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Why Zafgen Is Down 54% Over the Last Two Days
Someone knows something, but no one is talking.
Images
What: Zafgen (NASDAQ:ZFGN) fell 29% today giving it a two-day loss of a whopping 54%. As best anyone can tell, the decline started yesterday when investors learned the company cancelled some meetings it had with investors.
ZFGN Price Chart
ZFGN Price data by YCharts
So what: There are a lot of possibilities for why a company would cancel meetings with investors -- maybe the CEO got the flu? -- but given the radio silence from management while its stock is in freefall, it seems likely that the company's lawyers have ordered a quiet period.
Zafgen has a couple of clinical trials under way testing its lead drug, beloranib, in a genetic disease called Prader-Willi Syndrome that causes patient to have a chronic feeling of hunger and another in severe obesity. The quiet period could be because the company has good news or bad news from the clinical trials or potentially other news -- acquisition, management changes, etc.
Investors are clearly betting on bad news. It's possible that bad news was leaked, causing investors in the know to sell. It's also possible that investors are worried that someone else knows something -- even if no one knows anything -- and then the selling just reinforces investors' hunches that someone knows something.
Now what: I don't have any more information than any other investors. But here are some points to consider:
Positive efficacy data would require more time to work through than negative safety data.
Negative efficacy data can theoretically be presented as quickly as negative safety data, but companies sometimes data mine to try and find something positive to say about a negative clinical trial.
The longer this goes on, the less likely the issue is an acquisition or management change, which could be resolved and/or commented on -- even if it's "no comment" -- in a timely manner.
Buying Zafgen at this point will result in a substantial gain if the news turns out to be positive, but without any inside knowledge of the news, it would be more of a wager than an actual investment.
http://www.fool.com/investing/general/2015/10/13/why-zafgen-is-down-54-over-the-last-two-days.aspx?source=eogyholnk0000001&utm_source=yahoo&utm_medium=feed&utm_campaign=article
Added $15.80, cost now $16.43
Ah, ok, my platform shut down
was looking at Nasdaq AH
thanks
That was a settlement in mm's books. Not a fat finger.
Coming up AH, some dude hit a fat
finger trade for 12,200s @ $18.62
Bought ZFGN 17.32 for a bounce
Zafgen Granted Orphan Drug Designation in the European Union
for Beloranib, a First-in-Class MetAP2 Inhibitor for the Treatment of Craniopharyngioma
A fairly significant step.
http://finance.yahoo.com/news/zafgen-granted-orphan-drug-designation-110000884.html
$ZFGN recent news/filings
bullish
resistance breakout
## source: finance.yahoo.com
Thu, 10 Sep 2015 11:16:09 GMT ~ Zafgen to Present at Morgan Stanley Global Healthcare Conference
[at noodls] - BOSTON, Sept. 10, 2015 (GLOBE NEWSWIRE) -- Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity, today ...
read full: http://www.noodls.com/view/7BDBF070AB141D1A050BA20C08AEC04901FEEF03
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Thu, 10 Sep 2015 11:00:00 GMT ~ Zafgen to Present at Morgan Stanley Global Healthcare Conference
[GlobeNewswire] - BOSTON -- Zafgen, Inc. , a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity, today announced that Zafgen management will present ...
read full: http://finance.yahoo.com/news/zafgen-present-morgan-stanley-global-110000998.html
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Wed, 09 Sep 2015 11:15:13 GMT ~ Zafgen Completes Enrollment of Phase 2b Trial of Beloranib in Severe Obesity Complicated by Type 2 Diabetes
[at noodls] - BOSTON, Sept. 9, 2015 (GLOBE NEWSWIRE) -- Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex ...
read full: http://www.noodls.com/view/7BCADAE4ADFE6761923D7D6BC8266C040AC5C4A1
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Wed, 09 Sep 2015 11:00:00 GMT ~ Zafgen Completes Enrollment of Phase 2b Trial of Beloranib in Severe Obesity Complicated by Type 2 Diabetes
[GlobeNewswire] - BOSTON -- Zafgen, Inc. , a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced it has ...
read full: http://finance.yahoo.com/news/zafgen-completes-enrollment-phase-2b-110000417.html
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Fri, 28 Aug 2015 17:04:11 GMT ~ ZAFGEN, INC. Financials
read full: http://finance.yahoo.com/q/is?s=zfgn
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$ZFGN charts
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$ZFGN company information
## source: otcmarkets.com
Link: http://www.otcmarkets.com/stock/ZFGN/company-info
Ticker: $ZFGN
OTC Market Place: Not Available
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Company name: Zafgen, Inc.
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$ZFGN extra dd links
Company name: Zafgen, Inc.
## STOCK DETAILS ##
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## COMPANY NEWS ##
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## STOCK ANALYSIS ##
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Guru Analysis (nasdaq.com): http://www.nasdaq.com/symbol/ZFGN/guru-analysis
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Corporation WIKI (corporationwiki.com): http://www.corporationwiki.com/search/results?term=Zafgen%2C+Inc.&x=0&y=0
## FUNDAMENTALS ##
Call Transcripts (nasdaq.com): http://www.nasdaq.com/symbol/ZFGN/call-transcripts
Annual Report (companyspotlight.com): http://www.companyspotlight.com/library/companies/keyword/ZFGN
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Revenue/EPS (nasdaq.com): http://www.nasdaq.com/symbol/ZFGN/revenue-eps
SEC Filings (nasdaq.com): http://www.nasdaq.com/symbol/ZFGN/sec-filings
Latest filings (otcmarkets.com): http://www.otcmarkets.com/stock/ZFGN/filings
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Key Statistics (yahoo.com): http://finance.yahoo.com/q/ks?s=ZFGN+Key+Statistics
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Cash Flow (yahoo.com): http://finance.yahoo.com/q/cf?s=ZFGN+Cash+Flow&annual
## HOLDINGS ##
Major holdings (cnbc.com): http://data.cnbc.com/quotes/ZFGN/tab/8.1
Insider transactions (yahoo.com): http://finance.yahoo.com/q/it?s=ZFGN+Insider+Transactions
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## SOCIAL MEDIA AND OTHER VARIOUS SOURCES ##
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Market Watch (marketwatch.com): http://www.marketwatch.com/investing/stock/ZFGN
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Morningstar (morningstar.com): http://quotes.morningstar.com/stock/s?t=ZFGN
Bussinessweek (businessweek.com): http://investing.businessweek.com/research/stocks/snapshot/snapshot_article.asp?ticker=ZFGN
$ZFGN DD Notes ~ http://www.ddnotesmaker.com/ZFGN
Zafgen Completes Enrollment of U.S. Phase 3 Trial
of Beloranib in Prader-Willi Syndrome - MarketWatch
On Track to Report Top Line Data in Early Q1 2016
BOSTON, May 28, 2015 (GLOBE NEWSWIRE via COMTEX) --
Zafgen, Inc. ZFGN, +0.89% a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced that the Company has completed enrollment of ZAF-311, also known as the Beloranib Efficacy Safety and Tolerability in Prader-Willi syndrome (bestPWS) study, a Phase 3 clinical trial of beloranib for the treatment of patients with Prader-Willi syndrome (PWS). The objective of the study is to evaluate the efficacy and safety of beloranib in PWS patients over 6 months of randomized treatment, followed by a six-month open label extension. The trial includes 108 patients with PWS enrolled across 15 sites in the U.S.; the planned enrollment target number was 102 patients.
PWS is the most common known genetic cause of life-threatening obesity and results in constant and unrelenting hunger that drives patients with PWS to engage in problematic hunger-related behaviors, known as hyperphagia, and to gain excessive weight. As a result, many of those affected become morbidly obese and suffer significant mortality. There is currently no cure or effective treatment for PWS.
"We're pleased to announce that we have met and ultimately exceeded our enrollment target for this important Phase 3 trial of beloranib in patients with Prader-Willi syndrome," said Thomas Hughes, Ph.D., Chief Executive Officer of Zafgen. "We remain committed to advancing beloranib and further exploring its potential as an effective treatment option for patients and families living with this challenging condition. We expect the first data readout from this trial early in the first quarter next year."
BestPWS is a six-month trial consisting of randomized, double-blind, placebo controlled, twice-weekly subcutaneous injections of 1.8 mg or 2.4 mg of beloranib or placebo in 108 patients with PWS. The primary efficacy endpoints for this trial are hyperphagia-related behaviors and body weight. Secondary endpoints include changes in total body fat mass, LDL-c, HDL-c, C-reactive protein (CRP) which is a marker of systemic inflammation, among others, and quality of life.
At the time of screening, patients enrolled in the trial are, on average, ~20 years old, morbidly obese (BMI ~40 kg/m2), roughly equal number of males and females, and have a hyperphagia total score consistent with moderate to severe hyperphagia. Thus, the enrolled population is representative of the general PWS population and what was intended for this Phase 3 clinical trial.
"BestPWS is the first of two pivotal clinical trials of beloranib in PWS patients," said Dennis Kim, M.D., Chief Medical Officer of Zafgen. "Patients with PWS and their families are in need of a novel and effective treatment option, and beloranib has the potential to be the first therapy to help improve hyperphagia and body weight, improving the lives of patients, families and caretakers alike. This is the first time that a double-blind, randomized placebo controlled Phase 3 clinical trial in PWS has been conducted."
For more information about this trial, please visit www.clinicaltrials.gov.
About Beloranib
Beloranib is a novel, first-in-class injectable small molecule therapy with a unique mechanism of action that reduces hunger while stimulating the use of stored fat as an energy source. Beloranib is a potent inhibitor of methionine aminopeptidase 2, or MetAP2, an enzyme that modulates the activity of key cellular processes that control metabolism. MetAP2 inhibitors work, at least in part, by directing MetAP2 binding to cellular stress mediators, and, thus, reducing the tone of signals that drive lipid synthesis by the liver and fat storage throughout the body. In this manner, MetAP2 inhibition increases metabolism of fat as an energy source. Zafgen holds exclusive worldwide rights (exclusive of South Korea) for the development and commercialization of beloranib. Zafgen exclusively licensed beloranib from Chong Kun Dang (CKD) Pharmaceutical Corp. of South Korea.
About Prader-Willi Syndrome (PWS)
Prader-Willi syndrome (PWS), the most common known genetic cause of life-threatening obesity, results in constant and unrelenting hunger that drives patients with PWS to engage in problematic hunger-related behaviors and gain excessive weight. As a result, many of those affected become morbidly obese and suffer significant mortality. There is currently no cure for this disease. Although the cause is complex, it results from a deletion or loss of function of a cluster of genes on the 15th chromosome. PWS typically causes low muscle mass and function, short stature, incomplete sexual development, and a chronic feeling of hunger that, coupled with a metabolism that utilizes drastically fewer calories than normal, can lead to excessive eating and life-threatening obesity. PWS occurs in males and females equally and in all races, with the same incidence around the world. Prevalence estimates have ranged from 1:8,000 to 1:50,000.
About Zafgen
Zafgen ZFGN, +0.89% is a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders. Zafgen is focused on developing novel therapeutics that treat the underlying biological mechanisms through the MetAP2 pathway. Beloranib, Zafgen's lead product candidate, is a novel, first-in-class, twice-weekly subcutaneous injection being developed for the treatment of multiple indications, including severe obesity in two rare diseases, Prader-Willi syndrome and obesity caused by hypothalamic injury, including craniopharyngioma-associated obesity; and severe obesity in the general population. Zafgen is also developing ZGN-839, a liver-targeted MetAP2 inhibitor, for the treatment of nonalcoholic steatohepatitis, or NASH, and abdominal obesity. Zafgen aspires to improve the lives of patients through targeted treatments and has assembled a team accomplished in bringing therapies to patients with both rare and prevalent metabolic diseases.
Safe Harbor Statement
Various statements in this release concerning Zafgen's future expectations, plans and prospects, including without limitation, Zafgen's expectations regarding beloranib as a treatment for HIAO, Prader-Willi syndrome, and severe obesity in the general population, its expectations with respect to the timing and success of its clinical trials, the expected requirements and timing of additional clinical trials and pre-clinical studies, and its plans regarding commercialization of beloranib may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Zafgen's ability to successfully demonstrate the efficacy and safety of its product candidates, the pre-clinical and clinical results for its product candidates, which may not support further development, actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials, obtaining, maintaining and protecting its intellectual property, Zafgen's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties, competition from others developing products for similar uses, Zafgen's ability to manage operating expenses, Zafgen's ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives, Zafgen's dependence on third parties for development, manufacture, marketing, sales and distribution of products, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the section entitled "Risk Factors" in Zafgen's most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in Zafgen's subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Zafgen's views only as of today and should not be relied upon as representing its views as of any subsequent date. Zafgen explicitly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Media Relations Contact: Shauna Elkin (212) 850-5613 Shauna.Elkin@fticonsulting.com
Copyright (C) 2015 GlobeNewswire, Inc. All rights reserved.
http://www.marketwatch.com/story/zafgen-completes-enrollment-of-us-phase-3-trial-of-beloranib-in-prader-willi-syndrome-2015-05-28
Q1 ZFGN: $234 mln cash at quarter end.
Top 2 holders, Kolchinsky & Edelman initiated their stake in Q3 2014
From The Filing
Quarter Highlighted by Accelerated Enrollment in bestPWS Clinical Trial?Six Month Data Now Expected in Early Q1 2016
Company on Track to Report Data from Ongoing ZAF-203 Clinical Trial in Late 2015/Very Early 2016
Ends Quarter with Cash and Marketable Securities of $234 Million Following Recent Follow-on Offering
BOSTON, Mass., May 12, 2015 ? Zafgen, Inc. (Nasdaq: ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced its first quarter 2015 financial results.
Z afgen Q1 2015 Business Highlights
Announced an accelerated rate of patient enrollment in recent months in the bestPWS (Beloranib Efficacy Safety and Tolerability in PWS) clinical trial in patients with a rare genetic disorder, Prader-Willi syndrome (PWS) and has reached the original patient recruitment target of 102 patients. Enrollment closeout is expected to be completed in the near term and the total patients in the trial will slightly exceed the original 102 patient goal. Release of top line results is now expected to occur early in the first quarter of 2016.
Based on constructive ongoing dialogue with the U.S. Food and Drug Administration (FDA), the Company has finalized its plan regarding the statistical analysis of primary efficacy endpoints for the bestPWS clinical trial. Both hyperphagia-related behaviors and body weight will be co-primary efficacy endpoints and will be evaluated at a significance level of p-value less than 0.05. With 102 patients enrolled, the trial is adequately powered to demonstrate these effects of beloranib.
Enrolled approximately two-thirds of a target 150 patients in the Phase 2b clinical trial (ZAF-203) to establish the long-term weight loss benefits of MetAP2 inhibitor treatment with beloranib in patients with severe obesity complicated by type 2 diabetes, which began randomized treatment in December 2014. The Company remains on track to release six-month interim data in this subset of patients in late 2015 or very early 2016.
In January 2015, announced positive results from a Phase 2 clinical trial of beloranib in patients with hypothalamic injury-associated obesity (HIAO), a rare, severe, and difficult-to-treat form of obesity. The Company also announced new weight loss and safety data from this Phase 2 clinical trial of beloranib in HIAO at the Endocrine Society Annual Meeting (ENDO 2015). Results from this trial showed that after four weeks of treatment, patients randomized to beloranib lost on average 3.40 kg of body weight vs. 0.25 kg on average for patients randomized to placebo (p=0.01). Results from the open-label extension phase of the trial suggested no apparent waning of the effect of beloranib over eight weeks of treatment.
Raised approximately $130 million through a follow-on public offering in January 2015 which included the full-exercise of the underwriters? option to purchase additional shares of common stock.
?We are very pleased with our accomplishments for the first quarter of 2015. We are thrilled to have seen a high rate of enrollment at our most recently-opened bestPWS clinical trial sites, which will enable us to release six month data from our first pivotal Phase 3 clinical trial early in the first quarter of 2016,? said Dr. Thomas Hughes, Chief Executive Officer of Zafgen. ?We are grateful to the patients and their families for their enthusiasm and commitment to making the bestPWS trial possible.?
?With enrollment progressing well in our Phase 2b trial (ZAF-203) in patients with severe obesity complicated by type 2 diabetes, we remain on track to release important six month interim data in late 2015 or very early 2016,? said Dr. Dennis Kim, Chief Medical Officer of Zafgen. ?The ZAF-203 trial will provide our first look at the effects of beloranib treatment on both body weight and glycemic control in the setting of type 2 diabetes, an important and difficult to treat co-morbidity of obesity.?
?We were pleased to have completed our recent follow-on offering in January 2015, bringing in total net proceeds of approximately $130 million and ending the current quarter with a total cash position of approximately $234 million,? said Patricia Allen, Chief Financial Officer of Zafgen. ?This is an incredibly productive and exciting time for Zafgen and we are investing this capital in the development of beloranib in multiple indications, along with advancing our ZAF-839 program in nonalcoholic steatohepatitis, or NASH, and our second-generation molecules in obesity. We are also expanding our organization to deliver on our multiple development programs and establish our commercial operations in anticipation of approval of beloranib in Prader-Willi syndrome.?
First Quarter 2015 Financial Results
Cash and Cash Equivalents and Marketable Securities
As of March 31, 2015, the Company had cash and cash equivalents and marketable securities totaling $234.2 million.
In January 2015, the Company sold an aggregate of 3,942,200 shares of common stock through an underwritten public offering at $35.00 per share, before underwriting discounts, which included the full-exercise of the underwriters? option to purchase an additional 514,200 shares of common stock at $35.00 per share. The net proceeds to the Company were approximately $129.6 million.
Net Loss
The Company reported a net loss for the first quarter of 2015 of $13.5 million, or $0.53 per share, compared to a $4.5 million net loss, or $6.18 per share, for the first quarter of 2014. The
weighted average common shares (basic and diluted) outstanding used to compute net loss per share were 25,615,282 for the first quarter of 2015, compared to 729,391 for the first quarter of 2014.
Research and Development Expenses
Research and development expenses for the first quarter of 2015 were $10.2 million, compared to $3.3 million for the first quarter of 2014. The increase in research and development expenses for the quarter ended March 31, 2015 as compared to the first quarter of 2014 was primarily due to increased costs associated with the advancement of the Company?s beloranib program, ZGN-839 and other early stage development programs (consisting of our second-generation MetAP2 inhibitors).
General and Administrative Expenses
General and administrative expenses for the first quarter of 2015 were $3.0 million, compared to $1.2 million for the first quarter of 2014. The increase in general and administrative expenses for the quarter ended March 31, 2015 as compared to the first quarter of 2014 was primarily due to increased personnel related costs, increased public company costs, increased travel and other related costs, and increased professional fees.
2015 Financial Guidance
The Company continues to expect that its cash and cash equivalents and marketable securities balance will be greater than $145.0 million at December 31, 2015.
8K
(More:) http://stocknewsflow.com/1374690_000119312515184006_0001193125-15-184006
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Zafgen Presents Positive Safety and Efficacy Data
From Phase 2 Trial of Beloranib in Severe Obesity and Proof of Concept Trial in Prader-Willi Syndrome at ECO 2...
Poster Numbers: PO.111, PO.112
Beloranib Treatment Led to Rapid and Significant Weight Loss and Improvements in Cardiometabolic Biomarkers, Supports Potential to Improve Common Co-Morbid Conditions
PRAGUE, Czech Republic, May 8, 2015 (GLOBE NEWSWIRE) -- Zafgen, Inc. (Nasdaq:ZFGN), a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced positive efficacy and safety data from its ZAF-201 Phase 2 trial of beloranib, a MetAP2 inhibitor, in obese patients. The Company also announced efficacy and safety data from ZAF-211, a proof of concept study of beloranib in patients with Prader-Willi syndrome (PWS). These findings, presented at the 22nd European Congress on Obesity (ECO) on May 7-8, 2015 in Prague, Czech Republic, demonstrated meaningful weight loss and improvement in cardiometabolic biomarkers.
"We are very pleased to present these results to the European obesity research community from our trials in patients with severe obesity and PWS, which demonstrated that treatment with beloranib is not only safe, but also showed meaningful improvements in body weight in obese patients," said Thomas Hughes, Ph.D., Chief Executive Officer of Zafgen. "In both trials, beloranib treatment also improved a variety of biomarkers associated with cardiovascular disease risk and inflammation, supporting its potential to improve common co-morbid conditions affecting patients with obesity and PWS."
Beloranib is a novel, first-in-class injectable small molecule therapy with a unique mechanism of action that reduces drive to eat while stimulating the use of stored fat as an energy source.
"Significant reductions in total and LDL cholesterol and triglyceride levels and an increase in HDL cholesterol were noted in the beloranib 2.4 mg group. A significant increase in HDL cholesterol and decrease in triglyceride levels was observed with beloranib 1.2 mg. Consistent with reduced fat mass and improved adipose tissue function and inflammation, significant (p < 0.001) changes in adiponectin, leptin, and hs-CRP were observed with beloranib."
(Read more:) http://ir.zafgen.com/releasedetail.cfm?ReleaseID=912033
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AFGN: Options Become Available Tomorrow, Expect Some Volitility
New Listings - April 2015
http://www.theocc.com/market-data/series/new-listings/
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ZFGN FBR Capital intiates with outperform, PT $60
Analysts at FBR Capital initiated coverage on Zafgen Inc (NASDAQ: ZFGN)
with a Outperform rating. The target price for Zafgen is set to $60.
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The Best Stock to Invest in Obesity Drugs (OREX, ZFGN)
http://www.fool.com/investing/general/2015/04/12/the-best-stock-to-invest-in-obesity-drugs.aspx
Let's eliminate Roche and Novo Nordisk off the top. Both are large companies, so you wouldn't be investing for their obesity drugs so much as the rest of their stable of approved drugs.
And if that isn't enough, Roche's Xenical has been on the market for years without making much of a bang. Novo Nordisk's Saxenda is relatively new, but it has to be injected, so it'll primarily be used by obese diabetics since a lower-dose version of the drug -- marketed as Victoza -- is available for diabetics looking to control their blood sugar levels.
VIVUS's Qsymia and Arena's Belviq have been on the market for a couple of years, but they've failed to impress doctors or patients because of side effects and minimal efficacy, respectively. They might be able to mount a comeback someday, and Arena has potential with its drugs outside of obesity, but it's hard to call either of them the best obesity drug stocks.
That leaves Orexigen's Contrave and Zafgen's beloranib. Let's take a closer look.
Source: Takeda.
Contrave
Orexigen and its marketing partner Takeda originally tried to get Contrave approved in 2011, but the Food and Drug Administration turned down the application, requesting the companies run a cardiovascular outcomes trial to eliminate the possibility that Contrave was causing heart problems.
After some negotiating, Orexigen complied with the FDA's request, the trial data was satisfactory, and the FDA signed off on its approval.
Contrave is often referred to as the Goldilocks of obesity drugs because it produces more weight loss than Belviq and has less extreme side effects than Qsymia. The drug has quickly taken share from both drugs in part because Takeda has been willing to spend more money on a sales force than VIVUS or Arena's marketing partner Eisai.
Beloranib
Rather than developing beloranib for general obesity, Zafgen has chosen to test the drug's ability to treat a couple of orphan diseases that cause patients to add pounds uncontrollably. Prader-Willi Syndrome is an inherited disease that causes patients to have an unrelenting hunger. And hypothalamic injury-associated obesity occurs after damage or removal of a patient's hypothalamus, often when removing a craniopharyngioma tumor.
Beloranib has shown promising results in both diseases, reducing body fat content in Prader-Willi Syndrome patients and producing weight loss in patients with hypothalamic injury-associated obesity.
Zafgen is running a phase 3 trial in Prader-Willi Syndrome, which should read out by the end of this year.
The biotech is also developing follow-on compounds that target the same pathway that could be used for general obesity, but we're years away from that drug being on the market.
Final verdict
The story of the best obesity drug stock is far from complete.
Zafgen clearly has the easier pathway to sales. Unlike general obesity, doctors don't need to be convinced that patients with Prader-Willi Syndrome and hypothalamic injury-associated obesity need additional treatment because diet and exercise isn't enough to control their obesity.
But Orexigen has the advantage in terms of potential market, with more than a third of Americans considered obese. Zafgen will be able to charge a premium for its obesity drugs since it treats orphan indications, but the upside is limited because there are a limited number of patients.
We can only declare a winner when one of them hits sales of a billion dollars annually, which is the hurdle for being labeled a blockbuster drug. Rather than trying to figure out which company will eventually win, the best move for investors interested in this space might be to buy both, especially since the two initially won't compete directly.
Brian Orelli and The Motley Fool have no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
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Zafgen (NASDAQ:ZFGN): Q4 EPS of -$0.48 beats by $0.36.
The Company reported a net loss for the fourth quarter of 2014 of $10.9 million, or $0.48 per share, compared to a $3.8 million net loss, or $5.35 per share, for the fourth quarter of 2013. The Company reported a net loss for the year ended December 31, 2014 of $36.5 million, or $3.00 per share, compared to a $14.0 million net loss, or $19.53 per share, for the full year ended December 31, 2013. The weighted average common shares (basic and diluted) outstanding used to compute net loss per share were 22,783,817 for the fourth quarter of 2014, compared to 729,391 for the fourth quarter of 2013. The weighted average common shares (basic and diluted) outstanding used to compute net loss per share were 12,189,155 for the year ended December 31, 2014, compared to 729,001 for the year ended December 31, 2013.
Read more: Zafgen Inc.: Zafgen Reports Fourth Quarter and Full Year 2014 Financial Results
http://www.twst.com/update/102075-zafgen-inc-zafgen-reports-fourth-quarter-and-full-year-2014-financial-results
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Zafgen will host a conference call on Thursday, March 19, 2015 at 4:30 p.m. ET to discuss its financial results for the fourth quarter and the full year ended December 31, 2014.
Participants may access the call by dialing 844-824-7428 in the U.S. or 973-500-2177 outside the U.S. The call will also be webcast live on the Company's website at www.zafgen.com. A replay of this conference call will be available beginning at 7:30 p.m. ET on March 19, 2015 through March 26, 2015 by dialing 855-859-2056 in the U.S. or 404-537-3406 outside the U.S. Please provide Conference ID number 5923144.
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Cowen Came Out With The Earliest ZFGN Coverage
and so far the most accurate PT. Despite it's price performance since the IPO, the stock seems to be flying under analyst radars, but not investors apparently.
Zafgen Analyst Ratings, Earnings, Dividends & Insider Trades (NASDAQ:ZFGN)
http://www.analystratings.net/stocks/NASDAQ/ZFGN/?ShowRankings=1
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Zafgen Announces New Weight Loss and Safety Data
from Phase 2 Trial of Beloranib in Hypothalamic Injury Associated Obesity at ENDO 2015 (NASDAQ:ZFGN)
http://ir.zafgen.com/releasedetail.cfm?ReleaseID=900435
BELORANIB TREATMENT LED TO RAPID AND SIGNIFICANT WEIGHT LOSS AND IMPROVEMENTS IN CARDIOMETABOLIC BIOMARKERS, SIMILAR TO RESULTS SEEN IN CONVENTIONAL OBESITY PATIENTS
Poster Number LBS-095
SAN DIEGO, March 7, 2015 (GLOBE NEWSWIRE) -- Zafgen, Inc., a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders, today announced positive efficacy and safety data from a recently completed Phase 2 trial of beloranib, a MetAP2 inhibitor, in patients with hypothalamic injury associated obesity (HIAO). These findings, presented for the first time at the Endocrine Society Annual Meeting (ENDO) on March 7, 2015, demonstrated meaningful and statistically significant weight loss and improvement in cardiometabolic biomarkers.
"We are very pleased with the results from this latest study of patients with HIAO, which demonstrated proof of concept for both the safety and effectiveness of beloranib on body weight and cardiovascular risk markers in this patient population," said Thomas Hughes, Ph.D., Chief Executive Officer of Zafgen. "These positive results also indicate that the efficacy of beloranib in HIAO patients is similar to that observed in conventionally obese patients, as beloranib treatment leads to meaningful and statistically significant weight loss in both patient populations."
HIAO is a rare form of medically induced obesity resulting from damage to the hypothalamus following resection of central nervous system tumors such as craniopharyngiomas. The hypothalamus is a homeostatic control center in the brain that provides oversight of multiple hormonal systems, metabolic rate, hunger, and satiety. Patients affected by HIAO fail to regulate metabolism and food intake normally, resulting in rapid and intractable weight gain, treatment resistant severe obesity, and associated co-morbidities.
Beloranib is a novel, first-in-class injectable small molecule therapy with a unique mechanism of action that reduces hunger while stimulating the use of stored fat as an energy source.
This Phase 2 randomized, double-blind, placebo-controlled trial evaluated the efficacy, safety and tolerability of beloranib 1.8 mg administered as twice-weekly subcutaneous injections for four weeks followed by an optional 4-week, open-label extension. The trial enrolled 14 patients who were mostly women with a mean age of 31.9 years, mean body mass index (BMI) of 42.9 kg/m2 and mean body weight (BW) of 126.4 kg. All patients had radiographic evidence of hypothalamic damage with documentation of subsequent rapid and significant BW gain. Patients were not counseled to adhere to any diet or exercise regimens as part of the trial.
Results from this trial showed that after four weeks of treatment, patients randomized to beloranib lost on average (± standard error of mean) -3.40 ± 0.6 kg of BW vs. -0.25 ± 0.8 kg for placebo (p=0.01). Results from the open-label extension suggested no apparent waning of the effect of beloranib within eight weeks of treatment. Furthermore, known markers of beloranib response, including major cardiovascular risk factors such as lipid parameters and markers of inflammation, were also improved at both four and eight weeks of treatment, corresponding with beloranib treatment.
In this Phase 2 trial, there were no early discontinuations due to adverse events (AEs), severe AEs or serious AEs in patients receiving beloranib. In addition, no clinically significant abnormal laboratory measures, vital signs, or electrocardiography (ECG) findings were observed. The most common AEs occurring in more than one patient treated with beloranib were dizziness, headache, and nasopharyngitis. These AEs were generally mild and transient in nature.
"The results of this proof of concept study are important, as they show that beloranib has a unique mechanism of action which mediates weight loss through actions independent from a fully functional hypothalamus," said Ashley H. Shoemaker, M.D., M.S.C.I., Assistant Professor of Pediatric Endocrinology and Diabetes at Vanderbilt University. "Beloranib continues to demonstrate promising results, and results from this study support its potential as a safe and effective treatment option for this unique patient population."
About Beloranib
Beloranib is a novel, first-in-class injectable small molecule therapy with a unique mechanism of action that reduces hunger while stimulating the use of stored fat as an energy source. Beloranib is a potent inhibitor of methionine aminopeptidase 2, or MetAP2, an enzyme that modulates the activity of key cellular processes that control metabolism. MetAP2 inhibitors work, at least in part, by directing MetAP2 binding to cellular stress mediators, and, thus, reducing the tone of signals that drive lipid synthesis by the liver and fat storage throughout the body. In this manner, MetAP2 inhibition increases metabolism of fat as an energy source. Zafgen holds exclusive worldwide rights (exclusive of South Korea) for the development and commercialization of beloranib. Zafgen exclusively licensed beloranib from Chong Kun Dang (CKD) Pharmaceutical Corp. of South Korea.
About Hypothalamic Injury-Associated Obesity (HIAO)
HIAO is most commonly caused by damage incurred during removal of a central nervous system tumor called craniopharyngioma but it can also result from less common types of hypothalamic injury such as strokes, brain trauma, or radiation therapy to the brain. Craniopharyngioma is a rare form of benign brain tumor that occurs most commonly during childhood and infiltrates near the optic nerve, pituitary gland and the hypothalamus. Treatment of these tumors commonly involves surgical removal of the tumor mass, followed by radiation treatment, which results in disruption or removal of neighboring structures including the hypothalamus. Post-treatment hypothalamic dysfunction results in hyperphagia and significant obesity in up to 50% of these patients, resulting in a variety of co-morbid conditions and a deteriorated quality of life. Craniopharyngioma-associated obesity occurs in males and females equally and in all races, with the same incidence around the world. The incidence estimates have ranged from 0.13 to 0.17 per 100,000 per year, or approximately 400 to 500 new cases per year in the United States and 650 to 850 new cases per year in the European Union.
About Zafgen
Zafgen (Nasdaq:ZFGN) is a biopharmaceutical company dedicated to significantly improving the health and well-being of patients affected by obesity and complex metabolic disorders. Zafgen is focused on developing novel therapeutics that treat the underlying biological mechanisms through the MetAP2 pathway. Beloranib, Zafgen's lead product candidate, is a novel, first-in-class, twice-weekly subcutaneous injection being developed for the treatment of multiple indications, including severe obesity in two rare diseases, Prader-Willi syndrome and obesity caused by hypothalamic injury, including craniopharyngioma-associated obesity; and severe obesity in the general population. Zafgen aspires to improve the lives of patients through targeted treatments and has assembled a team accomplished in bringing therapies to patients with both rare and prevalent metabolic diseases.
Safe Harbor Statement
Various statements in this release concerning Zafgen's future expectations, plans and prospects, including without limitation, Zafgen's expectations regarding beloranib as a treatment for HIAO, Prader-Willi syndrome, and severe obesity in the general population, its expectations with respect to the timing and success of its clinical trials, the expected requirements and timing of additional clinical trials and pre-clinical studies, and its plans regarding commercialization of beloranib may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements can be identified by terminology such as "anticipate," "believe," "could," "could increase the likelihood," "estimate," "expect," "intend," "is planned," "may," "should," "will," "will enable," "would be expected," "look forward," "may provide," "would" or similar terms, variations of such terms or the negative of those terms. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Zafgen's ability to successfully demonstrate the efficacy and safety of its product candidates, the pre-clinical and clinical results for its product candidates, which may not support further development, actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials, obtaining, maintaining and protecting its intellectual property, Zafgen's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties, competition from others developing products for similar uses, Zafgen's ability to manage operating expenses, Zafgen's ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives, Zafgen's dependence on third parties for development, manufacture, marketing, sales and distribution of products, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the section entitled "Risk Factors" in Zafgen's most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, as well as discussions of potential risks, uncertainties, and other important factors in Zafgen's subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Zafgen's views only as of today and should not be relied upon as representing its views as of any subsequent date. Zafgen explicitly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Media & Investor Relations Contact:
Shauna Elkin
(212) 850-5613
Shauna.Elkin@fticonsulting.com
Source: Zafgen, Inc.
News Provided by Acquire Media
Zafgen Offers Hope For The Obese - Zafgen, Inc.
(NASDAQ:ZFGN) | Seeking Alpha
It is no secret that obesity is linked to health risks. Obesity is associated with a higher risk of cancer, diabetes, heart disease, and stroke, as well as the psychological effects from discrimination and the stigma. Weight is not the only excess, however. Spending is as well.
Obese individuals spend on average 40% more on healthcare than those with average weight, increasing US medical costs by $161 billion annually.Indirect costs add to the total, including $8.5 billion for absenteeism attributable to obesity, $378 million in additional airline fuel, and $2.9 billion in additional automobile fuel.[Inflation adjusted from year 2010 dollars.] Cumulatively, obesity costs the United States roughly $196 billion annually, as seen in the chart below, more than lung disease or Alzheimer's.
{read more): http://seekingalpha.com/article/2903226-zafgen-offers-hope-for-the-obese
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Zafgen's lockup expired on Dec, 16 2014 (180 days)
http://www.nasdaq.com/markets/ipos/company/zafgen-inc-720058-75203
Zafgen Announces Pricing of Public Offering of Common Stock Nasdaq:ZFGN
BOSTON, Jan. 22, 2015 (GLOBE NEWSWIRE) -- Zafgen, Inc. (Nasdaq:ZFGN) today announced the pricing of its underwritten public offering of 3,942,200 shares of its common stock at a price of $35.00 per share before underwriting discounts, which includes the underwriters' option to purchase up to an additional 514,200 shares of common stock at the public offering price, less the underwriting discount.
The offering is expected to close on or about January 28, 2015, subject to customary closing conditions.
http://globenewswire.com/news-release/2015/01/23/699414/10116704/en/Zafgen-Announces-Pricing-of-Public-Offering-of-Common-Stock.html
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6-18-2014 Zafgen Hauls In $96M in Upsized IPO
| Xconomy
http://www.xconomy.com/boston/2014/06/18/zafgen-hauls-in-96m-in-upsized-ipo/
June 18 2014 $20.00
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Feb. 25: Zafgen to Present 2015 RBC Capital
Markets Conference (NASDAQ:ZFGN)
http://ir.zafgen.com/releasedetail.cfm?ReleaseID=897012
Clinical Trials - Zafgen
http://www.zafgen.com/zafgen/clinical-trials
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ZAFGEN INC
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