Gainers & Losers Of July 25: FLKS, MYOK, SYRS, PCRX, RETA...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of July 25, 2017.

GAINERS

1. Flex Pharma Inc. (FLKS)

Gained 11.03% to close Tuesday's (July 25) trading at $4.33.

News: The Company's drug candidate FLX-787 has been granted Fast Track status to treat severe muscle cramps in patients with amyotrophic lateral sclerosis.

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 quarter. -- Data readout from the Australian exploratory phase II study of FLX-787 in Multiple Sclerosis is expected by this year-end. An exploratory phase II study of FLX-787 in Amyotrophic Lateral Sclerosis is also ongoing in Australia.

2. MyoKardia Inc. (MYOK)

Gained 7.75% to close Tuesday's trading at $15.30.

News: No news

Upcoming event:

The Company is slated to report Q2, 2017 financial results on August 7, 2017.

Near-term catalysts:

-- Top line results from a phase I single ascending dose (SAD) study of dilated cardiomyopathy candidate MYK-491 in healthy volunteers are expected in the third quarter of 2017. -- Top line data from a phase II trial of MYK-461 in symptomatic, obstructive hypertrophic cardiomyopathy, dubbed PIONEER-HCM, are expected in the third quarter of 2017. -- A phase I study of MYK-491 in dilated cardiomyopathy patients is expected to be initiated in the second half of the year.

3. Syros Pharmaceuticals Inc. (SYRS)

Gained 7.68% to close Tuesday's trading at $22.14.

News: No news

Pipeline:

The Company has two lead product candidates - SY-1425 for genomically defined subsets of patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) under phase II testing, and SY-1365 for certain solid tumors, under phase I testing.

Near-term catalyst:

-- Initial clinical data from the ongoing Phase 2 clinical trial of SY-1425 are anticipated in the fall of 2017.

LOSERS

1. Novavax Inc. (NVAX)

Lost 27.15% to close Tuesday's trading at $1.10.

News: The Company reported positive top line data from its phase II safety and immunogenicity trial of the RSV F Vaccine in older adults, new preclinical data on its RSV F Vaccine construct and additional findings from prior phase II and phase III clinical trials in older adults (E201 and E301). However, investors are not excited about the results.

A phase III trial of the RSV F Vaccine for infants via maternal immunization, dubbed Prepare, is underway.

2. Pacira Pharmaceuticals Inc. (PCRX)

Lost 12.42% to close Tuesday's trading at $42.65.

News: The Company's Exparel, an approved local anesthetic for treating postoperative pain, did not demonstrate statistical significance in a phase III femoral nerve block study in patients undergoing a lower extremity surgical procedure (total knee arthroplasty, or TKA).

Exparel is being explored as a single-dose nerve block for prolonged regional analgesia. In another study where Exparel was administered as a brachial plexus block for patients undergoing one of two upper extremity surgeries (total shoulder arthroplasty or rotator cuff repair), statistical significance for the primary endpoint of cumulative pain scores over 48 hours was achieved.

In 2014, a phase III study of Exparel in femoral nerve block for total knee arthroplasty had achieved positive results.

Based on these phase III studies, the Company will again seek FDA expansion of the Exparel label to include administration via nerve block to produce regional analgesia.

3. Achaogen Inc. (AKAO)

Lost 9.34% to close Tuesday's trading at $19.90.

News: No news

Pipeline:

The Company's lead product candidate is Plazomicin, being developed to treat serious bacterial infections due to multidrug-resistant Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE), which has successfully completed phase III trials.

Near-term catalysts:

A New Drug Application for Plazomicin is expected to be submitted to the FDA in the second half of 2017 and a Marketing Authorization Application for the same is planned for submission to the European Medicines Agency in 2018.

4. AnaptysBio Inc. (ANAB)

Lost 8.67% to close Tuesday's trading at $27.90.

News: No news

Near-term catalysts:

-- Top-line results from a phase 2a clinical trial for ANB020 in adult patients with severe peanut allergy are anticipated during the second half of 2017. -- Top-line results from a phase 2a clinical trial for ANB020 for the treatment of adults with moderate-to-severe atopic dermatitis are anticipated during the second half of 2017. -- Top-line results from a Phase 1 clinical trial in healthy volunteers in Australia in which ANB019 is being administered in single and multiple doses, through subcutaneous and intravenous routes of administration are expected during the second half of 2017. AnaptysBio plans to initiate Phase 2 studies for the treatment of two orphan inflammatory diseases, generalized pustular psoriasis and palmo-plantar pustular psoriasis, using ANB019 during 2018.

5. Reata Pharmaceuticals Inc. (RETA)

Lost 8.32% to close Tuesday's trading at $32.52.

News: The Company announced its intent to offer and sell 2.25 million shares of its Class A common stock in an underwritten public offering pursuant to an existing shelf registration statement.

Pipeline:

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 Company reported encouraging initial data from the phase II portion of the CARDINAL trial yesterday (July 24).

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 in June of this year.

-- 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.

6. Ionis Pharmaceuticals Inc. (IONS)

Lost 8.14% to close Tuesday's trading at $54.71.

News: No news

Upcoming event:

The Company is slated to report Q2, 2017 results on August 8, 2017.

7. Akcea Therapeutics Inc. (AKCA)

Lost 7.58% to close Tuesday's trading at $13.77.

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.

8. Zynerba Pharmaceuticals, Inc. (ZYNE)

Lost 7.15% to close Tuesday's trading at $17.26.

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 July/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.