02.05.2017 04:12:52

Gainers & Losers Of May 1: VTGN, VSTM, TOCA, NTRP, AEZS...

(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of May 1, 2017.

GAINERS

1. VistaGen Therapeutics Inc. (VTGN)

Gained 12.12% to close Monday's (May, 1) trading at $2.22.

News: The Company's largest stockholder has signed a 6-month lock-up agreement.

Vistagen's largest institutional stockholder holds both common stock and substantially all (99.3%) of the Company's outstanding preferred stock.

Under the agreement, the stockholder and its affiliates agreed to not enter into any transaction involving the Company's securities during the term of the agreement, which runs through late-October 2017. The agreement covers approximately 36% of the Company's issued and outstanding equity securities on an as converted basis.

2. Verastem Inc. (VSTM)

Gained 11.34% to close Monday's trading at $2.16.

News: No news

The Company's lead drug candidate is Duvelisib.

Near-term catalyst:

- Top-line data from its phase III study of Duvelisib in patients with relapsed or refractory Chronic Lymphocytic Leukemia, dubbed DUO, are expected in mid-year 2017.

3. Tocagen Inc. (TOCA)

Gained 10.66% to close Monday's trading at $15.47.

News: No news

Recent event: On April 19, 2017, the Company announced the closing of its IPO and exercise of underwriters' option to purchase additional shares, which were sold at a price of $10.00 each.

Near-term catalyst:

Tocagen's lead product candidate is a combination of an investigational biologic, Toca 511, and an investigational small molecule, Toca FC, designed to be used together.

-- A phase 2/3 clinical trial of Toca 511 & Toca FC, for the treatment of patients with recurrent brain cancer, dubbed Toca 5, is underway. Top-line results from the phase 2 portion of the Toca 5 study are anticipated in the first half of 2018.

4. Trevena Inc. (TRVN)

Gained 8.87% to close Monday's trading at $3.56.

News: No news

Anticipated event:

Submit NDA for OLINVO for the management of moderate-to-severe acute pain in Q4, 2017.

LOSERS

1. Neurotrope Inc. (NTRP)

Lost 62.95% to close Monday's trading at $6.97.

News: The Company reported results from its phase II trial of Bryostatin-1 in patients with moderate to severe Alzheimer's disease.

In the phase II study, the pre-specified primary endpoint of Severe Impairment Battery (SIB) (used to evaluate cognition in severe dementia) was met in the Completer population, but not in the mITT population.

The modified intent-to-treat (mITT) population consisted of all patients who received study drug and had at least one efficacy/safety evaluation after 12 weeks of treatment. The Completer population consisted of those patients within the mITT population who completed the 13-week assessment.

Further analysis of the data from the phase II study is ongoing, and Neurotrope plans to present more data and analyses from this study at future medical conferences. Once all of the data and analyses have been reviewed, the Company plans to meet with the FDA to address the clinical and regulatory path forward for Bryostatin-1.

2. Aeterna Zentaris Inc. (AEZS) (AEZS.TO)

Lost 59.70% to close Monday's trading at $1.35.

News: The Company's phase III study of drug candidate Zoptrex in women with locally advanced, recurrent or metastatic endometrial cancer failed to meet key goals.

The phase III study, dubbed ZoptEC, enrolled over 500 patients, who were centrally randomized in a 1:1 ratio and received either Zoptrex or chemotherapy medication Doxorubicin intravenously, every three weeks and for up to nine cycles.

ZoptEC did not achieve its primary endpoint of demonstrating a statistically significant increase in the median period of overall survival of patients treated with Zoptrex as compared to patients treated with Doxorubicin.

3. Intra-Cellular Therapies Inc. (ITCI)

Lost 24.10% to close Monday's trading at $10.49.

News: The FDA has requested additional information to confirm findings observed in nonclinical animal toxicology studies of Lumateperone are not indicative of a safety risk associated with long term exposure in humans.

Lumateperone is the Company's lead drug candidate, being developed for the treatment of schizophrenia.

Lumateperone has been evaluated in 2 phase III studies, and both the studies have demonstrated positive results.

4. Apollo Endosurgery Inc. (APEN)

Lost 11.74% to close Monday's trading at $8.12.

News: No news

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

Recent event: On March 8, 2017, the Company reported financial results for the fourth quarter and year ended December 31, 2016.

Net loss for the fourth quarter 2016 was $19.7 million or $35.01 per share on revenue of $15.4 million. This compared with a net loss of $5.4 million or $23.98 per share and revenue of $16.5 million in the fourth quarter 2015.

5. Radius Health Inc. (RDUS)

Lost 9.62% to close Monday's trading at $35.31.

News: The Company reported wider loss for the first quarter ended March 31, 2017 due to an increase in general and administrative expenses.

The net loss for Q1, 2017 widened to $56.9 million or $1.32 per share from $40.5 million or $0.94 per share in the year-ago quarter.

Recent event: On April 28, 2017, the FDA approved the Company's TYMLOS injection for the treatment of postmenopausal women with osteoporosis at high risk for fracture.It is cautioned that because of the unknown relevance of the rodent osteosarcoma findings to humans, cumulative use of TYMLOS and parathyroid hormone analogs for more than 2 years during a patient's lifetime is not recommended. The drug is expected to be launched in the U.S. this month.

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