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NKTR:
I'm probably as guilty as most in thinking my companies make good buyout candidates (though I don't always want it to happen)... that being said if data holds up once September rolls around (when the BMY option expires) and the PROPEL data is out doesn't the company go to one of three bidders?
Its interesting Robin hasn't done a financing not many (now 10b) companies only have a couple hundred million in the bank! Granted he wants to sell 181 for a bunch of upfront cash but still.
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, Updated January events
Audentes Call to Review Interim Data from First Dosed Cohort from ASPIRO
1/4/18 8:00am ET
https://edge.media-server.com/m6/p/8tfaxqgh
Goldman Sachs Healthcare CEOs Unscripted: A View from the Top
1/4/18
https://cc.talkpoint.com/gold006/010418a_as/
Biotech Showcase
1/8-10/18
https://ebdgroup.knect365.com/biotech-showcase/
Annual OneMedForum
1/8-10/18
https://www.onemedmarket.com/onemedforum-sf2018
JP Morgan Annual Healthcare Conference
1/8-11
https://jpmorgan.metameetings.net/events/healthcare18/agenda
Needham Annual Stock Growth Conference
1/17-18
http://wsw.com/webcast/needham84/
Noble Financial Annual Emerging Growth Investor Conference
1/29-30
http://nobleconference.com/what.htm
BIO Biotechnology CEO & Investor Conference
2/12-13
Leerink Partners Global Healthcare Conference
2/14-15
RBC Capital Markets Healthcare Conference
2/21-22
BTIG Medical Technology, Life Sciences & Diagnostics Conference
2/26-3/1
Morgan Stanley European MedTech & Services Conference
2/26-27
Raymond James Institutional Investors Conference
3/4-7
Canaccord Genuity Musculoskeletal Conference
3/6
Credit Suisse Global Healthcare Conference
3/6-7
Roth Annual Growth Stock Conference
3/11-14
Cowen & Co. Annual Health Care Conference
3/12-14
Barclays Capital Global Healthcare Conference
3/13-15
Oppenheimer's 28th Annual Healthcare Conference
3/20–21
BioCentury Future Leaders in the Biotech Industry Conference ?
3/23
Needham Healthcare Conference
3/27-28
H.C. Wainwright Global Life Sciences Conference
4/8–10
Deutsche Bank Healthcare Conference
5/8-9
Bank of America Merrill Lynch Healthcare Conference
5/15-17
Citi Swiss Healthcare Day 2018
5/17
UBS Global Life Science Conference
5/21-23
--
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”).
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© 2018 InvestorsHub.com, Inc.
Was waiting for JP Morgan link to update but from company pr's beginning uncertain if they'll provide full listing of company presentations as in the past (to non-clients anway). If anyone finds/gets link would appreciate it!
A (very) small Conference is on 1/4/18
Goldman Sachs Healthcare CEOs Unscripted: A View from the Top
https://cc.talkpoint.com/gold006/010418a_as/
Forgetting price for the moment there are a couple things to consider:
1-While doctors do have flexibility to prescribe off label in the US the drug will have some sort of REMS making off label use unlikely.
2-I'm not into tanning but consider the delivery method do you think a lot of people will want a subcutaneous implant not to mention some AE's that go along with Scenesse for a tan?
3-There is the issue of COGS (not sure on what it is for Scenesse) too so they couldn't make the price too low.
IMO the best opportunity in tanning would be some OTC topical form of afamelanotide or some derivative molecule.
I don't think Scenesse is happening for Vitiligo either that's just my opinion based on a few things (poor trial, limited efficacy, company delaying development). Again I think a different molecule would be better suited for this indication.
That being said I really like Scenesse for EPP and other Orphan indications just wish the company was more competent at developing in these indications not to mention dealing with regulators and payers.
I don't agree with that. NICE is notorious for finding fault with new medicines being too expensive. Also look at what happened with PTC they got a positive recommendation but the pricing was not disclosed so reference pricing wouldn't be easily achieved. That is why its often one of the last to get reimbursement. Each government has their own policy. The Germany policy I've commented on earlier from my Intermune experience and Clinuvel did it all wrong IMO! Since there was (is) no reference drug for EPP and its an Orphan indication while still a complex process the German system is much more favorable. InterMune was the first to go through IQWIG and eventually went through arbitration but they had an initial price and sales before this! The process involved a mandatory reevaluation at set points (I believe it was 2 years or when costs to Germany system reached 50m Euro). I suspect the process was much harder being first and yet they started sales there immediately with one of the highest prices in the EU. Clinuvel would have been wise to hire/contract someone who new the process instead of wait what was it ~ 2 years to go there!
Here is a link to the NICE report (note there are some detailed PDF's available from this page)
https://www.nice.org.uk/guidance/indevelopment/gid-hst10009/consultation/html-content
Don't know why anyone is surprised if NICE didn't initially recommend Vertex's CF drugs there was no way they would recommend Scenesse especially if the company is sticking to the "uniform pricing" nonsense. Since they apparently have limited bandwidth to pursue concurrent reimbursements this should have been (very) low on the priority unless they were open to price negotiations (the main objective of NICE). Just another dumb decision by management no surprise here.
TRIL:
Do you or anyone else know if they had a previous shelf expiring (or used up)? TIA
Thanks for the explanation! Is this the traditional way foreign companies list on the US? Going through old statements I see Gentium was listed that way.
Charles Seife / SRPT:
I am really surprised you'd give this guy credibility! I stopped reading his article the first time because it lacked substance was pure tabloid. Sure you can infer conspiracy in everything if you like! He is just a "journalist" looking to make a story whether or not one exists. I skimmed through his other Scientific America and his style is similar pure conspiracy theory. He conveniently omits real facts like Sarepta's "plunge" caused by AE's and death was clarified as 3 deaths were ALL patients in their 20's I think 1 didn't even receive drug.
Specifically about the kidney issue. His reference is from study 201/202 given those kids are still on therapy its quite the stretch to say the drug caused kidney damage in them!
The choice of Journal alone should raise doubts about an rigor in his "analysis"!
BMRN - Hemophilia A
I noted a couple things on twitter. It seems like the super responders (1 in particular) had the Factor level drop to normal (briefly) and is now at near normal. Considering his level was over 300 at one point that is rather substantial. Its above my paygrade to speculate but I would be concerned if its a sign of loss of expression or two could it be the body is somehow self regulating and adjusting? Also if so the lower dose being tested in the second P3 would seem less necessary.
The n's are small and some fluctuation is normal... with that caveat though the median level is also dropping (though slightly) without individual data hard to speculate but durability has been one of my concerns.
Those things being said the results are quite remarkable! It seems ONCE (Hemophilia B) gets all the spotlight in the Hemophilia GT space but BMRN is actually putting the vast majority of patients at normal Factor levels with minimal AE's (1 SAE was because of a patient needing knee replacement and the other resolved with Tylenol).
I also wonder about pricing if Roche is charging ~500k one would think 4-5x that if durability remains would be cheap for BMRN's GT.
NKTR:
Sorry don't know if they are presenting anything at ESMO. They just presented PIVOT data and PROPEL has been active for less than 6 months so doubt they have any data for that.
Its noteworthy that Robin hasn't done a financing and with all the studies they're paying for the already high burn will go up in '18. For all his critics he's done a few things well one being execute meaningful partnerships (and prior to Nektar he sold Sirna at a peek who sold the assets to ALNY at a fraction of what Merck paid). So I am hopefully of a meaningful upfront for 181, perhaps a meaningful milestone if its approved on just the 1 efficacy study too.
Paul also posted this link from the instute responsible for the paper: https://www.cancerresearch.org/scientists/clinical-development/clinical-accelerator/landscape-of-immuno-oncology-drug-development
End Points had a summary on it here: https://endpts.com/there-are-2004-cancer-immunotherapies-crowding-into-the-pipeline-now-what/
ASH Analyst/Investor Events (updated)
(All times ET)
ABLX: 12/10 10:00am https://edge.media-server.com/m6/p/rfd8tqdz
AGIO: 12/11 8:00pm https://edge.media-server.com/m6/p/cdbo84c3
AKTX: 12/10 8:00pm https://edge.media-server.com/m6/p/yj8pdmbf
AMGN: 12/9 11:30am https://edge.media-server.com/m6/p/beo5icoz
ARGX: 12/11 12:00pm https://edge.media-server.com/m6/p/92c7yttw
BGNE: 12/9 8:00pm https://edge.media-server.com/m6/p/owd38k36
blue: 12/10 8:30pm http://investor.bluebirdbio.com/events-and-presentations/upcoming-events
bpmc: 12/11 6:00am https://edge.media-server.com/m6/p/pysgkosy
CELG: 12/10 8:00pm https://edge.media-server.com/m6/p/g9arq55v
GBT: 12/11 8:15pm https://event.webcasts.com/starthere.jsp?ei=1170178&tp_key=c02f43a58e
GEN.CO: 12/11 8:00pm https://edge.media-server.com/m6/p/ddbvrvjy
INCY: http://www.incyte.com/ir/events-and-presentations.aspx
JUNO: 12/11 8:30pm http://ir.junotherapeutics.com/news-events
KPTI: http://investors.karyopharm.com/events.cfm
MPSYY: 12/12 11:00am https://morphosys-events.webex.com/mw3100/mywebex/default.do?service=1&siteurl=morphosys-events&nomenu=true&main_url=%2Fmc3100%2Fe.do%3Fsiteurl%3Dmorphosys-events%26AT%3DMI%26EventID%3D548661217%26UID%3D528129912%26Host%3DQUhTSwAAAARGm3ZX3_-pmw1_lV1828ddwb7ItI39EAsIMvu-XZ_gdBtGjFjFk3vxavfgFCga_AyKDRLVniRYySoLnYhMI6dH0%26FrameSet%3D2%26MTID%3Dm96f129db6f71dd7aecd1430998cbcda2
ONCE: 12/11 12:30pm https://edge.media-server.com/m6/p/mrg93js5
ROG.VX: 12/13 10:00am https://www.roche.com/investors/updates/inv-update-2017-11-14.htm
SGEN: 12/11 8:00pm https://edge.media-server.com/m6/p/eixd3qgv
SNSS: 12/9 8:30pm http://ir.sunesis.com/events-and-presentations/upcoming-events
TGTX: 12/10 8:15pm http://ir.tgtherapeutics.com/events.cfm
XLRN: 12/11 7:00am https://edge.media-server.com/m6/p/chsmdnhv
Comprehensive analysis of the clinical immuno-oncology landscape
https://academic.oup.com/annonc/advance-article/doi/10.1093/annonc/mdx755/4693829
h/t Paul D. Rennert @PDRennert
Ablynx ASH Event
Ablynx management to host conference call on additional Phase III HERCULES data
12/10 10am (ET) https://edge.media-server.com/m6/p/rfd8tqdz
Thanks for the detail!
Buyouts / Tax repatriation
I have a general question and a few comments
I haven't kept up with all the tax reform and differences so I may not be accurate but if the repatriation tax rate is 10% why would most companies do it? That is taking a 10% hit while you could keep it overseas? The finance people are much smarter (and creative) then I if they wanted to do things like issue (cheap) debt and maintain the cash or do acquisitions through foreign subsidiaries couldn't they?
On Endpoints list. I wish people would get creative! Sure some of those may be bought out but most have been talked about for 5+ years! A lot of these companies have issues making a deal complicated.
1) GLPG also has a standstill with GILD (when it ends has not been released) given their (current) most valuable asset is Filgotinib ownership interest they're the most likely suitor.
2) BMRN stock is at lows and they don't seem interested in selling in the past (had a board issue over it years back) and doubt they would anywhere near these levels.
3) VRTX has a nice CF franchise that is the only reason someone would buy them... but with a risk of a (potentially big) dent from ABBV/GLPG I think a buyer would be especially cautious wanting to ensure triples from them are superior to competitors.
Other than SRPT I don't follow the others closely to comment and even SRPT though there is new management I'd be surprised at a near term deal they have a lot of question marks that could (greatly) impact valuation in the next 6+ months.
ASH Analyst/Investor Events
(All times ET)
AGIO: 12/11 8:00pm https://edge.media-server.com/m6/p/cdbo84c3
AKTX: 12/10 8:00pm https://edge.media-server.com/m6/p/yj8pdmbf
AMGN: 12/9 11:30am https://edge.media-server.com/m6/p/beo5icoz
ARGX: 12/11 12:00pm https://edge.media-server.com/m6/p/92c7yttw
BGNE: 12/9 8:00pm https://edge.media-server.com/m6/p/owd38k36
blue: http://investor.bluebirdbio.com/events-and-presentations/upcoming-events
bpmc: 12/11 6:00am https://edge.media-server.com/m6/p/pysgkosy
CELG: 12/10 8:00pm https://edge.media-server.com/m6/p/g9arq55v
GBT: 12/11 8:15pm https://event.webcasts.com/starthere.jsp?ei=1170178&tp_key=c02f43a58e
GEN.CO: 12/11 8:00pm https://edge.media-server.com/m6/p/ddbvrvjy
INCY: http://www.incyte.com/ir/events-and-presentations.aspx
JUNO: http://ir.junotherapeutics.com/news-events
KPTI: http://investors.karyopharm.com/events.cfm
MPSYY: 12/12 11:00am https://morphosys-events.webex.com/mw3100/mywebex/default.do?service=1&siteurl=morphosys-events&nomenu=true&main_url=%2Fmc3100%2Fe.do%3Fsiteurl%3Dmorphosys-events%26AT%3DMI%26EventID%3D548661217%26UID%3D528129912%26Host%3DQUhTSwAAAARGm3ZX3_-pmw1_lV1828ddwb7ItI39EAsIMvu-XZ_gdBtGjFjFk3vxavfgFCga_AyKDRLVniRYySoLnYhMI6dH0%26FrameSet%3D2%26MTID%3Dm96f129db6f71dd7aecd1430998cbcda2
ONCE: 12/11 12:30pm https://edge.media-server.com/m6/p/mrg93js5
ROG.VX: 12/13 10:00am https://www.roche.com/investors/updates/inv-update-2017-11-14.htm
SGEN: 12/11 8:00pm https://edge.media-server.com/m6/p/eixd3qgv
SNSS: 12/9 8:30pm http://ir.sunesis.com/events-and-presentations/upcoming-events
TGTX: 12/10 8:15pm http://ir.tgtherapeutics.com/events.cfm
XLRN: 12/11 7:00am https://edge.media-server.com/m6/p/chsmdnhv
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, Updated December/January events, Added stubs for Some future Events
Stifel Nicolaus Healthcare Conference
11/14-15
http://wsw.com/webcast/stifel10/
Jefferies Global Healthcare Conference
11/15-16
http://wsw.com/webcast/jeff108/
Voyager R&D Day in NY
11/16 2:00pm ET
http://ir.voyagertherapeutics.com/phoenix.zhtml?c=254026&p=irol-EventDetails&EventId=5263488
Piper Jaffray Healthcare Conference
11/28-29
Evercore ISI Biopharma Catalyst/Deep Dive Conference
11/29-30
UltraGenyx R&D Day
12/4 8am - 1pm
https://edge.media-server.com/m6/p/ymyvc5ek
Mizuho’s Global Healthcare Conference
12/4-5 (Think just 1x1 format no webcasts)
Citi Global Healthcare Conference
12/6-7
Sunesis ASH Update
12/9
BMO 2017 Prescriptions for Success Healthcare Conference
12/14
https://cc.talkpoint.com/bmoc001/121417a_as/
Biotech Showcase
1/8-10/18
https://ebdgroup.knect365.com/biotech-showcase/
Annual OneMedForum
1/8-10/18
https://www.onemedmarket.com/onemedforum-sf2018
JP Morgan Annual Healthcare Conference
1/8-11
https://www.jpmorgan.com/country/US/EN/detail/1320543220127
Needham Annual Stock Growth Conference
1/17-18
Noble Financial Annual Emerging Growth Investor Conference
1/29-30
BIO Biotechnology CEO & Investor Conference
2/12-13
Leerink Partners Global Healthcare Conference
2/14-15
RBC Capital Markets Healthcare Conference
2/21-22
BTIG Medical Technology, Life Sciences & Diagnostics Conference
2/26-3/1
Morgan Stanley European MedTech & Services Conference
2/26-27
Raymond James Institutional Investors Conference
3/4-7
Canaccord Genuity Musculoskeletal Conference
3/6
Credit Suisse Global Healthcare Conference
3/6-7
Roth Annual Growth Stock Conference
3/11-14
Cowen & Co. Annual Health Care Conference
3/12-14
Barclays Capital Global Healthcare Conference
3/13-15
Oppenheimer's 28th Annual Healthcare Conference
3/20–21
BioCentury Future Leaders in the Biotech Industry Conference ?
3/23
Needham Healthcare Conference
3/27-28
H.C. Wainwright Global Life Sciences Conference
4/8–10
Deutsche Bank Healthcare Conference
5/8-9
Bank of America Merrill Lynch Healthcare Conference
5/15-17
Citi Swiss Healthcare Day 2018
5/17
UBS Global Life Science Conference
5/21-23
--
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.
Evercore ISI Biopharma Catalyst/Deep Dive Conference 11/29-30
Not a complete list times are ET feel free to update (add/edit/correct)
. ABBV 11/29 8:00am https://www.veracast.com/webcasts/evercoreisi/biopharma2017/98101290385.cfm
. AMGN 11/30 9:30am https://www.veracast.com/webcasts/evercoreisi/biopharma2017/56205116328.cfm
. ANAB 11/30 4:35pm https://www.veracast.com/webcasts/evercoreisi/biopharma2017/68121214254.cfm
. BIIB 11/29 2:20pm https://www.veracast.com/webcasts/evercoreisi/biopharma2017/24115109258.cfm
. BMRN 11/29 11:00am https://www.veracast.com/webcasts/evercoreisi/biopharma2017/42107230527.cfm
. BMY 11/29 11:45am https://www.veracast.com/webcasts/evercoreisi/biopharma2017/24108156464.cfm
. DERN 11/30 8:45am https://www.veracast.com/webcasts/evercoreisi/biopharma2017/09204138782.cfm
. DRNA 11/30 1:35pm https://www.veracast.com/webcasts/evercoreisi/biopharma2017/04215176872.cfm
. IMGN 11/30 1:15pm https://www.veracast.com/webcasts/evercoreisi/biopharma2017/99203187186.cfm
. IONS 11/30 8:45am https://www.veracast.com/webcasts/evercoreisi/biopharma2017/95203290888.cfm
. LLY 11/30 4:15pm https://www.veracast.com/webcasts/evercoreisi/biopharma2017/13101161786.cfm
. MYL 11/30 3:30pm https://www.veracast.com/webcasts/evercoreisi/biopharma2017/69221101839.cfm
. OVID 11/30 12:50pm https://www.veracast.com/webcasts/evercoreisi/biopharma2017/99213121987.cfm
. PRTA 11/30 1:15pm https://www.veracast.com/webcasts/evercoreisi/biopharma2017/21214276819.cfm
. QURE 11/29 3:05pm https://www.veracast.com/webcasts/evercoreisi/biopharma2017/74120183724.cfm
. RGNX 11/29 2:20pm https://www.veracast.com/webcasts/evercoreisi/biopharma2017/04115276671.cfm
. TOCA 11/29 1:35pm https://www.veracast.com/webcasts/evercoreisi/biopharma2017/61114163761.cfm
. VYGR 11/29 3:30pm https://www.veracast.com/webcasts/evercoreisi/biopharma2017/33118230039.cfm
. VRX 11/29 11:00am https://www.veracast.com/webcasts/evercoreisi/biopharma2017/83107100165.cfm
OK I've had it with management/board
We desperately need changes at the management/board level. The slides of the AGM were posted
http://www.asx.com.au/asxpdf/20171128/pdf/43pn6c5k23mn2y.pdf
along with the chairman's address
http://www.asx.com.au/asxpdf/20171128/pdf/43pn41njvympfw.pdf
and its clear they are in over the heads and worse is they seem to be patting themselves on the back about it!
The chairman's letter pats the CEO for negotiations in German a language not his native tongue and criticizes bureaucrats for not accepting "innovative" pricing. Is he kidding? It really says 2 things
1-What the heck is someone not fluent in German (much less German reimbursement regulations, IQWIG, GBA, Amnog Law...) doing at the table! No wonder we got the shaft!
2-Why is a tiny biotech who has 0 prior approvals trying to "revolutionize" pricing/reimbursement! They have no skill-set to even mimic what big companies have done much less "innovate"
Then in the AGM slides we find out.
1-Not only is the filing delayed (yet again) but even if they meet the timeline outlined (early 2019) they don't anticipate actually treating a patient till end of 2019! What the heck are they (not) doing to prepare!
2-They are talking about "acquisitions" building their pipeline? Get real they can't do one drug right and they want to acquire? That sounds like it well go well! I have no problem with a small singapore operation to further develop in house technology but don't waste shareholder money in licensing!
They are truly incompetent and it seems they don't realize it. There is no sign of humbleness in accepting their weakness and seeking help (hiring competent people to do the negotiations with payers, R&D people to run proper trials not like the EPP/Vitiligo disasters). Its time for an activist baring that the best hope is on US approval we get a buyout!
Don't know what they'll discuss/answer questions to but I am very disgusted with what I read in both the chairman's comments and the slide presentation. Didn't see a mention of a US filing but some slides on CLVLY so maybe they talk about it?
I posted these on sharescene
Piper Jaffray’s 29th Annual Healthcare 11/28-29
Couldn't find a link to all the webcasts so decided to build one. This is a small subset please feel free to add/update/correct! Some may PR in coming days.
. ADVM: 12:00 11/28 https://event.webcasts.com/starthere.jsp?ei=1172947&tp_key=7c14743a7c
. APVO: 4:00 11/28 https://event.webcasts.com/starthere.jsp?ei=1171432&tp_key=c895f3c113
. AVEO: 10:00 11/28 https://event.webcasts.com/starthere.jsp?ei=1171464&tp_key=a5ad019213
. ATNX: 1:00 11/29 http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-calendar
. BCRX: 3:00 11/28 https://event.webcasts.com/starthere.jsp?ei=1171468&tp_key=c1d7e416b9
. CARA: 11:00 11/28 https://event.webcasts.com/starthere.jsp?ei=1171053&tp_key=8553d3056d
. CCXI: 11:30 11/28 https://event.webcasts.com/starthere.jsp?ei=1171880&tp_key=f71a711b38
. CDNA: 2:30 11/28 http://investors.caredxinc.com/eventdetail.cfm?eventid=186252
. ELGX: 2:50 11/29 https://event.webcasts.com/starthere.jsp?ei=1171882&tp_key=a17513e1b6
. HALO 8:00 11/29 https://event.webcasts.com/starthere.jsp?ei=1171470&tp_key=c8e6d1683c
. HZNP: 11:30 11/28 https://event.webcasts.com/starthere.jsp?ei=1171413&tp_key=701ac80c2e
. INO: 9:00 11/29 https://event.webcasts.com/starthere.jsp?ei=1171411&tp_key=29e07ed4c4
. MTEM: 9:30 11/28 https://event.webcasts.com/starthere.jsp?ei=1171215&tp_key=3ce376224c
. NOVN: 12:00 11/29 https://event.webcasts.com/starthere.jsp?ei=1171950&tp_key=a37e6cbf10
. NUVA: 8:30 11/29 https://event.webcasts.com/starthere.jsp?ei=1171684&tp_key=d7b0629550
. NVUS: 2:10 11/29 http://ir.novustherapeutics.com/events-and-presentations/events
. OXFD: 12:00 11/28 https://event.webcasts.com/starthere.jsp?ei=1172585&tp_key=f5af11806b
. PDLI: 8:00 11/28 https://event.webcasts.com/starthere.jsp?ei=1171460&tp_key=ec703eb232
. REPH: 4:30 11/28 https://event.webcasts.com/starthere.jsp?ei=1171423&tp_key=3139c09c32
. SBPH: 9:50 11/29 http://ir.springbankpharm.com/events-and-presentations/upcoming-events
. SCYX: 1:00 11/28 http://ir.scynexis.com/events-and-presentations
. SGMO: 8:30 11/29 https://event.webcasts.com/starthere.jsp?ei=1172631&tp_key=09e4270225
. SLNO: 12:00 11/29 http://investors.soleno.life/events-and-presentations/event-calendar
. TPIV: 3:50 11/29 https://event.webcasts.com/starthere.jsp?ei=1172662&tp_key=8c2e0f2508
. TTPH: 9:30 11/29 https://event.webcasts.com/starthere.jsp?ei=1171450&tp_key=dda991e4e4
. VCYT: 9:30 11/28 https://event.webcasts.com/starthere.jsp?ei=1171881&tp_key=c596912d41
BMRN / Rare diseases
There is a Biomarin Movie (30 minutes) about the disease/development/regulatory process for Brineura which was approved to treat the CLN2 form of Batten disease. I thought was excellent from just about every aspect. I suspect Biomarin was involved in the making and some may see it as biased, though I think its still worthwhile.
It starts off talking about the disease and the families. Its such a terrible disease that should give some perspective to investors on what the impact is on those with these types of diseases and their families.
It talks a little about how the drug was developed and how the program kept going, then about the filing and regulatory process with some insights I wasn't aware of and how important it was to have patient advocacy for the approval of the drug.
The video is freely available on YouTube
3 R&D Day webcasts tomorrow!
KURA 8:30am ET http://ir.kuraoncology.com/phoenix.zhtml?c=253913&p=irol-EventDetails&EventId=5265699
VYGR 2:00pm ET http://ir.voyagertherapeutics.com/phoenix.zhtml?c=254026&p=irol-eventDetails&EventId=5265483
SCMP 9:00AM ET http://mp163420.cdn.mediaplatform.com/163420/wc/mp/4000/14701/55932/96417/Lobby/default.htm
I made it a twitter poll
https://twitter.com/MauriceOnTW/status/930952779081900034
NKTR:
Yes they said they started enrolling (the sarcoma study) a few weeks ago.
They'll actually have (at least) 4 separate trials with 214 combo reporting data in '18
. PIVOT-02 (combo with Nivo)
. The Sarcoma study (combo with Nivo)
. PROPEL (combo Tecentriq or Keytruda)
. REVEAL (combo with NKTR-262)
The takeda program has some programs with approved agents so something may enter clinic in '18
THere was also a preclinical poster with a cancer vaccine (jbog posted an article)
Also they are looking at combo with other agents
Baker Brothers
Is there a good article on how Julian and Felix got started (initial wealth) and their backgrounds to be able to pick so well? Since everyone seems to follow them would imagine their story has been written.
If someone wants to update/keep track...
RARE gets a PVR for their approval today
http://ir.ultragenyx.com/releasedetail.cfm?ReleaseID=1048901
Ligand Investor Analyst Day (Earlier today)
Slides: http://www.terrapinn.com/conference/world-orphan-drug-congress/index.stm
Webcast: http://www.wsw.com/webcast/cc/lgnd5
Esbriet Long Term treatment / IPF
Just to follow up
Here is one study Roche did on long term treatment (I believe there may be more data but didn't look much for it)
https://www.roche.com/media/store/releases/med-cor-2015-09-29.htm
I think for current IPF investors it is more meaningful to focus on whats going on now.
Roche is testing Pirfenidone with their former IL-13 drug (they kept ILD rights)
https://clinicaltrials.gov/ct2/show/NCT01872689
Also while its general thought the two drugs (Ofev and Esbriet) aren't well tolerated (especially together) both companies have run studies combining them. If developing a new IPF treatment you still wouldn't want to be much worse than the combined drugs. I wouldn't want the argument that yes our efficacy is not quite as good but we're much better tolerated (that sounds like a second line argument to me). Here are a couple links on those studies
http://www.atsjournals.org/doi/abs/10.1164/rccm.201706-1301OC
http://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2017.195.1_MeetingAbstracts.A5398
No I haven't either.
I believe the way it works is the agency decides whether or not they grant it at the time of the filing is accepted. When they file FDA has 60 days to accept the application (basically says its complete and they will review it) or issue a CRL (Complete Response Letter). Along with that they'll designate the review as priority or standard.
Since this company misstates things and tells us little its hard to say exactly what they actually did and when they did it. Until told otherwise I am assuming they did not file but hopefully they did. To me the 60 days after is key I'm more nervous about a CRL at this point and more delays! I would highly expect priority review based on the disease and unmet need alone but with current management there is always the risk they didn't dot their i's.
Jefferies London Healthcare conference 11/15-16
Here is a list of presenting companies and the schedule
http://www.jefferies.com/CMSFiles/Jefferies.com/files/Conferences/111517/2017%20London%20Healthcare%20Conference%20-%20Agenda.pdf
If they don't update the company webcast links here
http://wsw.com/webcast/jeff108/
To get the webcast for the specific company just add the symbol at the end of the above link
e.g. Abeona would be http://wsw.com/webcast/jeff108/abeo
IPF:
I have not seen the paper to comment fully still I think one should NOT read too much into this
1-We already know IPF is a progressive disease and neither approved agent halts progression.
2-Its a rather small study in a HIGHLY variable disease
3-Granted its biased but Roche actually has some much larger datasets on treatment benefit continuing out past 1 year.
With those caveats its interesting ITMN's second study (ASCEND) was designed to be 48 weeks because one of the trials in the first studies (CAPACITY) was significance till that point (and ended up failing badly while the other was stat significant).
I am long FGEN and other companies with IPF interest and was an ITMN long for disclosure.
Thanks for the PR! I had seen the poster
http://www.nektar.com/application/files/4015/1041/9944/NKTR-214__2017SITC_Poster-P434.pdf
but not the PR here is a link for anyone else interested
http://nouscom.com/assets/news/press-releases/Nouscom%20SITC%202017%20PR%20FINAL%2013%20Nov%202017.pdf
Seems they are private still. FWIW Nektar seems interested in very broadly developing 214 with multiple mechanisms (including their own).
NKTR / BMY:
I am probably biased but I agree
Here is the slide deck from the investor/analyst call
http://files.shareholder.com/downloads/NKTR/5526231820x0x963823/31BC81B9-0A4E-468F-81F4-4DC74C2D40AF/NKTR-SITC2017-investor_presentation.pdf
A couple things that stick out all with the caveat of small n's.
1. It would appear some of the CR's happened LATER and some PR's were improving according to the doctors there so the potential to improve response as more scans occurs is not only possible but seemed likely (supported by the spider graphs).
2. The SAE profile would appear possibly BETTER then single agent Nivolumab. They actually gave some rational related to TREG's and different autoimmune diseases which relates to Nektars licensed drug 358. Two SAE's at I believe the .009 included hypotension and didn't catch other case both resolved and patients resumed treatment (at lower dose).
3. There seems excitement about enrolling expansion and sarcoma study. Said 50 patients already enrolled in expansion and Investigator for Sarcoma said thinks it will rapidly enroll after this data.
4. Pointed out 2 PR's in expansion one Melanoma and one in triple negative breast cancer.
A lot to absorb in the call just a few things that stood out.