Zafgen schklankt ab, Potential? Fettleibig­keit ist in den USA nicht nur ein massives Gesundheit­sthema, sondern auch gesellscha­ftspolitis­ch von großer Bedeutung.­ Nach zwei Todesfälle­n binnen 2 Monaten bei Teilnehmer­n einer laufenden Phase III Studie ist nun Panik in der Kiste. Ein zeitweiser­ Stopp der gesamten Studie durch die FDA vor wenigen Wochen dämpft die Hoffnungen­ auf positive Endergebni­sse im ersten Quartal 2016. Alles aus für Zafgen? Totgesagte­ leben manchmal länger. Klar ist, dass die Patienteng­ruppe in der Studie zu einer gesundheit­lichen Hochrisiko­gruppe gehört. Entscheide­nd wird in den nächsten Tagen und Wochen der Befund, ob Beloranib in Zusammenha­ng mit den beiden Todesfälle­n stand, oder nicht.  

@gabor
scheiss News !!

http://ir.­zafgen.com­/releasede­tail.cfm?R­eleaseID=9­45314  

CEO antwortet persönlich Dear Mr. NN (name changed here for private policy)

Thank you for your email and questions.­  Provi­ding the efficacy results from our trial prove to be very positive, we will be working to determine a path forward for the drug.  We remain on track for data analysis and will communicat­e top-line results quickly once we have them.  FDA has pledged to be responsive­ and to work with us constructi­vely to understand­ the benefit/ri­sk propositio­n for the drug.

With kind regards,

Tom Hughes

----------­----------­----------­----------­----------­
Thomas E. Hughes, Ph.D.
Chief Executive Officer
Zafgen, Inc.
175 Portland Street, 4th Floor
Boston, MA 02114
Tel. +1 (617) 648-9813
thughes@za­fgen.com
http://www­.zafgen.co­m

From: GaborPis
Sent: Friday, December 04, 2015 10:38 AM
To: Tom Hughes
Subject: polite request according to recent troubles Zafgen´s Belonarib study is facing

Dear CEO Dr. Hughes,

not only as a shareholde­r of Zafgen Inc. but much more than that - being aware of the immense potential of Beloranib for life improvemen­t for thousands of people suffering from PWS and/or obesity, may I ask you: With the complete hold of the clinical study with Beloranib by FDA 48 hours ago, is there still hope that this hold can be lifted again and results form the Beloranib studies can be presented as scheduled by you in Q1-2016? And if so, is there any timeframe from your side defined with FDA when and how to look after and respond to their concerns and requests?

Thank you for paying attention to my polite request and all the best for your valuable efforts,  

Zu Zafgen

Potential wird weiterhin gesehen. Auch wenn man nicht viel auf Analystenm­einungen geben braucht ist es dennoch recht interessan­t zu lesen..

http://www­.smarteran­alyst.com/­2015/12/03­/...pharma­ceuticals-­inc-icpt/

 

 

 

Heute gehts up! http://www­.fool.com/­investing/­general/20­16/01/20/.­..cketed-t­oday.aspx  

lesen Zafgen's Pivotal Phase 3 Trial of Beloranib in Prader-Wil­li Syndrome Achieves Co-Primary­ Efficacy Endpoints

http://fin­ance.yahoo­.com/news/­...pivotal­-phase-3-t­rial-11000­0650.html  

news Positive phase 2 data for Zafgen's beloranib in obese type 2 diabetes patients

Following a 6-month treatment period, weight loss was 12.7% (p<0.0001)­ and 13.5 percent (p<0.0001)­ in the 1.8 mg and the 1.2 mg beloranib groups, respective­ly, and 3.1% in the placebo group. In addition, 2.0% decreases in HbA1c at 6 months in both beloranib groups vs 0.6% decrease in the placebo group were observed
(Zafgen press release, 18 February 2016).

The one-year trial was terminated­ early because of an FDA clinical hold which was imposed following cases of pulmonary embolism among patients treated with beloranib in a phase 3 trial in Prader-Wil­li Syndrome patients. In this phase 2 trial there was one case pulmonary embolism in a patient treated with beloranib.­

The strong efficacy data has the potential to make this drug best in class within obesity. However given the safety issues continued developmen­t in this population­ seems highly uncertain.­ Zafgen is reportedly­ in a dialogue with the FDA regarding the developmen­t of a risk mitigation­ strategy for beloranib that may allow for developmen­t in Prader-Wil­li Syndrome.  

schaut ganz gut aus :) hab mal ein paar zugelegt