Gainers & Losers Of Mar.9: CBAY, IMMU, TGTX, NSPR, TNDM… – RTT News

By NEVAGiles23

The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of March 9, 2017.

GAINERS

1. Ocera Therapeutics Inc. (OCRX)

Gained 71.82% to close Thursday's trading at $1.89.

News: The Company reported additional encouraging results from its Phase 2b STOP-HE study of intravenous (IV) OCR-002 in hospitalized patients with Hepatic Encephalopathy.

The initial STOP-HE results, reported in January 2017, had demonstrated highly statistically significant reduction in ammonia levels over placebo, strong evidence of benefit across multiple endpoints with higher doses (15g, 20g), clinical improvement dose trend, increased responder rate with increased dose and superiority over placebo at all doses. OCR-002 was also safe and well-tolerated.

The additional study data revealed on Thursday indicates that IV OCR-002 provided clinical benefit over placebo in other parameters as well, such as the Physician Overall Evaluation, Model for End-Stage Liver Disease (MELD) scores, and in renal function as measured by the change from baseline in Blood Urea Nitrogen (BUN) levels.

2. Cymabay Therapeutics Inc. (CBAY)

Gained 20.29% to close Thursday's trading at $4.09.

News: The Company will provide a corporate overview at the 29th Annual ROTH Conference on March 13th and at the Oppenheimer 27th Annual Healthcare Conference on March 21st.

Near-term catalysts:

- The results from phase II study of Cymabay's investigational drug Seladelpar in primary biliary cholangitis are expected in 3Q 2017. - The company's most advanced product candidate is Arhalofenate for treatment of gout, which has completed phase II studies. The drug candidate is licensed to Kowa Pharmaceuticals America, Inc. in the U.S.

Licensing discussions for other territories are underway. Ex-US licensing agreement for Arhalofenate is expected to be inked this year.

3. Neuralstem Inc. (CUR)

Gained 19.64% to close Thursday's trading at $5.30.

News: The preclinical data of the Company's NSI-566 spinal cord-derived neural stem cells in a rodent model of traumatic brain injury shows robust engraftment and long-term survival. The data are published in Journal of Neurotrauma.

NSI-566 is being explored in three indications: stroke, chronic spinal cord injury (cSCI), and Amyotrophic Lateral Sclerosis (ALS).

A phase I safety study of NSI-566 for the treatment of paralysis from chronic motor stroke is being conducted at the BaYi Brain Hospital in Beijing, China. In addition, NSI-566 was evaluated in a Phase 1 safety study to treat paralysis due to chronic spinal cord injury as well as a Phase 1 and Phase 2a risk escalation, safety trials for ALS. Subjects from all three indications are currently in long-term observational follow-up periods to continue to monitor safety and possible therapeutic benefits, according to the company.

Near-term catalyst:

-- Data from a phase II trial of NSI-189 for the treatment of major depressive disorder is expected in 3Q 2017.

4. Immunomedics Inc. (IMMU)

Gained 19.48% to close Thursday's trading at $6.01.

News: A global licensing agreement between Seattle Genetics (SGEN) and Immunomedics, worth over $2 billion, has been put on hold by a Delaware judge, following an injunction filed by venBio Select Advisor LLC, the largest shareholder of Immunomedics, to block the deal.

The license agreement between Seattle Genetics and Immunomedics was signed last month, and it involves antibody-drug conjugate, Sacituzumab govitecan, or IMMU-132.

Sacituzumab Govitecan (IMMU-132) is Immunomedics' lead investigational drug. As part of the agreement, Seattle Genetics is responsible for initiating phase III clinical trials of IMMU-132 in patients with metastatic triple-negative breast cancer (TNBC) and will be responsible for submitting the initial Biologics License Application to the FDA for accelerated approval.

VenBio is seeking to thwart the deal saying it undervalues the potential of IMMU-132. Now that a temporary restraining order has been placed on the deal, maybe there is an opportunity for a better deal.

5. Curis Inc. (CRIS)

Gained 20.78% to close Thursday's trading at $3.08.

News: The Company reported Q4 and full-year 2016 financial results and updated the progress of its pipeline.

The net loss for Q4, 2016 narrowed to $11.3 million or $0.08 per share on total revenue of $2.36 million. This compared with a net loss of $13.5 million or $0.10 per share and total revenue of $2.09 million in the year-ago period.

As for its clinical pipeline, the company noted that its phase I trial for CA-170 continues to progress on track through the dose escalation stage, and extension of the CA-170 Phase 1 study is all set to begin with enrollment of immunotherapy-nave patients in Korea and Spain, and with additional trial centers in other European countries projected to open in the second quarter.

A phase II trial of another drug candidate CUDC-907 in patients with relapsed/refractory MYC-altered diffuse large B cell lymphoma, or DLBCL , is expected to complete enrollment within the first half of this year.

6. VIVUS Inc. (VVUS)

Gained 16.35% to close Thursday's trading at $1.21.

News: The Company reported Q4 and full-year 2016 financial results.

VIVUS reversed to profit in the fourth quarter and full year of 2016 from net losses in the comparable year-ago periods.

Net income for the 2016 fourth quarter and full year was $56.6 million or $0.54 per share and $23.3 million or $0.22 per share, respectively, as compared to a net loss of $12.2 million or $0.12 per share and $93.1 million or $0.90 per share in 2015, respectively.

VIVUS had cash, cash equivalents and available-for-sale securities of $269.5 million at December 31, 2016.

The company noted that it will use its strong cash position for the acquisition and development of a new product pipeline to drive value creation for its stockholders while addressing the unmet needs of patients.

7. TG Therapeutics Inc. (TGTX)

Gained 16.26% to close Thursday's trading at $11.80. Shares of TG Therapeutics have been on the rise since announcing positive top line data from its phase III trial of TG-1101 in patients with high risk Chronic Lymphocytic Leukemia, dubbed GENUINE, on March 6, 2017.

News: The Company has priced an underwritten public offering of 5,128,206 shares of its common stock at a price of $9.75 per share.

Anticipated event: Q4 and full-year 2016 financial results and an update on business outlook for 2017 are slated to be presented on March 10, 2017.

LOSERS

1. InspireMD Inc. (NSPR)

Lost 37.56% to close Thursday's trading at $1.23.

News: The Company has priced its public offering of shares of Series C Convertible Preferred Stock, Series B warrants and Series C warrants.

Each share of Series C Convertible Preferred Stock is convertible into 4 shares of common stock at a conversion price equal to $1.60 per share. The Series B warrants have an exercise price of $2.00 per share of common stock and Series C warrants have an exercise price of $1.60 per share of common stock.

The gross proceeds from the offering are estimated to be up to $7.5 million. The offering is expected to close on or about March 14, 2017.

2. Cogentix Medical Inc. (CGNT)

Lost 13.12% to close Thursday's trading at $1.92.

News: The Company reported Q4 and full-year 2016 financial results.

Net loss for Q4 2016 widened to $18.57 million or $0.40 per share on revenue of $13.2 million. This compared with a net loss of $1.09 million or $0.04 per share and revenue of $13.64 million in the year-ago period.

3. BIOLASE Inc. (BIOL)

Lost 12.41% to close Thursday's trading at $1.20.

News: The Company reported Q4 and full-year 2016 financial results

The net loss for the fourth quarter of 2016 widened to $4.4 million or $0.07 per share as revenues declined to $13.8 million. This compared with a net loss of $2.5 million or $0.04 per share and revenue of $14.5 million in the fourth quarter of 2015.

4. Tandem Diabetes Care Inc. (TNDM)

Lost 11.63% to close Thursday's trading at $1.90.

News: The Company reported Q4 and full-year 2016 financial results.

The net loss for the fourth quarter of 2016 widened to $14.82 million or $0.48 per share as sales fell to $28.91 million. This compared with a net loss of $12.09 million or $0.40 per share and sales of $29.12 million in the fourth quarter of 2015. Tandem has also filed a registration statement on Form S-1 with the SEC relating to a proposed follow-on public offering of approximately $50 million of its common stock.

by RTT Staff Writer

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