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Gainers & Losers Of Aug.8: FGEN, CUTR, ESPR, DEPO, DERM...

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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 8, 2017.

GAINERS

1. FibroGen Inc. (FGEN)

Gained 48.20% to close Tuesday's (Aug.8) trading at $49.50.

News: The Company reported positive results from its phase II study of Pamrevlumab in patients with idiopathic pulmonary fibrosis.

In the phase II study, Pamrevlumab met the primary efficacy endpoint of change of forced vital capacity percent predicted (FVC % predicted), a measure of change in lung volume, from baseline to week 48 of the study.

2. Cutera Inc. (CUTR)

Gained 21.01% to close Tuesday's trading at $32.25.

News: The Company reported strong Q2, 2017 financial results and increased its earnings and revenue outlook for full year 2017.

The Company reported a net income of $1.95 million or $0.13 per share compared to a net loss of $1.23 million or $0.09 per share in the year-ago quarter. Revenue for the recent second quarter rose to $36.4 million from $27.5 million in the year earlier quarter.

Looking ahead to full year 2017, the Company now expects EPS to range between $0.50 and $0.54 on revenue range of $144 million to $147 million. Previously, the Company was expecting EPS to range between $0.45 and $0.50 on revenue of about $140 million.

3. Esperion Therapeutics Inc. (ESPR)

Gained 15.41% to close Tuesday's trading at $52.13.

News: The Company announced positive top-line results from its phase II study evaluating the LDL-C lowering efficacy and safety of the Bempedoic acid/Ezetimibe combination plus Atorvastatin against placebo in patients with hypercholesterolemia.

The six-week study met its primary endpoint of greater LDL-C lowering from baseline of 64 percent in the Bempedoic acid/Ezetimibe combination plus Atorvastatin group compared to placebo. Ninety five percent of patients receiving treatment achieved greater than or equal to 50 percent LDL-C lowering reduction and 90 percent achieved LDL-C levels of less than 70 mg/dL.

4. MyoKardia Inc. (MYOK)

The stock rallied for the second straight day, gaining 15.10% to close Tuesday's trading at $36.20.

News: No news

Recent event:

On August 7, 2017, the Company reported positive topline data from the first patient cohort of its phase II study of Mavacamten in symptomatic, obstructive hypertrophic cardiomyopathy patients, dubbed PIONEER-HCM. The news sent the stock soaring over 83% that day.

5. Fluidigm Corp. (FLDM)

Gained 14.02% to close Tuesday's trading at $3.09, erasing yesterday's loss.

News: No news

Recent event:

On August 3, 2017, the Company reported financial results for the second quarter ended June 30, 2017.

Non-GAAP net loss for the second quarter of 2017 slightly narrowed to $9.0 million or $0.31 per share from $9.9 million or $0.34 per share for the second quarter of 2016. Revenue for the recent second quarter declined 15% to $23.9 million from $28.2 million in the second quarter of 2016.

6. Coherus Biosciences Inc. (CHRS)

Gained 8.87% to close Tuesday's trading at $13.50.

News: The Company reported Q2, 2017 results and provided corporate outlook for the years 2017 and 2018.

Net loss attributable to the Company narrowed to $55.3 million or $1.08 per share in the recent second quarter from $70.0 million or $1.72 per share for the same period in 2016. Total revenue for the second quarter of 2017 was $1.4 million, as compared to $14.1 million in the second quarter of 2016.

Near-term catalysts:

-- Anticipate resubmitting the BLA for CHS-1701 in the U.S. at the end of the fourth quarter of 2017. CHS-1701 is a biosimilar for Amgen's blockbuster drug Neulasta.
-- Anticipate European positive opinion on CHS-1701 in the first half of 2018.
-- Anticipate a decision on CHS-1420 from the PTAB on the petition for Inter Partes Review of AbbVie's U.S. Patent 9,085,619 no later than September 12, 2017. CHS-1420 is a biosimilar for AbbVie's Humira.
-- Anticipate a BLA submission for CHS-1420 in the U.S. during the first half of 2018.

7. CytomX Therapeutics Inc. (CTMX)

Gained 8.28% to close Tuesday's trading at $14.78.

News: Investors are encouraged by the Company's strong pipeline momentum.

A phase 1/2 clinical trial of CX-072 as monotherapy and in combination with Yervoy or Zelboraf in patients with all types of cancers is ongoing.

Patient enrollment is underway in a Phase 1/2 clinical trial evaluating CX-2009 as monotherapy in a subset of CD166-positive cancers.

CX-2029, a first-in-class PDC-targeting CD71 being developed by CytomX in collaboration with AbbVie, was advanced into GLP toxicology studies, resulting in a $15 million milestone payment from AbbVie to CytomX to be received during the 3Q'17.
CytomX remains on track to file an IND for CX-2029 in 2018.

LOSERS

1. Depomed Inc. (DEPO)

Lost 33.42% to close Tuesday's trading at $6.14.

News: The Company reported lackluster Q2 results and lowered its revenue guidance for the year.

On a non-GAAP basis, the Company's adjusted earnings declined to $5.48 million or $0.08 per share from $14.04 million or $0.19 per share in the year-ago quarter. Total revenues dropped to $100.5 million in the recent second quarter from $116.7 million in the comparable year-earlier period.

Looking ahead, the Company lowered its full year 2017 revenue outlook on a GAAP basis to $395 to $410 million from its prior forecast of $405 to $425 million. On a non GAAP basis, revenue forecast for the year has been lowered to $400 to $415 million range from its previous guidance of $410 to $430 million.

2. Dermira Inc. (DERM)

Lost 13.36% to close Tuesday's trading at $22.43.

News: The Company has entered into a licensing agreement with Roche. A charge of $135 million related to the acquisition of in-process research and development will be incurred by Dermira upon the closing of this agreement.

Pursuant to the agreement, Dermira will obtain exclusive, worldwide rights to develop and commercialize Lebrikizumab for atopic dermatitis and other indications for which Roche doesn't have rights.

Roche will retain certain rights, including exclusive rights to develop and promote Lebrikizumab for interstitial lung diseases, such as idiopathic pulmonary fibrosis.

Under the terms of the agreement, Dermira will make an initial payment of $80 million to Roche and payments totaling $55 million in 2018. Dermira will also be obligated to make additional payments upon the achievement of certain milestones, comprising $40 million upon the initiation of Dermira's first Phase 3 clinical study, up to $210 million upon the achievement of regulatory and first commercial sale milestones in certain territories and up to $1.025 billion based on the achievement of certain thresholds for net sales of Lebrikizumab for indications other than interstitial lung disease.

The transaction is expected to close in the third quarter of 2017.

Dermira plans to initiate a Phase 2b dose-ranging study assessing Lebrikizumab in adult patients with moderate-to-severe atopic dermatitis in the first quarter of 2018.

3. Kura Oncology Inc. (KURA)

Lost 13.04% to close Tuesday's trading at $9.00.

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

Net loss for the second quarter of 2017 was $7.8 million or $0.40 per share compared to a net loss of $6.7 million or $0.36 per share for the second quarter of 2016. No revenues have been generated.

Near-term catalysts:

-- Additional data from phase II trial of Tipifarnib in HRAS mutant head and neck squamous cell carcinomas expected in the second half of 2017.
-- Additional data from phase II trial of Tipifarnib in Peripheral T-cell Lymphoma anticipated in the second half of 2017.
-- Data from phase II trials of Tipifarnib in myelodysplastic syndromes (MDS) and in chronic myelomonocytic leukemia (CMML) expected in the first half of 2018.

4. Novelion Therapeutics Inc. (NVLN)

Lost 12.26% to close Tuesday's trading at $8.09.

News: The Company has lowered its revenue outlook for 2017.

Total net revenue for full year 2017 is expected to be between $135 million and $145 million compared to the prior range of between $155 million and $165 million.

5. Gemphire Therapeutics Inc. (GEMP)

Lost 11.38% to close Tuesday's trading at $8.80. This is the second straight day of loss for the stock.

News: No news

Recent event:

On August 7, 2017, the Company reported top-line results from phase 2b trial of Gemcabene in hypercholesterolemia patients, dubbed ROYAL-1. The stock lost nearly 47% of its value that day.

In ROYAL-1, Gemcabene met the primary endpoint and demonstrated a statistically significant lowering in LDL-C, but the magnitude of LDL-C lowering was less than observed in certain prior studies of Gemcabene.

Near-term catalysts:

-- Top-line results from phase 2b trial of Gemcabene in subjects with severe hypertriglyceridemia, dubbed INDIGO-1, are targeted for the first quarter of 2018 based on current pace of enrollment.
-- Initiate phase 2 clinical development program of Gemcabene in nonalcoholic steatohepatitis, known as AZURE-1, in the second half of 2017 with top-line results targeted for second half of 2018.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

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