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Earnings today after market close.
Expecting positive results...
ZFGN always beat analyst expectations.
Now they can concentrate on finding some positive results with FDA guidelines set and letting go unneeded personal. $5.00 stock again soon.
"The in vitro assays we presented to the FDA reflect Zafgen's deep understanding of the significant difference of ZGN-1061 on endothelial cell biology as compared to our prior compound and we believe represent a truly sophisticated and optimized approach to evaluate important safety information about ZGN-1061," said Priya Singhal, M.D., M.P.H, Head of Research and Development. "We are working to rapidly implement the in vivo animal study, which aims to establish the relevance of the in vitro mechanism and safety margins. We appreciate the FDA's thorough feedback and continuing collaboration throughout this process."
Given the current status and expected timelines of Zafgen's development programs, the Company has implemented plans to reduce its operating expenses and prioritize key resources, with an immediate corporate restructuring as well as other strategies to preserve resources. This restructuring includes a workforce reduction of approximately 25%, in addition to other attrition in 2019. With these changes, Zafgen now expects its projected cash runway to last greater than two years, given its current operating plan.
"Since our constructive Type A meeting with the FDA earlier this year, we've been focused on gaining clarity on the path forward, reaching agreement on the in vivo study design and protocol, and preparing for strong initiation and execution of the study," said Jeffrey Hatfield, Chief Executive Officer. "As we move ahead with ZGN-1061 having accomplished these goals, we have also taken steps to ensure the effective use of capital as we look to the future. This includes the difficult but prudent decision to restructure at this time. We are deeply grateful for the entire team's dedication and many contributions."
News out after the bell!
ZFGN strikes deal with FDA.
1.39 AH HOD...
$ZFGN Zafgen, Inc. (NASDAQ:ZFGN) has 92 institutional investors and shareholders that have filed 13D/G or 13F forms with the Securities Exchange Commission (SEC). These institutions hold a total of 28,642,877 shares. Largest shareholders include Atlas Venture Advisors, Inc., Great Point Partners Llc, Armistice Capital, Llc, Farallon Capital Management Llc, Vanguard Group Inc, FMR LLC / Fidelity, AWM Investment Company, Inc., 683 Capital Management, LLC, Mangrove Partners, and BlackRock Inc..
Zafgen, Inc. (NASDAQ:ZFGN) ownership structure shows current positions in the company by institutions and funds, as well as latest changes in position size. Major shareholders can include individual investors, mutual funds, hedge funds, or institutions. The Schedule 13D indicates that the investor holds more than 5% of the company and intends to actively pursue a change in business strategy.
https://fintel.io/so/us/zfgn
Love these left for dead plays as some big money can be made. Been adding on the sell off now waiting for the payoff on an FDA go. GLTY
Inching higher everyday towards the PT
JMP Securities invites you to attend its annual life sciences equity research conference, which brings institutional investors together with senior executives of leading publicly traded and privately held companies in the areas of biopharmaceuticals, biotechnology, and medical devices and technologies. Fireside chats and thematic panel discussions incorporating a range of senior executives, key opinion leaders, practitioners and patients will highlight the primary trends shaping the life sciences marketplace today.
Participating Companies
https://jmpls.ljfevents-rsvp.com/participating-companies/
Looking that way and loaded with shares for the long term. GLTY
Phase 3 no doubt coming. Conditional approval in australia and new zealand have been met.
Zafgen to Present at the JMP Securities Life Sciences Conference
June 13, 2019 16:15 ET | Source: Zafgen, Inc.
BOSTON, June 13, 2019 (GLOBE NEWSWIRE) -- Zafgen, Inc. (Nasdaq:ZFGN), a clinical-stage biopharmaceutical company leveraging its proprietary knowledge of MetAP2 systems biology to develop novel therapies for patients affected by a range of metabolic diseases, announced today that Jeffrey Hatfield, Chief Executive Officer of Zafgen, Inc. is scheduled to present at the JMP Securities Life Sciences Conference on Thursday, June 20, 2019, at 10:30 a.m. ET.
A live audio webcast and replay of the presentation will be available through the Events and Presentations page of the Investors section of the Company's website (www.zafgen.com) for 90 days following the conclusion of the live event.
About Zafgen
Zafgen (Nasdaq:ZFGN) is a clinical-stage biopharmaceutical company leveraging its proprietary MetAP2 biology platform to develop novel therapies for patients affected by complex metabolic diseases. Zafgen has pioneered the study of MetAP2 inhibitors in both common and rare metabolic disorders and is currently advancing programs for type 2 diabetes, Prader-Willi syndrome and liver diseases. Learn more at www.zafgen.com.
Media/Investor Relations Contacts:
Zafgen, Inc.
Patricia Allen
Chief Financial Officer
617-648-9792
Media
Krystle Gibbs
Ten Bridge Communications
krystle@tenbridgecommunications.com
508-479-6358
Investors
John Woolford
Westwicke
john.woolford@westwicke.com
443-213-0506
http://www.globenewswire.com/news-release/2019/06/13/1868702/0/en/Zafgen-to-Present-at-the-JMP-Securities-Life-Sciences-Conference.html
Latest transcript:
Investment Highlights
•
A rare disease focused clinical stage biopharmaceutical company with a pipeline of novel product candidates that are intended
to address unmet need in a variety of metabolic diseases
•
ZGN 1061 for type 2 diabetes with concomitant obesity and/or NASH
•
Diabetes market evolving towards therapies with enhanced A1C lowering efficacy and positive effects on common co morbidities (ob esity/NAFLD)
•
Phase 2 proof of concept trial demonstrated significant A1C lowering efficacy and weight loss, with a safety and tolerability pr ofile generally
comparable to placebo
•
Nonclinical ZGN 1061 studies have demonstrated significant NASH model efficacy, and complementary efficacy in combination with a GLP 1
•
Next milestone: Update on development plans by end of 3Q 2019
•
ZGN 1258 for rare metabolic diseases, including Prader Willi syndrome
•
Prader Willi syndrome is a rare, lethal disease emerging in childhood, with ~200,000 afflicted worldwide; no current therapeutic options available
•
Development plans suspended due to unexpected finding in long term toxicology studies
•
ZGN 1345 for metabolic liver disease
•
Multiple metabolic related liver diseases exist with high unmet medical need, from NAFLD/NASH to hepatocellular carcinoma
•
Compound is an orally dosed MetAP2i with high liver concentrations but minimal to no detectable systemic exposure; once daily do sing expected
•
Named as development candidate 4Q 2018; nonclinical development work underway
•
March 31, 2019 cash position of $105M; runway expected to extend through at least 2020
ZGN
1061 Next Steps
•
Reviewing comprehensive data sets with diabetes/NASH KOLs and potential partners
•
Important progress made toward addressing the FDA Clinical Hold:
•
Received FDA Type A meeting minutes to previously announced clinical hold
•
FDA acknowledged newly developed in vitro assays of human plasma coagulation and tissue factor expression qualitatively
differentiate ZGN 1061
•
Working with FDA to translate in vitro data and confirm relevant safety margins in an in vivo model
•
Exploring a second IND in a population with higher unmet medical need
•
Company expects to provide an update on development plans by end of 3Q 2019
•
Submitting abstracts to present full results of the Phase 2 clinical trial at upcoming medical meetings in 2019
ZGN
1258 Summary
•
Unexpected finding observed in long term toxicology studies
•
Degeneration and other anomalies in muscle tissue from 4 and 6 month rodent studies
•
Observed in different degrees in both vehicle and all dose arms; finding more pronounced at higher doses
•
Finding never observed previously, specific to ZGN 1258
•
Not seen in prior ZGN 1258 rodent studies
•
Not seen in any other species with ZGN 1258
•
Not seen in any other Zafgen MetAP2i program in any long term toxicology study
•
Plan to file an IND suspended while finding is investigated
•
Company will provide an update at a later time, if warranted, following further evaluation
PWS Commitment Continues
•
PATH for PWS natural history study collaboration continues
•
Study being conducted in collaboration with the Foundation for
Prader Willi Research (FPWR) and National Organization for Rare
Disorders (NORD)
•
PATH for PWS designed as 4 year / 500 participant non interventional
natural history study
•
Enrollment kicked off at FPWR annual conference in October; >400
enrolled as of March 2019
ZGN
1345 Oral, Liver Focused MetAP2 Inhibitor
•
ZGN 1345 advanced to development candidate status in 4Q 2018
•
Orally dosed MetAP2i; expected once daily dosing
•
High concentrations in the liver; minimal to no detectable exposure systemically
•
High MetAP2 levels strongly correlated with more severe outcomes in advanced liver disease
•
Positive early data in multiple nonclinical liver disease models with high unmet medical need; further nonclinical
studies ongoing
Been green for 2 days on heavy accumulation. Something BIG is coming?
Squeeze or fast trak ?
Zafgen (ZFGN)
Cowen & Co. analyst Yaron Werber maintained a Hold rating on Zafgen today. The company’s shares opened today at $1.35, close to its 52-week low of $1.25.
According to TipRanks.com, Werber is a 4-star analyst with an average return of 12.5% and a 61.2% success rate. Werber covers the Healthcare sector, focusing on stocks such as Ultragenyx Pharmaceutical, Inc., Rocket Pharmaceuticals Inc, and Unum Therapeutics Inc.
https://www.analystratings.com/articles/analysts-offer-insights-on-healthcare-companies-zafgen-nasdaq-zfgn-and-pharming-group-other-otc-phguf/
Phase 3 on its way.....
News: $ZFGN Zafgen Presented Full Results of Phase 2 Clinical Trial for ZGN-1061 at the American Diabetes Association's 79th Scientific Sessions
Delivered comprehensive oral presentation on both cohorts of the clinical trial, including previously announced results for second cohort evaluating doses up to 1.8 mg Company also presented data demonstrating that treatment with ZGN-1061 improves measures of insulin sensitivity and b...
Find out more https://marketwirenews.com/news-releases/zafgen-presented-full-results-of-phase-2-clinical-trial-for-zgn-1061-at-the-american-diabetes-association-s-79th-scientific-sessions-8329472.html
Zafgen Presented Full Results of Phase 2 Clinical Trial for ZGN-1061 at the American Diabetes Association's 79th Scientific Sessions
Mon June 10, 2019 7:00 AM|GlobeNewswire|About: ZFGN
Delivered comprehensive oral presentation on both cohorts of the clinical trial, including previously announced results for second cohort evaluating doses up to 1.8 mg
Company also presented data demonstrating that treatment with ZGN-1061 improves measures of insulin sensitivity and beta-cell function
BOSTON, June 10, 2019 (GLOBE NEWSWIRE) -- Zafgen (ZFGN), Inc. (Nasdaq:ZFGN), a clinical-stage biopharmaceutical company leveraging its proprietary knowledge of MetAP2 systems biology to develop novel therapies for patients affected by a range of metabolic diseases, today announced that the Company presented the full results of its Phase 2 clinical trial for ZGN-1061 in an oral presentation at the American Diabetes Association's 79th Scientific Sessions. Zafgen also presented a poster on data demonstrating that treatment with ZGN-1061 improved measures of glycemic control, including insulin sensitivity and beta-cell function.
Zafgen previously announced positive results from its Phase 2 clinical trial conducted outside the U.S., including data for the second cohort that included doses up to 1.8 mg, in January 2019. The clinical trial met all of its primary objectives at the 1.8 mg dose, which included glycemic control, or change in A1C, and safety and tolerability. The 12-week data demonstrated that treatment with the 1.8 mg dose of ZGN-1061 produced substantially more improvement in A1C versus placebo than the 0.9 mg dose versus placebo. Progressive and notable reduction in body weight also occurred in patients treated with the 1.8 mg dose. The data showed a favorable safety and tolerability profile for ZGN-1061, with no treatment-related serious adverse events and no cardiovascular (CV) safety signals observed in the trial.
The Phase 2 clinical trial also examined the effects of ZGN-1061 on other markers of glycemic control. In data presented during the poster session, patients who participated in a mixed-meal tolerance test demonstrated significant improvements in postprandial glucose excursion with ZGN-1061 (p<0.001 for both the 0.9 and 1.8 mg doses) and a trend for improvement in insulin levels from baseline to Week 12. ZGN-1061 also demonstrated improvement in beta-cell function and insulin sensitivity in an exploratory combined analysis of 0.9+1.8 mg ZGN-1061 (p=0.02 and p=0.07) using a modeling approach. These data suggest improved glycemic control with ZGN-1061 may be driven by changes in insulin sensitivity and beta-cell function in this population of patients with advanced diabetes.
The poster will be available on the Company’s website.
About Zafgen
Zafgen is a clinical-stage biopharmaceutical company leveraging its proprietary MetAP2 biology platform to develop novel therapies for patients affected by complex metabolic diseases. Zafgen has pioneered the study of MetAP2 inhibitors in both common and rare metabolic disorders. Learn more at www.zafgen.com.
Biopharmaceutical Zafgen (ZFGN) Trading 44% Below Cash Value
End of June...accumulation going on as time goes by.
PT is 6 and above if fda will green light the new drug investigation.
Finding Abnormal Returns With The Russell Index Rebalancing Every June
https://seekingalpha.com/article/4268687-finding-abnormal-returns-russell-index-rebalancing-every-june
The company is optimistic.
"We believe the new in vitro data generated was encouraging, and the FDA was helpful with guidance regarding data needed to move forward in type 2 diabetes," Zafgen CEO Jeffrey Hatfield said in a statement.
What's Next
Zafgen said it is evaluating serious, rare disease indications for which ZGN-1061 could be useful.
The FDA was supportive of Zafgen seeking guidance on a second investigational new drug application for ZGN-1061 as appropriate.
Zafgen is set to provide an update on development plans by the end of the third quarter.
Today Zafgen's hold rating reiterated at Piper Jaffray Companies. $5.00 PT. and Zafgen's buy rating reiterated at Wedbush. $6.00 PT., plus Zafgen's hold rating reiterated at Cowen Inc.
ZFGN double whammy, CMO resigns, scrapped drug plans
2 yr. low
https://www.schaeffersresearch.com/Content/news/2019/03/12/penny-stock-at-bottom-of-nasdaq-after-scrapped-drug-plans?&utm_source=3%2f12%2f2019&utm_medium=email&utm_campaign=MMC&trackback=MMCezine&utm_content=topheadlines
* * $ZFGN Video Chart 06-28-18 * *
Link to Video - click here to watch the technical chart video
Helloooo Anyone here?? ZFGN Up 15.7 % ..Hope someone got a piece! ..of ZFGN
Here comes $10
* * $ZFGN Video Chart 06-25-18 * *
Link to Video - click here to watch the technical chart video
Trial met all primary objectives, demonstrated efficacy and safety and established minimally effective dose of 0.9 mg for ZGN-1061
Anybody out there...? June catalyst approaching should dictate significant movement of share price one way. Which direction will it be?
"Global childhood obesity rises 10-fold in 40 years"
"The number of obese children and teenagers across the world has increased 10-fold over the past four decades and is about to overtake the number who are underweight, according to the most extensive analysis of body weight ever undertaken."
https://www.ft.com/content/3433cfdc-adaa-11e7-aab9-abaa44b1e130?mhq5j=e5
It's from the IPO
Is Saniona ( Sanion listed on Nasdaq Stockholm )
a potential Zafgen 2.0?
Pipeline:
Tesomet - Type 2 diabetes - 23 billion USD (Clinical phase 2)
Tesomet PWS - Prader-Willi syndrome - 2 billion USD only in USA (Clinical phase 2)
Tesofensine - Obesity - 250 million USD only in Mexiko (Clinical phase 3) (Tested in 1300 patients.)
NS2359 - Cocaine addiction - 1,8 billion USD only in USA (Clinical phase 2)
GABA-A a2/a3 program - Neuropathic pain - 6 billion USD (Preclinical research)
Boehringer Ingelheim program - Schizofreni - 4,8 billion USD (Preclinical research)
IK - Inflammation,IBD - 5,9 billion USD (Preclinical research)
Nicotinic a6 program - Parkinson - 2,8 billion USD (Preclinical research)
Proximagen program - Neurological disorders - No data (Preclinical research)
Luc Therapeutic program - Ataxi - Rare disease (Preclinical research)
Approximately 40% of the stocks are own by the board and management.
Current market cap 133 million USD.
Alpha Deal analysis:
https://www.biostock.se/wp-content/uploads/2017/07/Saniona_AB_24072017_24.pdf
http://saniona.com/pipeline/
http://saniona.com/investors/ownership-struture/
What do you guys think?
Can Someone Explain the Investing Cash Flow?
This company reports significant income from investing on a quarterly basis, which would indicate a ~50% return being generated from trading short term corporates? I can't see how this is sustainable and if it isn't the burn rate doubles and they have a few quarters to survive, what am I missing?
Bids in 3.75
Disappointing day after big news
We just hit BOOOM!!!
I guess my dream was correct???? BOOOOM!!!
Yes, and a potential drug for a horrible disease. My bet says they got it.
Hey Panzer, these guys still lots of cash from IPO.
Had a dream ZFGN hit last night. Deploying more Panzers.
Panzers eyeing new ZFGN data in a couple weeks
Panzers adding 3K starter position
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Clinical Trials - Zafgen
http://www.zafgen.com/zafgen/clinical-trials
ZAFGEN INC
ONE BROADWAY 8TH FLOOR
CAMBRIDGE, MA 02142
Phone: 617-401-3051
Fax: NA
Email: tgrazio@zafgen.com
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