ARIA - ARIAD Pharmaceuticals Inc - Page 4

I avged down my august 3.50 calls today.
Added 6 @ .1 to the 4 I had at .7
avg now .3

10% gain!!!

Party at my place

another good day here

Up 3.65% today, up 4.6% after hours.

Couple good articles, price target of $6. Got a good pipeline and a deal with Merck. They just had some cash problems earlier this year.

http://seekingalpha.com/article/2102...ots-of-promise

http://www.thestreet.com/story/10855...s-under-5.html

ARIAD to Hold Conference Call on Monday, September 13, 2010 at 9:00 AM (ET)

Press Release Source: ARIAD Pharmaceuticals, Inc. On Friday September 10, 2010, 5:00 pm EDT
CAMBRIDGE, Mass.--(BUSINESS WIRE)--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA - News) will hold an investor conference call at 9:00 a.m. (ET) on Monday, September 13, 2010 to provide an update on the clinical development of its investigational pan-BCR-ABL inhibitor, AP24534. Harvey J. Berger, M.D., chairman and chief executive officer, will host the call along with other members of the ARIAD management team. The Company will announce the highlights in a press release to be issued before the market opens on September 13, 2010 prior to the conference call.

The live webcast can be accessed by visiting the investor relations section of the Company’s website at http://investor.ariad.com. The call can be accessed by dialing 866-730-5763 (domestic) or 857-350-1587 (international) five minutes prior to the start time and providing the pass code 10619323. A replay of the webcast will be available on the ARIAD website approximately two hours after completion of the call and will be archived for four weeks.


This is probably why it went up

ARIAD Announces Initiation of Ponatinib (AP24534) Pivotal Trial in Drug-Resistant or Intolerant Chronic Myeloid Leukemia
~ Registration trial for approval of ponatinib in CML

~ Regulatory agency agreement secured for trial design

~ Conference call today at 9:00 a.m. ET

Press Release Source: ARIAD Pharmaceuticals, Inc. On Monday September 13, 2010, 7:35 am EDT
CAMBRIDGE, Mass.--(BUSINESS WIRE)--ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA - News) today announced the initiation of the pivotal Phase 2 clinical trial of its investigational pan-BCR-ABL inhibitor, ponatinib (previously known as AP24534), in patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia positive acute lymphoblastic leukemia (Ph+ ALL). The PACE (Ponatinib Ph+ ALL and CML Evaluation) trial is designed to provide definitive clinical data for regulatory approval of ponatinib in this setting. Ponatinib has been granted orphan drug status in both the United States and Europe for the treatment of CML and Ph+ ALL.

“The start of the pivotal PACE trial represents an important step in the development of our second molecularly targeted cancer therapy,” stated Harvey J. Berger, M.D., chairman and chief executive officer. “With the strong clinical evidence observed to date of hematologic, cytogenetic and molecular anti-leukemia activity of ponatinib in heavily pretreated patients with CML, including those patients with the T315I mutation for whom no current treatments are available, we are highly optimistic about the likelihood of success for ponatinib in this registration trial. We also believe that the time to full patient enrollment in this study and to potential regulatory approval of ponatinib will be swift.”

Trial Design

The PACE trial is a global, single-arm clinical study of oral ponatinib in 320 patients with chronic phase, accelerated phase, or blast phase CML, as well as Ph+ ALL. Patients resistant or intolerant to dasatinib (Sprycel®) or nilotinib (Tasigna®), or with T315I mutation of BCR-ABL, will be enrolled in the trial. Patients will be grouped into one of six separate cohorts based on their phase of CML (i.e., chronic, accelerated or blast) and BCR-ABL mutation status (i.e., with or without the T315I mutation); Ph+ ALL patients will be grouped with blast phase CML. A total of 160 patients with chronic phase CML will be included. The primary endpoints are major cytogenetic response rate for chronic phase patients and major hematologic response rate for accelerated or blast phase CML patients and Ph+ ALL patients. Secondary endpoints in the trial include major molecular response rate, duration of response, progression-free survival, and overall survival.

Patients will receive ponatinib in tablet form once daily at a dose of 45 mg. The PACE trial will be conducted at approximately sixty centers in North America, Europe, Australia and Asia. Full patient enrollment is anticipated by year-end 2011.

“Clinical results from the ongoing Phase 1 trial of ponatinib, taken together with the preclinical data that characterize ponatinib as a potent, pan-BCR-ABL inhibitor, provide a strong rationale for advancing directly to a pivotal trial of ponatinib in a population of patients who have extremely limited, if any, treatment options,” stated Jorge Cortes, M.D., professor and deputy chair, Department of Leukemia, The University of Texas MD Anderson Cancer Center and a leading investigator in the PACE trial. “There is great interest in the PACE trial from clinicians and patients, and I look forward to having this investigational option available for patients with this disease.”

http://finance.yahoo.com/news/ARIAD-....html?x=0&.v=1

Ariad is a winner. I recommend all to buy on the dips.

When are phase III results due? Anyone know without guessing?

They're analyzing them right now for the SUCCEED trial but no one knows the date they will release them. Many expect that they file the NDA here in the 4Q, and most of their publications say, "year-end 2010."

But they could always run in to a few issues with the data or take longer than normal to analyze it. But I think before Christmas they'll release.

ARIAD Announces Interim Results from Randomized Phase 2 Trial of Oral Ridaforolimus in Advanced Endometrial Cancer
~ Primary endpoint of progression free survival nearly doubled from 1.9 months to 3.6 months in ridaforolimus-treated group

~ Patient enrollment stopped due to improvement in PFS



Press Release Source: ARIAD Pharmaceuticals, Inc. On Monday October 25, 2010, 9:20 am

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA - News) today announced interim results of a randomized, open‐label, active-control multicenter Phase 2 study of oral ridaforolimus, an investigational mTOR inhibitor, in patients with metastatic or recurrent endometrial cancer. Based on this interim analysis, the study demonstrated a statistically significant improvement in the primary endpoint of median progression-free survival (PFS) in patients receiving single-agent ridaforolimus compared to patients receiving standard-of-care treatment. The data were presented Saturday in the Plenary Session of the 13th Biennial Meeting of the International Gynecologic Cancer Society being held in Prague, Czech Republic. Ridaforolimus is currently being developed by Merck in multiple cancer indications under an exclusive license and collaboration agreement with ARIAD.



“We are very encouraged by the data with oral ridaforolimus, which for the first time demonstrated improvement in PFS in patients with advanced endometrial cancer receiving a targeted therapy in a well-controlled clinical trial,” stated Amit Oza, M.D., professor of medicine at the Princess Margaret Hospital, Toronto, Ontario, Canada. "These results support a previous non-randomized study of ridaforolimus in the same patient population.”



The interim analysis was based on 114 patients enrolled at 39 sites in North America and Europe. Patients in the trial were randomized to receive either oral ridaforolimus (n=57), or oral progestin (n=48) or chemotherapy (n=9), both standard treatments in patients with advanced endometrial cancer. PFS was determined using RECIST (Response Evaluation Criteria In Solid Tumors) criteria based on radiologic studies conducted every two months. An independent review committee evaluated all of the radiologic studies for determination of PFS. The interim analysis demonstrated a significant improvement in the study’s primary endpoint, PFS, with a statistically significant 1.7 month difference in median PFS (ridaforolimus, 3.6 months; standard of care, 1.9 months, p=0.007) and a hazard ratio of 0.52.



The interim analysis also showed that the most common adverse events observed with ridaforolimus were mucositis (38.2%), stomatitis (21.8%) and hyperglycemia (27.3%), which have been observed in previous studies and are considered to be class effects of mTOR inhibitors. Overall, patients treated with ridaforolimus had significantly more serious adverse events (23.6%) than patients treated with the standard of care (3.8%).



"Based on these data indicating a statistically significant improvement in the trial’s primary endpoint of PFS, Merck has stopped further enrollment in the trial, while continuing to follow surviving patients,” said Eric Rubin, M.D., vice president, Oncology, Merck Research Laboratories.



About Ridaforolimus



Ridaforolimus is a targeted and potent small-molecule inhibitor of the protein mTOR. mTOR acts as a central regulator of protein synthesis, cell proliferation, cell cycle progression and cell survival, integrating signals from proteins such as PI3K, AKT and PTEN known to be important to malignancy.


http://finance.yahoo.com/news/ARIAD-....html?x=0&.v=1

ARIAD Announces Proposed Public Offering of Common Stock
Financing to support PACE pivotal trial of ponatinib in patients with resistant or intolerant CML

Updates partnering strategy for ponatinib

Press Release Source: ARIAD Pharmaceuticals, Inc. On Monday October 25, 2010, 4:07 pm EDT

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA - News) announced today that it is offering to sell 16,000,000 shares of its common stock in an underwritten public offering. Jefferies & Company, Inc. and Oppenheimer & Co. are acting as joint book-running managers for the offering. ARIAD also expects to grant the underwriters a 30-day option to purchase up to 2,400,000 shares to cover over-allotments, if any.



This funding is expected to enable ARIAD to complete patient enrollment in the pivotal Phase 2 PACE trial of oral ponatinib, ARIAD’s investigational pan BCR-ABL inhibitor; to obtain at least six-months of follow-up response data; to complete analysis of the trial; and to prepare filings for marketing authorization of ponatinib. Depending on the results of the PACE trial, ARIAD anticipates filing a new drug application for ponatinib in the second half of 2012.



Importantly, the Company anticipates that this funding will allow ARIAD to retain the substantial potential commercial value of ponatinib in multiple lines of treatment for chronic myeloid leukemia (CML) and other cancers by focusing its partnering strategy on a regional collaboration in select markets outside of the U.S. The Company does not intend to pursue a global partnership for ponatinib.



ARIAD anticipates that Merck will complete the final analysis of the Phase 3 SUCCEED trial of oral ridaforolimus, ARIAD’s investigational mTOR inhibitor, in metastatic sarcomas in the first quarter of 2011 before ARIAD executes any collaboration agreement for ponatinib. There are $65 million of potential near-term regulatory milestones related to ridaforolimus in metastatic sarcomas.



The anticipated net proceeds from the offering, together with existing cash and cash equivalents, are expected to be sufficient to fund ARIAD’s operations into the second half of 2012, which does not include the effect of any payments relating to a potential collaboration agreement on ponatinib or any regulatory or sales milestone payments the Company may receive from Merck related to ridaforolimus.


http://finance.yahoo.com/news/ARIAD-....html?x=0&.v=1


Down 7% after hours

Everyone must own Ariad. Screaming, screaming buy.

Ariad is a goddamn winner. 20% gain in a month or so on no news? I'll take that

More gains to come, boys.

ARIAD Announces Oral Ridaforolimus Achieved Primary Endpoint of Improved Progression-Free Survival in Patients with Metastatic Soft-Tissue or Bone Sarcomas in the Phase 3 SUCCEED Trial

Investor Call Today at 9:00 a.m. ET

Press Release Source: ARIAD Pharmaceuticals, Inc. On Tuesday January 18, 2011, 7:35 am EST

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA - News), today announced top-line data showing that ridaforolimus, an investigational oral mTOR inhibitor, met the primary endpoint of improved progression-free survival (PFS) compared to placebo in the Phase 3 SUCCEED trial conducted in patients with metastatic soft-tissue or bone sarcomas who previously had a favorable response to chemotherapy. Merck is currently developing ridaforolimus in multiple cancer indications under an exclusive license and collaboration agreement with ARIAD. Complete findings from the SUCCEED trial will be submitted for presentation at an upcoming medical meeting this year.

Based on the full analysis of 552 PFS events in 711 patients, determined by an independent review committee, the blinded prospective study achieved its primary endpoint, with a statistically significant (p=0.0001) 28 percent reduction by ridaforolimus in the risk of progression compared to placebo (hazard ratio=0.72). Determination of median PFS for each arm of the trial demonstrated that ridaforolimus treatment resulted in a statistically significant 21 percent (3.1 week) improvement in median PFS (ridaforolimus, 17.7 weeks vs. placebo, 14.6 weeks).

Based on the full analysis of PFS determined by the investigative sites, there also was a statistically significant (p<0.0001) 31 percent reduction by ridaforolimus in the risk of progression compared to placebo (hazard ratio=0.69). Ridaforolimus treatment resulted in a statistically significant 52 percent (7.7 week) improvement in median PFS (ridaforolimus, 22.4 weeks vs. placebo, 14.7 weeks).

The most common side effects observed in the study to date were consistent with the known safety profile of ridaforolimus and included stomatitis (e.g., mouth sores), fatigue, diarrhea and thrombocytopenia.

This trial remains active, and study participants continue to be followed to gather additional data on secondary endpoints, including overall survival and the safety profile of ridaforolimus. Merck currently plans to file for marketing approval of oral ridaforolimus in 2011, subject to final collection and analysis of all available data from the trial.

“Patients with metastatic soft-tissue and bone sarcomas have extremely limited treatment options available to them,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “These top-line data illustrate how devastating metastatic sarcomas can be, even in patients who have responded favorably to conventional chemotherapy. We are very pleased with the positive outcome of the SUCCEED trial and the statistically significant improvement in progression-free survival in those patients treated with oral ridaforolimus.”

The SUCCEED trial is a randomized (1:1), placebo-controlled, double-blind study of oral ridaforolimus administered at 40 mg/day (five of seven days/week) in patients with metastatic soft-tissue or bone sarcomas who demonstrated a favorable response to prior conventional chemotherapy. Oral ridaforolimus was granted a Special Protocol Assessment (SPA) by the U.S. Food and Drug Administration for the SUCCEED trial. The European Medicines Agency has also provided protocol advice regarding the trial design as part of its Protocol Assistance program. More information about this trial can be found at http://clinicaltrials.gov/ct2/results?term=NCT00538239.

Investor Call Today at 9:00 a.m. ET

ARIAD will hold an investor webcast to discuss the top-line results of the SUCCEED trial today, January 18, 2011 at 9:00 am ET. The live webcast can be accessed by visiting the investor relations section of ARIAD's website at http://investor.ariad.com. Investors can access the call by dialing 866-804-6928 (domestic) or 857-350-1674 (international) five minutes prior to the start time and providing the pass code 14844206. A replay of the call will be available on the ARIAD website approximately two hours after completion of the call and will be archived for three weeks.

About Sarcoma

Sarcomas are a group of cancers of connective tissue of the body for which there are currently limited treatment options. Sarcomas can arise anywhere in the body and are divided into two main groups – bone tumors and soft-tissue sarcomas.

About Ridaforolimus

Ridaforolimus is an investigational targeted and potent small-molecule inhibitor of the protein mTOR, a protein that acts as a central regulator of protein synthesis, cell proliferation, cell cycle progression and cell survival, integrating signals from proteins, such as PI3K, AKT and PTEN, known to be important to malignancy.

http://www.youtube.com/watch?v=VrdwhXNt4qw

YAY for me!

So everyone bought when I said to buy right?

Wish i signed up to HSM earlier Whats a good entry point now? Looks like its found a top

Wish I had picked this on my radar earlier. No this is not a top.