Friday’s Top BioHealth Movers (ACOR, AVNR, CXM, LXRX, SVNT, SQNM, SPPI)

October 9, 2009 · Filed Under Financial, daily, fda · Comments Off 

This has been a quiet trading day, but not in the land of biotech and medical technologies that comprise the BioHealth sector.  These are this morning’s top movers in the group:

Acorda Therapeutics, Inc. (NASDAQ: ACOR) is down over 15% after the FDA made public the background material over Acorda’s Fampridine.  Full data can be found at:

AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) is up 6.5% at $2.45 and it was one of the top gainers this morning, but has since come off of highs of $2.68.  The company announced additional detailed results from the confirmatory double-blind Phase III STAR trial evaluating two doses of the investigational drug Zenvia™ in the treatment of pseudobulbar affect among patients with underlying multiple sclerosis (MS) or amyotrophic lateral sclerosis (ALS). Zenvia met the primary efficacy endpoint by reducing PBA episode rates by an incremental 11.9% beyond placebo. The lower dose Zenvia group did not achieve a statistically significant reduction in PBA episode rates compared to placebo.

Cardium Therapeutics Inc. (AMEX: CXM) is one of the top winners of all stocks today with a 19% gain to $1.82.  This one is set to make a presentation soon, but the move today appears to be based upon a positive recommendation from a boutique firm called Skymark Research.

Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) is getting tooled after a secondary offering.  The company sold some 33,333,333 shares of common stock at $1.50 per share after a $1.77 close yesterday.  We have shares down about 13% at $1.53.  It turns out that 19,894,076 shares are being offered through the underwriters and 13,439,257 shares are being offered to Invus, L.P., Lexicon’s largest stockholder.

Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) is seeing a surprise 7% gain to $14.28 this morning.  This is surprising considering that its secondary offering of 4.3 million shares priced at $13.29.  One item helping more is that this stock was also Raised to Outperform over at Oppenheimer.

Sequenom Inc. (NASDAQ: SQNM) is running again on no news and is up another 9.8% at $3.67 today.  Traders keep touting that there may be no intentional wrongdoing from management and the recently fired staffers.  This is still very much an at-risk company, although making any predictions at this point would be based entirely upon incomplete data that still has many unknowns.

Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) is down some 17% at $5.12 after it received a complete response letter from FDA for FUSILEV in advanced metastatic colorectal cancer noting that it did not demonstrate that FUSILEV is non-inferior to leucovorin.  The response also recommended that it meet with them to discuss options for continuing to seek approval of FUSILEV in advanced metastatic colorectal cancer.

JON C. OGG

Unusual Number of 52-Week Highs in BioHealth Stocks (BCRX, CRIS, NKTR, OGXI, SCLN, SVA, SPPI, TRGT, VICL)

August 31, 2009 · Filed Under daily, flu · Comments Off 

As you will see, there are many new 52-week highs out there in some drug and biotech names…. Some of this is on swine flu news despite a big drop in the stock market today, but here goes:

  • BioCryst Pharmaceuticals Inc. (BCRX) hit $13.24 today…. 52-week low is $0.85.
  • Curis Inc. (NASDAQ: CRIS) hit $2.25 today, the drug discovery company has a small cap at $140 million; 52-week low is $0.68.
  • Nektar Therapeutics (NASDAQ: NKTR) hit 8.29 but on very low volume, 52-week low is $8.29.
  • OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) hit a high of $42.99, also on fairly thin trading volume…. The 52-week low is all the way down at $2.00 on this cancer company.  In 2007, this was over a $100 stock…
  • SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) is up big on heavy block trading as it hit $4.90 vs. a 52-week low of $0.63.
  • Sinovac Biotech Ltd. (AMEX: SVA) is what led the flu names today after securing Chinese approval for its swine flu vaccine.  Shares are up over 40% at $8.90… but it hit $9,44 today versus a 52-week low of $0.75.
  • Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) is up over 7% and hit $8.32 on strong volume… 52-week low is $0.55.
  • Targacept, Inc. (NASDAQ: TRGT) hit $14.69 today, but on thin trading volume, compared to a 52-week low of $1.40.
  • Vical Inc. (NASDAQ: VICL) hit a high of $4.93 versus a low of $1.04.  This is on strong volume and is after a rise of flu awareness stocks in China.

JON C. OGG
August 31, 2009

The Rise of Biotechs May Be Attracting The Shorts (PFE, MRK, BAX, BDSI, SPPI, GNBT, AVII, CEGE, BBH, GILD)

July 13, 2009 · Filed Under General · Comments Off 

Biotechnology stocks have risen faster than any sector in the past 30 days, although the new short-interest data suggest traders are now increasing their directional bets against the group.

Large biotechs including Pfizer Inc. (NYSE: PFE) and Merck & Co. (NYSE: MRK) are in the top 10 of all large-cap stocks with the greatest increase in the number of shares shorted. And biotechs including Baxter (BAX) are among the stocks seeing a greater than 50 percent increase in short interest from mid-June until the end of that month, the most recent short interest data available.

Perhaps one reason biotechs are an increasing near-term target of the shorts is that the group’s price movement has been counter to the overall market. The price of all biotech stocks with a market cap of $1 billion or more is up 3.6 percent in the past 30 days, vs. a drop of 6.2 percent for the S&P 500. Biotech is the only group to advance more than 3 percent over that time period, other than health care services, up 3.2 percent.

Pfizer is not a stock most traders bet against, with only 3.5 percent of its float sold short. But the short interest of Pfizer rose 16.2 percent to more than 235 million shares by the end of June. Merck shares, with a heftier 6.9 percent sold short, saw its short interest rise 9.1 percent over the same time period.

Some smaller biotech names have seen a very large short interest increase, including BioDelivery Sciences International (Nasdaq: BDSI), up 93 percent. Spectrum Pharmaceuticals Inc. (Nasdaq: SPPI) short interest is up 54 percent. Biotech stocks with at least a 40 percent rise in short interest include Generex Biotechnology Corp. (Nasdaq: GNBT), AVI BioPharma Inc. (Nasdaq: AVII) and Cell Genesis Inc. (Nasdaq: CEGE).

One of the biotech ETFs that is watched most closely by traders is the Biotech HOLDRs (BBH). One of its top holdings is Gilead Sciences Inc. (Nasdaq: GILD), which makes up roughly a third of the index. Its stock saw a 17 percent increase in its short interest to more than 20 million shares.

The biotech Holdrs in early July rose to levels not seen since September 2008, although the index has fallen early this month after creating a bearish candlestick pattern. The fall occurred not not long after MACD, an oscillator watched by technical traders, turned negative — Mike Tarsala

Space-rocket Spectrum Pharma's shares may sputter (SPPI)

July 6, 2009 · Filed Under Cancer, General, fda · Comments Off 

Specrtum Pharmaceuticals (Nasdaq: SPPI) are  lower in very early premarket trading after the FDA asked for data from the company’s already completed Phase III study to support the company’s proposed labeling of its product Zevalin as a first-line consolidation therapy for treating non-Hodgkins lymphoma.

No additional clinical studies have been requested. The additional data requested do not involve new data analyses.

Still, the request appears to be a hiccup for shareholders who may have been expecting a fairly straightforward process for getting a supplemental biologics license application this month for Zevalin from the FDA in treating one of the five most common cancers in the U.S. Timing for approval was generally expected shortly after the FDA set a target date of July 2, 2009 for its review.

Spectrum shares have been one of the most spectacular momentum names in biotech, rising to more than $7 in recent weeks, up from less than $1 in October, 2008. The stock was last quoted at $6.17.

It is not clear what objections the FDA may have regarding the proposed labeling of the product, and how the labeling may affect potential sales. Under the proposed labeling, it had been assumed that the license would have increased by roughly 18,000 the target market for Zevalin, which costs about $25,000 per treatment.

The company plans to formally respond to the FDA’s requests by this Wednesday, July 8, 2009.

The company’s first-line indolent trial, or so-called FIT trial of Zevalin in December 2007 demonstrated both the efficacy and safety of Zevalin in a multinational study involving more than 400 patients. Zevalin significantly improved median survival to 37 months from 13 months.

Anticipating an approval, Spectrum has been working to set up the sales infrastructure for Zevalin ahead of the expected license approval. – Mike Tarsala

Biotech Stocks On the Move Early Wednesday (AMAG, MYGN, SPPI, NVAX)

July 1, 2009 · Filed Under General · Comments Off 

AMAG Pharmaceuticals:

AMAG Pharmaceuticals Inc. (Nasdaq: AMAG) are up about 6 percent with more than 17,000 shares traded as of 8 a.m. Eastern this morning, after the FDA approved the company’s Feraheme drug as an iron replacement therapy for patients with chronic kidney disease.

The approval removes an overhang for the company. It first sought FDA approval for the drug in December 2007, and twice received requests for more information on it last year.

Myriad Genetics:

Myriad Genetics (Nasdaq: MYGN) shares are down more than 15 percent on very strong premarket trading volume early this morning. The company last night said it expects fiscal Q4 revenue of $86 million, shy of the $91.6 million analysts had anticipated, citing high unemployment and patients cancelling or delaying doctor visits.

Several analysis firms including Oppenheimer and RBC Capital have downgraded the company’s shares this morning, with several citing worries about revenue growth rates.

Spectrum Pharmaceuticals:

Spectrum Pharmaceuticals (Nasdaq: SPPI) Inc. shares are down roughly 8 percent on nearly 60,000 shares traded as of 8:15 a.m. Eastern. The company announced early this morning that it will raise $21 million from institutional investors at $7.15 a share. The stock had been trading near $7.65 a share.

Novavax:

Shares of vaccine maker Novavax Inc. (Nasdaq: NVAX) are up very slightly in premarket trading, seeing some continued buying a day after Spanish health authorities licensed its technologies to make pandemic and seasonal flu vaccines.

The stock had risen more than 30 percent yesterday on the news.

Boutique research firm Rodman and Renshaw raised its target on Novavax shares to $5 from $4 this morning, suggesting Spain is providing additional validation fo the company’s technology and it may be a foothold for Novavax to register its vaccine in other countries. — Mike Tarsala

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