02.02.2017 04:24:51
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Gainers & Losers Of The Day: PULM, ETRM, SMMT, BVX, ARQL...
(RTTNews) - The following are some of the biotech stocks that made their way onto the Day's Gainers & Losers' list of February 1, 2017.
GAINERS
1. Pulmatrix Inc. (PULM)
Gained 73.49% to close Wednesday's (February 1, 2017) trading at $3.73. After two consecutive days of losses, following a $5 million registered direct offering on January 30, 2017, the stock seems to be moving up.
News: No news
The closing of registered direct offering in which the company agreed to sell about 2 million shares of common stock, at a price of $2.50 per share, is expected to take place on or about February 2, 2017.
The company's most-advanced program is PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease. PUR0200 has successfully completed phase I testing.
PUR0200 is being developed by Pulmatrix in partnership with Mylan N.V (MYL). The option for non-US marketing rights to PUR0200 is retained by Mylan.
Last month, the company's drug candidate PUR1900, under preclinical testing, for treating fungal infections in the lungs of cystic fibrosis patients, was designated as a "Qualified Infectious Disease Product" by the FDA.
2. EnteroMedics Inc. (ETRM)
Gained 33.23% to close Wednesday's trading at $8.38.
News: No news
Following the Jan.5th news about the company's vBloc neurometabolic therapy having been implanted at MedStar Health in Maryland and Roper St. Francis in South Carolina, bringing the total number of institutes to have implanted the therapy to 13, the company's shares have been on a tear. The stock touched an intra-day high of $30.41 on Jan.10th, and has since given back most of its gains.
The vBloc therapy is approved for use in helping with weight loss in people aged 18 years and older who are obese. It has received FDA approval and CE Mark.
On January 18th, the company announced a $16.5 million underwritten public offering. The underwritten public offering and full exercise of over-allotment option, which brought home gross proceeds of $19.0 million closed on January 23rd.
Anticipated event: Q4 and full-year 2016 financial results scheduled for Feb.15, 2017.
3. Moleculin Biotech Inc. (MBRX)
Gained 32.58% to close Wednesday's trading at $2.36.
News: No news
Near-term catalyst: Report data from phase II trial evaluating Annamycin as a potential treatment for relapsed or refractory acute myeloid leukemia by the second half of 2017.
4. Infinity Pharmaceuticals Inc. (INFI)
Gained 21.26% to close Wednesday's trading at $2.51.
News: No news
The key drug candidate in the pipeline is IPI-549, an oral immuno-oncology compound.The company has set itself a couple of goals to be achieved this year.
Near-term catalysts:
- Present additional data from a Phase 1 study of IPI-549 in patients with advanced solid tumors later this year - Report Phase 1 data from the monotherapy dose-escalation phase as well as the IPI-549 plus Opdivo dose-escalation phase in 2017 - Complete the dose-escalation phase evaluating IPI-549 monotherapy in the first half of 2017 - Begin enrolling patients with advanced solid tumors in the monotherapy expansion cohort during the second half of 2017 - Complete the dose-escalation combination phase evaluating IPI-549 plus Opdivo in the second half of 2017 - Begin enrolling patients with non-small cell lung cancer (NSCLC), melanoma and squamous cell carcinoma of the head and neck (SCCHN) in combination expansion cohorts evaluating IPI-549 plus Opdivo in the second half of 2017.
5. Alcobra Ltd. (ADHD)
Gained 20.95% to close Wednesday's trading at $1.27.
News: No news.
Recent happenings:
The stock touched a 52 week low of $0.83 on January 17th, following the failure of its second phase III clinical trial of investigational product Metadoxine Extended Release (MDX) for the treatment of ADHD in adult patients to meet the primary endpoint.
The trial, dubbed MEASURE, did not demonstrate a statistically significant difference from placebo in the change from baseline of the investigator rating of the Conners' Adult ADHD Rating Scales.
The company reported positive top line results from the first phase III study of Metadoxine Extended Release (MDX) in adult patients with ADHD in October 2014.
6. Summit Therapeutics plc (SMMT)
Gained 13.94% to close Wednesday's trading at $11.93.
News: Following constructive end of Phase 2 meetings with the US and European regulators, the company has designed a phase III program for novel C. difficile infection antibiotic Ridinilazole.
The proposed phase III program is expected to include two trials evaluating Ridinilazole as compared to the standard of care, Vancomycin, each of which would enrol approximately 700 patients with CDI with the primary endpoint being superiority in sustained clinical response ('SCR').
The phase III trials are anticipated to start in the first half of 2018.
7. Esperion Therapeutics Inc. (ESPR)
Gained 12.05% to close Wednesday's trading at $13.58
News: No news
Near-term catalyst:
The company's lead drug candidate is Bempedoic Acid, an oral, once-daily LDL-C lowering therapy. It is under 3 phase III trials - in patients with atherosclerotic cardiovascular disease (ASCVD), heterozygous familial hypercholesterolemia (HeFH) and patients considered "statin intolerant" with hypercholesterolemia who are inadequately treated with current lipid-modifying therapies.
Top-line results from all of the pivotal studies in the phase III program are expected by mid-2018.
LOSERS
1. Catabasis Pharmaceuticals Inc. (CATB)
Lost 70.79% to close Wednesday's trading at $1.18.
News: Part B of the phase II trial evaluating Edasalonexent in Duchenne Muscular Dystrophy did not meet primary efficacy endpoint.
The Part B of the trial, dubbed Move DMD, enrolled 31 boys. The primary efficacy end point for Part B was average change from baseline to week 12 in MRI T2 measures in boys given Edasalonexent compared to placebo, and it was not met.
2. Galena Biopharma Inc. (GALE)
Lost 22.42% to close Wednesday's trading at $1.28.
News: Mark W. Schwartz has resigned from the company and its affiliates as the President, Chief Executive Officer, and member of the Board of Directors.
An interim Chief Executive Officer is expected to be appointed in the next couple of weeks. The company is also in the process of engaging an independent advisory firm to evaluate strategic alternatives to maximize stockholder value.
3. Bovie Medical Corp. (BVX)
Lost 21.16% to close Wednesday's trading at $2.98.
News: The company's sales channel partnership with Hologic for J-Plasma product line is not going to be extended when it expires at the end of February 2017.
The sales channel partnership agreement between the two companies to accelerate J-Plasma sales growth was signed last July.
Anticipated event: Q4 and full year 2016 financial results to be reported on March 9, 2017.
4. Synergy Pharmaceuticals Inc. (SGYP)
Lost 14.57% to close Wednesday's trading at $6.04.
News: The company has priced its underwritten public offering of 20.32 million shares of its common stock at $6.15 per share.
The offering is expected to close on or about February 6, 2017, subject to customary closing conditions.
5. ArQule Inc. (ARQL)
Lost 13.58% to close Wednesday's trading at $1.40.
News: No news
Near-term catalysts:
-- Full data from the initial two cohorts in phase 1 trial of ARQ 092 for Proteus syndrome expected in the early part of this year -- A phase III trial of Tivantinib for hepatocellular carcinoma is scheduled to conclude in early 2017, and top-line data is expected in the first quarter of 2017.
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