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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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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: 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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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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Repros Patent Problems Began When Harry Met Joe

Thu, 09 May 2013 08:00:00 EDT

THE WOODLANDS, Tex. (TheStreet) -- Investors who have read through Repros Therapeutics' regulatory filings know about the unresolved and worrisome patent conflict involving the company's testosterone-boosting pill Androxal. Less known but more interesting are the events behind this patent fight, including allegations that Repros' CEO stole the idea for Androxal from a New York fertility doctor.

Call the story, "When Harry Met Joe." Except there's no fake orgasm over pastrami sandwiches at Katz's.

Harry is Dr. Harry Fisch, a New York urologist and fertility specialist. For male patients with low testosterone, particularly those who still want to have kids, Fisch has long prescribed clomiphene, a decades-old hormone treatment normally used to boost fertility in women. In men, clomiphene raises testosterone but also preserves sperm count. ...

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Amarin Trouble Grows As Does Evidence Against Fish Oil's Benefits

Thu, 09 May 2013 00:15:00 EDT

BOSTON (TheStreet) -- A large study has once again demonstrated the failure of fish oil supplements to reduce heart disease or death in patients at higher risk for heart disease. The negative results of the Italian Risk and Prevention Study, published yesterday in the New England Journal of Medicine, could not come at a worse time for Amarin and its prescription fish oil pill Vascepa.

Amarin is already struggling to convince doctors and patients to try Vascepa, so the last thing the company needs is more definitive clinical evidence ripping apart the theory that daily fish oil intake leads to improved heart health.

Vascepa was not used in the Italian study published Wednesday, but still, the odds of Amarin convincing a large pharmaceutical company to partner up on Vascepa's marketing or acquire the entire company went from low to nearly impossible. ...

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Happy Day for Arena Bulls, Bears as Belviq Launch Finally Arrives

Tue, 07 May 2013 11:53:28 EDT

SAN DIEGO (TheStreet) -- Areniacs rejoice! The DEA has finally published the rule establishing Arena Pharmaceuticals' weight-loss pill Belviq as a Schedule IV drug and allowing the commercial launch to begin in 30 days.

Arena shorts rejoice! You've been waiting more than 10 months for Arena and partner Eisai to finally start posting disappointing sales of Belviq.

Today is a happy day for everyone. ...

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Fire Aveo's CEO for Incompetence and Arrogance Rivaling ImClone's Sam Waksal

Mon, 06 May 2013 12:26:12 EDT

CAMBRIDGE, Mass. (TheStreet) -- Aveo Oncology CEO Tuan Ha-Ngoc hasn't been fired yet. That's disappointing. After the FDA and its advisory panel thrashed Aveo's kidney cancer drug tivozanib last Thursday -- excoriating the company for conducting a flawed and unethical clinical trial -- you'd think Aveo's directors would have convened an emergency board meeting to send Ha-Ngoc and his executive team packing.

Then again, Aveo's chairman is Henri Termeer, who wasn't exactly the sort of CEO to take personal responsibility for major screw ups under his watch while running Genzyme. Termeer also had a bad habit of ignoring FDA's recommendations, just like Ha-Ngoc.

So with these two running the show at Aveo, the question to ask might not be when will the company's directors fire Ha-Ngoc, but how big of a bonus will Ha-Ngoc get this year? ...

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FDA Rejection of Titan's Probuphine Looks Like a Mugging

Wed, 01 May 2013 10:19:05 EDT

SOUTH SAN FRANCISCO, Calif. (TheStreet) -- The U.S. Food and Drug Administration came down hard on Titan Pharmaceuticals , rejecting its Probuphine implantable therapy for opioid dependence and requesting a lot of new clinical data and other information before the company can resubmit.

Titan shares reacted as you'd expect -- down 73% to 44 cents in Wednesday trading.

Titan said it was "surprised and disappointed" in the FDA's Complete Response Letter but remains committed to addressing the agency concerns and getting Probuphine approved. The company and its partner Braeburn Pharmaceuticals intend to meet with the FDA to clarify exactly what's required. ...

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Raptor's FDA Approval Is New Test for Orphan Drug Pricing

Wed, 01 May 2013 07:51:06 EDT

NOVATO, Calif. (TheStreet) -- On Tuesday, Raptor Pharmaceuticals joined the coveted ranks of orphan disease companies with an FDA-approved therapy. Regulators approved Raptor's Procysbi to treat nephropathic cystinosis, a rare genetic condition that affects about 500 kids and adults in the U.S. and 3,000 worldwide.

Investors love orphan disease companies because they can charge sky-high prices -- Alexion Pharmaceuticals , for example, charges about $500,000 per year for Soliris -- and insurance companies reimburse without much protest. But as the number of orphan disease companies with approved products grow, so too are concerns about a backlash. As the cost of orphan drugs rise, will insurance companies erect more roadblocks in the way of reimbursement?

Raptor is an interesting test case because Procysbi isn't a new drug, just a long-acting version of Cystagon, approved in 1994 to treat nephropathic cystinosis. Cystagon must be taken on a strict, every six-hour schedule. Procysbi is administered twice a day. ...

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FDA Tells Delcath No Approval Without New Clinical Trial

Tue, 30 Apr 2013 10:53:40 EDT

NEW YORK (TheStreet) -- Delcath Systems is in serious trouble two days before an FDA advisory panel meets to review its medical device-chemotherapy system known as Melblez. In a scorching review, the FDA makes it fairly clear that Melblez will not be approved until Delcath conducts a new clinical trial.

Delcath shares had plunged 36.69% to 88 cents just before noon.

FDA spells out its demand on pages 28-29 of the Melblez briefing document made public Tuesday morning. The entire document is only 34 pages long, so FDA sorta buried the lede: ...

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Lexicon Pharma Falls on Concerns Raised by Merck-Pfizer Diabetes Partnership

Mon, 29 Apr 2013 13:07:48 EDT

Updated with analyst quote.

THE WOODLANDS, Tex. (TheStreet) -- Lexicon Pharmaceuticals are down 15% Monday following the announcement of a diabetes partnership between Merck and Pfizer , raising worries that Lexicon may be having trouble nailing a diabetes deal of its own.

Merck and Pfizer -- more often viewed as bitter rivals -- are taking the unusual step of collaborating on the development and marketing of Pfizer's diabetes drug ertugliflozin, the companies announced Monday. ...

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Auxilium CEO Goes Against Type, Buying Instead of Selling

Mon, 29 Apr 2013 10:17:23 EDT

CHESTERBROOK, Penn. (TheStreet) -- Adrian Adams was named chief executive officer of Auxilium Pharmaceuticals in December 2011 with the reputation as a great salesman. His prior CEO posts at Inspire Pharmaceuticals, Kos Pharmaceuticals and Sepracor had all ended with the companies being bought out for handsome premiums. Naturally, investors speculated Adams would do the same with Auxilium.

Except Adams hasn't sold Auxilium. Instead, the salesman has turned into a buyer. On Monday, Auxilium acquired privately held Actient Holdings, a marketer of urology products, for $585 million in cash plus Auxilium stock contingencies and warrants.

Auxilium shares are down 7% to $14.89 in early Monday trading. ...

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