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Gainers & Losers Of Aug.2: ONCE, ILMN, XENT, NOVN, FLKS...

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The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of August 2, 2017.

GAINERS

1. Spark Therapeutics Inc. (ONCE)

Gained 19.72% to close Wednesday's (Aug.2) trading at $79.72.

News: The Company presented encouraging preliminary interim data from its phase 1/2 trial of SPK-8011.

According to the Company, SPK-8011 has shown initial human proof-of-concept in three participants in the trial.

As of the Aug. 1, 2017 data cutoff, the first two participants, who have received a single administration of SPK-8011, have now been followed for 23 weeks and 12 weeks, respectively. During this time, there has been a steady and consistent rise in factor VIII activity levels that have now stabilized at levels of 11 percent and 14 percent of normal, respectively, noted the Company.

In the third participant, who received a higher dose of SPK-8011, although the results are too early, his factor activity level is tracking proportionally higher, consistent with the dose escalation.

To know more about Spark Therapeutics, visit our Company Spotlight column.

2. Illumina Inc. (ILMN)

Gained 14.83% to close Wednesday's trading at $197.85.

News: The Company reported better-than expected Q2, 2017 results, and rosy outlook for the year.

The non-GAAP net income attributable to Illumina stockholders for the recent second quarter was $121 million or $0.82 per share on total revenue of $662 million. This compares with a non-GAAP net income of $127 million or $0.86 per share and revenue of $600 million in the year-ago quarter. Analysts polled by Thomson Reuters were expecting earnings of $0.69 per share and revenue of $642.36 million.

Looking ahead to fiscal 2017, the company expects non-GAAP earnings per share attributable to Illumina stockholders of $3.60 to $3.70 and revenue growth of about 12%. The analysts' consensus estimates for the year call for an EPS of $3.63 and revenue growth of 10.70%.

3. Intersect ENT Inc. (XENT)

Gained 9.26% to close Wednesday's trading at $30.10.

News: The Company reported a narrower loss on higher revenue for Q2, 2017, and has raised its revenue outlook for full year 2017.

The net loss for Q2, 2017 shrunk to $2.27 million or $0.08 per share from $5.96 million or $0.21 per share in the year-ago quarter. Revenue for the recent second quarter was $24.0 million, a 24% increase over the second quarter 2016.

For the third quarter of 2017, the Company expects to achieve revenue of $21 million to $21.5 million.

Looking ahead to full year 2017, the Company has boosted its revenue outlook to $91-$93 million from the prior guidance of $89-$91 million.

4. Global Blood Therapeutics Inc. (GBT)

Gained 8.37% to close Wednesday's trading at $27.20.

News: No news

Near-term catalysts:

Global Blood's lead product candidate is GBT440, which is under a phase III trial in people with sickle cell disease. The study, dubbed HOPE, is expected to enroll up to 400 adults and adolescents with SCD who have had at least one episode of vaso-occlusive crisis (VOC) in the previous year. Top-line data from the HOPE study are anticipated in the first half of 2019.

GBT440 is also being explored as a potential treatment for acute and chronic hypoxemic pulmonary disorders.

-- A phase IIa trial of GBT440 for the treatment of hypoxemia in patients with idiopathic pulmonary fibrosis (IPF) who are on supplemental oxygen at rest, initiated last November, is underway. This study, known as ZEPHYR, is designed to enroll a total of 16 IPF patients, 45 to 80 years of age - with data expected to be announced in the second half of this year.
-- Another phase IIa trial evaluating the effect of GBT440 in adults with idiopathic pulmonary fibrosis (IPF) and hypoxemia, initiated last June, is also ongoing - with trial results expected in the second half of this year.
-- The hypoxemic program of the Company also includes an open label study evaluating the safety of GBT440 and its effect on oxygen saturation in fit healthy volunteers at rest and following maximal exercise under normoxic (normal levels of oxygen in the blood) and hypoxic conditions. This study is known as BASECAMP, and data from this trial are also anticipated in the second half of 2017.

5. Cerus Corp. (CERS)

Gained 7.66% to close Wednesday's trading at $2.39.

News: The Company has entered into an amended growth capital credit facility with Oxford Finance LLC to secure additional capital to support growth initiatives.

Under the amended facility, Cerus received an immediate $30 million loan at closing on July 31, 2017 and has the option to draw another $10 million subject to achieving a specified revenue milestone.

A portion of the proceeds from the initial $30 million loan were used to repay the outstanding term loans of approximately $17.6 million provided under the original agreement with Oxford.

6. ChemoCentryx Inc. (CCXI)

Gained 7.01% to close Wednesday's trading at $10.69.

News: No news

Pipeline:

The Company's lead drug candidate is Avacopan, which is under phase III trial in anti-neutrophil cytoplasmic auto-antibody (ANCA)-associated vasculitis, dubbed ADVOCATE.

CCX140, CCX872 and Vercirnon are the other clinical programs of the Company.

Near-term catalyst:

The Company is scheduled to release second quarter 2017 financial results after market close on Tuesday, August 8, 2017.

7. DexCom Inc. (DXCM)

Gained 6.67% to close Wednesday's trading at $71.30.

News: The Company reported better-than-expected Q2, 2017 financial results.

The non-GAAP net loss was $14.2 million or $0.16 per share on revenue of $170.6 million. Analysts polled by Thomson Reuters were expecting a loss of $0.21 per share and revenue of $166.3 million. In the year-ago second quarter, the Company incurred a non-GAAP net loss of $20.2 million or $0.24 per share and revenue of $137.3 million.

8. Agios Pharmaceuticals Inc. (AGIO)

Gained 5.10% to close Wednesday's trading at $61.64.

News: The FDA approved IDHIFA, the first oral targeted therapy, for the treatment of patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 2 (IDH2) mutations.

IDHIFA, known generically as Enasidenib, is jointly developed by Agios Pharmaceuticals Inc. (AGIO) in collaboration with Celgene Corp. (CELG).

LOSERS

1. Novan Inc. (NOVN)

Lost 17.15% to close Wednesday's trading at $4.54.

News: The Company provided an updated corporate presentation that included certain preliminary information on its financial condition at June 30, 2017.

According to the Company, cash at June 30, 2017 was $19 million.

Strengthening its balance sheet is a near-term goal to enable an increase in operating runway, said the Company.

Upcoming event:

The Company is slated to file its 10Q for Q2, 2017 on August 11, 2017.

2. AcelRx Pharmaceuticals Inc. (ACRX)

Lost 13.24% to close Wednesday's trading at $2.95. This is the second straight day of loss for the stock.

News: No news

Recent event:

On August 1, 2017, the Company provided a business update and reported financial results for Q2, 2017.

Net loss for the second quarter of 2017 widened to $13.1 million or $0.29 per share from $11.1 million or $0.24 per share for the second quarter of 2016. During the recent second quarter, AcelRx recognized revenue of $2.2 million under the collaboration agreement with Grunenthal. This compares to revenue of $1.3 million in the year-ago quarter.

Near-term catalysts:

-- Resubmit NDA for Zalviso, a patient-activated, non-invasive analgesic system for the management of moderate-to-severe acute pain in adult patients in the hospital setting, to the FDA in the fourth quarter of this year.

Zalviso is already available in the E.U. In the U.S. it was turned down by the FDA in 2014.

3. Strongbridge Biopharma plc (SBBP)

Lost 9.80% to close Wednesday's trading at $6.90.

News: No news

Near-term catalysts:

The Company will provide an update on the launch of KEVEYIS, discuss the second quarter 2017 financial results and provide corporate highlights on August 7, 2017.

The Company acquired the U.S. rights to KEVEYIS from a subsidiary of Taro Pharmaceutical Industries Ltd. last December. KEVEYIS was approved by the FDA in August 2015 to treat hyperkalemic, hypokalemic, and related variants of Primary Periodic Paralysis, which is a group of rare hereditary disorders that causes potentially severe episodes of muscle weakness and/or paralysis.

4. Flex Pharma Inc. (FLKS)

Lost 9.71% to close Wednesday's trading at $4.00.

News: The Company reported financial results for Q2, 2017 and provided an update on its clinical development and corporate activities.

Net loss for the recent second quarter was $8.8 million or $0.51 per share on total revenue of $336 thousand. Analysts polled by Thomson Reuters were expecting a loss of $0.58 per share and revenue of $520 thousand. In the second quarter of 2016, the Company had incurred a loss of $11.4 million or $0.71 per share and revenue of $113 thousand.

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