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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: Added Sidoti, Citi, SFE Investor day, Lilly Event, Added/Updated some September conference links added a few further out conferences
Wedbush Life Sciences Management Access Conference
8/11-12
http://wsw.com/webcast/wedbush30/
35th Annual Canaccord Genuity Growth Conference
8/12-13
http://wsw.com/webcast/canaccord18/
Sidoti Emerging Growth Conference
9/2
http://www.webcaster4.com/Webcast/ListenPage?companyId=1223&webcastId=10211
Rodman & Renshaw 17th Annual Global Investment Conference
9/8-10
http://wsw.com/webcast/rrshq25/
FBR Second Annual Healthcare Conference
9/9
http://www.fbr.com/Company/Events.aspx
Baird's 2015 Health Care Conference
9/9-10
http://wsw.com/webcast/baird43/
Citi’s 10th Annual Biotech Conference
9/9-10
Goldman Sachs European Medtech and Healthcare Services Conference
9/9-10
BioCentury 22nd Annual NewsMakers in the Biotech Industry Conference
9/10
http://www.biocentury.com/conferences/newsmakers/dates
BAML Global Healthcare Conference
9/16-18
Morgan Stanley 2015 Healthcare Conference
9/16-18
1st Annual Ladenburg Thalmann Healthcare Conference
9/29
Aegis Capital Growth Conference
10/7-9
SFE Investor Day
10/8
Nektar R&D Day
10/8
Stifel Healthcare Conference
11/17-18
Piper Jaffray Healthcare Conference
12/1-2
Lilly Animal Health and Alzheimer's Disease Review
12/8
https://investor.lilly.com/eventdetail.cfm?eventid=161845
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Thanks Dewophile! Appreciate the info it addresses my concern about the higher dose.
FGEN:
Perhaps its in the full paper (I don't have a copy) if someone has access or knows what happened with the 2 higher doses (2.5 and 3mg/kg) would appreciate you posting. They don't seem to be reported in the abstract or the PR but are in the clinicaltrials.gov record. TIA
https://clinicaltrials.gov/ct2/show/NCT00761657
FGEN:
Randomized placebo-controlled dose-ranging and pharmacodynamics study of roxadustat (FG-4592) to treat anemia in nondialysis-dependent chronic kidney disease (NDD-CKD) patients
PR: http://finance.yahoo.com/news/nephrology-dialysis-transplantation-reports-phase-221819000.html
http://www.ncbi.nlm.nih.gov/m/pubmed/26238121/#fft
H/t Jason @JasonHolman5
Besarab A, et al. Nephrol Dial Transplant. 2015.
Authors
Besarab A1, Provenzano R2, Hertel J3, Zabaneh R4, Klaus SJ1, Lee T1, Leong R1, Hemmerich S1, Yu KP1, Neff TB1.
Author information
1FibroGen, Inc., San Francisco, CA, USA.
2St Clair Specialty Physicians, Detroit, MI, USA.
3Kidney Care Associates, LLC, Augusta, GA, USA.
4Northwest Louisiana Nephrology, Shreveport, LA, USA.
Citation
Nephrol Dial Transplant. 2015 Aug 3. pii: gfv302. [Epub ahead of print]
Abstract
BACKGROUND: Roxadustat (FG-4592) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis. This Phase 2a study tested efficacy (Hb response) and safety of roxadustat in anemic nondialysis-dependent chronic kidney disease (NDD-CKD) subjects.
METHODS: NDD-CKD subjects with hemoglobin (Hb) =11.0 g/dL were sequentially enrolled into four dose cohorts and randomized to roxadustat or placebo two times weekly (BIW) or three times weekly (TIW) for 4 weeks, in an approximate roxadustat:placebo ratio of 3:1. Efficacy was assessed by (i) mean Hb change (?Hb) from baseline (BL) and (ii) proportion of Hb responders (?Hb = 1.0 g/dL). Pharmacodynamic evaluation was performed in a subset of subjects. Safety was evaluated by adverse event frequency/severity.
RESULTS: Of 116 subjects receiving treatment, 104 completed 4 weeks of dosing and 96 were evaluable for efficacy. BL characteristics for roxadustat and placebo groups were comparable. In roxadustat-treated subjects, Hb levels increased from BL in a dose-related manner in the 0.7, 1.0, 1.5 and 2.0 mg/kg groups. Maximum ?Hb within the first 6 weeks was significantly higher in the 1.5 and 2.0 mg/kg groups than in the placebo subjects. Hb responder rates were dose dependent and ranged from 30% in the 0.7 mg/kg BIW group to 100% in the 2.0 mg/kg BIW and TIW groups versus 13% in placebo.
CONCLUSIONS: Roxadustat transiently and moderately increased endogenous erythropoietin and reduced hepcidin. Adverse events were similar in the roxadustat and placebo groups. Roxadustat produced dose-dependent increases in blood Hb among anemic NDD-CKD patients in a placebo-controlled trial.
CLINICAL TRIALS REGISTRATION: Clintrials.gov #NCT00761657.
© The Author 2015. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.
PMID 26238121 [PubMed - as supplied by publisher]
GLPG / ABBV:
DARWIN 2 24-week monotherapy data in RA confirm previous results
and support best-in-class potential for filgotinib
. ACR50 responses up to 45% as once-daily monotherapy
. DAS28(CRP) low disease activity up to 50%
. Similar efficacy at 100 and 200 mg
. Safety profile in DARWIN 2 consistent with previous filgotinib RA
studies
. These data complete the delivery of the final data package to AbbVie;
triggers the licensing decision period
PR: http://www.glpg.com/files/1114/3922/1696/PR_Darwin2_W24_FINAL.pdf
Webcast: http://edge.media-server.com/m/p/65755a5j
Slides: http://www.glpg.com/files/3614/3937/2304/Webcast_DARWIN_2_week_24_FINAL.pdf
Transcript: http://www.glpg.com/files/8214/3937/2240/DARWIN_2_final_results_transcript.pdf
I was a bit surprised to see Fierce (John Carroll's) tweet too I thought someone from the media would at least seek comment before giving their opinion.
Given past I was a little surprised at what they licensed. Do you think it is a similar strategy as before (price increase) or potential other uses/bigger market opportunity?
Thanks for the link!
So it seems a partnership for industrial use is near term.
Thanks for the notes!
Do you follow NKTR-214 by chance? On the call yesterday they indicated that its possible the currently planned Phase 1/2 study could potentially function as pivotal. I am sure some of it is Howard Robin's "enthusiasm" (it sounds better then hype since I'm long ) but perhaps part of it is the regulatory environment may be more favorable (if it shows true breakthrough potential).
On another topic did you happen to catch the SRPT call? Though I suspect there has been meaningful decline in 6MW (Though I hope not I wouldn't be shocked if it is even accelerating a bit given the nature of the disease) they indicated, other than the 2 who lost ambulation earlier, they are all still ambulatory. I suspect that doesn't change your opinion any? They will also release 4th biopsy data and the 6MWT data prior to the advisory committee.
Here is the Boston Business Journal story
http://www.bizjournals.com/boston/blog/bioflash/2015/08/sarepta-ceo-all-boys-in-duchenne-trial-still.html?ana=twt
Thanks.
I searched the site for clips but only EKSO clips were from 2014.
Missed the live feed. Do you have a link to a replay by chance or can you say if they said anything new/interesting? 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, Added Wedbush link, Canaccord Conference
Wedbush Life Sciences Management Access Conference
8/11-12
http://wsw.com/webcast/wedbush30/
35th Annual Canaccord Genuity Growth Conference
8/12-13
http://wsw.com/webcast/canaccord18/
Rodman & Renshaw 17th Annual Global Investment Conference
9/8-10
http://www.meetmax.com/sched/event_30869/~public/conference_home.html?event_id=30869
FBR Second Annual Healthcare Conference
9/9
Baird's 2015 Health Care Conference
9/9-10
Goldman Sachs European Medtech and Healthcare Services Conference
9/9-10
BioCentury 22nd Annual NewsMakers in the Biotech Industry Conference
9/10
BAML Global Healthcare Conference
9/16-18
Morgan Stanley 2015 Healthcare Conference
9/16-18
1st Annual Ladenburg Thalmann Healthcare Conference
9/29
Nektar R&D Day
10/8
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The contest is getting interesting after a big early lead by WYOBUFORD and freezes, kinda reminds me of the Madlock vs. Griffey batting race (1976) .
When does the contest end?
SRPT:
Sorry I am still not following where the harm is coming from approving E. Is it that patients will never take a potentially better drug, D, because of AE profiles? If so how is that different than other areas where 2 (or more) drugs in the same class are approved? Many claim Lipitor was not the best statin but won out because of marketing. In the E vs D debate if one drug ends up showing meaningful benefit I would imagine switching would occur in numbers porportion to magnitude of perceived efficacy improvement. I still believe both drugs should be approved and both likely offer some modest improvement with neither being substantial. I do agree they have different profiles and could see some doing a little better with one over the other but it remains to be seen if that is an easily identifiable population. Still I don't see the harm in approving eteplirsen (w/wo drisapersen being approved).
My point on starting early is the modest benefit that some (I) believe eteplirsen has may become more meaningful with (much) longer and earlier use. So the argument against it not being worthy of approval because it does almost nothing could be proven inaccurate in real world application (thats not practical in clinical trials) with patients taking the drug for life from a young age. The distrophin data while confrontational is the best supportive argument that I know of (at least for Eteplirsen). I imagine its something the agency will consider and likely both companies will present some data to support the argument of long term/early use improving outcomes.
DMD
Here is a link to a couple documents with FDA guidance/proposed guidance from a discussion on FGEN DMD
http://www.siliconinvestor.com/readmsg.aspx?msgid=30165062
SRPT:
SRPT:
I would agree with your assessment that the drug has a modest effect (I've been of that belief long before becoming a shareholder if one goes back to see my posts) and unfortunately (especially for the kids) they will likely still become non-ambulatory at some time. I will also concede that better care and parent involvement may also be increasing the perceived benefit.
That being said you don't seem open to the idea that FDA would approve a drug with modest efficacy and a benign safety profile for an indication where there are no approved therapies not to mention its a life threatening indication for children. Basically, I don't think the bar needs to be very high. I am also very pleased at what I've publicly seen with the CEO change and the non-confrontational approach with regulators, competitors and seeing this as part of a treatment regimen. These are all positives that Dr. Kaye has done.
Not to bring up the old ERT argument again (and I am certainly not comparing the efficacy to ERT's) but one important finding that I think may be quite pertinent is that starting treatment very early in the disease and treating longer exaggerates the benefit.
GLPG / ABBV:
Appreciate the comments. I was going by the pretty charts and thought the 2x100 mg was significantly enough better that they (or Abbvie) would prefer that despite GLPG saying the QD dosing was the way to go.
For what its worth I saw some of the Cowen report (from a @dougheuringaria tweet I don't have a copy) saying Abbvie could divide up the indications between the two.
GLPG:
On IPF I thought along the line they said it was a portfolio decision (Not sure going by memory don't have notes saying as such) but I could be mixing it up with one of their other programs. They've had no shortage of setbacks in their early stage development!
On Crohn's Think JAK1 is involved in process and the company said they will present more supportive data in august. Also think being JAK2 sparing will help patients recover quickly since they have low level of red blood cells.
GLPG/ABBV:
I can think of no advantage for Abbvie to decide prior to the full 60 days. I did a relisten of the call and to clarify the slight difference in when the 60 days starts. Apparantly Abbvie will get the data any day now and in "a couple weeks" is when Galappagos will report them to the public. Additionally there were rumors (I forget which news media) that J&J was interested in partnering should Abbvie decline. I personally expect Abbvie to license it I see this as a very small investment to make even if their JAK compares favorably (I am guessing it does not but don't have much to go on besides vaguely recalling GLPG management mentioning seeing some preclinical data on Abbvie's JAK in much earlier CC's) it takes risk/competition away.
I thought the data especially for ACR-70 were particularly strong. Further there is more data on male 200mg dosing to possibly remove that restriction in Phase 3 (note this was in the US only). My main concern when I first saw results was the patient death. Its not clear what if any role filgotinib had nor apparently will it likely ever be known. But apparently the DSMB was not concerned enough to intervene and the company said no other deaths have occurred in any trial (including Chrohn's).
I still have the majority of my shares when I took some money off the table part of my thinking was the royalties (on both programs) was less than I expected.
My original reply was to Dew's link to PGS's analysis of JAK's so I am hoping he will do an update .
GLPG / ABBV:
Galapagos' selective JAK1 inhibitor filgotinib meets key efficacy endpoints, shows ACR70 responses up to 39%, and maintains safety profile after 24 weeks of treatment in DARWIN 1 Phase 2B study
PR: http://www.glpg.com/files/6014/3820/0865/PR_Darwin1_24W_FINAL.pdf
Webcast: http://edge.media-server.com/m/p/jtbu3hgp
Slides: http://i.media-server.com/version/1438261847/m/a/3rczdbtq/iv/g9em5h2nx8q5rqp4r5pmvbhjdkzcypsth8ze6dmj3spqn74c_121598639/download
Didn't make notes yet but a Couple Comments from first listen:
1-Abbvie has 60 days from Darwin 2 ("any day") results to decide on licensing. Would "gladly" wave criteria requiring them to listen if they are not interested.
2-1 Death happened because of Pneumonia not clear if drug related as happened in hospital outside of investigator. 3 Weeks prior blood work was normal (nothing to show concern).
3-Not concerned with high dose in male patients. Monitored male hormone and no safety signal also in Darwin 3 much more males on high dose also did preclinical studies that think give freedom to operate.
BLRX:
I haven't looked at them in a while. My main (only?) interest was their celiac drug. As I recall they had some tolerability issues but I don't remember if they were going to move ahead with a low dose or try to refomulate. Do you happen to know what they are doing?
On the Abbvie call they got asked about their Celiac drug and though they gave a non-answer (still looking at it and no decision reached yet) it gave me the sense they may drop it so may be one less competitor if BLRX drug has a chance.
Thanks for the scouting report.
Both Kelley Johnson and Uribe played well for us sorry to see them go. I'm sure the Braves tried to move the other Johnson without the Mets biting. I guess they will play him at third the rest of the year and hope he goes back to '13 form so they can move him in the off season.
Its been a good and rapid effort to undo just about everything Frank Wren touched while GM. In ~6 months they've really exploded the team and the farm system not to mention scouting too!
Reportedly Rob Whalen & John Gant
It looks like they are low level pitching prospects I don't follow the minors that closely these days. Any opinions on them (I know we are on opposite sides of this trade)
FGEN:
While one can never be certain with Biotechs I don't see it as likely:
1-Their 50/50 share of Roxadustat development with AZ will stop (except in China) once they reach $116.5 million. At end of Q1 they indicated $52.1 million remained so probably next quarter sometime their obligation will be reached.
2-They just received a 120 million milestone from AZ (in addition to 15 million a quarter earlier)
3-If they decide to partner 3019 I would expect a pretty substantial up-front but this remains a big if on when/if they do so.
From the PR after the 120M
"FibroGen expects to have approximately $410 million to $415 million of cash, cash equivalents, investments, and receivables on June 30, 2015 "
vTv Therapeutics
Here is a link to the paper on the 2B results
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4021072/pdf/1471-2377-14-12.pdf
vTv Therapeutics
Another Alzheimers IPO on http://www.retailroadshow.com/
They also have other programs in Diabetes, Inflammation, Muscle Weakness and cancer.
http://t.co/dUfwYNuJ5m (Retail Roadshow Link)
http://vtvtherapeutics.com/
Changes:
2nd In NL West: San Francisco
2nd In NL Central: Pittsburgh
NL Wildcard #1: Pittsburgh
NL Wildcard #2: Chi Cubs
Team With Best Record In Baseball: Kansas City
EXAS:
Apparently the event will be live streamed.
Here is a link to a brochure courtesy of the Hedgefund Manager himself
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2015-Agenda-for-Clinical-Laboratory-Meeting.pdf
Biotech opportunity in China
I don't know anything about that company but you know one of your (and my) holdings has a couple of products that may hit the China market in the not too distant future . In addition to roxadustat the corneal implements seems like an interesting opportunity I don't think the street has any value in for that (but I don't have any idea how to value it as well given no idea on pricing/uptake).
Antibiotic Reports courtesy of John Tucker
https://onedrive.live.com/?cid=202e32df7425048c&id=202E32DF7425048C%211597&ithint=folder,pdf&authkey=!AN-lIEeheI9nMBk
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 July-September Events, Added Nektar R&D Day
Goldman Sachs Healthcare Conference
6/10-15
http://cc.talkpoint.com/gold006/060915a_ae/
Citi European Healthcare Conference
6/15-16
BIO International Convention
6/15-18
http://convention.bio.org/schedule/
JMP Life Sciences Conference
6/23-24
http://wsw.com/webcast/jmp27/
2nd Annual ROTH Healthcare Day
6/24
http://www.roth.com/main/Page.aspx?PageID=7005
J.P. Morgan European Health Care Conference
6/25
https://www.jpmorgan.com/pages/jpmorgan/investbk/conferences/european_healthcare
Cantor Fitzgerald's Healthcare Conference
7/8
http://wsw.com/webcast/cantor2/
Wedbush Life Sciences Management Access Conference
8/12-13
Rodman & Renshaw 17th Annual Global Investment Conference
9/8-10
http://www.meetmax.com/sched/event_30869/~public/conference_home.html?event_id=30869
FBR Second Annual Healthcare Conference
9/9
Baird's 2015 Health Care Conference
9/9-10
Goldman Sachs European Medtech and Healthcare Services Conference
9/9-10
BioCentury 22nd Annual NewsMakers in the Biotech Industry Conference
9/10
BAML Global Healthcare Conference
9/16-18
Morgan Stanley 2015 Healthcare Conference
9/16-18
1st Annual Ladenburg Thalmann Healthcare Conference
9/29
Nektar R&D Day
10/8
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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.
CUV.AX / CLVLY:
Phase 3 Scenesse results for EPP published in NEJM
I don't have full access seems that all but the tables are available for free from the below link.
http://www.nejm.org/doi/full/10.1056/NEJMoa1411481?query=TOC
Phase 3 Scenesse results published in NEJM
http://www.nejm.org/doi/full/10.1056/NEJMoa1411481?query=TOC
Would you have speakers at your own Investor Day roundtable that you knew didn't buy into the company line?
MCRB:
Sorry I missed your posts earlier when posting the Seres Retail Roadshow information.
It seems like an interesting company though its something I am not comfortable enough with to invest at this time. I was surprised at the level of interest it seems the valuation will be much higher than I expected for the stage of development they are at.
They claim to be the leader. Do you know of any other companies/programs that are in the clinic? I take it you are considering a position any other thoughts on the company/DD info/links would be appreciated.
Seres Therapeutics:
Watching a retail roadshow presentation of an interesting company with a different approach (then I am familiar with at least). Their lead program is for recurrent C Diff, SER-109. They have a breakthrough designation already for those who care about those things. The CEO sounds a bit overly confident (maybe that is good though). What makes them unusual (to me) is their approach From their website
Seres is developing Ecobiotic® therapeutics to treat diseases that have an underlying microbiome biology
Reminds me of an episode of House. Ironically the daughter who was short did not have dwarfism and could be treated with growth hormone but wanted to remain like her mother.
I was specifically looking at PlasmaTech Biopharmaceuticals (PTBI).
http://www.plasmatechbio.com/
It seems there are a lot of companies entering and using very similar delivery methods and if the target is well established made me wonder how difficult a hurdle it would be to enter.
Gene Therapy:
I started looking at a (transformed) gene therapy company that caught my attention because of a focus in some LSD's. I quickly realized that they are basically a virtual company that licensed their technology from some universities then I began to wonder what the possibility that once the initial hurdles around delivery, safety and whatever else are overcome and regulators feel comfortable to approve a few of these just how high a hurdle will it be for others to develop gene therapy products? I realize in some diseases it will be harder than others but might this turn out to be a bit of a commodity field (and hence much lower pricing)?