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Winner of AL East - Baltimore
2nd In AL East - Boston
Winner of AL Central - Kansas City
2nd In AL Central - Detroit
Winner of AL West - Los Angeles
2nd In AL West - Houston
AL Wildcard #1 - Boston
AL Wildcard #2 - Detroit
Winner of NL East - Washington
2nd In NL East - New York
Winner of NL Central - Chicago
2nd In NL Central - St. Louis
Winner of NL West - Arizona
2nd In NL West - Los Angeles
NL Wildcard #1 - St. Louis
NL Wildcard #2 - Los Angeles
Team With Best Record In Baseball - Chicago Cubs
Team With Worst Record In Baseball - Philadelphia
TB # 1: Who hits the most HR in Baseball (Combined) - Davis (Baltimore)
TB # 2: Who has the Most RBIS in Baseball (Combined) - Davis (Baltimore)
BMRN / Gene Therapy:
To answer a question I had about retreatment (maybe others already were comfortable with a treat once only), on the Barclay's call BMRN was asked about the possibility (what type of efficacy needed) and they said that typically its not possible to retreat because the patient gets an immune response. I wonder if any of the other companies are looking at ways to get around the immune response should the treatment be efficacious just not curative?
FGEN:
FG-3019 anti-connective tissue growth factor monoclonal antibody: results of an open-label clinical trial in IPF
Here is a like to the FG-3019 IPF Phase 2. If anyone has a copy they would like to share I'd appreciate or any interesting tidbits.
http://erj.ersjournals.com/content/early/2016/03/10/13993003.01030-2015
Abstract
FG-3019 is a fully human monoclonal antibody that interferes with the action of connective tissue growth factor, a central mediator in the pathogenesis of fibrosis.
This open-label phase 2 trial evaluated the safety and efficacy of two doses of FG-3019 administered by intravenous infusion every 3 weeks for 45 weeks in patients with idiopathic pulmonary fibrosis (IPF). Subjects had a diagnosis of IPF within the prior 5 years defined by either usual interstitial pneumonia (UIP) pattern on a recent high-resolution computed tomography (HRCT) scan, or a possible UIP pattern on HRCT scan and a recent surgical lung biopsy showing UIP pattern. Pulmonary function tests were performed every 12 weeks, and changes in the extent of pulmonary fibrosis were measured by quantitative HRCT scans performed at baseline and every 24 weeks.
FG-3019 was safe and well-tolerated in IPF patients participating in the study. Changes in fibrosis were correlated with changes in pulmonary function.
Further investigation of FG-3019 in IPF with a placebo-controlled clinical trial is warranted and is underway.
Parker Hannifin’s Robotic Exoskeleton Gets FDA OK for Personal Use
http://www.wsj.com/articles/parker-hannifins-robotic-exoskeleton-gets-fda-ok-for-personal-use-1457624461
Perhaps a big name out marketing will help the industry as a whole take off and push more reimbursement coverage.
FGEN (more notes):
Appreciate the notes and comments. Here are mine if anyone is interested some overlap but thought to just post everything as a JPG. I pay more attention to 3019 .
If I recall correctly he pushed for PC data release implying that it could be a meaningful disclosure to investors. I can understand your skepticism on unresectable patients becoming resectable not having the same survival as those originally resectable. Why wouldn't they continue to treat for Abraxane+Gemcitabine+3019? I don't understand the pathology of PC but is the thinking there is no stroma left after resection and that is the only target 3019 would help with?
Webcast Calendar
[Please see updating procedure at
the end of this post. All times are
U.S. ET unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Removed entries > ~1 month old, Added/Updated March conferences
18th Annual BIO CEO & Investor Conference
2/8-9
http://www.bio.org/events/conferences/bio-ceo-about-company-presentations
LEERINK Partners 5th Annual Global Healthcare Conference
2/10-11
http://wsw.com/webcast/leerink26/
SunTrust Robinson Humphrey Orphan Drug Day 2016
2/23
RBC Capital Markets 2016 Healthcare Conference
2/23-24
2016 London Healthcare Conference
https://www.credit-suisse.com/nl/en/investment-banking/client-offering/corporate-access/events-calendar/conferences.html
3/1-2
Cowen & Co. 36th Annual Healthcare Conference
3/7-9
http://wsw.com/webcast/cowen30/
Future Leaders in the Biotech Industry
http://www.biocentury.com/conferences/futureleaders/dates
3/11
28th Annual Roth Conference
http://www.roth.com/main/Page.aspx?PageID=7270
3/13-16
ProQR R&D Day
http://www.proqr.com/rd-day/
3/14
28th Annual ROTH Conference
http://wsw.com/webcast/roth30/
3/14-16
Barclays Global Healthcare Conference
https://cc.talkpoint.com/barc002/031516a_ae/
3/15-17
Jefferies Immuno-Oncology Summit
4/7-8
15th Annual Needham Healthcare Conference
http://wsw.com/webcast/needham76/
4/12-13/16
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Procedure for Updating Calendar
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NEJM Testosterone
Is this the link your looking for?
http://www.nejm.org/doi/full/10.1056/NEJMoa1506119?query=TOC
FGEN / AZN:
I tweeted the text
https://twitter.com/MauriceOnTW/status/697457396566880256
You can get the whole transcript from here:
https://www.astrazeneca.com/content/dam/az/our-company/investor-relations/presentations-and-webcast/2016/Full-Year_and_Q4_2015_Results_transcript.pdf
Other Q4 AZN materials are here:
https://www.astrazeneca.com/our-company/investor-relations/astrazeneca-FY-2015-results.html
BIO-CEO Webcasts
For those that don't want to download here is the list with links
Abeona Therapeutics, Inc (NASDAQ: ABEO) http://www.veracast.com/webcasts/bio/ceoinvestor2016/97132155761.cfm
AcelRx Pharmaceuticals (NASDAQ: ACRX) http://www.veracast.com/webcasts/bio/ceoinvestor2016/43221483141.cfm
Adaptimmune Therapeutics plc (NASDAQ: ADPT) http://www.veracast.com/webcasts/bio/ceoinvestor2016/49205143624.cfm
Aethlon Medical, Inc. (NASDAQ: AEMD) http://www.veracast.com/webcasts/bio/ceoinvestor2016/91231510265.cfm
Aimmune Therapeutics (NASDAQ: AIMT) http://www.veracast.com/webcasts/bio/ceoinvestor2016/05105266474.cfm
Akebia Therapeutics (NASDAQ: AKBA) http://www.veracast.com/webcasts/bio/ceoinvestor2016/57115438166.cfm
Alkermes (NASDAQ: ALKS) http://www.veracast.com/webcasts/bio/ceoinvestor2016/01229417464.cfm
Alnylam Pharmaceuticals (NASDAQ: ALNY) http://www.veracast.com/webcasts/bio/ceoinvestor2016/27229553128.cfm
Anavex Life Sciences Corp. (NASDAQ: AVXL) http://www.veracast.com/webcasts/bio/ceoinvestor2016/85223495157.cfm
Apricus Biosciences, Inc. (NASDAQ: APRI) http://www.veracast.com/webcasts/bio/ceoinvestor2016/63107432854.cfm
Aradigm Corporation (NASDAQ: ARDM) http://www.veracast.com/webcasts/bio/ceoinvestor2016/59111571767.cfm
Asterias (NYSE: AST) http://www.veracast.com/webcasts/bio/ceoinvestor2016/01233200435.cfm
Athersys, Inc. (NASDAQ: ATHX) http://www.veracast.com/webcasts/bio/ceoinvestor2016/53125563953.cfm
Aurinia Pharmaceuticals Inc (NASDAQ: AUPH, TSX: AUP) http://www.veracast.com/webcasts/bio/ceoinvestor2016/61225590319.cfm
AVEO Oncology (NASDAQ: AVEO) http://www.veracast.com/webcasts/bio/ceoinvestor2016/97205209804.cfm
Axsome Therapeutics (NASDAQ: AXSM) http://www.veracast.com/webcasts/bio/ceoinvestor2016/31132344882.cfm
BioBlast Pharma Ltd. (NASDAQ: ORPN) http://www.veracast.com/webcasts/bio/ceoinvestor2016/47215444087.cfm
Biocept, Inc. (NASDAQ: BIOC) http://www.veracast.com/webcasts/bio/ceoinvestor2016/83201309717.cfm
BioLineRx (NASDAQ: BLRX, TASE: BLRX) http://www.veracast.com/webcasts/bio/ceoinvestor2016/42132126086.cfm
Bionik Laboratories (OTCQX: BNKL) http://www.veracast.com/webcasts/bio/ceoinvestor2016/36123221253.cfm
Bio-Path Holdings, Inc. (NASDAQ: BPTH) http://www.veracast.com/webcasts/bio/ceoinvestor2016/37132190378.cfm
BioSpecifics Technologies Corp. (NASDAQ: BSTC) http://www.veracast.com/webcasts/bio/ceoinvestor2016/33113462134.cfm
Caladrius Biosciences, Inc. (NASDAQ: CLBS) http://www.veracast.com/webcasts/bio/ceoinvestor2016/42215146764.cfm
Calithera Biosciences (NASDAQ: CALA) http://www.veracast.com/webcasts/bio/ceoinvestor2016/04227188419.cfm
Capnia, Inc. http://www.veracast.com/webcasts/bio/ceoinvestor2016/30117228201.cfm
Celator Pharmaceuticals, Inc (NASDAQ: CPXX) http://www.veracast.com/webcasts/bio/ceoinvestor2016/36123102667.cfm
CEL-SCI Corporation (NYSE MKT: CVM) http://www.veracast.com/webcasts/bio/ceoinvestor2016/15213207203.cfm
Cerecor Inc. (NASDAQ: CERC) http://www.veracast.com/webcasts/bio/ceoinvestor2016/29129243741.cfm
Cerulean Pharma Inc. (NASDAQ: CERU) http://www.veracast.com/webcasts/bio/ceoinvestor2016/49123593542.cfm
CoLucid Pharmaceuticals, Inc. (NASDAQ: CLCD) http://www.veracast.com/webcasts/bio/ceoinvestor2016/45227430457.cfm
Conatus Pharmaceuticals Inc. (NASDAQGM: CNAT) http://www.veracast.com/webcasts/bio/ceoinvestor2016/41229394669.cfm
ContraFect Corporation (NASDAQ: CFRX) http://www.veracast.com/webcasts/bio/ceoinvestor2016/66205503932.cfm
ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV) http://www.veracast.com/webcasts/bio/ceoinvestor2016/74215577223.cfm
Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) http://www.veracast.com/webcasts/bio/ceoinvestor2016/76203419102.cfm
Curis, Inc. (NASDAQ: CRIS) http://www.veracast.com/webcasts/bio/ceoinvestor2016/89132240349.cfm
Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC) http://www.veracast.com/webcasts/bio/ceoinvestor2016/64111283084.cfm
CymaBay Therapeutics, Inc. (NASDAQ: CBAY) http://www.veracast.com/webcasts/bio/ceoinvestor2016/89223278295.cfm
Cytokinetics, Inc (NASDAQ: CYTK) http://www.veracast.com/webcasts/bio/ceoinvestor2016/62123479143.cfm
CytoSorbents Corporation (NASDAQ: CTSO) http://www.veracast.com/webcasts/bio/ceoinvestor2016/82132422656.cfm
CytRx Corporation (NASDAQ: CYTR) http://www.veracast.com/webcasts/bio/ceoinvestor2016/68113220851.cfm
Delcath Systems, Inc. (NASDAQ: DCTH) http://www.veracast.com/webcasts/bio/ceoinvestor2016/54127184706.cfm
DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) http://www.veracast.com/webcasts/bio/ceoinvestor2016/88109146586.cfm
Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX) http://www.veracast.com/webcasts/bio/ceoinvestor2016/51207588253.cfm
DURECT Corporation (NASDAQ: DRRX) http://www.veracast.com/webcasts/bio/ceoinvestor2016/89132598621.cfm
Egalet Corporation http://www.veracast.com/webcasts/bio/ceoinvestor2016/87233147660.cfm
Fireside Chat with Dale Schenk, PhD, CEO, Prothena http://www.veracast.com/webcasts/bio/ceoinvestor2016/55107691430.cfm
Fireside Chat with John F. Milligan, PhD, President and Chief Operating Officer, Gilead http://www.veracast.com/webcasts/bio/ceoinvestor2016/99225607628.cfm
Galectin Therapeutics Inc (NASDAQ: GALT) http://www.veracast.com/webcasts/bio/ceoinvestor2016/49111409587.cfm
Galena Biopharma Inc. (NASDAQ: GALE) http://www.veracast.com/webcasts/bio/ceoinvestor2016/93115285203.cfm
Genocea Biosciences Inc (NASDAQ: GNCA) http://www.veracast.com/webcasts/bio/ceoinvestor2016/52132493294.cfm
GlycoMimetics (NASDAQ: GLYC) http://www.veracast.com/webcasts/bio/ceoinvestor2016/67129410052.cfm
Harvard Apparatus Regenerative Technology, Inc. http://www.veracast.com/webcasts/bio/ceoinvestor2016/33201574618.cfm
Helomics Corporation http://www.veracast.com/webcasts/bio/ceoinvestor2016/91224392494.cfm
Histogenics Corporation (NASDAQ: HSGX) http://www.veracast.com/webcasts/bio/ceoinvestor2016/12231267433.cfm
Horizon Pharma plc (NASDAQ: HZNP) http://www.veracast.com/webcasts/bio/ceoinvestor2016/33127411346.cfm
Immune Pharmaceuticals http://www.veracast.com/webcasts/bio/ceoinvestor2016/83132414089.cfm
ImmunoCellular Therapeutics, Ltd (NYSE MKT: IMUC) http://www.veracast.com/webcasts/bio/ceoinvestor2016/15125106468.cfm
Inovio Pharmaceuticals, Inc. http://www.veracast.com/webcasts/bio/ceoinvestor2016/23109294480.cfm
Izun Pharmaceuticals http://www.veracast.com/webcasts/bio/ceoinvestor2016/65207382495.cfm
La Jolla Pharmaceutical Company (NASDAQ: LJPC) http://www.veracast.com/webcasts/bio/ceoinvestor2016/83131400408.cfm
MabVax Therapeutics Holdings, Inc. (OTCQB: MBVX) http://www.veracast.com/webcasts/bio/ceoinvestor2016/67211111435.cfm
Mast Therapeutics, Inc. (NYSE MKT: MSTX) http://www.veracast.com/webcasts/bio/ceoinvestor2016/18125454228.cfm
MEI Pharma, Inc. (NASDAQ: MEIP) http://www.veracast.com/webcasts/bio/ceoinvestor2016/41132265783.cfm
Mirna Therapeutics Inc. (NASDAQ: MIRN) http://www.veracast.com/webcasts/bio/ceoinvestor2016/73213173207.cfm
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) http://www.veracast.com/webcasts/bio/ceoinvestor2016/93109214189.cfm
Nicox (EPA: COX) http://www.veracast.com/webcasts/bio/ceoinvestor2016/46209521583.cfm
Ocera Therapeutics, Inc (NASDAQ: OCRX) http://www.veracast.com/webcasts/bio/ceoinvestor2016/99209417574.cfm
OncBioMune Pharmaceuticals INC (OTCQB: OBMP) http://www.veracast.com/webcasts/bio/ceoinvestor2016/73231196757.cfm
OncoCyte (NYSE: OCX) http://www.veracast.com/webcasts/bio/ceoinvestor2016/69203394347.cfm
Oncolytics Biotech (OTCQX: ONCYF, TSX: ONC) http://www.veracast.com/webcasts/bio/ceoinvestor2016/46211270812.cfm
OncoMed Pharmaceuticals, Inc. (NASDAQ: OMED) http://www.veracast.com/webcasts/bio/ceoinvestor2016/25111113665.cfm
Onconova Therapeutics, Inc. (NASDAQ: ONTX) http://www.veracast.com/webcasts/bio/ceoinvestor2016/93132212069.cfm
OncoSec Medical Incorporated (NASDAQ: ONCS) http://www.veracast.com/webcasts/bio/ceoinvestor2016/76113125724.cfm
Opexa Therapeutics (NASDAQ: OPXA) http://www.veracast.com/webcasts/bio/ceoinvestor2016/67113585454.cfm
Orexigen Therapeutics, Inc. (NASDAQ: OREX) http://www.veracast.com/webcasts/bio/ceoinvestor2016/84229269429.cfm
Oxigene, Inc. (NASDAQ: OXGN) http://www.veracast.com/webcasts/bio/ceoinvestor2016/35115199631.cfm
PDL BioPharma, Inc. (NASDAQ: PDLI) http://www.veracast.com/webcasts/bio/ceoinvestor2016/53233461098.cfm
Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS) http://www.veracast.com/webcasts/bio/ceoinvestor2016/72107109727.cfm
Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) http://www.veracast.com/webcasts/bio/ceoinvestor2016/29131126663.cfm
Protea Biosciences Group, Inc. (OTCQB: PRGB) http://www.veracast.com/webcasts/bio/ceoinvestor2016/34103292263.cfm
Prothena Corporation plc (NASDAQ: PRTA) http://www.veracast.com/webcasts/bio/ceoinvestor2016/33109401186.cfm
Provectus Biopharmaceuticals, Inc (NYSE MKT: PVCT) http://www.veracast.com/webcasts/bio/ceoinvestor2016/23129153885.cfm
pSivida Corp. (NASDAQ: PSDV) http://www.veracast.com/webcasts/bio/ceoinvestor2016/27213527117.cfm
RaNA Therapeutics, Inc http://www.veracast.com/webcasts/bio/ceoinvestor2016/48113376986.cfm
RedHill Biopharma Ltd (NASDAQ: RDHL, TASE: RDHL) http://www.veracast.com/webcasts/bio/ceoinvestor2016/06233328287.cfm
Relmada Therapeutics (OTCQB: RLMD) http://www.veracast.com/webcasts/bio/ceoinvestor2016/12131578666.cfm
Relypsa, Inc. (NASDAQ: RLYP) http://www.veracast.com/webcasts/bio/ceoinvestor2016/77221204857.cfm
RespireRx (NASDAQ: RSPI) http://www.veracast.com/webcasts/bio/ceoinvestor2016/83109575564.cfm
Rexahn Pharmaceuticals (NYSE MKT: RNN) http://www.veracast.com/webcasts/bio/ceoinvestor2016/89132179585.cfm
RXi Pharmaceuticals Corporation (NASDAQ: RXII) http://www.veracast.com/webcasts/bio/ceoinvestor2016/23227517193.cfm
SciClone Pharmaceuticals Inc (NASDAQ: SCLN) http://www.veracast.com/webcasts/bio/ceoinvestor2016/59203171542.cfm
Selvita S.A. (WSE: SLV) http://www.veracast.com/webcasts/bio/ceoinvestor2016/25207120538.cfm
Sophiris (NASDAQ: SPHS) http://www.veracast.com/webcasts/bio/ceoinvestor2016/45209206598.cfm
SteadyMed Therapeutics (NASDAQ: STDY) http://www.veracast.com/webcasts/bio/ceoinvestor2016/17203585606.cfm
StemCells, Inc. (NASDAQ: STEM) http://www.veracast.com/webcasts/bio/ceoinvestor2016/94127289855.cfm
Stemline Therapeutics http://www.veracast.com/webcasts/bio/ceoinvestor2016/28233579841.cfm
Summit Therapeutics (NASDAQ: SMMT) http://www.veracast.com/webcasts/bio/ceoinvestor2016/27213475548.cfm
Synthetic Biologics, Inc. (NYSE MKT: SYN) http://www.veracast.com/webcasts/bio/ceoinvestor2016/83103495204.cfm
TG Therapeutics, Inc. (NASDAQ: TGTX) http://www.veracast.com/webcasts/bio/ceoinvestor2016/67207229182.cfm
Tobira Therapeutics, Inc (NASDAQ: TBRA) http://www.veracast.com/webcasts/bio/ceoinvestor2016/54231308183.cfm
Tonix Pharmaceuticals Holdings, Inc. (NASDAQ: TNXP) http://www.veracast.com/webcasts/bio/ceoinvestor2016/85105160183.cfm
Trevena Inc (NASDAQ: TRVN) http://www.veracast.com/webcasts/bio/ceoinvestor2016/84107279171.cfm
Vascular Biogenics (NASDAQ: VBLT) http://www.veracast.com/webcasts/bio/ceoinvestor2016/47215257222.cfm
Verastem, Inc. (NASDAQ: VSTM) http://www.veracast.com/webcasts/bio/ceoinvestor2016/12201214082.cfm
Viking Therapeutics, Inc. http://www.veracast.com/webcasts/bio/ceoinvestor2016/44132398115.cfm
vTv Therapeutics (NASDAQ: VTVT) http://www.veracast.com/webcasts/bio/ceoinvestor2016/61225427102.cfm
Zafgen (NASDAQ: ZFGN) http://www.veracast.com/webcasts/bio/ceoinvestor2016/42227229542.cfm
ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) http://www.veracast.com/webcasts/bio/ceoinvestor2016/43221178744.cfm
It is in the last 10-15 minutes during the Q&A where they talk about the FDA correspondence. They commented that they are to give their response by March 7th and under the process FDA has 30 days to respond. It wasn't directly said directly but FDA could ask for more info and the timeline could get pushed out further. They are seeking use in stroke and spinal cord injury in their label.
They also said industrial business has ability to overtake medical quickly. Initially starting the passive devices for things at shoulder height and above. Then as add robotics capability will expand to other areas.
The replay is now available for anyone interested here is the link:
Webcast Calendar
[Please see updating procedure at
the end of this post. All times are
U.S. ET unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Updated links for February Conferences, Added ProQR R&D Day
J.P. Morgan 34th Annual Healthcare Conference
1/11-14
http://jpmorgan.metameetings.com/confbook/healthcare16/login.php
18th Annual Needham Growth Conference
1/13-14/16
http://wsw.com/webcast/needham75/
NK Investor Day webcast
1/14/16, 3pm ET
http://ir.nantkwest.com/phoenix.zhtml?c=254059&p=irol-EventDetails&EventId=5213675
Noble Financial
1/17-20/16
https://nobleconference.com/home
18th Annual BIO CEO & Investor Conference
2/8-9
http://www.bio.org/events/conferences/bio-ceo-about-company-presentations
LEERINK Partners 5th Annual Global Healthcare Conference
2/10-11
http://wsw.com/webcast/leerink26/
SunTrust Robinson Humphrey Orphan Drug Day 2016
2/23
RBC Capital Markets 2016 Healthcare Conference
2/23-24
2016 London Healthcare Conference
3/1-2
https://www.credit-suisse.com/nl/en/investment-banking/client-offering/corporate-access/events-calendar/conferences.html
Cowen & Co. 36th Annual Healthcare Conference
3/7-9
http://wsw.com/webcast/cowen30/
Future Leaders in the Biotech Industry
3/11
http://www.biocentury.com/conferences/futureleaders/dates
28th Annual Roth Conference
3/13-16
http://www.roth.com/main/Page.aspx?PageID=7270
ProQR R&D Day
http://www.proqr.com/rd-day/
3/14
Barclays Global Healthcare Conference
3/15-17
Jefferies Immuno-Oncology Summit
4/7-8
15th Annual Needham Healthcare Conference
4/12-13/16
http://wsw.com/webcast/needham76/
--
Procedure for Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old calendar.
2. Make your additions or modifications, inserting new items in alphabetical or chronological order as the case may be.
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I think one could make a mad lib (i think that is what they were called), substitute TRIL with ___<insert symbol>___ and "their cash position and that they now have started phase 1" with ____<positive aspects of the company>____ why they think their stock should not be down as much. Don't mean to make lite of it but I am sure just about everyone here could rattle a few stocks that they think are weaker then they should.
I have my share of down Bio's. Its an unfortunate negative aspect of investing in this sector and like many investing in some much more volatile Bio's the pain seems more extreme. Its certainly not easy to watch/participate but there aren't too many that have held up.
Thanks for the abstract and thanks dewophile for the S1 reference.
Noticed the abstract is available from here
http://www.fibrogen.com/publications#
FGEN:
The PR referred to a prior study
In a previous study, increasing doses of FG-3019 were combined with gemcitabine plus erlotinib for treatment of subjects with advanced pancreatic cancer. That study (N=75) indicated a dose-related increase in survival. At the lowest doses of FG-3019, no subjects survived for one year, while at the highest doses approximately 30% of subjects survived one year.
Did anyone catch the technology panel this morning? I tried tuning in late but it was over didn't see a replay. If anyone has a link to a replay or can highlight the presentation would appreciate it. TIA
Webcast Calendar
[Please see updating procedure at
the end of this post. All times are
U.S. ET unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Removed entries > ~1 month, Updated events 2-4/16
J.P. Morgan 34th Annual Healthcare Conference
1/11-14
http://jpmorgan.metameetings.com/confbook/healthcare16/login.php
18th Annual Needham Growth Conference
1/13-14/16
http://wsw.com/webcast/needham75/
NK Investor Day webcast
1/14/16, 3pm ET
http://ir.nantkwest.com/phoenix.zhtml?c=254059&p=irol-EventDetails&EventId=5213675
Noble Financial
1/17-20/16
https://nobleconference.com/home
18th Annual BIO CEO & Investor Conference
2/8-9
http://www.bio.org/events/conferences/bio-ceo-investor-conference
LEERINK Partners 5th Annual Global Healthcare Conference
2/10-11
http://leerink.metameetings.com/confbook/healthcare16 ?
SunTrust Robinson Humphrey Orphan Drug Day 2016
2/23
RBC Capital Markets 2016 Healthcare Conference
2/23-24
2016 London Healthcare Conference
3/1-2
https://www.credit-suisse.com/nl/en/investment-banking/client-offering/corporate-access/events-calendar/conferences.html
Cowen & Co. 36th Annual Healthcare Conference
3/7-9
http://wsw.com/webcast/cowen30/
Future Leaders in the Biotech Industry
3/11
http://www.biocentury.com/conferences/futureleaders/dates
28th Annual Roth Conference
3/13-16
http://www.roth.com/main/Page.aspx?PageID=7270
Barclays Global Healthcare Conference
3/15-17
Jefferies Immuno-Oncology Summit
4/7-8
15th Annual Needham Healthcare Conference
4/12-13/16
http://wsw.com/webcast/needham76/
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(Slight OT): Ohad Hammer @ohadhammer is finally on twitter. A lot of people follow/read his blog. His latest blog is up too. Still thinks Bio valuations are high and (still) critical of all the late stage DMD drugs (BMRN, SRPT, PTCT)
H/T to @chasingthealpha
Other charts that look OK relatively speaking.. GLPG & FPRX with medium sell signals. Everything else looks like crap - lol.
I don't think its that simple the FDA is guilty of being too involved with the patient families. I don't recall that ever being done before. Janet Woodcock in particular probably said too much. BTW Adan Feuerstein tweeted that she will be in attendance at the adcom. At 2:45pm PPMD also sent out a request to urge people to contact house members with this. Along with a letter to Janet Woodcock
http://community.parentprojectmd.org/profiles/blogs/action-alert-urge-house-member-apply-fdasia-tools-to-duchenne
https://secure2.convio.net/ppmd/site/Advocacy?cmd=display&page=UserAction&id=216
I think a defeat here likely sets DMD drug development back a few years. If the magnitude of efficacy needed will require a 3-5 year trial (just speculating on my part) to show significance BMRN won't and SRPT can't do that.
If FDA had written that yes but unfortunately that is from the applicant
SRPT:
Reading the SRPT addendum and a little inferring of what has has transpired one would have good reason to suspect FDA has very mixed opinions in its hierarchy and/or continued change in thought process. I read this sentence from the addendum as may be posted on a message board like this
"THE PROPOSAL TO COMPARE WITH HISTORICAL CONTROL PATIENTS ORIGINATED FROM THE FDA"!!! [emphasis, caps, red, exclamations added quote from addendum]
SRPT:
I don't think I've seen anyone mention $SRPT's addendum in response to FDA requests (has 4 year data) and also refutes some briefing document remarks. Its here if anyone is interested
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/UCM481913.pdf
All documents are here:
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/ucm481907.htm
SRPT BMRN:
Just speculating based on watching the panel and the wording in the CRL/briefing docs. Since accelerated approval was being sought and there were repeated mentions/questions on Dystrophin, I wonder if that was a big obstacle in the review. SO it may really come down to is dystrophin measurement acceptable and of sufficient quantity to correlate with 6MW/other improvements.
HALO:
I don't follow them closely since I sold out with that caveat their guidance was probably a bit worse (lower revenue, higher burn) than people expected. When I sold out (probably a couple years ago now) they said they would likely not need a financing going forward (Counting the royalty I think they are up to 3 or 4). After the Roche Immunogen royalty rate was announced (and one reason I sold) I began to wonder why their royalty would be higher. The company had said mid single digits with the street saying 5%. Maybe someone who follows them more closely can say if the company has since confirmed that or if in fact its more like 3-4%. The other concern is PEG-PH20 companion diagnostic and I'm not sure where they stand on that. I still like PEG-PH20 though I'm less sure of it than before (I am long NKTR so still have an interest).
JP Morgan Conference website has more than just the webcasts. For those (like me) who may have been late to notice there are many reports available at this page:
http://jpmorgan.metameetings.com/confbook/healthcare16/special_reports.php
I browsed through a couple and some of interest may be:
- Questions For Management
http://jpmorgan.metameetings.com/confbook/healthcare16/stash/misc/JPM_US_Biotechnology_2016-01-07_1907238.pdf
- Conference Playbook
http://jpmorgan.metameetings.com/confbook/healthcare16/stash/misc/2016%20JPM%20Conference%20Playbook_aprvd_v2.pdf
- Biosimilars
http://jpmorgan.metameetings.com/confbook/healthcare16/stash/misc/111315%20Biosimilars%20Primer_compressed.pdf
OCRX:
Perhaps JQ's speculation about food effect but to me I wouldn't delay ~6 months with a further Phase 1 study for that I'd dose with/without in Phase 2 to prove efficacy and then partner/ optimize formulate.
I'm no expert but I thought the graphs look pretty good (especially for BID). The one thing that caught my attention is the one sentence was why specifically point out the bold parts (my emphasis) and perhaps that is what they are really trying to optimize?
We are focused on developing an oral formulation of OCR-002 that is safe, well tolerated and effective with twice-daily dosing.
Ocera Announces Complete Plasma Data From Pilot Phase 1 Study for Orally-Available OCR-002 in Development for the Prevention of Chronic Hepatic Encephalopathy
http://ir.ocerainc.com/releasedetail.cfm?ReleaseID=949534
Graphs @:
http://www.globenewswire.com/NewsRoom/AttachmentNg/a8e16308-54a6-438a-8cb6-ea86dd1c0354
The mean maximum concentration (Cmax) of plasma PAA from the three pilot OCR-002 extended-release formulations ranged from approximately 50 to 90µg/mL occurring at various time points over 4 to 9 hours after dosing. For comparison, RAVICTI® produced a mean plasma PAA Cmax of approximately 10µg/mL at 4 to 6 hours after dosing. The plasma PAA data after a single oral dose of 6mL RAVICTI® are consistent with published data in healthy subjects.3,4 In addition, PAA exposure with the extended-release formulations of OCR-002 showed lower inter-subject variability than RAVICTI®.
Plasma profiles of PAGN, the end-product of ammonia scavenging, also demonstrated a similar pattern as the PAA profiles. The mean Cmax of plasma PAGN from the pilot extended-release formulations of OCR-002 ranged from approximately 30 to 45µg/mL occurring at various time points over 4 to 10 hours after dosing. For comparison, RAVICTI® produced a mean plasma PAGN Cmax of about 20 to 25µg/mL at approximately 5 hours. These data are also consistent with the published data in healthy subjects.3,4
The JP Morgan schedule is now up (may need to register to see it):
http://jpmorgan.metameetings.com/confbook/healthcare16/agenda.php
This is actually disappointing to see... for those of us who like royalty companies .
It seems there is a growing use of royalty streams in a similar fashion. Rather than flat out selling the royalty to someone.
From my Gold royalty investment days (long ago not recent) management would always like to get some (significant) upside potential when they acquire a royalty. With competition from those using the royalty as collateral or to a stream to pay back the loan it keeps the possible upside still with the royalty holder.
There are still IB hosted calls with management . I remember (a couple years ago) Intermune got permission to make the replay available. I don't recall if any material non-public info was disclosed though. I believe it mostly centered on reimbursement concerns in Europe.
Webcast Calendar
[Please see updating procedure at
the end of this post. All times are
U.S. ET unless indicated otherwise.]
NOTE: ANYONE MAY UPDATE THIS FILE
Edits: Removed entries > ~1 month, Consolidated entries , Added some events 1-4/16
Oppenheimer 26th Annual Healthcare Conference
12/8-9
http://www.opco.com/conferences/healthcare15/index.aspx
ALNY R&D Day webcast
12/10/15, 8:00-11:30am ET
http://edge.media-server.com/m/p/fy9m5tbr
Valeant Investor Day
12/16 8:00am ET
http://ir.valeant.com/investor-relations/events-and-presentations/Event-Details/2015/Valeant-Investor-Day/default.aspx
Goldman Sachs “Healthcare CEOs Unscripted: A View from the Top”
1/5/16
https://cc.talkpoint.com/gold006/010516a_ae/
Biotech Showcase 2016
1/11-15
http://www.ebdgroup.com/bts/index.php
J.P. Morgan 34th Annual Healthcare Conference
1/11-14
http://jpmorgan.metameetings.com/confbook/healthcare16/login.php
18th Annual Needham Growth Conference
1/13-14/16
http://wsw.com/webcast/needham75/
NK Investor Day webcast
1/14/16, 3pm ET
http://ir.nantkwest.com/phoenix.zhtml?c=254059&p=irol-EventDetails&EventId=5213675
Noble Financial
1/17-20/16
https://nobleconference.com/home
18th Annual BIO CEO & Investor Conference
2/8-9
LEERINK Partners 5th Annual Global Healthcare Conference
2/10-11
SunTrust Robinson Humphrey Orphan Drug Day 2016
2/23
RBC Capital Markets 2016 Healthcare Conference
2/23-24
Cowen & Co. 36th Annual Healthcare Conference
3/7-9
28th Annual Roth Conference
3/13-16
Barclays Global Healthcare Conference
3/15-17
15th Annual Needham Healthcare Conference
4/12-13/16
http://wsw.com/webcast/needham76/
--
Procedure for Updating Calendar
When adding or modifying entries, please follow these steps:
1. Copy the complete text from the old calendar.
2. Make your additions or modifications, inserting new items in alphabetical or chronological order as the case may be.
3. Near the top of the message, give a very brief description of your changes (e.g. “Edits: Added JPMorgan conference”).
4. Post the updated calendar in a new message as a reply to the message with the old calendar.
Peter posted these links on twitter a good read and presentation has some good info too. I thought to post here for those who haven't seen it and for anyone interested in a deeper discussion.
A Year in Review: Important Intel Gleaned from CDER Report on New Drug Approvals
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2015/12/a-year-in-review-important-intel-gleaned-from-cder-report-on-new-drug-approvals.html
CDER New Drug Review: 2015 Update
http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM477020.pdf
I found a couple of things interesting (in no set order):
1. I still don't like who FDA can claim to be more efficient but the two month added to the review period lowered the bar IMO. If they are "weeding out" the bad applications with the extra time (what the law blog theorizes) then good applicants are being punished because of bad ones hardly a just system.
2. Slides 19,33,34 and If law blog theory is correct might Drisparsen still have some hope? I wonder if they may try to find some narrow approval label (and obvious black box warning)?
3. Slide 47 probably why SRPT never tried for BTD
Goldman Sachs “Healthcare CEOs Unscripted: A View from the Top”
https://cc.talkpoint.com/gold006/010516a_ae/
1/5/16
SKP.L
Thanks. Skyepharma is one I looked at briefly a couple years ago when sentiment was really down but (unfortunately) didn't look close enough. As I recall they had one (potential) big product and a bunch of little ones. I will have to take a closer look again.
I bought LGND years ago when they transitioned to the royalty model which I like a lot. I sold too early trying to be clever and raise cash thinking it was too ahead of itself (foolish mistake).
I owned another (small canadian) drug royalty company that was bought out on the very cheap (At one point they had a royalty on Cambridge Antibody which was entailed to Humara royalty). I looked briefly at PDL but their royalties/deals didn't seem particularly appealing.
Royalty Pharma at one point was looking to go public but don't know if they decided wasn't worth the trouble and they probably don't need the cash now. Judging by the size of deals they've done I doubt they need the cash either.
If anyone knows of other (preferably investable) drug royalty companies/funds would be interested in the names.
I could say the same thing about PLX... wait I actually did
https://twitter.com/MauriceOnTW/status/674988089731899392
I don't know what it is about Israeli Bio/Pharma not named TEVA there seems to be a lot of skepticism along with some extreme volatility at times. FOr the later I have seen people say the TASE exchange is subject to more questionable activity (MKND recent equity offering there being one example http://mayafiles.tase.co.il/RPdf/1001001-1002000/P1001389-00.pdf )
LGND:
Here is a link to the slide deck:
http://content.equisolve.net/_c4c55a2d9fdcb6ecb2e9b88bf9ca774f/ligand/db/184/594/pdf/OMT+Conference+CallvFINAL.pdf
ANd to the CC:
https://event.webcasts.com/viewer/event.jsp?ei=1088242
Its one stock I sold WAY too early and regret since I sold to raise cash thinking it was ahead of itself. If I recall correctly Higgins background is Economics and I see this as more financial based rather than science based.
FGEN PC
Here is the relevant part of the discussion from the last earnings call (co Seeking Alpha Transcript). Given the update then was as of November it only gives ~2 months more time
http://seekingalpha.com/article/3682386-fibrogen-s-fgen-ceo-tom-neff-on-q3-2015-results-earnings-call-transcript?part=single
12 subjects are currently enrolled in the FG-3019 study, seven have finished their study. As of November the update report is as follows; three of these seven patients were randomized to standard of care, meaning gemcitabine and abraxane upon restoring six months later they are still not eligible for resection therapy. The other four patients were randomized to FG-3019 plus standard of care. Of these four, one discontinued therapy due to an SAE unrelated to study drug and the other three have finished therapy.
Each of the three on FG-3019 that have finished six months of therapy has been rescored as eligible for resection treatments success and two of the three have had RGO [ph] resections, clear margins and the other one I said on R01 resection.
There is no question the resection surgery is a potential major clinical benefit for patients when we design this trial we assume one to two patients would have resection with chemotherapy alone out of upto 20 control arm patients. Even though these early results were notable since the three 3019 resections out of four patients treated for 3019 are more than we expected for the entire control arm and a 40 patient trial, it is still too early to know what the outcome will be and what the next steps are.
...
This is a pilot study wherein we plan to enrol up to 40 patients with the provided that once we were convinced of either efficacy and evidence enough to move forward or lack of efficacy we either to proceed or stop. So conceptually we could anywhere from now until 40 patients make a decision to go to the next step.
The data so far is certainly of note. The numbers are too small however to be sure. And so, we will continue to looking at patients for a while. The feeling here is if what we've seen so far with three 3019 patients that had completed six months doing as they did effect. Patent continues, we'll probably go talk to the agency about the endpoint and how they like to see this addressed as a next step.
ARIA:
Here is the clinicaltrials.gov record
https://clinicaltrials.gov/ct2/show/NCT02627677
It looks like they will follow the patients for quite some time for some of the secondaries.