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Pfizer's Genotropin meets main goal in Phase IIIb study
Pfizer's (PFE) Genotropin growth hormone achieved the primary endpoint in a Phase IIIb study of children aged 24-30 months who are small for their age.
After 24 months, children who took Genotropin grew more than those in the untreated control group.
Eight participants suffered a combined 14 serious adverse events, of which two were related to treatment with Genotropin. The side effects were consistent with the drug's known safety profile.
looking for details on EXEL, I believe company was guiding for successful early trial halt so I guess bearish or buying op?
hi DC..yup nice boing off 12 lows coming off halt..have a few minutes this morning, swamped for a few weeks
Lockhart sounds a dovish note
Atlanta Fed chief Dennis Lockhart tries to walk back Janet Yellen's "six-months" comment on rate hikes (putting the first boost in H1 of 2015), saying that time frame is a minimum and suggesting rates won't move higher until the second half of next year.
"I think it's going to be longer than that indication ... We’re not going to flip a switch from easy money to tight money. We’re not going to flip a switch where overnight you go from one environment to a radically different environment. I don’t see that happening."
Separately, St. Louis' Jim Bullard says the FOMC hasn't talked about or committed to a specific month to end QE. “This is not a calendar-based policy - it’s a data-based policy."
ETFs: SHY, BIL, SHV, VGSH, SCHO, DTUL, SST, DTUS, TUZ
Global Geophysical files for bankruptcy, shares -57.5% premarket
Global Geophysical Services (GGS) -57.5% premarket after announcing it has filed for Chapter 11 bankruptcy due to heavy debt and will seek court approval for $60M in debtor-in-possession financing.
GGS says it nevertheless has a strong order backlog and is seeing increasing demand for its services, and its financing will provide liquidity to execute existing projects as well as enable it pursue additional programs.
GGS's foreign subsidiaries are not included in the bankruptcy filing
BODY -22%p/m..
Pre Market Movers: $INSM 13.70(-25.14%) $EXEL 5.00(-22.36%) $GCA 6.50(-18.03%) $RGSE 4.11(-12.37%) $BODY 1.46(-9.88%
EXEL -22% p/m..Exelixis price target lowered to $9 from $11 at Stifel
Stifel cut its price target on Exelixis after the company announced that a committee had determined that its Phase III trial should continue based on lack of sufficient survival benefit to halt the trial,. The firm had expected the trial to be stopped early due to efficacy. Stifel notes that trials of competing drugs have been stopped early due to favorable results. However, it thinks the final results of Exelixis' trial could still be positive and keeps a Buy rating on the shares.
http://www.theflyonthewall.com/permalinks/entry.php/EXELid1984114/EXEL-Exelixis-provides-update-on-COMET-phase--pivotal-trial-
EXEL -22% p/m..Exelixis price target lowered to $9 from $11 at Stifel
Stifel cut its price target on Exelixis after the company announced that a committee had determined that its Phase III trial should continue based on lack of sufficient survival benefit to halt the trial,. The firm had expected the trial to be stopped early due to efficacy. Stifel notes that trials of competing drugs have been stopped early due to favorable results. However, it thinks the final results of Exelixis' trial could still be positive and keeps a Buy rating on the shares.
http://www.theflyonthewall.com/permalinks/entry.php/EXELid1984114/EXEL-Exelixis-provides-update-on-COMET-phase--pivotal-trial-
INSM 30% drop..cc @ 8..Insmed says ARIKAYCE did not achieve primary endpoint in Phase 2 trial
Insmed Incorporated reported results from the company’s phase 2 clinical trial of ARIKAYCE, or liposomal amikacin for inhalation, for the treatment of patients with treatment resistant nontuberculous mycobacterial lung infections. The randomized, double-blind, placebo-controlled phase 2 clinical trial compared ARIKAYCE, added to standard of care treatment, versus standard of care treatment plus placebo, in 90 adult patients with treatment resistant NTM lung disease. Eligibility for the study required patients to have been on the American Thoracic Society/Infectious Disease Society of America guideline therapy for at least six months prior to screening and to continue to have persistently positive mycobacterial cultures. The primary efficacy endpoint of the study was a semi-quantitative measurement of the change in mycobacterial density on a seven-point scale from baseline to the end of the randomized portion of the trial. ARIKAYCE did not meet the pre-specified level for statistical significance although there was a positive trend in favor of ARIKAYCE. However, ARIKAYCE did achieve statistical significance with regard to the clinically relevant key secondary endpoint of culture conversion, with 11 out of 44 patients treated with ARIKAYCE demonstrating negative cultures by day 84 of the study as compared to 3 out of 45 patients treated with placebo. Patients receiving ARIKAYCE experienced a greater number of adverse events than those receiving placebo. All adverse events experienced with ARIKAYCE were consistent with those seen in similar patient populations receiving inhaled antibiotics. The most common side effect was laryngeal irritation. The company plans to incorporate these results into discussions with the regulatory agencies in the United States and Europe to determine next steps for ARIKAYCE. The company also intends to apply for Breakthrough Therapy Designation for ARIKAYCE in the United States based upon the culture conversion results. ;.
Insmed met 'much more meaningful' secondary endpoint, says Piper Jaffray
Piper Jaffray says Insmed's Phase 2 Study of Arikayce for nontuberculous mycobacteria met the "much more meaningful and clinically relevant" secondary endpoint of culture conversion while missing the less clinically relevant primary endpoint of sputum density. Piper says the drug works and thinks the stock could end up staying close to where it is currently given the split decision on endpoints. The firm reiterates an Overweight rating on Insmed.
http://www.theflyonthewall.com/permalinks/entry.php/INSMid1984221/INSM-Insmed-says-ARIKAYCE-did-not-achieve-primary-endpoint-in-Phase--trial
INSM 30% drop..cc @ 8..Insmed says ARIKAYCE did not achieve primary endpoint in Phase 2 trial
Insmed Incorporated reported results from the company’s phase 2 clinical trial of ARIKAYCE, or liposomal amikacin for inhalation, for the treatment of patients with treatment resistant nontuberculous mycobacterial lung infections. The randomized, double-blind, placebo-controlled phase 2 clinical trial compared ARIKAYCE, added to standard of care treatment, versus standard of care treatment plus placebo, in 90 adult patients with treatment resistant NTM lung disease. Eligibility for the study required patients to have been on the American Thoracic Society/Infectious Disease Society of America guideline therapy for at least six months prior to screening and to continue to have persistently positive mycobacterial cultures. The primary efficacy endpoint of the study was a semi-quantitative measurement of the change in mycobacterial density on a seven-point scale from baseline to the end of the randomized portion of the trial. ARIKAYCE did not meet the pre-specified level for statistical significance although there was a positive trend in favor of ARIKAYCE. However, ARIKAYCE did achieve statistical significance with regard to the clinically relevant key secondary endpoint of culture conversion, with 11 out of 44 patients treated with ARIKAYCE demonstrating negative cultures by day 84 of the study as compared to 3 out of 45 patients treated with placebo. Patients receiving ARIKAYCE experienced a greater number of adverse events than those receiving placebo. All adverse events experienced with ARIKAYCE were consistent with those seen in similar patient populations receiving inhaled antibiotics. The most common side effect was laryngeal irritation. The company plans to incorporate these results into discussions with the regulatory agencies in the United States and Europe to determine next steps for ARIKAYCE. The company also intends to apply for Breakthrough Therapy Designation for ARIKAYCE in the United States based upon the culture conversion results. ;.
Insmed met 'much more meaningful' secondary endpoint, says Piper Jaffray
Piper Jaffray says Insmed's Phase 2 Study of Arikayce for nontuberculous mycobacteria met the "much more meaningful and clinically relevant" secondary endpoint of culture conversion while missing the less clinically relevant primary endpoint of sputum density. Piper says the drug works and thinks the stock could end up staying close to where it is currently given the split decision on endpoints. The firm reiterates an Overweight rating on Insmed.
http://www.theflyonthewall.com/permalinks/entry.php/INSMid1984221/INSM-Insmed-says-ARIKAYCE-did-not-achieve-primary-endpoint-in-Phase--trial
KB Home beats by $0.02, beats on revenue
KB Home (KBH): FQ1 EPS of $0.12 beats by $0.02.
Revenue of $450.7M (+11.2% Y/Y) beats by $13.61M.
Chinese copper demand to grow for over a decade, Freeport exec says
China's copper consumption will grow for more than a decade as demand from the world's top user of the metal remains robust despite fears of an economic slowdown, a top executive at Freeport McMoRan (FCX) says.
Worries over slower growth in China, which accounts for 40% of global copper consumption, helped send prices to a 44-month low last week, down 12% YTD.
China's import volumes should remain brisk even if its GDP expansion slows to 3%-4%, while a recovery in the U.S. and European economies also should support copper consumption, FCX believes.
Kandi Technologies raises $11M in private placement
Highflier Kandi Technologies (KNDI) raises some money with the direct placement of 606K shares to two institutional investors at $18.24 each for proceeds of about $11M. As part of the deal, the company also issues those investors 90.9K warrants struck at $22.80 per share and expiring in 18 months.
Shares -4% premarket to $20.31.
EU tightening up on medical-devices, U.S. could be easing
Start-up medical-device makers have been attracted to Europe over the U.S., as the regulatory environment is more liberal in the EU.
In the latter region, for example, companies only have to show that their products are no worse than existing treatments, while in the U.S., superiority has to be proved.
"For very established treatments like heart-valve treatment, that is very difficult," says Regina Hodits of investor Wellington Partners. "The U.S. has cut itself off from certain paths of innovation with this policy."
However, things may be changing a bit, with the U.S. becoming more relaxed and the Europe becoming tighter following a breast-implant scandal. In saying that, FDA approvals tumbled 44% last year.
Volcano's iFR Modality get FDA nod
FDA clears Volcano's (VOLC) instant wave-Free Ratio. The physiologic measurement utilizes the same pressure wire and equipment used in cath labs but eliminates the injection of hyperemic agents into the patient that can stress the heart.
The regulatory approval means that 90% of the company's installed base of multi-modality systems can be upgraded.
Consensus estimates for 2014 and 2015 are a loss of $0.19/share on revenues of $415M and earnings of $0.06/share on revenues of $448M, respectively.
253 mutual funds have positions, down from 330 a year earlier.
Shares are up 3% year to date.
one lump or two? lol
Vera Bradley beats by $0.09, beats on revenue
Vera Bradley (VRA): Q4 EPS of $0.55 beats by $0.09.
Revenue of $157.5M (-3.1% Y/Y) beats by $10.64M.
Exact Sciences up 14% premarket
Shares of Exact Sciences (EXAS) are poised for an opening up move after yesterday's inadvertent posting of clinical trial results for Cologuard.
Compared to colonoscopy, the test was 92% sensitive for cancer stages I & II and 69% for precancerous polyps containing high-grade dysplasia (highest cancer risk).
The press release will be published today at 5 pm EDT.
FDA ad comm to vote on Cologuard March 27.
Consensus revenue estimates for 2014 and 2015 are $22.6M and $98.9M, respectively.
215 mutual funds have positions, up from 185 a year earlier.
Trading halted in Vera Bradley
Shares of Vera Bradley (VRA) are halted with news pending.
Orbitz Worldwide stung by Goldman Sachs downgrade
Orbitz Worldwide (OWW) is downgraded by Goldman Sachs to a Sell rating from Neutral on a valuation call.
OWW -6.2% premarket
GM bob
FedEx Corporation misses by $0.23, misses on revenue
FedEx Corporation (FDX): FQ3 EPS of $1.23 misses by $0.23.
Revenue of $11.3B (+3.2% Y/Y) misses by $160M
Alder files for $115M IPO
Alder Biopharmaceuticals has filed to raise up to $115M in an IPO on Nasdaq.
The company develops anti-bodies for treating a range of conditions, and its pipeline includes Clazakizumab, which the the company is developing with Bristol-Myers Squipp for Rheumatoid Arthritis, and ALD403 for migraines.
Alder posted losses of $20.6M in 2013.
The company intends to trade under the ticker symbol ALDR.
Kindred to float a secondary offering
Kindred Biosciences (KIN) files an S-1 for a public offering of common shares. Gross proceeds will be ~$86M.
Proceeds to be used to accelerate and expand R&D, acquisitions and for general corporate purposes.
Price unannounced but total post-offering shares will total 16,227,120.
Consensus revenue estimate for 2015 is $5.9M.
28 mutual funds have positions.
Horizon and Vidara to marry in a reverse merger
Horizon Pharma (HZNP) acquires Vidara Therapeutics in a cash-and-stock reverse merger valued at $660M.
74% of Horizon Pharma plc (the new company name) ordinary shares will be exchanged for Horizon Pharma Inc.'s common shares. Vidara will receive 26% of Horizon Pharma plc plus $200M cash.
Expected pro forma revenues for 2014 are $250M - $265M.
Timothy P. Walbert, Horizon Pharma Inc. Chairman, President and CEO will lead the new entity.
thanks..AF's comment on ICPT..http://www.thestreet.com/story/12530329/1/new-heart-safety-report-caused-intercept-pharmas-friday-night-stumble.html
ICPT -$75 a/h..was as low as $340..don't see why..must be something said on earnings call.http://www.theflyonthewall.com/permalinks/entry.php/ICPTid1944352/ICPT-NIH-says-patients-on-Intercept-drug-had-more-bad-cholesterol-WSJ-says--?symbol=ICPT
Might be cheaper in a.m. will add if needed
BODY news filing 10k late..but by months end..damn thing under 3..might be interesting
Yawnnnnn? Boring a/h..some ARO -12% out of boredom
Bounce at 1.50 support?
Yup..lol
Busy..just logged on
Ha!..interesting droppers
http://finviz.com/screener.ashx?v=211&t=COVS,AE,WRLD,AMRC
WRLD 37% short..not in yet but bids in
AMRC -18%..multiple bottom?.http://finviz.com/quote.ashx?t=AMRC&ty=c&ta=1&p=d&b=1
AE -$15+..waiting 66.66..lol
WRLD -$19..37% short..tempting
COVS -25%..why not.