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GLPG:
As you suggested it seemed at least a possibility that GLPG may get FDA to reconsider the 200mg dose perhaps even before the start of the Phase 3 with more (EU) patients exposed or perhaps a 150mg daily dose. This from the F-1
In addition, there may be dose limitations imposed for male patients that are prescribed filgotinib, if approved. In connection with the DARWIN clinical program, we agreed with the FDA to exclude the 200 mg filgotinib daily dose for male subjects; males will receive a maximum daily dose of 100 mg in the U.S. sites in these trials. This limitation was not imposed by any other regulatory agency in any other jurisdiction in which the DARWIN clinical program is being conducted. We agreed to this limitation because in both rat and dog toxicology studies, filgotinib induced adverse effects on the male reproductive system and the FDA determined there was not a sufficient safety margin between the filgotinib exposure at the no-observed-adverse-effect-level, or NOAEL, observed in these studies and the anticipated human exposure at the 200 mg daily filgotinib dose. Accordingly, in connection with the DARWIN clinical program, in the United States, male subjects are recruited in the up-to-100-mg-daily-dose groups only. Male participants in those groups and their partners are required to use highly effective contraceptive measures for the duration of the study and during a washout period thereafter. As an additional safety measure, we monitor clinical laboratory changes in hormone levels for subjects in the DARWIN clinical program.
After the conclusion of the DARWIN dose-finding clinical program, we intend to discuss with the FDA the inclusion criteria for male subjects in any Phase 3 clinical trial for filgotinib. We expect these discussions will be supported by clinical data from the DARWIN clinical program (including data from male subjects treated with the 200 mg daily dose of filgotinib outside of the United States) as well as recently generated pre-clinical data that we believe demonstrates that the safety margin between filgotinib exposure at the no-observed-adverse-effect-level, or NOAEL, and the anticipated human exposure for doses between 150mg and 200mg meets the margin as requested by the FDA. However, even if filgotinib does receive regulatory approval or marketing authorization, the FDA or other regulatory authorities may impose dosing restrictions that differ from the approved dosing regimen in other jurisdictions.
GLPG:
It seems they upsized their offering.
http://www.renaissancecapital.com/news/natural-(stock)-selection:-galapagos-increases-proposed-ipo-deal-size-by-25-31405.html
The Mechelen, Belgium-based company now plans to raise $250 million by offering 6.0 million shares at $41.52, its closing price on Friday. The company had previously filed to raise $200 million by offering 4.7 million shares at $42.43. Galapagos will raise 25% greater proceeds than previously anticipated.
GILD (possible acquisitions):
They seem to have an interest in lung diseases with a few private company acquisitions of late and though it wasn't their best deal Myogen a while back.
UTHR and Actelion always get mentioned a lot probably because they are mature and perhaps nearing peak sales (but I've thought that for a while).
It seems to me GILD likes to acquire earlier (I believe a few of the private companies were still P2 assets). Along those lines as a dark horse speculation I wonder if they would consider a company like FGEN which could bring them into a few bigger areas though not the near term revenue potential.
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 Credit Suisse's Antibody Day
14th Annual Needham Healthcare Conference
4/14-15
http://wsw.com/webcast/needham71/
2015 Bloom Burton & Co. Healthcare Investor Conference
5/4-5
http://www.bloomburton.com/conference/
Credit Suisse's Antibody Day
5/6
http://cc.talkpoint.com/cred001/050615a_ae/
Deutsche Bank 40th Annual Health Care Conference
5/6-7
http://edge.media-server.com/m/s/ane28ds2/lan/en
Baird Growth Stock Conference
5/5-7
http://www.rwbaird.com/ci/conferences/Growth_Stock/1?isPreview=False
Bank of America Merrill Lynch Healthcare Conference
5/11-14
UBS Global Healthcare Conference
5/18-20
http://www.ubs.com/global/en/investment-bank/key-investor-conferences/global.html
http://ubsiconf.dealogic.com/iConference2/Conferences/Custom/List/180?menuItemId=100
BioEquity Europe
5/19-20
http://www.biocentury.com/conferences/bioequityeurope/dates
Jefferies 2015 Global Healthcare Conference
6/1-4
http://wsw.com/webcast/jeff88/
William Blair Annual Growth Stock Conference
6/9
Goldman Sachs Healthcare Conference
6/10-15
BIO International Convention
6/15-18
JMP Life Sciences Conference
6/23-24
http://wsw.com/webcast/jmp27/
Rodman & Renshaw 17th Annual Global Investment Conference
9/8-10
http://www.meetmax.com/sched/event_30869/~public/conference_home.html?event_id=30869
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aTyr Pharma:
Just watched the presentation on retail roadshow:
http://t.co/LQQHgoHz8L
Their website is:
http://www.atyrpharma.com/
They are early stage but seem like an interesting company. They are focusing on Physiocrines in the areas of muscle and lung. They currently have a program in a rare form of muscular dystrophy called facioscapulohumeral muscular dystrophy (FSHD).
From the presentation what I found interesting it seems they have the potential to stop early fibrosis so I imagine IPF will be a future focus.
Please delete duplicate post
I've had a position since the Tranzyme days. The current price is making me consider adding I agree with your statement about the enterprise value being too cheap. Plus with Horizon-Hyperion deal and not advancing that drug into HE. I think they do a deal at some point too (before financing) just not sure how good it will be unless they sell the whole company.
For what its worth I took advantage of the recent weakness in FGEN and took a position today. I'd like to add more but at lower prices. In terms of *magic molecules* I actually like their anti-fibrotic, FG-3019, longer term (100% owned potential in multiple large orphan indications) more than Roxadustat realizing that the majority of the current value is still in that.
I actually have a few more names on my shopping list to either take positions and/or add. Here are some on my list if anyone is interested. If others have lists I'd be curious to see as well.
CLVLY
CNAT
ITEK
MRNS
NKTR
OCRX
For time being No more quarterly conference calls too :( though if have an important event/announcement will.
I believe they said they were at ~60 centers enrolling at the beginning of the year and now at ~90 and most of European ones are now enrolling so I'd imagine good chance to improve from ~10/month enrollment.
Talked about encouraging conversations with partners for IV (Interested in keeping US though).
Is EKSO Bionics On The Verge Of A Major Marketing Campaign?
http://seekingalpha.com/article/3120886-is-ekso-bionics-on-the-verge-of-a-major-marketing-campaign
and here is the link to the Wired Story
http://www.wired.com/2015/04/try-new-exoskeleton-construction-workers/
East Bay wearable robot maker targets industrial workers and aging consumers (Video)
http://www.bizjournals.com/sanfrancisco/morning_call/2015/04/ekso-bionics-wearable-robot-exoskeleton-angold.html?ana=twt
The wearable robot that helps people walk again
http://www.cnbc.com/id/102630872
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 DB link, Added JMP Conference
14th Annual Needham Healthcare Conference
4/14-15
http://wsw.com/webcast/needham71/
2015 Bloom Burton & Co. Healthcare Investor Conference
5/4-5
http://www.bloomburton.com/conference/
Deutsche Bank 40th Annual Health Care Conference
5/6-7
http://edge.media-server.com/m/s/ane28ds2/lan/en
Baird Growth Stock Conference
5/5-7
http://www.rwbaird.com/ci/conferences/Growth_Stock/1?isPreview=False
Bank of America Merrill Lynch Healthcare Conference
5/11-14
UBS Global Healthcare Conference
5/18-20
http://www.ubs.com/global/en/investment-bank/key-investor-conferences/global.html
http://ubsiconf.dealogic.com/iConference2/Conferences/Custom/List/180?menuItemId=100
BioEquity Europe
5/19-20
http://www.biocentury.com/conferences/bioequityeurope/dates
Jefferies 2015 Global Healthcare Conference
6/1-4
http://wsw.com/webcast/jeff88/
William Blair Annual Growth Stock Conference
6/9
Goldman Sachs Healthcare Conference
6/10-15
BIO International Convention
6/15-18
JMP Life Sciences Conference
6/23-24
http://wsw.com/webcast/jmp27/
Rodman & Renshaw 17th Annual Global Investment Conference
9/8-10
http://www.meetmax.com/sched/event_30869/~public/conference_home.html?event_id=30869
--
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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GLPG / ABBV:
The F-1 contains more disclosure on the royalty rates with ABBV on both filgotinib and the CF partnership
GLPG0634 (filgotinib) royalty from F-1 "ranging from the low double digits to the lower twenties on net sales"
CF royalty from F-1 "mid-teens to twenty percent on net sales of licensed products payable on a product-by-product basis."
GLPG / ABBV:
Galapagos’ JAK1 inhibitor filgotinib (GLPG0634) meets primary and
other key efficacy endpoints after 12 weeks of treatment in DARWIN 1
Phase 2B study in moderate to severe rheumatoid arthritis patients
? ACR20 scores up to 80% at 12 weeks
? Statistically significant ACR50 and DAS28(CRP) scores with all doses
? Patient-reported improvements observed after one week of treatment
? Safety profile is consistent with previous filgotinib RA studies
ARIA:
Thanks for posting the link! I thought this quote (if true) was noteworthy.
three people close to events at Ariad said board members have been in active talks among themselves and with Berger in recent weeks, and some directors have sought to negotiate a settlement under which the chief executive would step down.
My guess is a reaction to the NEJM article/letter on DMF and PML that there may be longer term use risk and seeing patient lymphocyte counts may not be enough to reduce risk. A lot of analysts defend BIIB and it was even up a little on the day.
ABBV / GLPG / ABLX:
GLPG will report 12 week RA data this month (Darwin 1) then shortly there after 24 week data from Darwin 1&2 then Abbvie has to make a licensing decision. I believe the terms of the deal are if the Phase 2b meet a certain set of criteria (based on 24 week data) then Abbvie will license and pays a $200 million fee (along with P3 development and double digit royalties).
I imagine for Abbvie its worth the dollars to move both forward as long as the data is good (plus GLPG is oral).
I agree on Kimbrel being worth more but that was the price to eat Upton's contract. I read Maybe has 2 years 15 mil and Quentin 1 year 8 mil (and reports were Braves were considering releasing him). Upton was owed 46m+ over the next 3 years so the Braves save about 23 mil and more importantly get rid of the Wren albatross. I think the Markasis signing was early when they figured they would only partially dismantle the team .... I am just a little surprised they didn't trade Freeman.
I saw a mention that Paroubeck is a gamble could be very good (I think the tweet said raw talent) or could be a bust.
Maybin might be OK but I don't consider him someone to build around. Reading up on Wisler he may be a 2-3 type but Kimbrel was probably not just the best relief pitcher in baseball but had a relative bargain contract remaining. I think he should have garnered at least 3 top prospects. I guess that is the price to eat Uptons bad contract
The Upton deal killed us! I don't know what Wren was thinking when he signed him to such a long contract. Clearly the Rays knew he was in decline (and his stats showed it too). IMO this is the end of the Wren Era with getting rid of the Upton Albetros! Too bad it cost us Kimbrel. I fully expected they would trade kimbrel but I thought they would try to get a nicer package of prospects and eat Upton's contract for another year or two before releasing him maybe around the trade deadline a contender who had closer issues would have given them a lot. Given the Braves plan I think it was prudent to get something for Kimbrel rather then risk an injury (though he has never had arm problems) just would have liked to see more for him! The one pitcher is supposedly a top SD prospect but I would rather had a package of all prospects (and eat Melvin/BJ's) contract rather then a couple of mediocre outfielders and one or two good prospects.
I'm still ever the optimist and think the Braves may surprise some people they've loaded up with pitching prospects just like they did in the late 80's early 90's.
Wow to get someone to eat Melvin (BJ) Upton's contract the Braves trade Kimbrel. Not all the details out but looks like Maybin, Quentin and prospects
With SP going so few innings and the 5 man rotation I am really surprised MLB hasn't gone to a 27 or 28 man roster several years ago! I know its probably the salary issue even though these 26-28th men like would be very low salary (except for the big spenders of course ).
OCRX:
I think it was BMO that had a note that said the upsizing in the trial would increase the power. I am not a stats guru but if the effect size is smaller unless they increased the n significantly more than necessary I don't see how the power could be higher.
I didn't notice any mention of it in the press release so I don't know if its sloppy analysis or they talked to management.
I don't have the report I got thanks to a tweet by @dougheuringaria who is a great follow for information!
https://pbs.twimg.com/media/CBlZQRBVEAIL_rk.jpg:large
SRPT:
Here is the link to the Company PR:
http://investorrelations.sarepta.com/phoenix.zhtml?c=64231&p=irol-newsArticle&ID=2031244
Here is the link to the CC (8am ET 4/1)
http://edge.media-server.com/m/p/58ajbpxx/lan/en
Here is a link to page 2 (second last paragraph) of a (somewhat) relevant story by whom I hope is the next CEO:
http://www.weeklystandard.com/articles/failing-ris-challenge_819713.html?page=2
I don't recall Astrue discussing FDA interactions while CEO at TKT. In my opinion I believe here as a public figure he was being more critical.
In IPF, it seems likely that the Fibrogen drug works only in a subset of patients (maybe 25%), but when it does work, it works really well. So that complicates trial design some, and if you add another drug in combination things get even more complex.
Perhaps IPF is actually a bunch of different diseases with some common symptomatology, or perhaps there are some genetic differences.
FGEN:
Thanks for the reference to the correlation between HRCT and FVC.
I was thinking more if they decide to either go head to head or in combination with Esbriet and/or Ofev. A comparison with HRCT may be more favorable then relying on FVC alone where both drugs have shown benefit. I don't know much about nintedanib but I don't believe pirfenidone has ever been shown to have improved fibrosis (aside from anecdotal cases).
FGEN:
Do you think FDA would accept improvement/less worsening in Fibrosis (as compared to SOC) via HRCT as a valid endpoint in IPF? I recall FDA didn't like FVC at first with Intermune (when CAPACITY results were presented at the panel). It would seem to me HRCT would be a more accurate measure of effect on the underlying disease.
FGEN:
Just speculating the way the question was answered seemed they need to check with the partner to do something more than just disclose whether or not there was an interim analysis.
I have no position but have been considering one even at this level. I still find the potential of 3019 very interesting not just in IPF but perhaps some other fibrotic indications but realize I have to all but assume success in the anemia.
My Picks
Winner of AL East: Blatimore
2nd In AL East: Toronto
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: Houston
AL Wildcard #2: Detroit
Winner of NL East: Atlanta
2nd In NL East: Washington
Winner of NL Central: St. Lous
2nd In NL Central: Cincinnati
Winner of NL West: Los ANgeles
2nd In NL West: San Diego
NL Wildcard #1: Miami
NL Wildcard #2: San Diego
Team With Best Record In Baseball: Atlanta
Team With Worst Record In Baseball: Philadelphia
TB # 1: Who hits the most HR in Baseball (Combined): Jose Abreu
TB # 2: Who has the Most RBIS in Baseball (Combined): Freddie Freeman
AAVL:
Ohad took a position in his model portfolio but acknowledged it as high-risk, high-reward.
http://www.orf-blog.com/will-2015-mark-the-turnaround-for-antibody-drug-conjugates/#comments
I wonder how a basket of these high-risk, high-reward stocks will do. No position in AAVL though I do own one high-risk, high-reward that has been discussed on this board of late .
GLPG:
Thinking of a US IPO, " depends mainly on the results of a large-scale RA study"
Thanks to V.S. Schulz @portefeuillefun
http://fd.nl/ondernemen/1097952/galapagos-wil-mogelijk-beursintroductie-op-nasdaq
Via Google Translate so may contain translation errors
That writes the Belgian business daily De Tijd Wednesday. Or the IPO actually continues, according to the newspaper depends mainly on the results of a large-scale RA study conducted midkapper Galapagos. Those results are expected to be announced in mid-April.
CEO Onno van de Stolpe, Galapagos made his ambitions known at a conference of KBC Securities, which was attended by thirty investors. Van de Stolpe Wednesday was not available for an explanation, but a company spokesman told the business daily that the IPO "one of the options." Time also writes that pharmaceutical company AbbVie be interested to take over Galapagos.
No mention of Viekira Pak. I tried to find the FDA release but haven't yet. Andy did tweet this graphic.
https://pbs.twimg.com/media/CAnczkvUIAE8D0K.jpg:large
Someone noted on the thread if its limited to the use with amiodarone this would be very rare where it would provide a clinical hurdle (i.e. where no alternative could be used)
Edit:
Here is the link to the Dear Doctor letter (Word Doc)
http://t.co/Riqi31OfRF
Thanks to Meg Tirrell @megtirrell
Additional Slides posted by @AndyBiotech
https://pbs.twimg.com/media/CAns_t_UIAEG0d1.jpg:large
https://pbs.twimg.com/media/CAntB8pVIAEcmVS.jpg:large
Andy Biotech @AndyBiotech always on top of things with an interesting tweet
Whoa-> $GILD Sovaldi/Harvoni Label Change due to Symptomatic Bradycardia & One Case of Fatal Cardiac Arrest Reported w Coadmin of amiodarone
Measuring Dystrophin in Dystrophinopathy Patients and Interpreting the Data
Just started webcast link:
https://collaboration.fda.gov/dystrophinopathy
Schedule:
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM438637.pdf
BioCentury Future Leaders Webcast Link for today (3/20)
http://www.biocentury.com/conferences/futureleaders/dates/schedule
With RTRX's raise and what they reported in their 10-k I don't think they are selling as fast as before.
The company had a couple PR's this AM (Australia Time). One was publication in a peer journal:
http://www.asx.com.au/asxpdf/20150320/pdf/42xdp2rdpnwprf.pdf
Luger TA & Bohm M (2015). “An a-MSH analogue in erythropoietic
protoporphyria”. J Inv Dermatol. 135:929-931.
Full text online at http://www.nature.com/jid/journal/v135/n4/full/jid201516a.html
Another was in regard to presentations at the AAD meeting
http://www.asx.com.au/asxpdf/20150320/pdf/42xdp7v368r4b6.pdf
They also filed a form on Share Awards (I think the Wolgen gets a bonus on first commercial sale):
http://www.asx.com.au/asxpdf/20150320/pdf/42xdvlr1qqk2zt.pdf
2015 Regen Med Investor Day
http://arminvestorday.com/webcast/
3/25 8am ET