Showing posts with label Orexigen Therapeutics. Show all posts
Showing posts with label Orexigen Therapeutics. Show all posts

Tuesday, February 1, 2011

Baidu.com (Nasdaq:BIDU), Parexel (Nasdaq:PRXL), Orexigen (Nasdaq:OREX), AMD (NYSE:AMD) Among Big Movers Today

While most people today know about Orexigen (Nasdaq:OREX), which has dropped over 70 percent on the news their diet pill had been rejected by the FDA, other big movers today include Baidu.com (Nasdaq:BIDU), Parexel International (Nasdaq:PRXL) and Advanced Micro Devices Inc. (NYSE:AMD).

Also plunging were shares of Parexel International Corp., which fell after the pharmaceutical research contractor lowered its guidance for fiscal 2011, citing slow progress in signing new contracts with drugmakers.

Shares of Advanced Micro Devices Inc. continued to rise on Intel's (NASDAQ:INTC) chip problems and fallout from the unexpected firing of their CEO which brought the shares down.

Baidu.com continues to soar as they tripled their profit in the last quarter, beating analysts' estimates and looking good going forward.

Parexel International Corp. was trading at $20.99, dropping $2.22, or 9.56 percent, as of 3:32 PM EST. Orexion was at $2.60, plummeting $6.49, or 71.40 percent. AMD was up to $8.22, gaining $0.39, or 4.98 percent. Baidu.com was trading at $119.17, gaining $10.54, or 9.70 percent.

Orexigen Therapeutics (Nasdaq:OREX) Shares Demolished After Contrave Rejection

Shares of Orexigen Therapeutics (Nasdaq:OREX) are getting demolished today on news the Food and Drug Administration (NYSE:FDA) rejected Contrave as an obesity drug.

Orexion shares dropped over 72 percent on the day as of this writing.

It was thought that if the FDA rejected Contrave it would effectively kill the so-called obesity drug market, and it probably has.

That may be bad news for Orexigen, but probably good news for the public, as the idea you can take a pill to control weight, is ludicrous at best, as rejections of all entries in the segment have proven.

Since October alone three obesity drugs have been rejected, including Contrave.

The bottom line for all of this is the benefit of a weight-loss drug at this time is far outweighed by the inherent risk included with them. Risks related to heart valves was of particular concern, as well as some cancer appearing in rats in studies.

It will be years, if ever, before the attempt to develop an obesity drug is attempted again, as the prohibitive costs and high bar to meet is beyond the will of most companies, and largely a waste of time and money.

Orexion was trading at $2.55, dropping $6.54or 71.95 percent, as of 2:24 PM EST.

Wednesday, December 15, 2010

Amarin (Nasdaq:AMRN), Amicus (Nasdaq:FOLD), Dendreon (Nasdaq:DNDN), NPS (Nasdaq:NPSP), Orexigen (Nasdaq:OREX), Pharmasset (Nasdaq:VRUS), Best Biotech Ideas for 2011

Within the small and mid-cap biotech sector, Canaccord Genuity named its best ideas for 2011, which include Amarin (Nasdaq:AMRN), Amicus (Nasdaq:FOLD), Dendreon (Nasdaq:DNDN), NPS Pharmaceuticals (Nasdaq:NPSP), Orexigen (Nasdaq:OREX), Pharmasset (Nasdaq:VRUS) and NPS Pharmaceuticals (Nasdaq:NPSP).

Canaccord said, "We believe that small and mid-cap biotech stock performance will continue to be driven by key catalysts: late-stage clinical data, FDA decisions, and sales growth. In addition to profiling each of our Best Ideas, we are providing quick updates on many of our coverage companies, including what we expect in 2011."

Amarin: AMR101 had positive data from its first pivotal trial in patients with very triglycerides.

Amicus: Amigal for Fabry disease is in a pivotal Phase 3 trial set to yield top-line data in H2/11.

Dendreon is a Best Idea based on blockbuster sales potential for prostate cancer immunotherapy Provenge, fueled in the near term by continued manufacturing and commercial expansion as well as upcoming announcement of a European launch strategy.

NPS Pharmaceuticals is a Best Idea based on 2011 expectations of highly compelling Phase 3 data read-out for previously-validated GATTEX in short bowel syndrome as well as hormone replacement drug NPSP558 in secondary hypoparathyroidism.

Orexigen: Contrave for obesity recently received a positive FDA panel recommendation that we think paves the way for approval in 2011.

Pharmasset: Hepatitis C nuc polymerase inhibitors will be key components of future therapy, in our view. We expect key events in 2011, including: Phase 2b data and a Phase 3 start for Roche-partnered RG7128, Phase2b data for wholly owned PSI-7977, and data from Pharmasset’s proprietary all oral, two-nuc combination study of PSI-938 and PSI-7977.

Amarin closed Tuesday at $5.92, up $0.12, or 2.07 percent. Amicus closed at $4.01, up $0.03, or 0.75 percent. Dendreon ended at $36.28, down $0.28, or 0.77 percent. NPS Pharmaceuticals closed at $7.11, up $0.09, or 1.28 percent. Orexigen closed at $9.01, down $0.01, or 0.11 percent. Pharmasset was up to $47.19, gaining $0.42, or 0.90 percent.

Thursday, December 9, 2010

Orexigen's (NASDAQ:OREX) 'Contrave' Poised for Approval

After the recent positive input from an FDA panel concerning Orexigen's (NASDAQ:OREX) 'Contrave,' it was followed up by a conference call which offers more support for the probability that the drug will be approved.

Canaccord said, "Following the positive Dec. 7 FDA panel meeting, OREX hosted a conference call and provided additional details that strengthen our belief Orexigen is well prepared to navigate the regulatory and commercial landscape for its lead drug, Contrave, for the treatment of obesity. We continue to anticipate a H1/11 approval."

Canaccord Genuity reiterates a "Buy" on Orexigen Therapeutics, which was trading at $9.13, up $0.36, or 4.10 percent, as of 12:14 PM EST. They have a price target of $19 on them.

Vivus (NASDAQ:VVUS) Riding Wave of 'Contrave' Support?

With Orexigen Therapeutics (Nasdaq:OREX) finding support for 'Contrave,' prospects for Vivus (NASDAQ:VVUS) being approved for Qnexa seems to have improved.

Even so, Jefferies (NYSE:JEF) has waved a cautionary flag with Vivus, citing uncertainties over potential and probably delays.

They said, "While there is no denying that the OREX panel vote increases the prospects of Qnexa approval, we remain uncertain how to predict the FDA's next action in response to the panel vote. With VVUS shares indicated up significantly, current exuberance may not reflect the risk of a potential delay."

Jefferies maintains an "Underperform" on Vivus, which closed Wednesday at $9.00, up $1.20, or 15.38 percent. They lowered their price target on them from $4 to $3. Volume was almost six times the normal 3-month daily average.

Orexigen Therapeutics' (NASDAQ:OREX) 'Contrave' Recommendation Pushes Share Price Higher

Shares of Orexigen Therapeutics' (NASDAQ:OREX) skyrocketed Wednesday on the news they won the first U.S. panel recommendation for a prescription diet pill, which is their 'Contrave' offering.

Commenting on the positive step, Jefferies (NYSE:JEF) said, "We wouldn't bank on January final approval; there's likely a ways to go on REMS, labeling, and post-approval commitment negotiations. However, we're comfortable with 2011 approval and launch. OREX is substantially de-risked, and depending on the ultimate label, it could be an obvious partner takeout given hefty royalties and milestones."

There is no obligation on the part of the FDA to follow the recommendations of the panel, but definitely helps defuse concerns which have weight on the share price of Orexigen for some time.

EPS estimates for full year 2010 is $1.13, and for full year 2011, $1.22.

Jefferies maintains a "Buy" rating on Orexigen, which closed Wednesday at $8.77, soaring $3.90, or 80.08 percent. The daily 3-month average volume exploded from 1.5 million to 30 million. A price target of $17 is placed on them from Barclays, raising it from $12.

Wednesday, December 1, 2010

Orexigen Therapeutics (NASDAQ:OREX) Now at Good Entry Point

Saying Orexigen Therapeutics (NASDAQ:OREX) now offers a "great entry point," Canaccord Genuity maintains their "Buy" rating on the company.

Canaccord said, "We reiterate our rating and Top Pick designation for OREX. We believe that OREX’s Contrave for obesity will be approved by the FDA in 2011 following what we expect to be a positive FDA advisory committee meeting (ad com) on December 7. We think the current valuation reflects very low expectations and therefore offers a great entry point."

Orexigen Therapeutics closed Tuesday at $5.19, falling $0.40, or 7.16 percent. Canaccord has a price target of $14 on them.