OREX - Orexigen Therapeutics, Inc. (NASDAQ Stock)

[greencat]

Making a stair pattern. Has pulled back and its at the point it needs to make the up move.

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Orexigen Therapeutics, Inc.
3344 North Torrey Pines Court
Suite 200
La Jolla, CA 92037
United States - Map
Phone: 858-875-8600
Fax: 858-875-8650
Web Site: http://www.orexigen.com

DETAILS
Index Membership: N/A
Sector: Healthcare
Industry: Drug Manufacturers - Other
Full Time Employees: 47


BUSINESS SUMMARY
Orexigen Therapeutics, Inc., a biopharmaceutical company, focusing on the development of pharmaceutical product candidates for the treatment of obesity. The company’s lead combination product candidates targeted for obesity are Contrave, which is in Phase III clinical trials, and Empatic, which is in the later stages of Phase II clinical development. It selected these two product candidates for obesity based research regarding CNS regulation of appetite and energy expenditure, as well as mechanisms in the brain that reinforce unhealthy eating behaviors. Each of these product candidates is a combination of generic drugs that is screened for synergistic CNS activity. Orexigen Therapeutics was founded in 2002 and is headquartered in La Jolla, California.


TOP INSTITUTIONAL HOLDERS

Holder Shares % Out Value* Reported
FMR LLC 2,459,214 7.09 $6,418,548 31-Mar-09
OPPENHEIMER FUNDS, INC. 1,465,640 4.23 $3,825,320 31-Mar-09
FEDERATED INVESTORS, INC. 1,182,172 3.41 $3,085,468 31-Mar-09
Barclays Global Investors UK Holdings Ltd 958,129 2.76 $2,500,716 31-Mar-09
WASATCH ADVISORS INC 858,066 2.48 $2,239,552 31-Mar-09
PRINCIPAL FINANCIAL GROUP, INC. 832,700 2.40 $2,173,347 31-Mar-09
VANGUARD GROUP, INC. (THE) 673,323 1.94 $1,757,373 31-Mar-09
FRANKLIN RESOURCES, INC 600,710 1.73 $1,567,853 31-Mar-09
ADAGE CAPITAL PARTNERS GP, L.L.C. 588,901 1.70 $1,537,031 31-Mar-09
PUTNAM INVESTMENT MANAGEMENT, LLC 394,466 1.14 $1,029,556 31-Mar-09


TOP MUTUAL FUND HOLDERS

Holder Shares % Out Value* Reported
FEDERATED KAUFMANN FUND 1,000,000 2.89 $2,840,000 30-Apr-09
FIDELITY GROWTH COMPANY FUND 677,357 1.95 $2,411,390 31-May-09
OPPENHEIMER QUEST FOR VALUE FD-OPPENHEIMER QUEST OPPORTUNITY 484,880 1.40 $1,377,059 30-Apr-09
FRANKLIN STRATEGIC SERIES-FRANKLIN BIOTECHNOLOGY DISCOVE 476,754 1.38 $1,353,981 30-Apr-09
OPPENHEIMER BALANCED FUND 334,030 .96 $871,818 31-Mar-09
FIDELITY SELECT PORTFOLIOS - BIOTECHNOLOGY 317,199 .92 $1,129,228 31-May-09
ISHARES NASDAQ BIOTECHNOLOGY INDEX FUND 315,294 .91 $1,122,446 31-May-09
ISHARES RUSSELL 2000 INDEX FD 246,798 .71 $878,600 31-May-09
PRINCIPAL SMALL CAP GROWTH FD 245,854 .71 $698,225 30-Apr-09
WASATCH SMALL CAP GROWTH FUND 225,795 .65 $589,324 31-Mar-09

[fz4fun]

Made a big move today. I was in this back in May when it was in $2-3 range. I just jumped back in on a pull-back. Tried to get in under $10 but took $10.20 as an entry point. See where it goes now.

[Klipper22]

Nice looking bottom play with the close on Friday.

[Grizzums]

wow, nice pop!

[Volatile22]

up 66% premarket on FDA news.

Orexigen® Therapeutics, Inc. (Nasdaq: OREX) announced today that following a recent meeting with senior officials in FDA's Office of New Drugs (OND), the Company received written correspondence detailing OND's design requirements for a cardiovascular outcomes trial (CVOT) for Contrave® that would address the Complete Response Letter (CRL) received in January 2011. Orexigen believes that these design requirements are reasonable and feasible and provide the certainty required to reinitiate development of Contrave. Importantly, FDA stated that "if the interim analysis meets the specified criteria to exclude an unacceptable increased cardiovascular (CV) risk, the drug could be approved." Furthermore, FDA stated that "While we still plan to convene a public advisory committee meeting to discuss topics related to obesity drug development early next year, that meeting will not impact on the advice provided in this letter and the agency will honor the advice provided."

"We have been working with clinical experts, advocacy groups, and our partner, Takeda, throughout this process and are pleased with the feedback provided by FDA that identified a very clear and feasible path forward for this important therapy," said Michael Narachi, President and CEO of Orexigen.

The most important aspects of the CVOT design outlined by FDA include that the trial be powered based on an intent-to-treat analysis, along with criteria for interpreting the results at interim and final analyses that are similar to those that are applied to diabetes drugs. Specifically, FDA advised that the trial enroll a population of overweight and obese patients with an estimated background rate of 1.0-1.5% annual risk of major CV events. In this population, the upper bound of the 95% confidence interval should exclude a hazard ratio of 2.0 and 1.4 at the interim and final analyses, respectively. Both FDA and Orexigen estimate that such a study would require approximately 87 total events by the interim analysis to enable resubmission of the NDA for approval. Orexigen estimates that the entire study would require less than 10,000 patients and less than two years from study start to the interim analysis. The Company plans to meet with the review division to finalize a protocol with the objective of initiating the CVOT in the first half of 2012, with potential approval in 2014.

Based on this new feedback from FDA outlining a clear and feasible path forward for Contrave, the Company's three near-term priorities for the program are to: (1) finalize the trial protocol with FDA; (2) re-engage with parties that expressed interest in partnering the ex-North American markets for Contrave; and (3) implement the CVOT as soon as it is able.

"In my experience, Contrave demonstrated great potential for the treatment of obesity in a broad range of patients," said Ken Fujioka, MD, director of the Nutrition and Metabolic Research Center and The Center for Weight Management at the Scripps Clinic, and investigator for the Contrave Obesity Research Program. "On behalf of those working hard to address this significant unmet need, I am pleased to see that a pragmatic approach to bringing this therapy to market appears to be taking shape."

Orexigen management will host a conference call and webcast to discuss this update today at 4:30 p.m. Eastern time. The live call may be accessed by phone by calling (866) 730-5763 (domestic) or (857) 350-1587 (international), participant code 66064656. The webcast can be accessed live on the investor relations section of the Orexigen web site at Orexigen® Therapeutics and will be archived for 14 days following the call.

[greencat]

OREX moved down and filled the gap and now I believe that OREX will move up and fill the gap at $3.00

OREX Chart




Orexigen Therapeutics, Inc.
3344 North Torrey Pines Court
Suite 200
La Jolla, CA 92037
United States - Map
Phone: 858-875-8600
Fax: 858-875-8650
Web Site: http://www.orexigen.com

DETAILS
Index Membership: N/A
Sector: Healthcare
Industry: Drug Manufacturers - Other
Full Time Employees: 47


BUSINESS SUMMARY
Orexigen Therapeutics, Inc., a biopharmaceutical company, focusing on the development of pharmaceutical product candidates for the treatment of obesity. The company’s lead combination product candidates targeted for obesity are Contrave, which is in Phase III clinical trials, and Empatic, which is in the later stages of Phase II clinical development. It selected these two product candidates for obesity based research regarding CNS regulation of appetite and energy expenditure, as well as mechanisms in the brain that reinforce unhealthy eating behaviors. Each of these product candidates is a combination of generic drugs that is screened for synergistic CNS activity. Orexigen Therapeutics was founded in 2002 and is headquartered in La Jolla, California.


TOP INSTITUTIONAL HOLDERS

Holder Shares % Out Value* Reported
FMR LLC 2,459,214 7.09 $6,418,548 31-Mar-09
OPPENHEIMER FUNDS, INC. 1,465,640 4.23 $3,825,320 31-Mar-09
FEDERATED INVESTORS, INC. 1,182,172 3.41 $3,085,468 31-Mar-09
Barclays Global Investors UK Holdings Ltd 958,129 2.76 $2,500,716 31-Mar-09
WASATCH ADVISORS INC 858,066 2.48 $2,239,552 31-Mar-09
PRINCIPAL FINANCIAL GROUP, INC. 832,700 2.40 $2,173,347 31-Mar-09
VANGUARD GROUP, INC. (THE) 673,323 1.94 $1,757,373 31-Mar-09
FRANKLIN RESOURCES, INC 600,710 1.73 $1,567,853 31-Mar-09
ADAGE CAPITAL PARTNERS GP, L.L.C. 588,901 1.70 $1,537,031 31-Mar-09
PUTNAM INVESTMENT MANAGEMENT, LLC 394,466 1.14 $1,029,556 31-Mar-09


TOP MUTUAL FUND HOLDERS

Holder Shares % Out Value* Reported
FEDERATED KAUFMANN FUND 1,000,000 2.89 $2,840,000 30-Apr-09
FIDELITY GROWTH COMPANY FUND 677,357 1.95 $2,411,390 31-May-09
OPPENHEIMER QUEST FOR VALUE FD-OPPENHEIMER QUEST OPPORTUNITY 484,880 1.40 $1,377,059 30-Apr-09
FRANKLIN STRATEGIC SERIES-FRANKLIN BIOTECHNOLOGY DISCOVE 476,754 1.38 $1,353,981 30-Apr-09
OPPENHEIMER BALANCED FUND 334,030 .96 $871,818 31-Mar-09
FIDELITY SELECT PORTFOLIOS - BIOTECHNOLOGY 317,199 .92 $1,129,228 31-May-09
ISHARES NASDAQ BIOTECHNOLOGY INDEX FUND 315,294 .91 $1,122,446 31-May-09
ISHARES RUSSELL 2000 INDEX FD 246,798 .71 $878,600 31-May-09
PRINCIPAL SMALL CAP GROWTH FD 245,854 .71 $698,225 30-Apr-09
WASATCH SMALL CAP GROWTH FUND 225,795 .65 $589,324 31-Mar-09

[greencat]

OREX-There it is. I think it will make a handle to the cup pattern...

Originally Posted by greencat

OREX moved down and filled the gap and now I believe that OREX will move up and fill the gap at $3.00

OREX Chart




Orexigen Therapeutics, Inc.
3344 North Torrey Pines Court
Suite 200
La Jolla, CA 92037
United States - Map
Phone: 858-875-8600
Fax: 858-875-8650
Web Site: http://www.orexigen.com

DETAILS
Index Membership: N/A
Sector: Healthcare
Industry: Drug Manufacturers - Other
Full Time Employees: 47


BUSINESS SUMMARY
Orexigen Therapeutics, Inc., a biopharmaceutical company, focusing on the development of pharmaceutical product candidates for the treatment of obesity. The company’s lead combination product candidates targeted for obesity are Contrave, which is in Phase III clinical trials, and Empatic, which is in the later stages of Phase II clinical development. It selected these two product candidates for obesity based research regarding CNS regulation of appetite and energy expenditure, as well as mechanisms in the brain that reinforce unhealthy eating behaviors. Each of these product candidates is a combination of generic drugs that is screened for synergistic CNS activity. Orexigen Therapeutics was founded in 2002 and is headquartered in La Jolla, California.


TOP INSTITUTIONAL HOLDERS

Holder Shares % Out Value* Reported
FMR LLC 2,459,214 7.09 $6,418,548 31-Mar-09
OPPENHEIMER FUNDS, INC. 1,465,640 4.23 $3,825,320 31-Mar-09
FEDERATED INVESTORS, INC. 1,182,172 3.41 $3,085,468 31-Mar-09
Barclays Global Investors UK Holdings Ltd 958,129 2.76 $2,500,716 31-Mar-09
WASATCH ADVISORS INC 858,066 2.48 $2,239,552 31-Mar-09
PRINCIPAL FINANCIAL GROUP, INC. 832,700 2.40 $2,173,347 31-Mar-09
VANGUARD GROUP, INC. (THE) 673,323 1.94 $1,757,373 31-Mar-09
FRANKLIN RESOURCES, INC 600,710 1.73 $1,567,853 31-Mar-09
ADAGE CAPITAL PARTNERS GP, L.L.C. 588,901 1.70 $1,537,031 31-Mar-09
PUTNAM INVESTMENT MANAGEMENT, LLC 394,466 1.14 $1,029,556 31-Mar-09


TOP MUTUAL FUND HOLDERS

Holder Shares % Out Value* Reported
FEDERATED KAUFMANN FUND 1,000,000 2.89 $2,840,000 30-Apr-09
FIDELITY GROWTH COMPANY FUND 677,357 1.95 $2,411,390 31-May-09
OPPENHEIMER QUEST FOR VALUE FD-OPPENHEIMER QUEST OPPORTUNITY 484,880 1.40 $1,377,059 30-Apr-09
FRANKLIN STRATEGIC SERIES-FRANKLIN BIOTECHNOLOGY DISCOVE 476,754 1.38 $1,353,981 30-Apr-09
OPPENHEIMER BALANCED FUND 334,030 .96 $871,818 31-Mar-09
FIDELITY SELECT PORTFOLIOS - BIOTECHNOLOGY 317,199 .92 $1,129,228 31-May-09
ISHARES NASDAQ BIOTECHNOLOGY INDEX FUND 315,294 .91 $1,122,446 31-May-09
ISHARES RUSSELL 2000 INDEX FD 246,798 .71 $878,600 31-May-09
PRINCIPAL SMALL CAP GROWTH FD 245,854 .71 $698,225 30-Apr-09
WASATCH SMALL CAP GROWTH FUND 225,795 .65 $589,324 31-Mar-09