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Why Keryx is Lagging But Acadia is Zooming (Hint: It's About NCE)

Tue, 21 May 2013 10:38:18 EDT

KERX data by YCharts

BOSTON (TheStreet) -- Something is ailing Keryx Biopharmaceuticals because the stock is significantly underperforming the rest of the booming biotech sector.

The chart above explains what I mean. Keryx shares (the blue line) are down almost 13% since the start of February while the Nasdaq Biotechnology Index (NBI in orange) is up more than 23%. ...

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Rockwell Medical Run-Up Trade Follows Financing

Tue, 21 May 2013 08:00:00 EDT

WIXOM, MI (TheStreet) -- Consider a run-up trade in a biotech stock after it raises money. A recent example: Last January, Trius Therapeutics sold 6.3 million shares at a 9% discount to its market price at the time. Over the next two months -- and ahead of results from a clinical trial of its lead antibiotic -- Trius shares ran up more than 50%.

I'm giving this strategy another go with Rockwell Medical , marketer of dialysis related products. On Monday, Rockwell closed a $40 million stock offering, which should provide the company with enough cash to fund operations into 2014. Rockwell spends a lot of money and its balance sheet has been weak, so this latest offering -- priced at a small discount to market price -- should alleviate investors concerns about the company's cash and attract new buyers to the stock.

Rockwell's looming catalyst is data from two phase III studies of an experimental soluble iron solution added to the dialysis fluid of kidney dialysis patients in order to prevent iron deficiency and anemia. ...

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2013 FDA Drug Approval Calendar

Tue, 21 May 2013 07:00:00 EDT

BOSTON (TheStreet) -- Gilead Sciences and Amarin highlight the updated list of biotech and pharmaceutical companies with FDA drug approval decisions expected for the remainder of 2013.

The next era of hepatitis C therapy could begin on Dec. 6, if FDA approves Gilead's sofosbuvir. Amarin is hoping FDA approves an expanded label for its prescription-grade fish oil pill Vascepa on Dec. 20.

Sarepta Therapeutics and Pharmacyclics aren't on the list but are still very much in the investor spotlight. Sarepta and FDA are still going back and forth over the the company's request to file an accelerated approval application for eteplirsen to treat Duchenne muscular dystrophy. We may have some resolution early in the third quarter. ...

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Biotech Stock Mailbag: Vical, Sangamo, Spectrum Pharma

Fri, 17 May 2013 07:00:00 EDT

BOSTON (TheStreet) -- This week's Biotech Stock Mailbag:

@adamfeuerstein Will Vical be Feuerstein-R Rule breaker when results come 3rd qtr? yervoy synergy possible tooseekingalpha.com/article/143551...— K. Rudolph (@scientwest) May 15, 2013

I'm not optimistic about Vical or its skin cancer immunotherapy Allovectin. I believe failure will be the most likely outcome of the phase III study when results are announced in the third quarter. ...

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Biotech's Next Big Thing -- ASCO II

Thu, 16 May 2013 14:09:31 EDT

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ASCO '13 Preview: Oncothyreon's Failed Lung Cancer Vaccine

Wed, 15 May 2013 18:00:00 EDT

SEATTLE (TheStreet) -- New details about failed lung cancer immunotherapy from Oncothyreon were revealed for the first time Wednesday night in a research abstract for the American Society of Clinical Oncology (ASCO) annual meeting.

Stimuvax reduced the risk of death by 12 percent compared to a placebo -- a difference that failed to reach statistical significance by a wide margin, according to detailed results from the phase III study contained in the ASCO abstract.

Oncothyreon and partner Merck KGaA announced last December that the Stimuvax lung cancer study failed to meet its overall survival primary endpoint, but specific data were not disclosed at that time. ...

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10 ASCO '13 Abstracts You Can Read Right Now

Wed, 15 May 2013 18:00:00 EDT

CHICAGO (TheStreet) -- Ready, set ... ASCO download!

That's what a lot of healthcare investors are doing right now on the web site of the American Society of Clinical Oncology. It's ASCO abstract release day, which means summaries of thousands of cancer drug clinical trials were just made available in advance of the ASCO annual meeting at the end of the month.

I'm here to help save you some time with the searching and downloading. Below are 10 ASCO research abstracts of high interest to healthcare investors, covering drugs from Abbvie , Ariad Pharmaceuticals , Arqule , Array Biopharma , BioMarin Pharma , Clovis , Curis , Halozyme , Infinity Pharma , and Pharmacylics . ...

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ASCO '13 Preview: Roche's Next-Gen Rituxan Steps Up

Wed, 15 May 2013 18:00:00 EDT

CHICAGO (TheStreet) -- Treatment with Roche's experimental GA101 -- the next-generation version of the company's blockbuster drug Rituxan -- helped elderly patients with chronic lymphocytic leukemia more than double the time before their disease worsened compared to chemotherapy. Initial data, not yet mature, also suggests GA101 may be superior to Rituxan.

Results from a pivotal phase III study of GA101 were posted in a research abstract Wednesday night ahead of a planned presentation at the American Society of Clinical Oncology (ASCO) annual meeting. Last January, Roche announced that the GA101 study had met its primary endpoint but detailed data were held for presentation at the ASCO meeting.

Roche has engineered GA101, also known as obinutuzumab, to be a more potent version of Rituxan, the company's top-selling hematological monoclonal antibody therapy with 2012 sales of approximately $7 billion. Rituxan sales, however, could start to fade in 2016 when a biosimilar version of the drug is expected to enter the market. For this reason, development and approval of GA101 has taken on some urgency for Roche in order to protect a key drug franchise. ...

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ASCO '13 Preview: Gilead's Big Cancer Debut

Wed, 15 May 2013 18:00:00 EDT

FOSTER CITY, Calif. (TheStreet) -- Gilead Sciences' experimental cancer drug idelalisab demonstrated long-lasting tumor shrinkage in more than half of patients with advanced chronic lymphocytic leukemia (CLL). Responses were durable, with disease progression stalled for an average of 17 months -- noteworthy because CLL patients enrolled in the phase I study had already undergone an average of five prior therapies.

Results from the idelalisab study in CLL were announced Wednesday night in advance of a presentation at next month's American Society of Clinical Oncology (ASCO) annual meeting.

Gilead is known best these days for its dominant HIV drug business and soon-to-be-approved crop of hepatitis C therapies. But Gilead is also making a less-publicized push into cancer drug development. Idelalisab is the company's lead cancer asset, picked up through the acquisition of Calistoga Pharmaceuticals in 2011. ...

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ASCO '13 Preview: New 'Anti-PD-1' Therapies Shrink Tumors

Wed, 15 May 2013 18:00:00 EDT

CHICAGO (TheStreet) -- Bristol-Myers Squibb , Roche and Merck are each developing a new generation of cancer drugs that work by dismantling a cloaking mechanism used by cancer cells to hide from a patient's immune system. Bristol-Myers' Yervoy was the first of these drugs to be approved for melanoma in 2011 but the newer drugs, which act against cellular signals known as PD-1 and PDL-1, may be more potent in melanoma and have broader use against lung, kidney and breast cancer.

A preview of early-stage clinical trial results on these immune-boosting cancer drugs was released Wednesday night ahead of next month's American Society of Clinical Oncology (ASCO) annual meeting. Ultimately, PD-1 and PDL-1 drugs could generate billions of dollars in new sales for Bristol-Myers, Roche and Merck if early results are confirmed in ongoing and larger phase III studies.

The highlights: The combination of Bristol-Myers' Yervoy plus an experimental drug nivolumab shrank tumors in almost half of patients with advanced melanoma. Tumor response was greater and faster with the combination therapy than when either drug is used alone. ...

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Aveo Screwed Up but Its Kidney Cancer Drug Is Real

Wed, 15 May 2013 09:24:28 EDT

CAMBRIDGE, Mass. (TheStreet) -- AVEO Oncology has had a difficult time since its lead cancer compound tivozanib was roundly panned at a May 2 FDA advisory panel. By a 13-1 vote, experts on the FDA's panel concluded tivozanib did not demonstrate a favorable risk/benefit for the treatment of advanced kidney cancer. Despite scathing critiques of the design and conduct of Aveo's phase III trial, a deeper look at the data demonstrates tivozanib's efficacy is actually fairly similar to previously approved kidney cancer drugs. While the phase III trial might not be completely predictive of future success, at the very least, the trial is strong enough to justify an AVEO valuation above cash on hand.

There has been a lot written about the mistakes made by Aveo in designing and conducting the tivozanib study, and how these errors could have -- and should have -- been avoided. Setting aside that debate, I want to look at the tivozanib data in isolation to see what they say about the actual clinical activity of the kidney cancer drug. In particular, the FDA advisory panel compared tivozanib to seven other drugs approved in kidney cancer: Onyx Pharma's Nexavar, Pfizer's Sutent, Inlyta and Torisel, Novartis' Affinitor, Roche's Avastin and GlaxoSmithKline's Votrient. Are the tivozanib data dramatically out of sync with the trials results of the approved drugs?

Chemist and pharmaceutical analyst John Tucker (@JohnTuckerPhD on twitter) conducted an analysis correlating progression free survival (PFS) with overall survival (OS) for all seven drugs to determine the tivozanib results from Aveo's phase III trial were anomalous. If the tivozanib trial produced flaw results in terms of either PFS or OS, then it should appear outside of the correlation seen with the approved drugs. ...

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Synta Is Run-Up to ASCO Lung Cancer Data

Tue, 14 May 2013 10:16:23 EDT

LEXINGTON, Calif (TheStreet) -- Biotech run-up traders should be looking at a potentially valuable clinical trial catalyst with Synta Pharmaceuticals .

Synta is scheduled to present updated results from phase II (GALAXY-1) portion of its ganetespib lung cancer study on June 3rd at the American Society of Clinical Oncology (ASCO) annual meeting. Most the ASCO research abstracts are slated to be released on Wednesday, however, the Synta data have been classified as a "late breaker" and are therefore embargoed until the actual day of presentation.

The lung cancer market is worth billions of dollars in annual sales, so investors will be eyeing the gantespib data closely. Synta's market valuation of $500 million doesn't price in the overall ganetespib market opportunity, especially if the drug's use can be expanded beyond lung cancer into other tumor types. ...

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SEC Is Investigating Spectrum Pharma

Mon, 13 May 2013 07:19:09 EDT

HENDERSON, Nev. (TheStreet) -- The Securities and Exchange Commisson is investigating Spectrum Pharmaceuticals over the steep drop in Fusilev sales disclosed in March.

Spectrum tucked the disclosure of an SEC subpoena in its most recent 10-Q filed last Thursday. The company made no mention of the investigation in the press release announcing first-quarter financial results or on a subsequent conference call.

On April 1, 2013, the Company received a subpoena from the SEC for documents pursuant to a formal order of investigation. The subpoena followed the Company's March 12, 2013 announcement that it anticipated a change in ordering patterns of FUSILEV. The Company is cooperating with the SEC investigation. The Company cannot predict when the SEC will conclude its investigation or the outcome of the investigation. ...

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The Deal: Bain, TPG Get Windfall With Quintiles IPO

Fri, 10 May 2013 11:51:51 EDT

NEW YORK (TheDeal) -- Quintiles Transnational Holdings raised about $947 million for its private-equity backers including Bain Capital Partners and TPG Group as research services company held its public offering at $40, and then proceeded to rise.

Shares were little changed Friday at $42.07 after gaining 5.3% on Thursday, the company's debut on the New York Stock Exchange. The offering valued the Durham, N.C.-based provider of contract research services for the biotech and pharmaceutical markets at $5.2 billion. Also see: Living Together but Not Married? 5 Tips

Together with Bain and TPG Capital, London-based 3i Group plc and Singapore state-owned asset manager Temasek Holdings Pte. Ltd. sold 10.6 million of the shares in the IPO while Quintiles sold 13.1 million shares. Underwriters have an option to purchase an additional 3.5 million shares. ...

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Biotech Stock Mailbag: Synta, Zogenix, Sarepta, Amarin

Fri, 10 May 2013 07:00:00 EDT

BOSTON (TheStreet) -- This week's Biotech Stock Mailbag is open for business.

@adamfeuerstein SNTA getting hit hard, do you suspect SNTA to respond with a PR/Statement of some sort?Bit hard to ignore, I would think?— Bill H. (@bheafey) May 8, 2013

Synta Pharmaceuticals had a rough week, starting with the surprise and sudden resignation of R&D chief Sumant Ramachandra for "personal reasons." Ramachandra was hired in February so his exit just three months later is concerning, exacerbated by the presentation of ganetespib lung cancer data coming up next month at the ASCO annual meeting. ...

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