Adam Feuerstein

Amarin: FDA Panel Date, Misplaced Hype For Fixed-Dose Combo

twocents@thestreet.com (Adam Feuerstein) — Wed, 19 Jun 2013 15:22 GMT

BEDMINSTER, NJ (TheStreet) -- Two items on Amarin up for discussion: First, we now have a confirmed date for the Vascepa "ANCHOR" FDA advisory panel. Second, the misguided reasons Amarin bulls are so excited about a fixed-dose combination of Vascepa and a cholesterol-lowering statin.

Mark your calendars for Oct. 16. The FDA has scheduled an advisory panel to review Amarin's request to expand Vascepa's label to include treatment of mixed dyslipedemia -- the so-called blockbuster "ANCHOR" indication.

The scheduling of an FDA panel isn't a big surprise. On June 6, Amarin President John Thero told investors at a conference that the company was already prepping for just such a meeting. ...

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Sarepta's Eteplirsen Walk-A-Thon Now Stretches For 84 Weeks

twocents@thestreet.com (Adam Feuerstein) — Wed, 19 Jun 2013 13:43 GMT

CAMBRIDGE, Mass. (TheStreet) -- A handful of pre-teen boys suffering with Duchenne muscular dystrophy have now been treated with Sarepta Therapeutics' eteplirsen for 84 weeks. The boys are still walking, defying the debilitating and progressive nature of a disease that would be forcing them into wheelchairs without treatment.

As with previous updates from Sarepta's eteplirsen study, no significant safety problems were reported. No serious adverse events, no hospitalizations or treatment discontinuations.

Well, there was one disruption in the study but it was actually more evidence of eteplirsen's profound benefit for DMD patients. Here's how Sarepta describes it: ...

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Vanda's Sleep Disorder Drug Is A Nightmare

twocents@thestreet.com (Adam Feuerstein) — Wed, 19 Jun 2013 11:00 GMT

WASHINGTON, D.C. (TheStreet) -- Vanda Pharmaceuticals tells a pretty compelling story about the development of tasimelteon for the treatment of a rare sleep-pattern disorder that affects blind people. Dig into the company's clinical work on tasimelteon, however, and you'll find a disturbingly large number of irregularities and red flags which should ring alarm bells for any investor betting on the drug's approval.

Tasimelteon belongs to the melatonin family of compounds which helps regulate the 24-hour sleep-wake cycle, also known as circadian rhythm. For some people who are totally blind, having no light perception at all knocks the normal, 24-hour circadian rhythm off kilter. Their sleep patterns start to shift -- less sleep at night, more during the day.

The medical term for this condition is "non-24 sleep-wake disorder" (non-24) and there are no drugs approved to treat it. Ordinary, over-the-counter melatonin works for many non-24 sufferers (so does an alarm clock) but FDA classifies melatonin as a nutritional supplement, not a drug. ...

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Amicus Delays U.S. Approval Filing for Fabry Disease Drug

twocents@thestreet.com (Adam Feuerstein) — Mon, 17 Jun 2013 12:43 GMT

CRANBURY, NJ (TheStreet) -- The U.S. Food and Drug Administration refused a request from Amicus Therapeutics to amend the statistical plan for a failed phase III study of its experimental Fabry disease drug Amigal. As a result, Amicus is delaying the U.S. approval filing for Amigal until late 2014 or early 2015 -- after data from another phase III study is completed.

Amicus shares fell 22% to $2.50 in early Monday trading.

Last December, Amicus announced disappointing six-month results from a phase III study of Amigal in patients with Fabry disease. Forty-one percent of Amigal patients were counted as responders (meaning they had a 50% decrease in GL3 in their kidneys. By comparison, 28% of placebo patients were responded. The response trend clearly favored Amigal but the difference was not statistically significant. ...

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Elan Shareholder Vote Nixes Royalty Pharma Takeover -- For Now

twocents@thestreet.com (Adam Feuerstein) — Mon, 17 Jun 2013 11:44 GMT

DUBLIN (TheStreet) -- Elan's shareholders approved a share repurchase plan Monday, which forces Royalty Pharma's hostile tender offer to lapse unless an Irish court intervenes.

Royalty is offering $12.50 per share for Elan plus another $2.50 per share contingent on the multiple sclerosis drug Tysabri hitting certain sales targets. However, Royalty's tender offer was forced to lapse because Elan shareholders voted to approve one of four proposals made by company management.

The other three proposals, including a royalty agreement with Theravance and the acquisition of a privately held drug maker, were rejected. ...

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Elan Plants 'For Sale' Sign on Front Lawn

twocents@thestreet.com (Adam Feuerstein) — Fri, 14 Jun 2013 13:52 GMT

DUBLIN (TheStreet) -- Elan's Plan B: Surrender.

The Irish drug maker announced Friday a formal sales process to find a buyer for the company -- an acknowledgement that management's restructuring plan is likely to be rejected by shareholders on Monday.

Elan "invited" Royalty Pharma to participate in the sale process, even though Royalty's hostile tender offer of up to $15.50 per share for the company is still in play. Elan urged its shareholders not to accept Royalty's tender in the hope that another acquirer might step in with a higher price. ...

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Wall Street Realizes Myriad Genetics Monopoly on Breast Cancer Risk Tests Is Done

twocents@thestreet.com (Adam Feuerstein) — Fri, 14 Jun 2013 11:43 GMT

SALT LAKE CITY, Utah (TheStreet) -- Myriad Genetics' monopoly on genetic testing for breast cancer risk has been torn down by the U.S. Supreme Court's ruling on human gene patents Thursday. One day later, Wall Street analysts are reacting accordingly.

Sell side does an abrupt about face on $MYGN - after glowing reviews yesterday - both ML and RBC downgrade - CSFB very negative comments— Ian Estepan (@ianestepan) June 14, 2013

CSFB: we see competitors will offer the test for $995 (less than 1/3 $MYGN's current price) if they do not lower price payors will shift— Ian Estepan (@ianestepan) June 14, 2013 ...

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Biotech Stock Mailbag: Exact Sciences, Questcor, Biotech M&A, Celsion

twocents@thestreet.com (Adam Feuerstein) — Fri, 14 Jun 2013 11:00 GMT

BOSTON (TheStreet) -- Welcome to this week's Biotech Stock Mailbag.

@adamfeuerstein Too late for this week's mail bag, but would like your thoughts on $EXAS recovery from its deep dip after data.— hvypilot (@bigojetairliner) May 10, 2013

The results from the phase III study of Exact Sciences' non-invasive colon cancer screening test were labeled disappointing by a lot of investors, analysts and biotech stock commentators (ahem) when released on April 17. ...

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These Mutated Cystic Fibrosis Cells Are Worth Billions to Vertex Pharma

twocents@thestreet.com (Adam Feuerstein) — Thu, 13 Jun 2013 18:57 GMT

CAMBRIDGE, Mass. (TheStreet) -- This is my favorite data slide from Vertex Pharmaceuticals' presentation at the European Cystic Fibrosis Society meeting. The slide is important because it helps explain how Vertex will dominate cystic fibrosis therapy and one day generate $10 billion in annual sales. See the "roadmap" I wrote about Tuesday.

You don't need to be an expert in cystic fibrosis to understand this slide and why it's bullish for Vertex. Let's go through it. ...

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Myriad Genetics Shares Rise on Supreme Court Gene Patent Ruling

twocents@thestreet.com (Adam Feuerstein) — Thu, 13 Jun 2013 15:24 GMT

WASHINGTON, D.C. (TheStreet) -- The U.S. Supreme Court ruled Thursday that human genes are derived from nature and therefore cannot be patented. However, synthetic genetic material was patent eligible because it is not naturally occurring.

Shares of Myriad Genetics were up 10 percent to $37.29 on the court ruling mainly because the worst-case scenario -- justices ruling that all genetic material was ineligible for patent protection -- did not come to pass. The case focused on the legitimacy of patents held by Myriad for two genes -- BRCA1 and BRCA2 -- which are used to determine the risk for developing breast and ovarian cancer.

RBC Capital analyst Michael Yee, in a note to investor clients, called the court's ruling a positive for Myriad: ...

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Amgen Drug Delays Ovarian Cancer Re-Growth, Survival Benefit Unclear

twocents@thestreet.com (Adam Feuerstein) — Wed, 12 Jun 2013 13:57 GMT

THOUSAND OAKS, Calif. (TheStreet) -- An experimental drug from Amgen helped women with recurrent ovarian cancer extend the time before their disease worsened, according to results from a late-stage study announced Wednesday.

The Amgen drug, known as trebananib or AMG 386, has not yet helped ovarian cancer patients live longer, which may hamper efforts to get the drug approved in the U.S.

Roche has been unable to secure an expanded FDA approval for its blockbuster drug Avastin in ovarian cancer because studies have failed to demonstrate a survival benefit. Avastin is approved for ovarian cancer in Europe based on studies demonstrating a delay in the tumor progression. ...

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Vertex's Roadmap to $10 Billion in Cystic Fibrosis Drug Sales

twocents@thestreet.com (Adam Feuerstein) — Tue, 11 Jun 2013 13:00 GMT

CAMBRIDGE, Mass. (TheStreet) -- Think of the chart above as a simple roadmap explaining how Vertex Pharmaceuticals will one day come to dominate cystic fibrosis therapy and generate annual sales of $10 billion with little to no competition.

That's Vertex's plan, at least. ...

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Five Best-Performing Biotech Stocks of 2013 (Some May Surprise You)

twocents@thestreet.com (Adam Feuerstein) — Tue, 11 Jun 2013 11:00 GMT

BOSTON (TheStreet) -- The five best-performing biotech and drug stocks as we near the midway point in 2013:

1. Clovis Oncology CLVS data by YCharts

Clovis had "only" doubled in value through May 31 when the stock really took off following the presentation of data from a phase I study of its lung cancer drug CO-1686 at the American Society of Clinical Oncology (ASCO) annual meeting. When I say "data," I'm barely talking about the plural, given the small number of patients treated in the study. But tumor shrinkage reported with CO-1686 treatment was impressive, particularly in lung cancer patients with a specific mutation that made their tumors unresponsive to currently approved drugs. ...

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Ampio Blames Shorts But Won't Answer Legitimate Questions About Its Drugs

twocents@thestreet.com (Adam Feuerstein) — Mon, 10 Jun 2013 16:21 GMT

GREENWOOD VILLAGE, Col. (TheStreet) -- Instead of addressing questions about its drug-development plans posed by critics, Ampio Pharmaceuticals blames short sellers for trying to destroy the company.

On Friday, Ampio Chairman and CEO Mike Macaluso accused Seeking Alpha contributor Joe Dredly of trying to intentionally "damage the existing shareholders by triggering a downward pressure on their stock holdings."

In his statement, Macaluso also links Dredly with Peter Bortel, a hedge fund manager who wrote a series of negative articles about Ampio in 2011. While writing about Ampio, Bortel was also "working with a group of short selling speculators" and under investigation and a cease-and-desist order from the Securities and Exchange Commission, Macaluso claims. ...

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Biotech Stock Mailbag: 2013 Clinical Trials Calendar

twocents@thestreet.com (Adam Feuerstein) — Fri, 07 Jun 2013 11:00 GMT

BOSTON (TheStreet) -- I'm just back from covering the American Society of Clinical Oncology (ASCO) annual meeting -- and still recovering -- so apologies in advance for a less-full Biotech Stock Mailbag this week.

Bruce L. writes:

Besides the FDA Drug Approval Calendar, it would be helpful to know when phase III results are going to be announced. I just stumbled upon Insmed , which will announce phase III results soon and the stock has run from $3 to $11 in a few months. The run-up is where you can make a lot of money without the risk of the FDA. Publishing a list of quarterly clinical trial results would be very helpful. Keep up the good work!" ...

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As If Amarin Needs Another Worry, Here Comes A Vascepa FDA Panel

twocents@thestreet.com (Adam Feuerstein) — Thu, 06 Jun 2013 15:10 GMT

BEDMINSTER, NJ (TheStreet) -- Amarin President John Thero made news -- and not necessarily the good kind -- at an investor conference Thursday when he said the company was preparing for a Vascepa FDA advisory panel later this year.

A date for the FDA advisory panel has not been set, but Thero said the panel would review Amarin's prescription-grade fish oil pill for the so-called "Anchor" indication of treating patients with mixed dyslipidemia.

"There is an SNDA PDUFA date of December 20. Again, we are preparing for an advisory committee for that because it is the product that will be first in this indication for this class," said Thero, speaking at a healthcare investor conference Thursday sponsored by Jefferies. ...

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Aveo Fires 140 Workers As Punishment For CEO's Incompetence

twocents@thestreet.com (Adam Feuerstein) — Wed, 05 Jun 2013 15:06 GMT

CAMBRIDGE, Mass. (TheStreet) -- Aveo Oncology fired 140 middle and lower-level employees -- 62 percent of its workforce -- on Tuesday in order to save money to pay the salaries and bonuses of its top executives who blew up the company, decimated shareholder value and are too cowardly to accept responsibility for their incompetence.

At Aveo, accountability starts at the bottom.

"This is an incredibly sad day for Aveo," said CEO Tuan Ha-Ngoc on Wednesday's conference call. ...

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Clovis Doubles on Buzz Over Lung Cancer Drug

twocents@thestreet.com (Adam Feuerstein) — Mon, 03 Jun 2013 17:31 GMT

CHICAGO (TheStreet) -- There's some confusion over the spark that's causing Clovis Oncology shares to double in value today. The company has presentations on two cancer drugs at the big American Society of Clinical Oncology (ASCO) annual meeting but it's the lung cancer drug -- CO-1686 -- which has set Wall Street heart fluttering.

J.P. Morgan analyst Cory Kasimov told clients this morning that the CO-1686 data were "extremely impressive."

In our first real look at Phase 1/2 efficacy data for the irreversible EGFRm inhibitor, the drug showed 4 confirmed partial responses (PRs) in heavily pre-treated T790M+ NSCLC pts, and they may not yet even be close to the maximum tolerated dose (MTD). In addition, 3/4 evaluable T790M+ patients treated at 900 mg BID (highest dose to date) achieved PRs. There were no clear investor expectations going in, but we strongly believe this is better than anyone's best case. Indeed, we see this as unprecedented activity in this patient population (and at what may still be a suboptimal dose). Emphasis Kasimov's. ...

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Synta's Lung Cancer Drug Struggles to Remain Relevant

twocents@thestreet.com (Adam Feuerstein) — Mon, 03 Jun 2013 13:18 GMT

CHICAGO (TheStreet) -- The efficacy of Synta Pharmaceuticals' lung cancer drug ganetespib is weakening over time, which should raise even more concerns about the ongoing phase III clinical trial.

Snyta shares are down 17% to $6.15 in early Monday trading.

The latest update from the phase II "Galaxy-1" study, which compares ganetespib plus docetaxel against docetaxel alone in second-line non-small cell lung cancer, are being presented Monday during the American Society of Clinical Oncology (ASCO) annual meeting: ...

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Bristol And Merck's Cancer Drugs Won ASCO. Five Slides Explain Why.

twocents@thestreet.com (Adam Feuerstein) — Mon, 03 Jun 2013 13:09 GMT

CHICAGO (TheStreet) -- The five most important slides from this weekend's American Society of Clinical Oncology (ASCO) annual meeting -- where the anti-PD-1 therapies from Bristol-Myers Squibb and Merck stole the show.

This isn't a chart of real data but it's the best slide of the ASCO meeting because it explains why cancer immunotherapy is winning over targeted therapies, particularly in melanoma. It's the long survival tail!

Targeted therapies work fast but responses tend to be transient as cancer cells develop resistance. This means that early, impressive survival benefit aren't sustainable. ...

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ASCO '13 Live Blog: Prepping for Monday Trading

twocents@thestreet.com (Adam Feuerstein) — Mon, 03 Jun 2013 12:00 GMT

ASCO '13 Live Blog

CHICAGO (TheStreet) -- We get to see how cancer drug stocks fare in Monday trading following a weekend of data presentations at the American Society of Clinical Oncology (ASCO) annual meeting. Patrick Crutcher of Chimera Research Group and I are here for the next hour or so discussing the best and worst from the ASCO weekend to get ready for Monday's market open. Please join us and bring your questions and comments.

The anti-PD-1 drugs from Bristol-Myers Squibb and Merck are generating the biggest buzz at this year's ASCO for the dramatic benefit observed in early-stage studies of advanced melanoma patients. Expectations for Bristol-Myers' nivolumab were high going into the conference but Merck may have stolen the show Sunday with lambrolizumab data that look as good or better. ...

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Merck's Anti-PD1 Melanoma Drugs Shrinks Tumors In Half of Patients

twocents@thestreet.com (Adam Feuerstein) — Sun, 02 Jun 2013 15:15 GMT

CHICAGO (TheStreet) -- Merck's anti-PD-1 drug labrolizumab shrank tumors in 38 percent of advanced melanoma patients. At the best dose, 52 percent of the melanoma patients treated with the immune system-boosting drug experienced significant tumor shrinkage.

Updated results from the early-stage study are being presented today at the American Society of Clinical Oncology (ASCO) annual meeting and published simultaneously in the New England Journal of Medicine.

Lambrolizumab is Merck's strongly competitive answer to Bristol-Myers Squibb's nivolumab. Both drugs work by dismantling a cloaking mechanism known as PD-1 used by cancer cells to hide from a patient's immune system. Roche is developing a drug against a related target known as PDL-1. ...

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Roche's Avastin Fails to Prolong Survival of Brain Cancer Patients

twocents@thestreet.com (Adam Feuerstein) — Sun, 02 Jun 2013 11:30 GMT

CHICAGO (TheStreet) -- In 2009, the U.S. Food and Drug Administration granted accelerated approval to Genentech's drug Avastin to treat patients with advanced brain cancer that was no longer responding to prior therapy. Four years later, the benefit of Avastin as a brain cancer therapy is being called into question because the drug is not helping patients live longer.

Avastin when combined with chemotherapy and radiation failed to prolong survival in patients with newly diagnosed brain cancer, also known as glioblastoma, according to findings from two large clinical trials presented at the American Society of Clinical Oncology (ASCO) annual meeting.

Oncologists who treat brain cancer patients aren't likely to give up on Avastin altogether because so few drugs are effective against this type of cancer. For patients with advanced disease that is no longer responding to chemotherapy or radiation, Avastin can still delay the growth of new tumors. But Avastin's inability to demonstrate a survival benefit means the drug isn't likely to be used in newly diagnosed brain cancer patients. ...

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ASCO '13: Amgen's Cancer-Killing Virus Shows Skin-Cancer Survival Trend (Update)

twocents@thestreet.com (Adam Feuerstein) — Sat, 01 Jun 2013 22:02 GMT

Updated with new survival data.

CHICAGO (TheStreet) -- A herpes simplex virus re-engineered to kill cancer cells shrank tumors and produced an early trend towards prolonging the lives of patients with skin cancer, according to updated results from a phase III study conducted by Amgen that will be presented Saturday afternoon at the American Society of Clinical Oncology (ASCO) annual meeting.

The treatment of melanoma, or skin cancer, is a hot topic at this year's ASCO annual meeting, with a lot of attention focused on experimental but very promising drugs from Bristol-Myers Squibb , Merck and Roche that prime a patient's immune system to identify and kill cancer cells. ...

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ASCO '13: Array Drug First to be Effective Against Melanoma of the Eye

twocents@thestreet.com (Adam Feuerstein) — Sat, 01 Jun 2013 11:35 GMT

CHICAGO (TheStreet) -- An experimental drug from AstraZeneca and Array Biopharma shrank tumors in half of patients with melanoma of the eye and delayed the re-growth of tumors for twice as long as patients treated with temozolomide, a commonly used melanoma drug.

The phase II study of selumetinib, presented at the American Society of Clinical Oncology (ASCO) annual meeting, is the first to ever demonstrate a meaningful clinical benefit for patients with advanced melanoma of the eye.

Selumetinib is a pill which blocks a protein known as MEK used by cancer cells to grow. Array discovered selumetinib and licensed the drug to AstraZeneca in 2003. AstraZeneca is conducting phase II studies of selumetinib in non-small cell lung cancer, pancreatic cancer and thyroid cancer. ...

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Aveo Chairman: Expect 'Consequences" From Kidney Cancer Drug Debacle

twocents@thestreet.com (Adam Feuerstein) — Wed, 29 May 2013 15:50 GMT

AVEO data by YCharts

CAMBRIDGE, Mass. (TheStreet) -- The thrashing of Aveo Oncology's kidney cancer drug by an FDA advisory panel earlier this month will lead to "very significant consequences" at the struggling company, said Chairman Henri Termeer, in an interview following Aveo's annual shareholder meeting.

Termeer wouldn't elaborate on what "significant consequences" means for the continued employment of Aveo's management team, including CEO Tuan Ha-Ngoc. If a management shakeup is being considered, Termeer wasn't letting on. Aveo executives have the support of the board of directors, he said. ...

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Doc Claims SummerStreet's Amarin Report Is Inaccurate

twocents@thestreet.com (Adam Feuerstein) — Wed, 29 May 2013 13:58 GMT

Updated with comment from SummerStreet Research.

BEDMINSTER, NJ (TheStreet) -- A doctor mentioned in a bearish research note on Amarin published Tuesday by SummerStreet Research Partners says he was misquoted and did not tell an audience of primary care doctors that FDA wouldn't approve the company's prescription-grade fish oil Vascepa without further clinical data.

Dr. Eliot Brinton, reached by phone in Salt Lake City where he practices medicine, confirmed he is the "Amarin insider" mentioned in the Summer Street report. The report, however, was inaccurate, he says. ...

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Big Pharma Wants Fish Oil After All, But At Half Amarin's Selling Price

twocents@thestreet.com (Adam Feuerstein) — Tue, 28 May 2013 15:41 GMT

Updated with new stock prices.

PRINCETON, NJ (TheStreet) -- Big Pharma is interested in prescription-grade fish oil after all. AstraZeneca is buying Omthera Pharmaceuticals in an incentive-laden deal worth up to $443 million.

To buy Omthera, AstraZeneca passed over Amarin and its prescription-grade fish oil Vascepa. Perhaps Amarin will also find a Big Pharma buyer one day, except the market value for its only product has now been set at roughly half the company's current $1 billion market valuation. ...

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Prosensa IPO Filing Looks Good For Sarepta Therapeutics

twocents@thestreet.com (Adam Feuerstein) — Tue, 28 May 2013 13:40 GMT

LEIDEN, Netherlands (TheStreet) -- Prosensa Holding filed papers Friday seeking to raise as much as $60 million in an initial public offering. My initial reaction after hearing the news:

Prosensa files for IPO. confirms the deficiencies of drisapersen. Good for $SRPT.— Adam Feuerstein (@adamfeuerstein) May 24, 2013

Prosensa's planned IPO is an incremental positive for Sarepta Therapeutics . Why? Because of the answer to this question: ...

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Biotech Stock Mailbag: Amarin, MannKind, Palatin

twocents@thestreet.com (Adam Feuerstein) — Fri, 24 May 2013 11:00 GMT

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

I need to elaborate on a point about Amarin I first made Tuesday on Twitter.

@carpetscott FDA will not approve Vascepa for the Anchor indication in December. $AMRN— Adam Feuerstein (@adamfeuerstein) May 21, 2013 ...

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