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Gainers & Losers Of May 15: CBMG, ETRM, ALNY, EGRX, ONCS...

May15 051517

The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of May 15, 2017.


1. Cellular Biomedicine Group Inc. (CBMG)

Gained 62.26% to close Monday's (May 15) trading at $8.60.

News: The Company has added a second clinical trial site for its phase I clinical trial of C-CAR011 in patients with refractory Diffuse Large B-cell Lymphoma, dubbed CARD-1.

Initially designed as a single site trial, CARD-1 is being conducted at Jiangsu Provincial People's Hospital in Nanjing China. The second site where the trial will be conducted is Shanghai Tongji Hospital.

C-CAR011 is Cellular Biomedicine's proprietary anti-CD19 chimeric antigen receptor T-cell (CAR-T) construct that is entirely engineered and manufactured in the Company's own GMP manufacturing facility in China.

The Company noted that it is evaluating new interests in expanding its clinical development and CAR-T partnerships with leading hospitals in major cities in China.

The new trial will benefit patients in Shanghai and provide incremental data in safety and tolerability of C-CAR011 in more chemorefractory and aggressive DLBCL patients, according to Cellular Biomedicine.

2. EnteroMedics Inc. (ETRM)

Gained 31.18% to close Monday's trading at $6.10.

News: The Company reported Q1, 2017 financial results.

Net loss for the first quarter ended March 31, 2017 narrowed to $7.36 million or $1.27 per share from $7.41 million or $66.14 per share in the year-ago quarter.
Revenue generated from sales of obesity therapy vBloc dropped to $40 thousand in Q1, 2017 from $72 thousand in the year-ago quarter.

Analysts polled by Thomson Reuters expected the Company to incur a loss of $0.63 per share on revenue of $200 thousand.

Operating expenses declined to $7.05 million in the first quarter of 2017 from $7.57 million in the first quarter of 2016.

The Company will host a conference call on Tuesday, May 16, 2017 at 8:30 AM Eastern Time to discuss the Q1 results and to provide an update on the commercialization of vBloc Neurometabolic Therapy.

3. Ekso Bionics Holdings Inc. (EKSO)

Gained 19.63% to close Monday's trading at $1.95.

News: An interview with Thomas Looby, President and CEO of Ekso Bionics was aired on CNBC.

Ekso Bionics is a pioneer in the field of robotic exoskeletons. During the interview, the CEO provided an update on the stroke rehabilitation market.

Thomas Looby said, "In the area of stroke rehabilitation, there is a need to ignite patient neuroplasticity through repetitive motion and the Ekso GT technology is ideally positioned to meet that demand."

4. Alnylam Pharmaceuticals Inc. (ALNY)

Gained 16.26% to close Monday's trading at $66.00.

News: No news

Near-term catalysts:

-- A pivotal phase III program of Fitusiran in severe haemophilia A and B, dubbed ATLAS, is expected to be initiated early this year.
-- Top-line data from a phase III study of Patisiran in patients with hereditary ATTR amyloidosis with polyneuropathy, dubbed APOLLO, are expected to be reported in mid-2017.

5. BiondVax Pharmaceuticals Ltd. (BVXV)

Gained 15.07% to close Monday's trading at $8.40.

News: No news

Near-term catalyst:

-- Immunogenicity results from the Company's European Phase 2b clinical trial of universal flu vaccine candidate M-001 are expected by the end of Q2 2017. The company reported positive preliminary safety results from the trial last November.


Gained 14.87% to close Monday's trading at $26.50.

News: No news

The Company's lead compound is RA101495, currently under phase II program in paroxysmal nocturnal hemoglobinuria, or PNH. The phase II program consists of two studies - one conducted outside the U.S. and one conducted in the U.S.

Near-term catalyst:

-- Initial data from the two phase II studies of RA101495 in PNH are expected in mid-year 2017 and additional results at year-end.
-- A phase II trial of RA101495 in myasthenia gravis and a phase IB trial in lupus nephritis are expected to be initiated in the second half of 2017.

7. Ignyta Inc. (RXDX)

Gained 12.78% to close Monday's trading at $7.50.

News: The Company's lead compound Entrectinib has been granted Breakthrough Therapy Designation for the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric patients who have either progressed following prior therapies or who have no acceptable standard therapies.

Entrectinib is under development for solid tumors.

Near-term catalysts:

A phase II clinical trial of Entrectinib in cancer patients with "fusions" of NTRK1, NTRK2, NTRK3, ROS1, and ALK genes, dubbed STARTRK-2, is ongoing.

-- Complete TRK and ROS1 enrollment of STARTRK-2 in 3Q17
-- Announce top-line NDA registration-enabling data (after consultation with FDA) in the first half of 2018.

8. ImmunoGen Inc. (IMGN)

Gained 11.22% to close Monday's trading at $4.56.

News: No news

Near-term catalysts:

-- Initial data from phase 1b/2 trial of Mirvetuximab soravtansine in combination with Avastin, carboplatin, Doxil or Keytruda in ovarian cancer, dubbed FORWARD II, are expected in Q2, 2017.
-- Pooled data from over 100 ovarian cancer patients treated in multiple Mirvetuximab soravtansine phase 1 cohorts and data from phase I steroid eye drop expansion cohort are anticipated in Q2, 2017.
-- Initial phase I data for IMGN779 for the treatment of acute myeloid leukemia are expected in mid-2017.


1. Eagle Pharmaceuticals Inc. (EGRX)

Lost 13.60% to close Monday's trading at $82.30.

News: The Company has appointed Pete Meyers as its Chief Financial Officer, replacing David Riggs.

Riggs served as CFO of Eagle Pharma since 2013, and was instrumental in the Company's IPO.

The Company held its IPO on February 12, 2014, offering its shares at a price of $15 each.

2. OncoSec Medical Inc. (ONCS)

Lost 9.82% to close Monday's trading at $1.01.

News: No news

Recent event:

On May 10, OncoSec entered into a clinical trial collaboration and supply agreement with Merck (MRK) to evaluate the combination of OncoSec's ImmuoPulse IL-12 with Merck's anti-PD-1 therapy KEYTRUDA in a Phase II clinical trial, referred to as PISCES.

As per the agreement terms, OncoSec will sponsor and fund the study and Merck will provide KEYTRUDA. Additional details of the collaboration were not disclosed.

Near-term catalyst:

-- The Company will host its fiscal third quarter 2017 financial results conference call on Thursday, June 1 at 1:15 PM PT/4:15 PM ET.

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