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In addition to the 12 month review they have a mandatory discount. From my old InterMune notes in 2011 when they announced launching in Germany they said there was a mandatory 16% discount. Don't know if that is negotiated or not or is same today. Still quite an impressive price!
One thing I recall too is in Germany the G-BA has to automatically associate some benefit when the drug is for an orphan indication such as Scenesse. I recall too if sales were 50 million (in Germany) in a 12 month period the price would need to be renegotiated (though this is likely not an issue for Scenesse. in the foreseeable future).
CUV.AX / CLVLY / CLVLF:
Such a bad history in general for Australian biotechs.
I agree with both on Sale and Gallo. Gallo may really strike out a ton too which I guess may be liveable of hits 40+ consistently but it may take a while to get to that level (even the great Harper took a while). Sale's K's/dominance being down may be a concern too. But I think both teams know that and each would think the ads out way the minuses.
Anyway its just a rumor for now . He was scratched for another reason
http://www.mlbtraderumors.com/2016/07/chris-sale-involved-in-clubhouse-incident.html
http://m.mlb.com/news/article/191256686/white-sox-ace-chris-sale-scratched-from-start/
The sox may want to move him for his off field issues. He wasn't pleased with Management when LaRoche quit too.
Thanks for the heads up on Patheon's management ties!
An FYI for anyone interested the presentations don't stay up long I think today may be it for BOLD.
Audentes (BOLD) / Kadmon and some other upcoming IPO's have their webcasts available on retailroadshow for anyone interested.
http://www.retailroadshow.com/wp/roadshows.asp
Here is a link to the Cantor Webcast early today for anyone interested
http://wsw.com/webcast/cantor4/ekso/
United States Health Care Reform Progress to Date and Next Steps
Barack Obama, JD1
Here is a link to the JAMA article by President Obama for those interested (I haven't read it, its pretty long). My questions are 1-how much help did he get with it and/or 2-How does he have the time to research/write this?
http://jama.jamanetwork.com/article.aspx?articleid=2533698
Winner of AL Central: Cleveland
Winner of AL West: Texas
2nd In NL East: Miami
Winner of NL West: San Francisco
Team With Worst Record In Baseball: Minnesota
I'd agree about being in much better position then past interaction. Fast track (and other) designations don't necessarily imply approval. I saw a list recently of drugs getting Breakthrough designation that failed to get approval. Its more that the potential exists and the condition its a serious condition with high unmet need. If your interested you can read more here:
http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf
The significance of the PR to me is not so much fast track as there appears to be a path forward without an additional trial! This prior US phase 2 failed and it was reasonable to expect FDA might require an additional trial (and at this companies pace that would have been years!). One would expect priority review as well given the disease and lack of available treatment so in and of itself fast track/priority review pr's are generally not major events. A path forward without a need for another trial IS a big deal!
They need to do some preclinical tox work and their data is still a mess but hopefully with the meeting in october and some real world patient data well help saw FDA for approval.
ITEK:
They have to do 2 Phase 3's for approval so first one is testing multiple doses (they also need a long term safety study which they said would initiate in 2017). They said there is a .7 to .9 improvement every time double dose and the Phase 3 doses are 1000 mcg QD, 1500 mcg BID - 2000 mcg QD. They are also treating longer (12 weeks) which may offer a slight benefit.
The combo trial will test with latanoprost. In one presentation the company said FDA has refused to approve combo of Timolol and latanoprost.
ITEK:
There are probably a few people that follow/have positions some of the more followed SI charity contestants picked it too .
I took a smallish position this year when it (and other) Bio's collapsed. Its one I follow fairly closely too if someone has specific questions. I don't follow CANF's or know much about their compound though to contrast. Is CANF's compound modeled after adenosine as well?
The bull case I guess for ITEK is they have a very low bar for approval if they just have to beat placebo. The safety profile has been quite good I'm am actually more excited about the possibility of combo use they should be initiating a dose ranging combo trial very soon (guided 1H) with results in 2H '16. They also think the compound may work in other eye diseases (Both front and back of the eye).
Cantor Fitzgerald’s 7/12-13 Direct link to webcasts
http://wsw.com/webcast/cantor4/
Innate Pharma SA – Analysts and Investor Presentation
Wednesday 13th July 2016 at 12:00 PM BST / 13:00 PM CEST
https://events-emea1.adobeconnect.com/content/connect/c1/1083135494/en/events/event/shared/1996894283/event_registration.html?sco-id=2121659722&_charset_=utf-8
IPF Market:
I used to keep track of the companies/molecules I would hear about. I don't think I am catching all of them and some may have been stopped but I had in the neighborhood of about 30.
Don't recall which company was doing so (it was a very small one) but they referenced the InterMune sale for potential.
It still remains a difficult disease(s) and even though many are using similar targets I'd bet most still fail.
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 July - September Events
Goldman Sachs 37th Annual Global Healthcare Conference
6/7-9
https://cc.talkpoint.com/gold006/060716b_ae/
Jefferies 2016 Healthcare Conference
6/7-10
http://www.jefferies.com/OurFirm/Conferences/325/267
William Blair 36th Annual Growth Stock Conference
6/14-16
https://www.williamblair.com/News-and-Events/Events/2016/June/14/36th-Annual-Growth-Stock-Conference.aspx
GLPG R&D Day
6/15
Citi European Healthcare Conference 2016
6/21-22
JMP 2016 Life Sciences Conference
6/21-22
http://wsw.com/webcast/jmp29/
ROTH Capital Partners 3rd Annual Healthcare Day
6/22
J.P. Morgan European Healthcare Conference
6/23
Jefferies Alzheimer's Summit
6/28
Cantor Fitzgerald’s 2nd Annual Healthcare Conference
7/12-13
http://www.meetmax.com/sched/event_37633/~public/conference_home.html?event_id=37633
Canaacord Genuity Growth Conference
8/10-11
http://www.canaccordgenuity.com/en/cm/News-Events/Events/
Wedbush PacGrow Healthcare Conference
8/16-17
http://www.wedbush.com/services/cmg/equities-division/mgmt-access-events
Wells Fargo Securities Healthcare Conference
9/7-8
Citi's Annual Biotech Conference
9/7-8
http://citiconferences.com/
RW Baird Global Healthcare Conference
9/7-8
http://www.bairdconferences.com/conference2/Index/8
Biocentury NewsMakers in the Biotech Industry
9/9
http://www.biocentury.com/conferences/newsmakers/dates
Rodman and Renshaw 18th Annual Global Investment Conference
9/11-13
http://www.meetmax.com/sched/event_35153/~public/conference_home.html?event_id=35153
Morgan Stanley Global Healthcare Conference
9/12-14
Bank of America Merrill Lynch Global Healthcare Conference
9/14-16
Aegis Capital Growth Conference
9/20-22
Ladenburg Annual Healthcare Conference
9/27
RBC Smallcap Conference
https://www.rbccm.com/about/cid-202541.html
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SRPT: Issued this statement (Q&A) to Cure Duchenne for those who didn't see it on twitter (@jennmcnary tweeted to pictures) the text is here which is easier to read
http://cureduchenne.com/blog/an-update-for-the-duchenne-community/
PRTO:
They had an R&D Day in November that is still available.
http://ir.proteontherapeutics.com/phoenix.zhtml?c=253625&p=irol-EventDetails&EventId=5206322
Webcast (Direct Link): http://edge.media-server.com/m/p/xgcsk26y
Slides (Direct Link): http://phx.corporate-ir.net/External.File?t=1&item=VHlwZT0yfFBhcmVudElEPTUyMDYzMjJ8Q2hpbGRJRD02MDcwNTI=
I haven't had a chance to go through it yet though so can't comment on it. I did catch a recent presentation (not todays) and seems interesting at this market cap.
They are right on pace assuming they don't lose too much in the summer or pick it up in the fall they are right around 8/mo (see my prior post). In the big picture if they are a month or two late its not a big deal but I was hoping for a much more rapid enrollment which obviously isn't going to happen.
Thanks for the added info.
RVNC:
RVNC, which has an enterprise value of only ~$50M after the recent sell-off
Sally Church tweeted disagreeing with John LaMattina's interpretation of Pazdur's remarks. He responded by saying his article is based on quotes in Reuters and Fierce. If he didn't even hear Pazdur talk kinda makes his article worthless doesn't it?
AUPH:
They raised a relatively small amount what isn't clear to me is if this was deliberate since they have a near term value inflection event or access to capital was difficult.
Generally speaking I like that it was small and management participated but the flip side is did they have to on both counts?
He had a piece recently on Movantik. I am long NKTR so I am likely biased . My main criticisms are that he seemed to downplay OIC implying it was easily manageable and advertising for it would lead to more Opioid abuse. Interestingly I didn't recall reading any criticisms of lyrica advertisements in his article
.
AEGR/QLTI (Novelion) merger
Slides: http://files.shareholder.com/downloads/AEGR/2242402925x0x896515/AE4E2659-BAE1-4466-A4B0-387D476BAC2E/Odyssey_Investor_Deck_6-15-2016_Final.pdf
Webcast 8:30am ET Today (6/15): http://edge.media-server.com/m/p/pmx8k42p
GLPG R&D Webcast 8:00am ET today 6/15
http://edge.media-server.com/m/p/kx24dact
SMMT Utrophin R&D Webcast 8:30am ET today 6/15
http://edge.media-server.com/m/p/oow5xhwc
INFI CC Note
. Topline PFS on DUO CLL early in 2H '16
. Discussions with Abbvie for next steps, paused 1B/2 evaluating duvelisib with venetoclax pending business discussions all other studies are continuing.
. Update in early August when report Q2
. Grade 3+ in 10% of patients include neutropenia-28%, diarrhea-15%, thrombocytopenia-13%, anemia-12%, Infection-20% did have on-study death, majority disease progression
. Discussion with FDA in summer whether to file or not.
. If Abbvie doesn't proceed would receive all rights back.
. Stilling digging in data (differences between earlier studies)
. $200M milestone based on acceptance of file.
. If no path forward no cash payments from Abbvie. Payments to date covered development costs. 90 day wind-down if go that path.
I listened to the call think they are selling well below cash if have a chance for some positives but walked away for a few reasons:
- Their burn is much higher than I thought So by the time they give an update they won't be too much below cash. Doesn't seem like they would get much if anything when Abbvie walks though burn will go down as have some contractual obligations in head count.
- The Grade 3 events and on study deaths with mediocre data is a bit worrisome even if the data are better in CLL.
BIO CEO Webcast links
http://convention.bio.org/2016webcasts.aspx
Jefferies Webcast Links
http://wsw.com/webcast/jeff97/
AUPH:
I am 1 of the 6 and am long in real life too. Obviously I feel the odds of success in the Phase 2 are pretty good. Just to balance and give some of the negative things to think about:
1) Their balance sheet is quite weak. They are literally running on fumes to get to the Phase 2 readout in August.
2) I doubt this trial will satisfy regulatory requirements for 1 of 2 confirmatory trials because the duration seems too short compared to other Lupus trials. The company is also continuing out to 48 weeks.
3) The AURION data while encouraging don't really tell us much since its quite small and all it really does is show results in short duration (so far).
4) Lupus is quite a heterogenous disease so some patients nephritis will resolve without drug.
I haven't decided if the recent management changes are good or bad and the delay in raising funds (debt or equity) is just new management needing time to get something done or holding out for results. If the results are positive its natural to think they sell out to someone to run the Phase 3/take it to market. I thought it would make a good target for BMRN (they dabbled in Lupus with Riquent when La Jallo was a different company). Their recent plans to initiate a Japanese study made me wonder if they have a potential Japanese partner interested. If successful in Phase 2 I would be quite happy with them partnering to raise some capital and running the Phase 3's on their own and taking it to market.
I believe He is also an investor in AEGR so I guess that one is like facing Kershaw . I have them in charity portfolio but (fortunately) when I took a closer look (their balance sheet and revenues from their second product were much worse then I thought).
Abbvie R&D Day Tomorrow (June 3) 9am CT
http://www.abbvieinvestor.com/phoenix.zhtml?p=irol-eventDetails&c=251551&eventID=5223787
It is true that European companies are generally cheap compared with US, but that seems to be a semi-permanent state for unclear reasons.
IONS:
I don't follow the company closely but heard the call and my impression of management from that is quite negative.
Reading between the lines it would seems that a patient died and I'd venture platelet issues go beyond the two programs by the deliberate wording of "at these levels" remarks.
I agree with your time estimates (that assumes the company can get some basic tox studies done in reasonable fashion and I don't take anything for granted with this company!)
If FDA accepts their filing on current data I would imagine they would receive full approval (with luck they apply/get Breakthrough designation but at least should qualify for priority review) perhaps required to follow patients (registry) to ensure safety of the drug I don't know if they'd be able to or want to use the PASS protocol. I don't see what a reasonable/feasible primary endpoint would be. The two trials had primary endpoints of hours in direct sunlight. Its not a great endpoint but the secondaries would be dependent on amount of exposure and in a disease were patients avoid sunlight seems unethical to require them to be exposed x amount of time. Also with a heterogenous patient population I think it would be hard to standardize something to measure the amount of phototoxicity.
FDA has their own approval process and approval in EU cannot be directly leveraged toward US approval. There are several drugs approved in EU but not US (and vice versa). The one big benefit of EU approval is many other countries around the world accept that and it can be used toward gaining approval in a particular country though there is still a process for each country to get approved and reimbursed. Though with their limited resources I doubt they are prioritizing this, I would hope Clinuvel at some point actively does so in some other non-European key markets that have robust reimbursement.
I think this will be one of those rare diseases that once an approved drug is available and more information gets out it will be diagnosed more. With a lot of the rare diseases it turns out this way and this being such an unusual situation is probably not diagnosed quickly (especially in the less severe).
Unfortunately the company is not even at the point of filing with FDA from the last public comments it seemed they needed to do some additional toxicology work. The company met with FDA (December) and will meet with patients/key open leaders and I believe then a followup meeting will occur with the company.
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 UBS, B Riley, JMP; Update GS Link, ARIA & GLPG Events
Bloom Burton & Co. Healthcare Investor Conference
5/2-3
https://www.bloomburton.com/conference/
Deutsche Bank 41st Annual Healthcare Conference
5/4-5
https://conferences.db.com/americas/healthcare16/
Bank of America Health Care Conference
5/10-12
Piper Jaffray 3rd Annual GenomeRx Symposium
5/17-18
http://www.piperjaffray.com/2col.aspx?id=365
UBS Global Healthcare Conference
5/23-25
https://cc.talkpoint.com/ubsx001/052316a_ae/
17th Annual B. Riley Investor Conference
5/25
http://www.meetmax.com/sched/event_35099/~public/conference_presentations.html
2016 Marcum MicroCap Conference
6/1-2
http://www.marcumllp.com/microcap
Ariad ASCO Even
6/6 7:00am
investor.ariad.com
Goldman Sachs 37th Annual Global Healthcare Conference
6/7-9
https://cc.talkpoint.com/gold006/060716b_ae/
Jefferies 2016 Healthcare Conference
6/7-10
http://www.jefferies.com/OurFirm/Conferences/325/267
William Blair 36th Annual Growth Stock Conference
6/14-16
https://www.williamblair.com/News-and-Events/Events/2016/June/14/36th-Annual-Growth-Stock-Conference.aspx
GLPG R&D Day
6/15
Citi European Healthcare Conference 2016
6/21-22
JMP 2016 Life Sciences Conference
6/21-22
http://wsw.com/webcast/jmp29/
ROTH Capital Partners 3rd Annual Healthcare Day
6/22
J.P. Morgan European Healthcare Conference
6/23
Jefferies Alzheimer's Summit
6/28
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People are having fun at his wiki page. Someone posted something on twitter earlier
https://pbs.twimg.com/media/CiiMEihUkAABk9S.jpg:large
that is different then what is there in this picture (look at throws and hits) and may be gone/changed again soon
https://en.wikipedia.org/wiki/Rougned_Odor
AUP.TO / AUPH:
The company PR'd presenting data at http://www.era-edta.org/ May 21-24th
http://www.auriniapharma.com/dnn/LinkClick.aspx?fileticket=P-V2iHpDyZY%3d&tabid=41&mid=570
The PR gave the impression the posters would be available at the time of presentation but they were actually available yesterday
http://www.auriniapharma.com/dnn/ForInvestors/CorporatePresentations.aspx
The most meaningful poster is that of the AURION data (now 10 patients treated for 8+ weeks)
http://www.auriniapharma.com/dnn/LinkClick.aspx?fileticket=B1Tyvq9bbps%3d&tabid=121&mid=742
Previously they had reported on the first 7 (at 8 weeks). Then they reported 7/7 achieving > 25% reduction in proteinuria and 4/7 achieving a complete remission (defined as <= .5 mg/mg)). The update from the poster is 10/10 achieving > 25% reduction in proteinuria and 5/10 achieving CR.
Additional from their Q1 PR it looks like there will be 24 week data on the first 7 patients from the AURION trial which is significant in that it will come before the AURA-LV data is expected (previously said August).