Gainers & Losers Of July 17: ACRX, QDEL, AKCA, SGMO, SUPN...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of July 17, 2017.

GAINERS

1. AcelRx Pharmaceuticals Inc. (ACRX)

Gained 31.25% to close Monday's (July 17) trading at $3.15.

News: No news

Recent event:

Analyst at Jefferies Group LLC, Matthew Andrews, initiated coverage on AcelRx with a "buy" rating and a $7.00 price target last week.

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.

Another advanced product in the pipeline is Zalviso, a patient-activated, non-invasive analgesic system for the management of moderate-to-severe acute pain in adult patients in the hospital setting. Zalviso is already available in the E.U. In the U.S. it was turned down by the FDA in 2014.

-- Resubmission of Zalviso NDA to the FDA is expected by year-end.

2. Quidel Corp. (QDEL)

Gained 25.35% to close Monday's trading at $34.12.

News: The Company has agreed to acquire Triage MeterPro cardiovascular and toxicology assets and the B-type Naturietic Peptide assay business run on Beckman Coulter analyzers from Alere Inc. for a total consideration of $400 million plus $40 million in contingent consideration.

The above mentioned acquired businesses contributed revenue of $197 million in 2016. Quidel expects the transactions to close by September 30, 2017.

Near-term catalyst:

The Company is slated to report Q2 2017 earnings on July 26, 2017.

3. Aurinia Pharmaceuticals Inc. (AUPH) (AUP.TO)

Gained 10.86% to close Monday's trading at $7.45.

News: No news

Pipeline:

The company's investigational drug in focus is Voclosporin, a novel calcineurin inhibitor, which has the potential to improve near- and long-term outcomes in lupus nephritis when added to standard of care CellCept, also known as mycophenolate mofetil (MMF).

Voclosporin is under a phase III trial, dubbed AURORA. The first patient in the AURORA trial was dosed as recently as May of this year.

4. Akcea Therapeutics Inc. (AKCA)

Gained 10.55% to close Monday's trading at $10.48.

News: No news

Recent event: The Company's shares made their debut on the NASDAQ Global Select Market on July 14, 2017, at an opening price of $8.13 each.

The offering is expected to close on July 19, 2017, subject to customary closing conditions. In addition, Novartis Pharma AG has agreed to purchase $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. Impax Laboratories Inc. (IPXL)

Gained 8.06% to close Monday's trading at $18.10.

News: The FDA has approved the Company's AB rated generic Concerta Extended-Release tablets USP CII, 18, 27, 36 and 54 mg.

The product is expected to be launched by the end of this year.

Concerta XL is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65. Concerta XL had U.S sales of approximately $1.8 billion, according to IMS Health for the 12 months ending May 2017.

6. Eiger BioPharmaceuticals Inc. (EIGR)

Gained 7.57% to close Monday's trading at $9.95.

News: No news

Pipeline:

The Company's clinical programs include Lonafarnib, under phase II trial for Hepatitis Delta, the most severe form of viral hepatitis in humans; Lambda, which is also under phase II trial for Hepatitis Delta; Exendin 9-39, under phase II trial in post-bariatric hypoglycemia patients and Ubenimex, under phase II testing, in pulmonary arterial hypertension (study known as LIBERTY) and secondary lymphedema (study, dubbed ULTRA).

Near-term catalysts:

-- Lonafarnib HDV program: FDA meeting planned in the fourth quarter -- Lambda in HDV: interim data from LIMT HDV study in the fourth quarter at AASLD. -- Exendin 9-39 in PBH: initiation of Phase 2 - 28-day study in the fourth quarter of 2017 with data in the first half of 2018. -- Ubenimex in PAH: Phase 2 LIBERTY data anticipated in first quarter 2018 at JPM -- Ubenimex in Lymphedema: complete ULTRA enrollment in fourth quarter 2017; data anticipated in second quarter 2018.

LOSERS

1. Radius Health Inc. (RDUS)

Lost 9.35% to close Monday's trading at $42.97.

News: The Company announced the appointment of Jesper Høiland as its President and CEO.

Høiland replaces Robert Ward, under whose tenure, the Company successfully completed its IPO, advanced multiple pipeline assets, and obtained FDA approval for TYMLOS which was recently launched in the US.

2. Sangamo Therapeutics Inc. (SGMO)

Lost 6.93% to close Monday's trading at $9.40.

News: No news

Pipeline:

SB-525, under phase 1/2 clinical trial in adults with hemophilia A; SB-318 for Mucopolysaccharidosis (MPS) I; SB-913 for MPS II and SB-FIX for Hemophilia B, all of which are under phase 1 clinical trials.

3. Protagonist Therapeutics, Inc. (PTGX)

Lost 6.64% to close Monday's trading at $12.66.

News: No news

Pipeline: The Company's most advanced drug candidate in the pipeline is PTG-100, under phase 2b trial for the treatment of ulcerative colitis. The other clinical drug candidate of the Company is PTG-300 for the treatment of patients with chronic iron overload in rare diseases such as beta-thalassemia. A Phase 1 clinical study of PTG-300 in normal healthy volunteers was initiated in May of this year.

Near-term catalysts:

-- An interim analysis of the phase 2b trial of PTG-100 is expected to be completed in the second half of this year. -- Complete the Phase 1 clinical study of PTG-300 in 2017. -- Initiate a phase I study of PTG-200 in Crohn's Disease this year.

4. Reata Pharmaceuticals Inc. (RETA)

Lost 5.87% to close Monday's trading at $31.41.

News: No news

The Company's lead product candidates are Bardoxolone methyl and Omaveloxolone.

Near-term catalysts:

-- A phase III trial of Bardoxolone methyl for the treatment of pulmonary arterial hypertension, or PAH, associated with connective tissue disease, or CTD-PAH, dubbed CATALYST, is underway. Data from CATALYST are expected to be available during the first half of 2018. -- Bardoxolone methyl is also being studied in a phase II trial, known as LARIAT, for the treatment of pulmonary hypertension due to interstitial lung disease, or PH-ILD. Data from this trial are expected to be available in the second half of 2017. -- A pivotal phase II/III trial of Bardoxolone methyl, known as CARDINAL, for the treatment of chronic kidney disease, or CKD, caused by Alport syndrome, is also ongoing. The phase II data is expected in the second half of 2017.

Omaveloxolone is under two phase II studies - one in the indication of Friedrich's ataxia, dubbed known as MOXIe, and the other in mitochondrial myopathies, known as MOTOR. Each trial consists of two parts. Positive data from part I of the MOXIe trial were reported last month.

-- Data from the first part of MOTOR are expected in the second-half of 2017. -- Initiate part 2 of MOXIe trial during the second half of 2017. -- A phase 1b/2 trial, known as REVEAL, to evaluate Omaveloxolone in combination with existing immunotherapies for the treatment of metastatic melanoma is also ongoing. Data from the 1b dose escalation portion of REVEAL are expected during the second half of 2017.

5. NovoCure Limited (NVCR)

Lost 5.22% to close Monday's trading at $18.15.

News: No news

Near-term catalysts:

-- Initiate Phase 3 pivotal trial of its proprietary therapy called TTFields in locally advanced pancreatic cancer in the second half of 2017 (TTFields, the use of electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division.) -- Initiate a Phase 3 pivotal trial of TTFields in recurrent ovarian cancer in 2018. -- Data readout from a Phase 2 pilot trial of TTFields (STELLAR trial) in mesothelioma in 2018. -- Data readout from a Phase 3 pivotal trial of TTFields (METIS trial) in brain metastases in 2020. -- Data readout from a Phase 3 pivotal trial of TTFields (LUNAR trial) in non-small cell lung cancer expected in 2021.

6. Supernus Pharmaceuticals Inc. (SUPN)

Lost 5.20% to close Monday's trading at $41.95.

News: Piper Jaffray analyst downgrades SUPN to Neutral from Overweight.

Near-term catalysts:

-- Two phase III trials for SPN-810, currently in development for Impulsive Aggression in patients aged 6 to 12 years who have ADHD, are underway. Enrollment in the trials is expected to continue through 2017. -- A phase III trial of SPN-812, currently in development for patients aged 6 to 12 years with ADHD, is expected to be initiated during the second half of 2017.