Gainers & Losers Of July 18: CAPR, NVAX, TTOO, IMUC, SBPH...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of July 18, 2017.

GAINERS:

1. Capricor Therapeutics, Inc. (CAPR)

Gained 98.57% to close Tuesday's (July 18) trading at $1.36.

News: The FDA has granted Rare Pediatric Disease Designation to CAP-1002, Capricor's development candidate for the treatment of Duchenne muscular dystrophy (DMD).

CAP-1002 is under a phase I/II study, dubbed HOPE, in DMD patients.

The Company announced positive 6-month results from the HOPE trial in April of this year. The 12-month results from the HOPE Trial are expected to be announced in the fourth quarter of 2017.

2. Novavax Inc. (NVAX)

Gained 27.19% to close Tuesday's trading at $1.45.

News: No news

Near-term catalyst:

Top line data from phase II safety and immunogenicity trial of RSV F Vaccine in older adults (60 years of age and older) will be announced on July 24, 2017, at 4:30 p.m. ET.

3. T2 Biosystems Inc. (TTOO)

Gained 12.41% to close Tuesday's trading at $2.99.

News: The Company has received a CE Mark for its T2Bacteria Panel, enabling commercialization in Europe.

The T2Bacteria Panel provides highly accurate species-specific test results of targeted bacterial infections direct from whole blood in as fast as about 3.5 hours, and without the need for a time-consuming blood culture.

In the U.S., the T2Bacteria Panel is currently available for Research Use Only (RUO) and the Company is in the final stages of completing the FDA pivotal trial, after which a 510(k) application will be submitted to the FDA.

4. uniQure N.V. (QURE)

Gained 10.34% to close Tuesday's trading at $7.15.

News: The Company has been issued a new patent covering the expression of both Rep78 and Rep52 proteins from a Rep78 nucleic acid sequence in insect cells.

The new patent significantly expands uniQure's leading intellectual property portfolio related to large-scale, highly reproducible manufacturing of AAV in insect cells.

Jonathan Garen, chief business officer for uniQure said, "With the issuance of this patent, we have significantly increased the value of our patent portfolio and advanced our leadership in the manufacturing of AAV-based gene therapies."

5. Quidel Corporation (QDEL)

Gained 9.50% to close Tuesday's trading at $37.36. This is the second straight day of gain for the stock.

Recent event:

Yesterday (July 17), the Company announced that it will be acquiring Triage MeterPro cardiovascular and toxicology assets and the B-type Naturietic Peptide assay business 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.

6. Kitov Pharmaceuticals Holdings Ltd. (KTOV)

Gained 8.89% to close Tuesday's trading at $1.47.

News: The Company announced encouraging results from a pre-clinical study of NT-219.

NT-219 is the lead drug candidate of Kitov's subsidiary TyrNovo Ltd.. According to the trial results, NT-219 in combination with Keytruda converted non-responding tumors to responders and blocked tumor progression in an immune-oncology preclinical model.

Near-term catalyst:

The company's New Drug Application for KIT-302, which was developed to simultaneously treat pain caused by osteoarthritis and hypertension, is expected to be submitted to the FDA by the end of the third quarter of 2017.

7. Puma Biotechnology Inc. (PBYI)

Gained 8.54% to close Tuesday's trading at $93.45.

News: The FDA has approved the Company's Neratinib, formerly known as PB272, for the extended adjuvant treatment of HER2-positive early stage breast cancer.

Neratinib, which will be marketed as NERLYNX, is expected to become commercially available in September 2017.

Near-term catalyst:

The European Medicines Agency's decision on Neratinib is expected this quarter (Q3, 2017).

8. Amicus Therapeutics Inc. (FOLD)

Gained 6.97% to close Tuesday's trading at $13.81.

News: The Company's previously announced offering of common stock has closed and underwriters have exercised in full their option to purchase additional shares.

The Company commenced the underwritten public offering of its common stock on July 12, 2017. The gross proceeds from the offering to Amicus are expected to be $258.8 million.

Near-term catalysts:

-- Additional data from a global Phase 1/2 clinical study of ATB200/AT2221 for Pompe Disease are expected this quarter. Positive preliminary data from this study were reported last December. -- Top line data from phase III study of SD-101 for Epidermolysis Bullosa are expected this quarter (3Q, 2017) -- Submit NDA for Migalastat, seeking accelerated approval for Fabry disease, in the fourth quarter of 2017.

Migalastat is approved under the brand name Galafold in the European Union. Approved by the European Commission on May 30, 2016, Galafold brought in sales of $4.96 million last year.

9. Seres Therapeutics Inc. (MCRB)

Gained 6.81% to close Tuesday's trading at $12.24.

News: No news

Near-term catalysts:

-- Results from Phase 1b clinical study of SER-287 in subjects with mild-to-moderate ulcerative colitis, failing first line therapies, are expected in the second half of 2017. -- Top line data from Phase 1b clinical study of SER-262 in patients with primary C. difficile infection are also expected in the second half of 2017.

10. Flex Pharma Inc. (FLKS)

Gained 6.78% to close Tuesday's trading at $3.78.

Pipeline:

The Company's lead drug candidate is FLX-787, under phase II studies for Multiple Sclerosis and Amyotrophic Lateral Sclerosis in Australia.

Near-term catalysts:

-- Initiate phase II parallel-design studies of FLX-787 for Amyotrophic Lateral Sclerosis and Charcot-Marie-Tooth in the U.S. this year. -- Data readout from the Australian exploratory phase II study of FLX-787 in Multiple Sclerosis is expected by this year-end.

LOSERS

1. ImmunoCellular Therapeutics Ltd. (IMUC)

Lost 60.66% to close Tuesday's trading at $0.48.

News: The Company has priced its underwritten public offering of 5,000 shares of its Series B 8% Mandatorily Convertible Preferred Stock and related warrants to purchase up to 9,000 shares of Preferred Stock, at a public offering price of $1,000 per share of Preferred Stock and related Warrants.

The gross proceeds from this offering are expected to be of approximately $5 million. The Offering is expected to close on July 21, 2017, subject to the satisfaction of customary closing conditions.

2. Ritter Pharmaceuticals Inc. (RTTR)

Lost 19.05% to close Tuesday's trading at $0.51.

News: No news

Near-term catalyst:

-- An end of phase II meeting with the FDA is expected to be conducted this quarter, during which the Company will discuss the results of its recently completed phase 2b/3 trial of RP-G28 for the treatment of lactose intolerance.

In the phase 2b/3 trial, the results of which were reported on March 29th, RP-G28 showed a clinically meaningful beneficial effect on patients in both symptom reduction and global patient assessments of benefit.

3. Soligenix Inc. (SNGX)

Lost 11.75% to close Tuesday's trading at $2.48.

News: No news

Pipeline:

The Company's advanced product candidates include SGX301 for the treatment of cutaneous T-cell lymphoma, which is under phase III testing; SGX942 (dusquetide) for the treatment of oral mucositis in head and neck cancer, which recently advanced into phase III testing and SGX203 for the treatment of pediatric Crohn's disease.

Near-term catalyst:

-- Data from pivotal phase III study in cutaneous T-cell lymphoma with SGX301 are expected by the end of this year.

4. Aurinia Pharmaceuticals Inc. (AUPH)

Lost 8.99% to close Tuesday's trading at $6.78.

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.

5. Spring Bank Pharmaceuticals Inc. (SBPH)

Lost 8.85% to close Tuesday's trading at $14.32

News: No news

Pipeline:

The Company's lead product candidate is SB 9200, under Phase 2a trial, for the treatment of HBV. The top-line results from this study, dubbed ACHIEVE, are anticipated in the fourth quarter of 2017.

6. Vital Therapies Inc. (VTL)

Lost 7.14% to close Tuesday's trading at $2.60.

News: No news

Near-term catalyst:

-- The top line data from a phase III study of ELAD System in subjects with severe alcoholic hepatitis, dubbed VTL-308, are anticipated around mid-2018.