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Gainers & Losers Of Aug.9: NTRA, ACHN, OMER, SGRY, PGNX...

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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 9, 2017.

GAINERS

1. Natera Inc. (NTRA)

Gained 26.84% to close Wednesday's (Aug.9) trading at $10.35.

News: The Company reported Q2, 2017 financial results.

Net loss for the three months ended June 30, 2017 was $27.7 million or $0.52 per share compared to net loss of $23.2 million or $0.46 per share for the same period in 2016.

Total revenues in the recent second quarter were $53.6 million compared to $52.0 million for the second quarter of 2016, an increase of 3%, driven primarily by increased volume of tests processed, partially impacted by reduced average selling price of tests.

Looking ahead to 2017, Natera anticipates total revenue to range between $210 million and $230 million. The Company generated total revenue of $217.1 million in 2016.

2. Zynerba Pharmaceuticals Inc. (ZYNE)

Gained 21.21% to close Wednesday's trading at $7.60.

News: No news

Recent event:

On Aug.7, 2017, the Company announced that its phase II study of ZYN002 cannabidiol (CBD) gel in adult epilepsy patients with refractory focal seizures, dubbed STAR 1, did not meet the primary endpoint. The news sent the stock tumbling over 55% to $6.61 that day.

Near-term catalysts:

-- Top line data from a phase II study of ZYN002 CBD gel for the treatment of osteoarthritis, dubbed STOP, are expected to be reported soon.
-- Top line data from a phase II trial of ZYN002 CBD Gel in pediatric Fragile X Syndrome patients, called FAB-C, are expected to be released in September.

3. Achillion Pharmaceuticals Inc. (ACHN)

Gained 19.95% to close Wednesday's trading at $4.81.

News: The Company reported encouraging interim results from a phase II trial of ACH-4471 in patients with untreated paroxysmal nocturnal hemoglobinuria, or PNH.

The interim trial results in four patients demonstrate ability of ACH-4471 to reduce LDH and improve hemoglobin and fatigue scores in patients with untreated PNH. Patients with PNH have elevated levels of lactate dehydrogenase (LDH).

Near-term catalysts:

-- Initiate patient dosing in a phase 2 trial of ACH-4471 for patients with low C3 levels due to C3G or immune-complex membranoproliferative glomerulonephritis (IC-MPGN) during the second half of 2017. This 14-day trial is expected to enroll approximately 10 patients.
-- Initiate a first-in-human phase 1 clinical trial with ACH-5228, which is being developed for rare diseases, by year-end 2017.
-- Results from Janssen Pharmaceuticals' OMEGA-1, a phase 2b study investigating JNJ-4178, a once-daily combination of AL-335, Odalasvir, a compound licensed from Achillion, and Simeprevir, in treatment-naive and treatment-experienced subjects with HCV genotype 1, 2, 4, 5, and 6 infection, with and without cirrhosis are anticipated during the second half of 2017.

4. Omeros Corp. (OMER)

Gained 14.64% to close Wednesday's trading at $24.90.

News: The Company's total revenue in Q2, 2017, all relating to sales of eye drug Omidria, was up 40% from Q1, 2017 and 71% from the prior year's second quarter.

For the quarter ended June 30, 2017, total revenues were $17.2 million compared to $10.0 million for the same period in 2016 and $12.3 million in Q1, 2017. Net loss in Q2, 2017 widened to $14.4 million or $0.33 per share from $12.6 million or $0.32 per share in the comparable year-ago quarter.

5. Leap Therapeutics Inc. (LPTX)

Gained 12.60% to close Wednesday's trading at $7.15.

News: No news

Recent events:

-- On June 21, 2017, the Company entered into a clinical trial collaboration agreement with Merck to investigate Leap's drug candidate DKN-01 in combination with Merck's KEYTRUDA, in patients with relapsed or refractory advanced esophagogastric cancers.

-- On June 26, 2017, Leap was added to the Russell Microcap Index.

6. ACADIA Pharmaceuticals Inc. (ACAD)

Gained 12.42% to close Wednesday's trading at $33.21.

News: The Company reported a narrower loss for the second quarter of 2017 on higher net product sales.

For the three months ended June 30, 2017, the Company's net loss shrunk to $67.4 million or $0.55 per share from $71.3 million or $0.63 per common share for the same period in 2016.

Net product sales of NUPLAZID, which was first made available for prescription starting in May 2016, were $30.5 million for the recent second quarter, up from $0.1 million in the comparable year-ago quarter.

7. Regenxbio Inc. (RGNX)

Gained 11.23% to close Wednesday's trading at $20.80.

News: The Company reported Q2, 2017 financial results and provided an update on the anticipated milestones for the year.

Net loss was $14.5 million or $0.47 per share for the three months ended June 30, 2017, compared to a net loss of $14.4 million or $0.55 per share for the three months ended June 30, 2016. Revenues were $6.6 million in the recent second quarter, up from $2.4 million in the year-ago period.

Near-term catalysts:

-- A phase I clinical trial evaluating RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) is underway and an interim update from the trial is expected to be provided by the end of 2017.
-- A phase I/II clinical trial evaluating RGX-501 for the treatment of homozygous familial hypercholesterolemia (HoFH) is ongoing - with an interim update expected by the end of 2017.

LOSERS

1. Surgery Partners Inc. (SGRY)

Lost 36.55% to close Wednesday's trading at $12.15.

News: The Company reported disappointing Q2, 2017 financial results and trimmed its revenue outlook for the year.

In the second quarter of 2017, the Company's net loss attributable to Surgery Partners was $4.5 million or $0.09 per share compared to net income of $2.1 million or $0.04 per share for the same period last year.

Total revenues for the recent second quarter decreased 0.5% to $288.4 million from $289.7 million for the second quarter of 2016.

Looking ahead to full year 2017, the Company now expects revenue in the range of $1.18 billion to $1.20 billion, which reflects 7% to 9% growth over 2016. Previously, the Company was expecting 2017 revenue growth of 9% to 11%. The revised outlook of this year reflects the recent softness in healthcare utilization and payor mix shift experienced during the second quarter.

2. ChemoCentryx Inc. (CCXI)

Lost 22.58% to close Wednesday's trading at $7.85.

News: No news

Recent event:

The Company reported Q2, 2017 financial results on August 8, 2017.

Net loss for the recent second quarter narrowed slightly to $9.2 million or $0.19 per share from $10.0 million or $0.22 per share for the same period in 2016. Revenue was $8.9 million for the second quarter of 2017 compared to $2.8 million for the same period in 2016.

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.

3. Bellicum Pharmaceuticals Inc. (BLCM)

Lost 21.24% to close Wednesday's trading at $8.43.

News: No news

Recent event:

On August 8, 2017, the Company reported Q2, 2017 financial results and provided a corporate update.

Bellicum reported a net loss of $24.5 million or $0.74 per share on nil revenue for the second quarter of 2017. This compared to a net loss of $16.5 million or $0.61 per share and grant revenue of $101 thousand in the year-ago quarter.

Pipeline:

The company's lead product candidate is BPX-501, which is being evaluated in multiple phase 1/2 clinical trials in adults and pediatric patients with leukemias, lymphomas, and genetic blood diseases in the U.S. and Europe.

Near-term catalysts:

-- Enrollment in the Phase 1/2 clinical trial of BPX-501 in children with leukemias, lymphomas, or orphan inherited blood disorders, for which HSCT (hematopoietic stem cell transplantation) is curative, dubbed EU BP-004, remains on track for completion by the end of 2017.
-- An observational trial in pediatric patients receiving transplants from matched unrelated donors (MUD) without BPX-501 is expected to be initiated in the third quarter of 2017.
-- The top-line results from the above two studies are expected in the second half of 2018, with MAA filing planned for 2019.

4. Theravance Biopharma Inc. (TBPH)

Lost 19.84% to close Wednesday's trading at $23.88.

News: The Company reported a wider loss in Q2, 2017 as product sales declined 35% from the year-ago quarter.

The net loss for the recent second quarter widened to $66.3 million or $1.27 per share from $47.2 million or $1.06 per share in the year-ago quarter. Revenue for the second quarter of 2017 was $3.5 million, primarily related to U.S. net product sales of VIBATIV, compared to $5.4 million in the year-ago quarter.

For full year 2017, the Company's guidance on operating loss excluding non-cash share-based compensation has now been revised to a range of $205.0 million to $215.0 million from its prior forecast of $195.0 million to $205.0 million.

Near-term catalysts:

-- The New Drug Application for Revefenacin for the treatment of chronic obstructive pulmonary disease (COPD) is expected to be filed in the fourth quarter of this year.
-- A phase IIIb study comparing once daily nebulized Revefenacin with Spiriva once daily delivered via the HandiHaler on lung function in subjects with COPD and a Low Peak Inspiratory Flow Rate is expected to be completed in the first quarter of 2018.
-- A phase III study of Closed Triple (the triple combination therapy of fluticasone furoate, umeclidinium, and vilanterol in a single ELLIPTA inhaler) in COPD patients is underway, with results expected this year.
-- A phase III study of the Closed Triple in patients with asthma, dubbed CAPTAIN, is scheduled for completion in 2018.
-- Data from remaining cohorts of Phase 1b study of TD-1473 in patients with ulcerative colitis are expected to be released in 2018 and data from Phase 2a study of TD-9855 in patients with neurogenic orthostatic hypotension are slated for release in first half of 2018.

5. Progenics Pharmaceuticals Inc. (PGNX)

Lost 15.35% to close Wednesday's trading at $5.13.

News: The Company reported Q2, 2017 financial results and provided business update.

Net loss attributable to Progenics for the recent second quarter was $16.6 million or $0.24 per share on revenue of $2.8 million. This compared with a net loss of $5.6 million or $0.08 per share and revenue of $8.5 million in the corresponding 2016 period.

Near-term catalyst:

-- The New Drug Application for AZEDRA for the treatment of rare and difficult-to-treat neuroendocrine tumors, pheochromocytoma and paraganglioma is expected to be submitted to the FDA in August 2017.

6. Genocea Biosciences Inc. (GNCA)

Lost 14.55% to close Wednesday's trading at $4.11.

News: The Company reported Q2, 2017 financial results.

Net loss for the recent second quarter widened to $15.4 million or $0.54 per share from $11.0 million or $0.39 per share for the same period in 2016. No revenues have been generated.

The Company had cash of $35.2 million at June 30, 2017.

7. Zogenix Inc. (ZGNX)

Lost 13.77% to close Wednesday's trading at $10.65.

News: The Company reported Q2, 2017 financial results and provided an overview of the anticipated milestones.

Total net loss for the second quarter ended June 30, 2017 widened to $23.0 million or $0.93 per share from $18.8 million or $0.76 per share in the second quarter of 2016. Total revenue for the recent second quarter rose to $7.1 million from $2.1 million in the comparable year-ago quarter.

Near-term catalysts:

-- The top-line data from Study 1 of phase III program of ZX008 in Dravet Syndrome are expected in the third quarter of 2017. The phase III program consists of two studies 1501 and 1502. The results from the combined patient population of studies 1501 and 1502 would be reported as "Study 1".
-- Enrollment of second pivotal phase III of ZX008 in Dravet Syndrome, dubbed Study 1504, is now approximately two-thirds complete. Enrollment in this study is expected to be completed in the third quarter of 2017.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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