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FDA NEWS RELEASE
For Immediate Release: Dec. 14, 2012
Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves Iclusig to treat two rare types of leukemia
Drug approved 3 months ahead of schedule
The U.S. Food and Drug Administration today approved Iclusig (ponatinib) to
treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome
positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow
diseases.
Iclusig is being approved more than three months ahead of the product's
prescription user fee goal date of March 27, 2013, the date the agency was
scheduled to complete review of the drug application. The FDA reviewed the
Iclusig drug application under the agency's priority review program, which
provides for an expedited six-month review for drugs that may provide safe and
effective therapy when no satisfactory alternative therapy exists, or offer
significant improvement compared to marketed products.
Iclusig blocks certain proteins that promote the development of cancerous
cells. The drug is taken once a day to treat patients with chronic,
accelerated, and blast phases of CML and Ph+ ALL whose leukemia is resistant or
intolerant to a class of drugs called tyrosine kinase inhibitors (TKIs).
Iclusig targets CML cells that have a particular mutation, known as T315I,
which makes these cells resistant to currently approved TKIs.
"The approval of Iclusig is important because it provides a treatment option
to patients with CML who are not responding to other drugs, particularly those
with the T315I mutation who have had few therapeutic options," said Richard
Pazdur, M.D., director of the Office of Hematology and Oncology Products in
FDA's Center for Drug Evaluation and Research. "Iclusig is the third drug
approved to treat CML and the second drug approved to treat ALL this year,
demonstrating FDA's commitment to approving safe and effective drugs for
patients with rare diseases."
The FDA approved Bosulif (bosutinib) in September 2012 and Synribo
(omacetaxine mepesuccinate) in October 2012 to treat various phases of CML.
Marqibo (vincristine sulfate liposome injection) was approved in August 2012 to
treat Philadelphia chromosome negative ALL.
Iclusig is being approved under the agency's accelerated approval program,
which provides patients earlier access to promising new drugs while the company
conducts additional studies to confirm the drug's clinical benefit and safe
use. The therapy is being granted an orphan product designation because it is
intended to treat a rare disease or condition.
Iclusig's safety and effectiveness were evaluated in a single clinical trial
of 449 patients with various phases of CML and Ph+ ALL. All participants were
treated with Iclusig.
Considering the labor participation rate has precipitously declined in the past three years, the jobs report is less rosy than you think. I think the unemployment rate will continue to decline as less people are in the workforce and a new barometer will be required to open eyes.
Dont underestimate the investors who see this trend.
Luckily for us ARIA (and in fact other biotechs) is actually outside this scenario and will continue to rise as FDA approval looms.
Good Luck to all.
Ariad Pharmaceuticals Inc. (NASDAQ:ARIA):
Stifel Nicolaus surveyed 35 hematology/oncology specialists, and the firm now believes that the survey indicates that ARIAD’s ponatinib in front-line CML showed significant potential. The firm believes that the company’s outlook for the drug’s selling continues to be conservative, and it keeps its Buy rating on the stock.
GLA
ASTM raised to STRONG BUY by WBB Securities July 24, 2012 9:30 am
ASTM NEWS 06/06/2012 6pm
Ixmyelocel-T Shown to Protect Heart From Damage in Murine Model of Heart Failure
Data Showing Treatment With Ixmyelocel-T Resulted in Decreased Infarct Size Presented in Poster Presentation at the 18th Annual International Society for Cellular Therapy Meeting
GlobeNewswirePress Release: Aastrom Biosciences, Inc.
ANN ARBOR, Mich., June 6, 2012 (GLOBE NEWSWIRE) -- Aastrom Biosciences, Inc. (Nasdaq:ASTM - News), the leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, today announced results from a preclinical study demonstrating the ability of ixmyelocel-T to protect the ischemic heart from damage in a murine model of heart failure. Results were presented at the 18th Annual International Society for Cellular Therapy Meeting in a poster presentation entitled "Ixmyelocel-T protects the heart from damage in a murine model of heart failure."
In a blinded, vehicle-controlled study, a murine model of non-acute left anterior descending (LAD) coronary artery occlusion was used to evaluate ixmyelocel-T as a potential treatment for dilated cardiomyopathy (DCM). Hearts were analyzed four weeks following injection and those in the treated group experienced a significant decrease in infarct length compared to the vehicle control group. The results were consistent between two lots of ixmyelocel-T (Lot 1: 2.72+/- 0.77 vs. 6.14+/- 0.43, P<0.001; Lot 2: 3.80+/- 0. 37 vs. 7.34+/- 0.47, P<0.001). Animals treated with ixmyelocel-T demonstrated a reduced mortality compared to control (22% vs. 44%) and decreased infarct size and increased survival when compared to a vehicle control group.
Ixmyelocel-T therapy is a patient-specific, expanded multicellular therapy comprised of a mixture of cell types cultured from bone marrow mononuclear cells (BMMNCs). Early studies have shown ixmyelocel-T may have positive effects on activities such as tissue remodeling, immunomodulation and the promotion of angiogenesis, which can contribute to severe, chronic cardiovascular diseases.
DCM is a progressive disease of heart muscle. It is the third most common cause of heart failure and the most frequent cause of heart transplantation. The ability of ixmyelocel-T to promote tissue salvage in preclinical trials indicates that the therapy may be protective to the ischemic heart, a cause of DCM. There is currently no accepted preclinical model for DCM.
NEW YORK (TheStreet) -- Heska Corporation (Nasdaq:HSKA) has been upgraded by TheStreet Ratings from hold to buy. The company's strengths can be seen in multiple areas, such as its expanding profit margins, solid stock price performance and notable return on equity. We feel these strengths outweigh the fact that the company has had sub par growth in net income.
Highlights from the ratings report include:
46.50% is the gross profit margin for HESKA CORP which we consider to be strong. It has increased from the same quarter the previous year. Despite the strong results of the gross profit margin, HSKA's net profit margin of 3.00% significantly trails the industry average.
Compared to its closing price of one year ago, HSKA's share price has jumped by 50.96%, exceeding the performance of the broader market during that same time frame. We feel that the stock's sharp appreciation over the last year has driven it to a price level which is now somewhat expensive compared to the rest of its industry. The other strengths this company shows, however, justify the higher price levels.
HESKA CORP's earnings per share declined by 35.3% in the most recent quarter compared to the same quarter a year ago. This company has reported somewhat volatile earnings recently. But, we feel it is poised for EPS growth in the coming year. During the past fiscal year, HESKA CORP turned its bottom line around by earning $0.40 versus -$0.05 in the prior year. This year, the market expects an improvement in earnings ($0.68 versus $0.40).
Regardless of the drop in revenue, the company managed to outperform against the industry average of 5.3%. Since the same quarter one year prior, revenues slightly dropped by 1.7%. The declining revenue appears to have seeped down to the company's bottom line, decreasing earnings per share.
The return on equity has improved slightly when compared to the same quarter one year prior. This can be construed as a modest strength in the organization. Compared to other companies in the Pharmaceuticals industry and the overall market, HESKA CORP's return on equity significantly trails that of both the industry average and the S&P 500.
..this day day shows you just how little message board posters and, by extension, small investors really know about any biotech company research.
I'm sure some believe the 4pm 600k share purchase ($9,246,000 ) at $15.41 was a mistake.
....don't get me wrong the entertainment value is certainly worth viewing IMHO.
......GLA
ARIAD started at outperform by RBC.
On to $20
GLA
first $14 9:20 am
onward
ARIAD to Trade on the NASDAQ Global Select Market
CAMBRIDGE, Mass., Jan 03, 2012 (BUSINESS WIRE) -- ARIAD Pharmaceuticals, Inc.
(ARIA) today announced that the Company has been upgraded to trade on the NASDAQ
Global Select Market, the top listing tier for NASDAQ companies with the highest
initial listing standards of any exchange in the world based on financial and
liquidity requirements. Shares of ARIAD common stock will begin trading on the
NASDAQ Global Select Market effective today.
"We are honored to be added to the NASDAQ Global Select Market as we advance our
mission of becoming a leader in the discovery, development and global
commercialization of breakthrough cancer medicines," stated Harvey J. Berger,
M.D., chairman and chief executive officer of ARIAD.
ARIAD Announces Underwriters' Exercise of Over-Allotment Option
CAMBRIDGE, Mass., Dec 16, 2011 (BUSINESS WIRE) -- ARIAD Pharmaceuticals, Inc.
(ARIA) today announced that the underwriters of its previously announced public
offering have exercised in full their option to purchase an additional 3,225,000
shares of ARIAD's common stock at a public offering price of $10.42 per share. As
a result, ARIAD will issue a total of 24,725,000 shares of common stock for total
gross proceeds of approximately $258 million. The aggregate net proceeds to ARIAD
from this offering are expected to be approximately $243 million after deducting
underwriting discounts and commissions and estimated offering expenses. ARIAD
expects to issue and deliver all 24,725,000 shares on or about December 20, 2011,
subject to customary closing conditions.
J.P. Morgan Securities LLC, Cowen and Company, LLC and Jefferies & Company, Inc.
are acting as joint book-running managers and underwriters for the offering. BMO
Capital Markets Corp., Leerink Swann LLC, Oppenheimer & Co. Inc. and Rodman &
Renshaw, LLC are acting as co-managers for the offering.
stock future.........
Believe me if the offering was at 10.42 and the stock has traded near 11 to the tune of 4 million shares in the first hour of trading someone knows 20 is in the offing.
my 20k stays here, enjoy speculating
GLA
As Warren Buffett said, “”Be Fearful When Others Are Greedy and Greedy When Others Are Fearful.”
That applies yesterday and today a swe make money her.....
GLA
It continues to amuse me the amount of overreaction to short term prices that occurs on these bulletin boards.
Only fact
Wed 9:30 am 11.22 ..........12:37 pm friday 11.63
in between many traders lost a lot of money and made a lot of money chasing the hype/bash.
GLA
phase 1/2 refers to fast track possibility............
Isnt Q3 here beginning July 1, 2011, (two weeks from now)?
June 2, 2011 7:46 AM EDT
Needham & Company maintains a 'Buy' on Aastrom Biosciences (NASDAQ: ASTM), PT $6.
Needham analyst says, "Last night, Aastrom reported 12-month results from the RCT Phase 2b RESTORE-CLI trial, evaluating the safety and efficacy of its
expanded, bone marrow-derived cellular therapy, ixmyelocel-T, in patients with critical limb ischemia (CLI). The final analysis of 86 enrolled patients showed a statistically significant improvement in time to treatment failure, the primary endpoint for the trial, as well as a benign safety profile. The detailed data including amputation free survival (primary endpoint for the upcoming pivotal trial) will likely be presented at a 4Q11 medical meeting...We believe that a series of upcoming company events may serve to drive investor interest in regenerative medicine as a whole and ASTM stock in particular."