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NBRV Leaps On Study Data, CSII Takes A Hit, CLVS Abuzz, New Dimension For DMTX

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The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of September 18, 2017.

GAINERS

1. Dimension Therapeutics Inc. (DMTX)

Gained 40.48% to close Monday's (Sep.18) trading at $5.90.

News: The Company has received an acquisition proposal from Ultragenyx Pharmaceutical Inc. (RARE)

Ultragenyx has proposed to acquire Dimension for $5.50 per share in cash to be effectuated via a tender offer.

On August 25, 2017, Dimension entered into a definitive merger agreement with REGENXBIO Inc, and it was supported by Dimension's Board of Directors. As of this time, Dimension's Board of Directors has not changed its recommendation in support of the merger with REGENXBIO.

Now that a new offer has come up, Dimension's Board of Directors, in consultation with its independent legal and financial advisors, will carefully review and consider the Ultragenyx proposal.

2. Nabriva Therapeutics plc (NBRV)

Gained 29.30% to close Monday's trading at $8.87.

News: The Company has reported positive top-line results from its phase III trial of Lefamulin (IV/oral) in patients with moderate to severe community acquired bacterial pneumonia.

In the trial, dubbed LEAP 1, Lefamulin (IV/oral) met all primary FDA and EMA endpoints with a favorable tolerability profile.

Related link

Keep An Eye On These Biotech Stocks This Month

3. GlycoMimetics Inc. (GLYC)

Gained 18.19% to close Monday's trading at $13.97.

News: No news

Near-term catalysts:

-- Anticipate announcing durability of response and overall survival from phase II study of GMI-1271 for treatment of adults with relapsed/refractory acute myeloid leukemia in Q4, 2017.
-- A phase III trial of Rivipansel for the treatment of vaso-occlusive crisis of sickle cell diseases is expected to complete enrollment in the second half of 2018.

4. Quidel Corporation (QDEL)

Gained 14.24% to close Monday's trading at $40.91.

News: The Company announced a revised Agreement for its pending acquisition of Alere's B-type Naturietic Peptide (BNP) Assay business run on Beckman Coulter Analyzers.

The revised agreement reflects Quidel's direct commercial responsibility for all Beckman Coulter BNP sales globally, while the business arrangement for the pending acquisition of Alere's Triage MeterPro assets is substantially unchanged.

Quidel will acquire the Triage business, including real estate for the San Diego Triage facilities, and the global BNP business for a total consideration of up to $680 million, comprised of the previously announced $400 million purchase price for the Triage business, $40 million in contingent consideration for the EEA BNP business, and $240 million in deferred consideration for the rest-of-world BNP business.

5. Arbutus Biopharma Corp. (ABUS)

Gained 13% to close Monday's trading at $5.65.

News: No news

You will find more about ABUS in our Company Spotlight column.

6. AnaptysBio Inc. (ANAB)

Gained 11.63% to close Monday's trading at $35.80.

News: No news

Near-term catalysts:

-- Top-line results from phase IIa clinical trial of ANB020 in 12 adult patients with moderate-to-severe atopic dermatitis, including an assessment of the Eczema Area and Severity Index (EASI) score, are expected during the remainder of this year.
-- Top-line results from phase IIa trial assessing the tolerance of oral food challenge before and after administration of a single dose of ANB020 or placebo in a total of 20 adult patients with severe peanut allergy are also expected during the remainder of this year.

7. Progenics Pharmaceuticals, Inc. (PGNX)

Gained 11.46% to close Monday's trading at $7.10.

News: No news

Recent event:

-- On August 31, 2017, the Company announced that all Sections of New Drug Application for AZEDRA, for the treatment of rare and difficult-to-treat neuroendocrine tumors, pheochromocytoma and paraganglioma, have been submitted to the FDA, except notification of pre-approval inspection readiness.

The third party vendor has requested additional time to prepare for pre-approval inspection of the manufacturing site.

8. Clovis Oncology Inc. (CLVS)

Gained 10.48% to close Monday's trading at $76.74.

News: No news

Near-term catalysts:

-- Clovis plans to submit a supplemental New Drug Application for Rucaparib for a second-line and later maintenance treatment indication for all women with platinum-sensitive ovarian cancer before the end of October.

Rucaparib was granted accelerated approval by the FDA for treatment of patients with deleterious BRCA mutation associated advanced ovarian cancer who have been treated with two or more chemotherapies last December.

-- Rucaparib is under review in the Europe Union, and an opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected in late 2017.
-- Several late-stage clinical trials evaluating Rucaparib in combination with Opdivo in multiple tumor types are expected to begin before the end of 2017.

9. Vascular Biogenics Ltd. (VBLT)

Gained 10.48% to close Monday's trading at $5.80.

New: No news

Near-term catalysts:

-- A final DSMC review of the Company's phase III study of VB-111 in patients with recurrent glioblastoma (rGBM), dubbed GLOBE, is expected in late September.
-- Top-line data from the GLOBE trial anticipated in Q1 2018.
-- Initiation of a phase III study of VB-111 in ovarian cancer by year-end 2017.
-- Initiation of exploratory clinical study of VB-111 in combination with a checkpoint inhibitor in lung cancer in Q1 2018.

LOSERS

1. Kala Pharmaceuticals Inc. (KALA)

Lost 12.98% to close Monday's trading at $21.99.

News: No news

Recent events:

-- On July 20, 2017, the Company made its stock debut on The NASDAQ Global Select Market at an offering price of $15.00 per share.
-- On May 1, 2017, the Company reported positive results from its confirmatory phase III trial of KPI-121 1% for the treatment of inflammation and pain in patients who have undergone cataract surgery.

Near-term catalysts:

-- The two ongoing phase III trials of KPI-121 1% in dry eye disease are expected to complete in late 2017.

2. Digirad Corp. (DRAD)

Lost 7.25% to close Monday's trading at $3.20.

News: No news

Recent event:

On August 4, 2017, the Company reported Q2, 2017 financial results and confirmed its previously announced fiscal year 2017 financial guidance.

For fiscal 2017, the Company expects to generate revenues of approximately $125 million, adjusted net income per share of between $0.10 and $0.15, and free cash flow of between $9 and $10 million.

In fiscal 2016, the Company reported revenue of $125.5 million and adjusted net income per share of $0.36.

3. Cardiovascular Systems Inc. (CSII)

Lost 7.22% to close Monday's trading at $28.25.

News: The Company expects revenue for its fiscal 2018 first-quarter, ending September 30, 2017, to be reduced on account of the impact of Hurricanes Harvey and Irma.

The hurricanes' impact is expected to reduce first-quarter revenues below the range of $52.6 million to $53.6 million provided on August 2, 2017.

A revised revenue range will be provided when more definitive information is known about the ability of employees and customers to resume normal operations, says the Company.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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