Gainers & Losers Of July 31: SBBP, AKCA, ACRX, ICPT, ZYNE...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of July 31, 2017.

GAINERS

1. Dynavax Technologies Corp. (DVAX)

Gained 71.35% to close Monday's (July 31) trading at $15.85.

News: The Company's HEPLISAV-B, a vaccine candidate for immunization against hepatitis B infection in adults ages 18 years of age and older, has been recommended for approval by an FDA panel.

The FDA's final decision is expected by August 10, 2017.

2. Strongbridge Biopharma plc (SBBP)

Gained 16.91% to close Monday's trading at $7.95.

News: The Company announced that it 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.

3. Novan Inc. (NOVN)

Gained 12.62% to close Monday's trading at $5.98.

News: The Company will be providing an update on its activities and progress on August 2, 2017.

Pipeline: The Company's lead product candidate is SB204, a first-in-class topical for Acne, under late-stage development.

4. Akcea Therapeutics Inc. (AKCA)

Gained 7.71% to close Monday's trading at $14.39.

News: No news

Recent event:

The Company announced the closing of its IPO on July 19, 2017. Akcea shares made their debut on the NASDAQ Global Select Market on July 14, 2017, at an opening price of $8.13 each.

The gross proceeds from the offering were $143.8 million. In addition, Novartis Pharma AG purchased $50.0 million of Akcea's common stock in a separate private placement concurrent with the completion of Akcea's initial public offering at a price per share equal to the initial public offering price of $8.00 per share.

Pipeline:

The most advanced product candidate in the pipeline is Volanesorsen. The Company reported positive results from a phase III study in patients with familial chylomicronemia syndrome in March of this year.

Volanesorsen is also under a phase III trial for the treatment of familial partial lipodystrophy.

5. AcelRx Pharmaceuticals Inc. (ACRX)

Gained 6.85% to close Monday's trading at $3.90.

News: The Company will discuss the results of its phase III study of ZALVISO, a patient-activated, non-invasive analgesic system for the management of moderate-to-severe acute pain in adult patients in the hospital setting, on Tuesday, August 1, 2017.

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

Near-term catalysts:

-- FDA decision on DSUVIA (ARX-04) for treating moderate-to-severe pain is expected by October 12, 2017. -- ARX-04 is also under review in the EU, and an opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected to be rendered in the first half of 2018.

6. Foamix Pharmaceuticals Ltd. (FOMX)

Gained 6.69% to close Monday's trading at $5.26.

News: No news.

Near-term catalyst:

The Company is slated to report Q2, 2017 financial results on August 9, 2017.

7. Apollo Endosurgery Inc. (APEN)

Gained 6.47% to close Monday's trading at $6.42.

News: The Company is slated to report second quarter 2017 financial results on Tuesday, August 1, 2017 after the U.S. stock markets close.

The Company deals with less invasive medical devices for bariatric and gastrointestinal procedures.

8. LeMaitre Vascular Inc. (LMAT)

Gained 6.28% to close Monday's trading at $36.07.

News: No news

Recent event:

On July 27, the Company reported stellar Q2, 2017 results and boosted its earnings and revenue outlook for full year 2017.

The net income for Q2, 2017 was $4.63 million or $0.23 per share on sales of $25.75 million. This compares with a net income of $2.59 million or $0.14 per share and sales of $22.38 million in the year-ago quarter.

For the third quarter of 2017, the Company anticipates EPS of $0.20 and sales of $25.4 million.

For full year 2017, the Company upped its EPS outlook to $0.79 from its prior forecast of $0.70. The Company now expects sales for full year 2017 to be $101.9 million, up from its prior forecast of $100.5 million.

LOSERS

1. ImmunoGen Inc. (IMGN)

Lost 14.66% to close Monday's trading at $5.94.

News: No news

Recent event:

On July 28, 2017, the Company reported narrower-than expected Q2 results on higher revenue.

Near-term catalyst:

The Company anticipates filing an investigational new drug application for IMGN632, a CD123-targeting ADC integrating a more potent DNA-alkylating payload, intended to treat a range of hematological malignancies in Q3, 2017.

2. Clovis Oncology Inc. (CLVS)

Lost 13.48% to close Monday's trading at $84.81.

News: The Company has entered into a clinical trial collaboration agreement with Bristol-Myers Squibb Co. (BMY), as a result of which takeover rumors about Clovis appears to be losing steam. Under the clinical trial collaboration, the combination of Bristol-Myers' immunotherapy Opdivo and Clovis Oncology's FDA-approved Rubraca will be evaluated in phase II and pivotal phase III clinical trials in multiple tumor types.

Specific terms of the agreement were not disclosed. All three studies are expected to begin before the end of 2017.

3. Intercept Pharmaceuticals Inc. (ICPT)

Lost 13.26% to close Monday's trading at $117.13.

News: The Company reported positive results from a phase II clinical trial evaluating Obeticholic acid n combination with statin therapy on lipid metabolism in patients with nonalcoholic steatohepatitis, dubbed CONTROL.

The CONTROL trial is followed by a two-year long term safety extension (LTSE) open label phase which is currently ongoing.

During the ongoing LTSE phase, there has been one patient death due to acute renal and liver failure. While Intercept determined it could not be ruled out that this was possibly related to treatment, the principal investigator and the independent Data Safety Monitoring Committee determined the death was unlikely related to OCA. However, investors are spooked by the event, which led to the drop in stock price.

The Company also announced that its phase II trial evaluating obeticholic acid (OCA) for the treatment of patients with primary sclerosing cholangitis, dubbed AESOP, met its primary endpoint.

The Company also reported narrower-than-expected loss on higher-than-anticipated revenue for Q2, 2017.

The Company's net loss for Q2, 2017 was $86.56 million or $3.46 per share on total revenue of $30.88 million. This compared with a net loss of $77.3 million or $3.14 per share and total revenue of $5.52 million in the year-ago quarter.

4. Zynerba Pharmaceuticals, Inc. (ZYNE)

Lost 10.87% to close Monday's trading at $14.10.

News: No news

Pipeline:

The Company's lead product candidate is ZYN002 CBD Gel.

A phase II study of ZYN002 cannabidiol (CBD) gel in adult epilepsy patients with refractory focal seizures, dubbed STAR 1; a phase II open-label extension trial for ZYN002 CBD Gel in adult epilepsy patients, known as STAR 2; a phase II study of ZYN002 CBD gel for the treatment of osteoarthritis, dubbed STOP, and a phase II trial of ZYN002 CBD Gel in pediatric Fragile X Syndrome patients, called FAB-C, are ongoing.

Near-term catalysts:

-- Top-line data from the STAR 1 trial are expected in August of this year. -- Top-line data from the STOP trial are anticipated in the third quarter of 2017. -- Top line data from the FAB-C trial are expected to e reported in September of 2017.

5. ARCA biopharma Inc. (ABIO)

Lost 9.76% to close Monday's trading at $1.85.

News: No news

Near-term catalyst:

The Company expects the outcome of the Data and Safety Monitoring Board interim analysis of its GENETIC-AF trial to be announced this month (August).

GENETIC-AF is a phase 2B/3 double-blind, clinical superiority trial comparing the safety and efficacy of ARCA bio's investigational drug Gencaro to an approved drug TOPROL-XL for the treatment and prevention of recurrent atrial fibrillation or flutter (AF/AFL) in heart failure patients with reduced left ventricular ejection fraction (HFrEF).