver disease.

Near-term catalysts:

- A phase IIb trial of Emricasan in NASH cirrhosis patients, dubbed ENCORE-LF, is expected to be initiated in the second quarter of 2017
- Top-line data from an ongoing phase IIb trial of Emricasan in reducing hepatic venous pressure gradient in patients with compensated or early decompensated liver cirrhosis caused by nonalcoholic steatohepatitis (NASH), and severe portal hypertension, dubbed ENCORE-PH, are expected to be reported next year.
- Top-line data from a phase IIb clinical trial of Emricasan evaluating potential improvements in fibrosis and steatohepatitis in patients with fibrosis caused by NASH, dubbed ENCORE-NF, are also expected next year.
- Results after 2 years of twice-daily treatment or placebo from a phase 2b trial of Emricasan, in post-orthotopic liver transplant (POLT) recipients, dubbed POLT-HCV-SVR, are expected in the first half of 2018.

6. Akers Biosciences Inc. (AKER)

Gained 10.26% to close Thursday's trading at $2.15.

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.

LOSERS

1. Pulse Biosciences Inc. (PLSE)

Lost 17.40% to close Thursday's trading at $27.02.

News: No news

Recent event:

The Company submitted a 510(k) to the FDA for its PulseTx System for a general indication for soft tissue ablation on March 14th.

The PulseTx System is based on the Company's proprietary technology called Nano-Pulse Stimulation, or NPS, and it marks Pulse Bio's first FDA 510(k) submission.

Near term catalyst:

- The Company expects to initiate the first NPS pilot study in immuno-oncology this year.

Pulse Bio featured in our Company Spotlight column on February 17, 2017 when it was trading around $12.30.

2. Rosetta Genomics Ltd. (ROSG)

Lost 16.72% to close Thursday's trading at $2.79.

News: The Company reported 2016 fourth quarter and full year financial results.

Rosetta's loss in Q4 and full year 2016 was wider-than-expected.

On a non-GAAP basis, the net loss for the fourth quarter of 2016 widened to $4.1 million or $2.32 per share from $2.7 million or $1.73 per share in the year-ago quarter. Analysts polled by Thomson Reuters expected the Company to lose $1.38 per share.

3. Tonix Pharmaceuticals Holding Corp. (TNXP)

Lost 16.70% to close Thursday's trading at $4.64.

News: The Company has offered to sell 1.8 million shares of its common stock to the public at a price of $4.45 each.

The gross proceeds to Tonix from the offering are expected to be $8.01 million. The underwriters have a 45-day option to purchase up to 270,000 additional shares of common stock. The offering is expected to close on or about April 4, 2017.

4. Ritter Pharmaceuticals Inc. (RTTR)

Lost 12.50% to close Thursday's trading at $1.40, continuing its slide for the second day

News: No news

Recent event: On March 29th, 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.

5. Catalyst Biosciences Inc. (CBIO)

Lost 12.08% to close Thursday's trading at $9.24, continuing its slide for the second day.

News: No news

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. The news sent the stock soaring over 190% that day.

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.

6. Halozyme Therapeutics Inc. (HALO)

Lost 8.82% to close Thursday's trading at $13.03.

News: The phase 1b/2 trial of Halozyme's PEGPH20 plus modified FOLFIRINOX chemotherapy versus modified FOLFIRINOX alone in patients with previously untreated metastatic pancreas cancer has been temporarily closed to enrollment.

The decision to pause the enrollment was based on the independent Data Monitoring Committee's finding that the addition of PEGPH20 given every two weeks to modified FOLFIRINOX would be unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival.

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