Adam Feuerstein

Pfizer, Glaxo, J&J Grab ASCO Spotlight

twocents@thestreet.com (Adam Feuerstein) — Wed, 16 May 2012 22:01 GMT

BOSTON (TheStreet) -- New drugs from Pfizer and GlaxoSmithKline that precisely target genetic weaknesses in cancer were given spotlight treatment Wednesday night by the American Society of Clinical Oncology (ASCO) in a preview of its upcoming and closely followed annual meeting.

ASCO officials also highlighted a mid-stage study of Johnson & Johnson's Zytiga in early-stage (pre-surgical) prostate cancer patients. Later during the ASCO meeting, which starts in two weeks, J&J will present new Zytiga results from a phase III study in more advanced prostate cancer patients.

In all, ASCO released more than 4,500 research abstracts, or clinical summaries, of new cancer drug data Wednesday night in advance of its annual meeting. ...

Click to view a price quote on PFE.

Click to research the Drugs industry.

ASCO '12 Abstract Dump: Cancer Stocks in Focus

twocents@thestreet.com (Adam Feuerstein) — Wed, 16 May 2012 22:00 GMT

BOSTON (TheStreet) -- Investors got their first look at thousands of cancer drug research abstracts released Wednesday night by the American Society of Clinical Oncology (ASCO) in advance of its closely watched annual meeting.

Among the most significant cancer drug data unveiled for the first time Wednesday night came from phase III studies conducted by Aveo Pharmaceuticals and Exelixis, and randomized phase II studies of drugs discovered by Array BioPharma.

New disclosures of cancer drug data were also made available from Arqule, Ariad Pharmaceuticals, Pharmacyclics, Onyx Pharmaceuticals and Seattle Genetics, among many others. ...

Click to view a price quote on ARRY.

Click to research the Drugs industry.

Hot Biotech Stocks Traded by Hedge Funds in First Quarter

twocents@thestreet.com (Adam Feuerstein) — Wed, 16 May 2012 11:10 GMT

BOSTON (TheStreet) -- Noteworthy hedge fund trading in biotech and drug stocks, culled from the 13F filings for the first quarter: Hedge funds and mutual funds that manage more than $100 million are required to disclose their equity holdings, options and convertible debt on a Form 13F filed SEC within 45 days of the end of a quarter. Funds aren't required to report short positions betting on declines. Since we're already midway through the second quarter, these positions in biotech and drug stocks may already have changed. Things that make you go "Hmmmm…." SAC Capital picks up a new, 1.2 million-share position in Ardea Biosciences during the first quarter. On April 23, AstraZeneca announces the acquisition of Ardea for $1.3 billion. RA Capital, savvy Boston investors who are particularly fluent in the hepatitis C drug market, established a new position in Biocryst Pharmaceuticals with a 3 million-share pickup. Biocryst's experimental BCX5191 won't be entered into human studies until later this year, but the drug belongs to the same "nuc" class as Gilead Sciences' GS-7977. Amylin Pharmaceuticals was a popular stock to buy in the first quarter with rumors swirling around a sale of the diabetes drug company to a Big Pharma suitor. Hedge funds Healthcor Asset Management, Calamos Advisors and Tang Capital and RedMile Group were just some of Wall Street's investor pros establishing new positions.

Not all investors are waiting around to see if Amylin is sold. Millennium Management and SAC Capital both disposed of sizeable stakes in the company during the quarter. The two funds likely took profits from the run-up in Amylin's stock price since the takeout rumors first surfaced on March 28. Human Genome Sciences, locked in a takeover fight with partner GlaxoSmithKline, showed similar pattern of opportunistic hedge fund buying and selling. Perhaps most notable is Adage Capital's liquidation of its entire 3.85 million-share position in Human Genome during the January quarter. Orbimed Advisors, with a healthcare portfolio valued at more than $3 billion, initiated new positions in Onyx Pharmaceuticals, ImmunoGen, Neurocrine BioSciences and Array Biopharma during the January quarter. Orbimed also bought new shares of Chemocentryx, which went public in February.

Biotech stock positions exited by Orbimed, as of March 31, include Pharmacyclics, Grifols, Intermune and United Therapeutics. Amarin expects an FDA approval decision on its prescription-grade fish-oil drug AMR101 on July 26. Ahead of that all-important catalyst, Millennium Management, SAC Capital and Sectoral Asset Management added significantly to their existing stakes in Amarin. New positions were established by Brookside Capital and Apex Capital. YM BioSciences received some Boston hedge-fund love in the first quarter. RA Capital and Adage Capital each bought 2.3 million and 2 million shares respectively. The same cannot be said for Balyasny Asset Management, which dumped 2.7 million shares of YM Bio during the quarter. The fund still retained a small 350,000-share stake as of March 31. Mutual fund giant bought 4.15 million shares of Arena Pharmaceuticals during the first quarter, a new position in the obesity drug company. Mutual funds still greatly outnumber hedge funds on Arena's holders list, as of the end of the first quarter. More hedge funds may have been short Arena heading into last week's FDA advisory panel. ...

Click to view a price quote on ARNA.

Click to research the Drugs industry.

Mulling Arena Pharma's Future With Obesity Drug on Approval Path

twocents@thestreet.com (Adam Feuerstein) — Mon, 14 May 2012 19:09 GMT

SAN DIEGO (TheStreet) -- Thoughts, questions and reflections on Arena Pharmaceuticals following Thursday's FDA advisory panel, which voted 18-4 (with one abstention) to recommend the approval of lorcaserin for weight loss.

Congratulations, Arena. Well done. The company and its outside advisors did an excellent job presenting lorcaserin data to the panel. Not every argument the company made was necessarily persuasive, but it had data to back up its side. Most importantly, Arena was able to respond well to the questions and concerns raised by the experts on the panel about lorcaserin's safety -- rat tumors and cardiovascular risk, in particular.

Thinking back through the live blog of Thursday's panel, I can't recall any instance where Arena was dumbstruck or intimidated by the panelists' questions. Being well prepared is a big part of emerging from the FDA panel meat grinder with a positive outcome. ...

Click to view a price quote on ARNA.

Click to research the Drugs industry.

Arena Pharma: FDA Panel Live Blog

twocents@thestreet.com (Adam Feuerstein) — Thu, 10 May 2012 11:43 GMT

Arena Pharma FDA Panel Live Blog

WASHINGTON, D.C. (TheStreet) -- Arena Pharmaceuticals, the weight-loss drug lorcaserin and an FDA advisory panel: The Sequel.

For those that missed Part One, a quick recap: In September 2010, an FDA panel of experts voted 9-5 to recommend against the approval of Arena's lorcaserin. Panel members were unimpressed with the drug's mediocre efficacy and concerned about several potential safety problems, most notably a risk that a high prevalence of rat tumors could raised the cancer risk in humans. FDA followed the panel's negative recommendation and rejected lorcaserin. ...

Click to view a price quote on ARNA.

Click to research the Drugs industry.

FDA's Review of Arena Pharma's Obesity Drug Sunnier Than Expected

twocents@thestreet.com (Adam Feuerstein) — Tue, 08 May 2012 16:10 GMT

Updated with correction to accurately describe the 6% mean weight-loss observed in the lorcaserin phase III trials.

SAN DIEGO (TheStreet) -- The FDA's review of Arena Pharmaceuticals' weight-loss drug lorcaserin is... and it's more positive than I expected.

The outcome of Thursday's FDA advisory panel is still unknown, of course, but Arena bulls (the "Areniacs") should feel more confident in a positive vote recommending lorcaserin's approval. ...

Click to view a price quote on ARNA.

Click to research the Drugs industry.

Vertex Is the Next Gilead Sciences or Alexion

twocents@thestreet.com (Adam Feuerstein) — Mon, 07 May 2012 20:06 GMT

CAMBRIDGE, Mass. (TheStreet) -- Vertex Pharmaceuticals is the next Gilead Sciences. You think I'm reaching? Okay, then Vertex is the next Alexion Pharmaceuticals.

Either way, the big move higher in Vertex's stock price Monday, spurred by the release of strong cystic fibrosis data, is totally justified and likely undervalues the company going forward.

Vertex shares rose $20.71, or 55%, to $58.12 Monday following the announcement that two drugs -- the experimental VX-809 and currently marketed Kalydeco -- significantly improved lung function in patients with the most common genetic mutation causing cystic fibrosis. ...

Click to view a price quote on VRTX.

Click to research the Drugs industry.

Vertex: Two-Drug Cystic Fibrosis Therapy Improves Lung Function

twocents@thestreet.com (Adam Feuerstein) — Mon, 07 May 2012 13:57 GMT

if !IE-->endif-->Content on this page requires a newer version of Adobe Flash Player.if !IE-->endif-->

Updated with stock price, analyst reaction.

CAMBRIDGE, Mass. (TheStreet) -- Vertex Pharmaceuticals released preliminary data Monday showing two drugs -- the experimental VX-809 and currently marketed Kalydeco -- significantly improved lung function in patients with the most common genetic mutation causing cystic fibrosis. ...

Click to view a price quote on VRTX.

Click to research the Drugs industry.

Biotech Stock Mailbag: Exelixis, Protalix, Arena

twocents@thestreet.com (Adam Feuerstein) — Fri, 04 May 2012 11:34 GMT

BOSTON (TheStreet) -- David Sobek, political scientist, amateur biotech investor and widely followed Twitter commentator (@dsobek) writes that Exelixis is an under-appreciated and under-valued biotech stock, particularly given some updates on the prostate cancer drug cabozantinib expected at the American Society of Clinical Oncology (ASCO) annual meeting in June.

"Exelixis represents both a long-term value play and has a good chance to surprise investors with their data presentations at ASCO," writes Sobek at Seeking Alpha.

I appreciate Sobek's perspective on Exelixis but told him (via Twitter) that he's fighting against Wall Street biotech investors and their generally dim view of cabozantinib's potential. That makes it tough for Exelixis bulls like Sobek to win. ...

Click to view a price quote on EXEL.

Click to research the Drugs industry.

The Next Big Thing in Biotech: Pfizer

twocents@thestreet.com (Adam Feuerstein and Gregg Greenberg) — Fri, 04 May 2012 10:00 GMT

Senior columnist Adam Feuerstein says Pfizer is the next big thing in biotech.

26 Drugs Facing FDA Approval in 2012

twocents@thestreet.com (Adam Feuerstein) — Wed, 02 May 2012 17:45 GMT

Calendar updated to include several drug approvals inadvertently omitted.

BOSTON (TheStreet) -- Here's an updated list of biotech and pharmaceutical companies with pending FDA drug approval decisions for the rest of 2012.

The calendar on the following pages captures the most important U.S. regulatory events -- FDA drug approvals and advisory panels -- expected between May and December 2012. As every savvy biotech investor and trader knows, the volatility in biotech and drug stocks ramps significantly as U.S. regulators weigh whether to approve or reject new drugs. ...

Click to view a price quote on REGN.

Click to research the Drugs industry.

Juicy Details From Tang Capital's Lawsuit Against Savient Pharma

twocents@thestreet.com (Adam Feuerstein) — Tue, 01 May 2012 19:06 GMT

="Scripts/swfobject_modified.js" type="text/javascript">if !IE-->endif-->Content on this page requires a newer version of Adobe Flash Player.

if !IE-->endif-->

EAST BRUNSWICK, NJ (TheStreet) -- Savient Pharmaceuticals is insolvent and its directors are greedy pigs more interested in emptying the company's dwindling cash pile into their own pockets than repaying creditors, alleges a West Coast hedge fund and Savient's largest creditor in a lawsuit filed Tuesday. ...

Click to view a price quote on SVNT.

Click to research the Drugs industry.

Arena: FDA Adds Obesity Docs to Panel

twocents@thestreet.com (Adam Feuerstein) — Tue, 01 May 2012 12:25 GMT

BOSTON (TheStreet) -- Thoughts and observations on obesity drug stocks as Arena Pharmaceuticals gets ready to bring lorcaserin in front an another FDA advisory panel on May 10.

My apologies for beginning with some shameless self promotion: I will be live-blogging the Arena FDA panel, providing eight hours-plus of continuous, play-by-play coverage and instant analysis as obesity experts review and ultimately pass judgment on lorcaserin's efficacy and safety.

Don't miss out on all the excitement and suspense. More than 22,000 readers logged into my live blog of the Vivus FDA panel in February, which resulted in a 20-2 vote in favor of Qnexa. I expect another big crowd on May 10, so mark your calendars. ...

Click to view a price quote on ARNA.

Click to research the Drugs industry.

Celldex Screw-Up Nixes ASCO Data Slot

twocents@thestreet.com (Adam Feuerstein) — Tue, 01 May 2012 11:00 GMT

NEEDHAM, Mass. (TheStreet) -- A clerical error has cost Celldex Therapeutics the opportunity to present data on its breast cancer drug CDX-011 at the upcoming American Society of Clinical Oncology (ASCO) annual meeting.

This is hard to believe, but someone at Celldex clicked a wrong box on ASCO's online abstract submission form. As a result, ASCO rejected the CDX-011 abstract. Celldex appealed but ASCO refused to make an exception, the company says.

Doh! ...

Click to view a price quote on CLDX.

Click to research the Drugs industry.

Biotech Stock Mailbag: AVI, Aveo, Spectrum

twocents@thestreet.com (Adam Feuerstein) — Fri, 27 Apr 2012 10:00 GMT

BOSTON (TheStreet) -- Renton L. opens this week's Biotech Stock Mailbag: "Was there anything noteworthy in the AVI BioPharma update announced this week? Are you still optimistic about this drug's chances; maybe the market is getting this drug all wrong?"

AVI's eteplirsen is the first drug ever to significantly increase the production of dystrophin in boys with Duchenne muscular dystrophy (DMD). That's pretty darn remarkable, so yes, I believe there is reason for optimism.

The problem is that eteplirsen's ability to generate dystrophin has not yet translated into a meaningful clinical benefit for DMD patients. AVI presented new data this week showing small improvements in walking ability in some patients. The data were highly variable, however: Two patients with increased dystrophin production actually performed significantly worse on a six-minute walk test. ...

Click to view a price quote on AVII.

Click to research the Drugs industry.

The Next Big Thing in Biotech: M&A

twocents@thestreet.com (Adam Feuerstein and Gregg Greenberg) — Fri, 27 Apr 2012 09:00 GMT

Senior columnist Adam Feuerstein says M&A is the next big thing in biotech.

Amarin Shares Move Higher on Competing Fish Oil Data

twocents@thestreet.com (Adam Feuerstein) — Thu, 26 Apr 2012 14:41 GMT

PRINCETON, NJ (TheStreet) -- Omthera Pharmaceuticals released late-stage study results on its omega-3 (fish oil) drug Thursday, which while positive, don't appear to compare well to Amarin's competing product.

Amarin shares are up $1.43, or 14%, to $11.40 Thursday on reaction to the Omthera news.

Omthera said that a low and high dose of Epanova lowered triglyceride (TG) levels by 26% and 31% respectively in patients who entered the clinical trial with very high levels of the blood-based fat. ...

Click to view a price quote on AMRN.

Click to research the Drugs industry.

Amgen Goes to Turkey, Loses Biotech Cred

twocents@thestreet.com (Adam Feuerstein) — Wed, 25 Apr 2012 13:23 GMT

BOSTON (TheStreet) -- Amgen is saying "elveda" to the biotech sector.

That's Turkish for "goodbye." With the $700 million purchase of Turkey's Mustafa Nevzat Pharmaceuticals, a maker of generic drugs, Amgen's claim as "the world's largest biotech company" no longer holds much meaning.

Amgen has graduated to become a "pharmaceutical company" joining the ranks of Merck, Bristol-Myers Squibb and Pfizer. ...

Click to view a price quote on AMGN.

Click to research the Drugs industry.

Galena's Breast Cancer Vaccine Doomed to Fail

twocents@thestreet.com (Adam Feuerstein) — Tue, 24 Apr 2012 17:01 GMT

LAKE OSWEGO, Oregon (TheStreet) -- Galena Biopharma's breast cancer vaccine NeuVax will fail when results of a phase III clinical trial are eventually announced in three years or so.

I can boldy predict NeuVax's failure this far in advance because Galena is making the same mistakes and taking the same sloppy shortcuts that Keryx Pharmaceuticals did with its colon cancer drug perifosine. The warning signs with perifosine proved correct, as they will with NeuVax.

In early February, I called Galena (which was up 168% year to date at that time) a drug stock unworthy of the biotech bull market. This label still rings true, even more so given the stock's continued ascent. Galena's market value of nearly $80 million may seem puny but it's actually excessive when you consider that the company's only asset -- NeuVax -- is never going to reach the market. ...

Click to view a price quote on GALE.

Click to research the Drugs industry.

Vertex Hopes Two Cystic Fibrosis Drugs Better than One

twocents@thestreet.com (Adam Feuerstein) — Tue, 24 Apr 2012 12:25 GMT

if !IE-->endif-->Content on this page requires a newer version of Adobe Flash Player.if !IE-->endif-->

CAMBRIDGE, Mass. (TheStreet) -- Vertex Pharmaceuticals is expected to report strong initial sales of its cystic fibrosis drug Kalydeco on Thursday as investors shift their attention away from the waning performance of the company's hepatitis C drug Incivek.

Soon after Vertex reports first-quarter earnings, investor attention moves to two, more important events that will have a far greater influence on the future direction of the company's stock price: 1) The first look at the potency of two new hepatitis C drugs; and 2) results from a mid-stage "combo" study of Kalydeco and the experimental drug VX-809 in cystic fibrosis patients with the most commonly occurring (and therefore most commercially lucrative) genetic mutation F508del. ...

Click to view a price quote on VRTX.

Click to research the Drugs industry.

Biotech Stock Mailbag: Amarin

twocents@thestreet.com (Adam Feuerstein) — Mon, 23 Apr 2012 11:57 GMT

BOSTON (TheStreet) -- With my apologies, last week's Biotech Stock Mailbag is a few days late.

"Patent" asks, "Your latest thoughts on Amarin?"

The next challenge for Amarin and its ultra-purified fish oil AMR101 comes from Omthera Pharmaceuticals as it gets ready to announce late-stage study results from a potentially competitive omega-3 fatty acid product. ...

Click to view a price quote on AMRN.

Click to research the Drugs industry.

Cell Therapeutics Juggles Chainsaws To Distract Investors From Its Dead-End Course

twocents@thestreet.com (Adam Feuerstein) — Thu, 19 Apr 2012 19:12 GMT

SEATTLE (TheStreet) -- Cell Therapeutics CEO Jim Bianco threw another chainsaw into his reckless juggling act Thursday. Investors should avert their eyes, unless they enjoy the sight of inevitable severed limbs.

In Bianco latest act of daring-do, Cell Therapeutics is shelling out $15 million to Singapore's S*Bio to license the myelofibrosis drug pacritinib. That doesn't seem like a lot of money for a drug supposedly ready to enter phase III trials, except pacritinib, formerly known as SB1518, was thrown away by Onyx Pharmaceuticals last year.

Why did Onyx license pacritinib from S*Bio and then give the drug back? Perhaps it was the phase II data in myelofibrosis presented last year, which showed lackluster efficacy (worse than similar drugs from Incyte and YM BioSciences) and alarming rates of diarrhea, nausea and vomiting. ...

Click to view a price quote on CTIC.

Click to research the Drugs industry.

Gilead, Bristol Put Profits Ahead of Best Care for Hep C Patients

twocents@thestreet.com (Adam Feuerstein) — Thu, 19 Apr 2012 15:13 GMT

Updated with comment from EASL.

BARCELONA (TheStreet) -- The most effective new therapy for hepatitis C -- two pills that could cure nearly every patient treated -- may never see the light of day because the developers of these new medicines, Bristol-Myers Squibb and Gilead Sciences, seem unable to work together.

Apparently, profits are more important than best patient care. ...

Click to view a price quote on BMY.

Click to research the Drugs industry.

Human Genome Rejects $2.6B Bid From GlaxoSmithKline (Update 1)

twocents@thestreet.com (Adam Feuerstein) — Thu, 19 Apr 2012 11:28 GMT

Updated with further information on GlaxoSmithKline's unsolicited bid for Human Genome

NEW YORK (TheStreet) -- Human Genome Sciences received an unsolicited buyout proposal of $13 a share in cash, or about $2.6 billion, from GlaxoSmithKline but rejected the offer saying the bid "does not reflect the value inherent" in the company.

The Glaxo bid represents an 81% premium to Human Genome's closing price Wednesday of $7.17. ...

Click to view a price quote on HGSI.

Click to research the Drugs industry.

Gilead, Bristol Hep C Drug Data Arrives at EASL

twocents@thestreet.com (Adam Feuerstein and Nathan Sadeghi-Nejad) — Thu, 19 Apr 2012 10:10 GMT

Updated with new information throughout.

BARCELONA (TheStreet) -- Finally, highly anticipated data from studies of all-oral hepatitis C therapies under development by Gilead Sciences and Bristol-Myers Squibb have been released this morning at the European Association for the Study of Liver Disease (EASL) annual meeting.

Here are the headline EASL data most important to investors: ...

Click to view a price quote on GILD.

Click to research the Drugs industry.

Arena Pharma's Own Data Point to Weight-Loss Drug Rejection

twocents@thestreet.com (Adam Feuerstein) — Wed, 18 Apr 2012 13:26 GMT

SAN DIEGO (TheStreet) -- Last week's column on Vivus and Arena Pharmaceuticals drew some strong reactions from the Arena faithful, almost all of whom were spitting mad that I dared say publicly what almost everyone else already believes:

Arena's weight-loss drug lorcaserin isn't going to be approved any time soon. FDA, however, is getting ready to approve Vivus' Qnexa.

In particular, the "Areniacs" accused me of lying about lorcaserin and being paid off to write disparaging, false and misleading statements about Arena by short sellers and other criminal market manipulators. This paragraph, in particular, raised a fuss: ...

Click to view a price quote on ARNA.

Click to research the Drugs industry.

Endocyte Shares Rise on Merck Cancer Deal

twocents@thestreet.com (Adam Feuerstein) — Mon, 16 Apr 2012 13:58 GMT

if !IE-->endif-->Content on this page requires a newer version of Adobe Flash Player.if !IE-->endif-->

WEST LAFAYETTE, Ind. (TheStreet) -- Endocyte shares doubled in value Monday following the licensing of its experimental ovarian cancer drug EC145 to Merck.

Under terms of the agreement, Merck is paying $120 million in cash to Endocyte for worldwide rights to EC145, which recently began a late-stage study in patients with advanced ovarian cancer. Endocyte must continue to pay for the phase III study, with results expected in 2014. ...

Click to view a price quote on ECYT.

Click to research the Drugs industry.

The Next Big Thing in Biotech: Alexza

twocents@thestreet.com (Adam Feuerstein and Gregg Greenberg) — Fri, 13 Apr 2012 10:30 GMT

Adam Feuerstein, senior columnist for <I>TheStreet</I>, explains why Alexza Pharmaceuticals is the next big thing in biotech.

Biotech Stock Mailbag: All You Need to Know About Hep C Drugs

twocents@thestreet.com (Adam Feuerstein) — Fri, 13 Apr 2012 09:30 GMT

BOSTON (TheStreet) -- Let's roll with this week's Biotech Stock Mailbag.

Jackson P. asks, "Is there any data that has not leaked from EASL which will be important to the hepatitis C stocks?"

The EASL meeting kicks off officially April 18 and runs through April 22. As Jackson notes, I've written a lot about selective disclosure of research abstracts and data leaks leading up to the EASL meeting, but let's now focus attention on investor expectations for new data to be presented at the meeting and what it may mean for hepatitis C drug stocks. ...

Click to view a price quote on CLDX.

Click to research the Drugs industry.

More Hep C Drug Abstracts Leak Ahead of EASL Confab

twocents@thestreet.com (Adam Feuerstein) — Wed, 11 Apr 2012 12:44 GMT

BOSTON (TheStreet) -- More hepatitis data supposedly kept under wraps by the European Association for the Study of the Liver (EASL) in advance of next week's closely followed annual meeting has made its way into the hands of Wall Street investors.

Fortunately for EASL, the leaked research abstracts, including one describing the important "Electron" study of Gilead Sciences' hepatitis C drug GS-7977, doesn't contain new information and therefore isn't particularly stock moving.

On Tuesday, an investor who asked to remain anonymous emailed me three research abstracts involving hepatitis C drug data from Gilead Sciences and Bristol-Myers Squibb. All of the abstracts were supposed to be embargoed and therefore not publicly available, according to EASL rules. ...

Click to view a price quote on BMY.

Click to research the Drugs industry.