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Gainers & Losers Of August 1: OXFD, ENZY, ZYNE, GERN, ACRX...

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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 1, 2017.

GAINERS

1. Oxford Immunotec Global PLC (OXFD)

Gained 14.94% to close Tuesday's (Aug.1) trading at $19.31.

News: The Company reported second quarter 2017 financial results and raised its revenue outlook for the year.

Net loss for the second quarter of 2017 widened to $16.8 million or $0.74 per share from $6.4 million or $0.29 per share in the second quarter of 2016. Revenue for the recent second quarter was $26.1 million, representing 36% growth over second quarter 2016 revenue of $19.2 million.

Looking ahead to full year 2017, the Company now expects revenue of between $103 and $106 million, up from its prior outlook range of $102 to $105 million. The revised revenue outlook represents 20% to 23% year-over-year growth.

2. Enzymotec Ltd. (ENZY)

Gained 11.24% to close Tuesday's trading at $9.40.

News: No news

Recent event:

On July 28, 2017, Enzymotec announced that Dror Israel will join the Company on August 7, 2017 and will assume the position of Vice President and Chief Financial Officer following a transition period. Israel succeeds Oren Bryan, who has served as Enzymotec's Chief Financial Officer since 2008 and will remain on board during the transitional period.

Near-term catalyst:

-- The Company is scheduled to release financial results for the second quarter ended June 30, 2017 on Wednesday, August 16, 2017, before the market opens.

3. Celldex Therapeutics Inc. (CLDX)

Gained 7.42% to close Tuesday's trading at $2.46.

News: No news

Near-term catalysts:

-- Data from phase 1 study of CDX-0158 in patients with advanced refractory gastrointestinal stromal tumors (GIST) and other KIT-positive tumors are expected by year-end 2017.
-- Enrollment in phase 1 study of CDX-014 in advanced renal cell carcinoma is expected to be completed by year-end 2017.

4. Neos Therapeutics Inc. (NEOS)

Gained 6.98% to close Tuesday's trading at $6.90.

News: No news

Near-term catalyst:

-- The Company's NDA for NT-0201, proposed for the treatment of ADHD, is under FDA review, with a decision expected on September 15, 2017.

Recent FDA approval:

In June of this year, the Company was granted approval for Cotempla XR-ODT, the first and only methylphenidate extended-release orally disintegrating tablet for the treatment of attention-deficit/hyperactivity disorder (ADHD) in patients 6 to 17 years old.

5. Zynerba Pharmaceuticals Inc. (ZYNE)

Gained 6.81% to close Tuesday's trading at $15.06.

News: The Company announced Q2, 2017 financial results and provided an overview of its recent operational highlights.

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 this month (August).
-- Top-line data from the STOP trial are also anticipated in August.
-- Top line data from the FAB-C trial are expected to e reported in September of 2017.

6. Minerva Neurosciences Inc. (NERV)

Gained 6.77% to close Tuesday's trading at $7.10.

News: No news

Near-term catalyst:

The Company is scheduled to release financial results and business updates for the second quarter of 2017 on Thursday, August 3, 2017.

LOSERS

1. Proteostasis Therapeutics Inc. (PTI)

Lost 20.77% to close Tuesday's trading at $2.25.

News: The Company's drug candidates PTI-428 and PTI-801 have progressed to longer duration studies in cystic fibrosis subjects.

In a phase 1/2 study, PTI-428 was administered together with background Orkambi or as monotherapy in CF subjects over a 14-day period (7-day dosing followed by 7-day follow-up period).

In the Phase 1 portion of Phase 1/2 study of PTI-428 study, 11 subjects in the Orkambi cohort and eight in the PTI-428 monotherapy cohort were enrolled, with each group enrolling 2 placebo subjects. All adverse events (AEs) were mild or moderate and none occurred in more than one subject.

The Company has initiated the phase II portion of the trial, enrolling CF subjects on background Orkambi taking PTI-428 or placebo for 28 days. Preliminary data is expected in Q4 2017.

A phase 1/2 study of PTI-801 has been endorsed by the Cystic Fibrosis Foundation Therapeutics Development Network (TDN) Protocol Review Committee and the European Cystic Fibrosis Society Clinical Trial Network (CTN). Screening of CF subjects for 14-day dosing in this study is in the process of being initiated, with initial data expected in Q4 2017, noted the Company.

2. Geron Corp. (GERN)

Lost 15.47% to close Tuesday's trading at $2.24.

News: The Company provided an update to its sole product candidate Imetelstat, being developed for the potential treatment of lower risk myelodysplastic syndromes and relapsed or refractory myelofibrosis by Janssen Research & Development, LLC.

Imetelstat is under two trials, dubbed IMerge and IMbark.

IMerge is a Phase 2/3 clinical trial evaluating Imetelstat in transfusion dependent patients with lower risk myelodysplastic syndromes. IMbark is a phase II trial of Imetelstat in relapsed or refractory myelofibrosis.

The part 1 of IMerge is a Phase 2, open-label, single-arm trial, originally design to enroll approximately 30 patients and Part 2 is designed to be a Phase 3, randomized, controlled trial in approximately 170 patients.

Now, the Company has decided to enroll approximately 20 additional patients in Part 1 of the trial, and enrollment into the expanded Part 1 is expected to begin in the fourth quarter of 2017.

Moreover, Janssen's decision of whether to move forward to Part 2 of IMerge will depend upon data from the expanded Part 1 of IMerge, feedback from ongoing FDA interactions and other Imetelstat program information.

As regards IMbark, Geron expects Janssen to perform an internal data review in the first quarter of 2018. The primary analysis for IMbark is expected to begin by the end of the third quarter of 2018.

3. AcelRx Pharmaceuticals Inc. (ACRX)

Lost 12.82% to close Tuesday's trading at $3.40.

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

Net loss for the second quarter of 2017 widened to $13.1 million or $0.29 per share from $11.1 million or $0.24 per share for the second quarter of 2016.
During the recent second quarter, AcelRx recognized revenue of $2.2 million under the collaboration agreement with Grunenthal. This compares to revenue of $1.3 million in the year-ago quarter.

Near-term catalysts:

-- Resubmit NDA for Zalviso, a patient-activated, non-invasive analgesic system for the management of moderate-to-severe acute pain in adult patients in the hospital setting, to the FDA in the fourth quarter of this year.

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

-- 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.

4. NantKwest Inc. (NK)

Lost 10.06% to close Tuesday's trading at $5.81.

News: The Company announced final results of a phase I clinical trial of aNK cell therapy in relapsed hematological malignancies.

The phase I study was designed to assess safety and preliminary evidence of efficacy in patients with relapsed, refractory hematological malignancies whose disease recurred after autologous hematopoietic cell transplantation (AHCT).

According to the trial results, 42% of patients exhibited a response. Two out of the 12 patients in the safety study with relapsed Hodgkin's Lymphoma and Multiple Myeloma, demonstrated durable complete response with single agent aNK therapy, and remain free of disease to date, 10 years and 2 years respectively.

5. Pulmatrix Inc. (PULM)

Lost 9.21% to close Tuesday's trading at $2.07.

News: No news

Near-term catalysts:

-- The pre-clinical data on PUR1900 targeting fungal infections for severe asthma and cystic fibrosis patients, slated to be reported in the first half of 2017, is overdue.
-- Secure a strategic partner(s) for development of PUR0200 in the U.S. Pulmatrix has an agreement with Mylan N.V. (MYL) for the development of PUR0200 outside the U.S. that was signed in June 2015.

PUR0200 is a novel dry powder formulation of a currently marketed once daily LAMA bronchodilator Spiriva HandiHaler, for the treatment of chronic obstructive pulmonary disease. PUR0200 is currently being developed in Europe based on PK bioequivalence, and the US development program is being planned.

-- Pulmatrix intends to seek a pre-IND meeting with the FDA to inform the US clinical development path for PUR0200 in the second half of 2017.

by RTTNews Staff Writer

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