by DrKSSMDPhD | September 28, 2016 7:28 am
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$AUPH – Aurinia Announces Plans for Single Phase III Clinical Trial for Voclosporin in the Treatment of Lupus Nephritis Following Successful Completion of End of Phase II Meeting With FDA.
http://finance.yahoo.com/news/aurinia-announces-plans-single-phase-204200510.html
OUCH! “The FDA has informed the Company that voclosporin is not eligible for breakthrough therapy designation at this time.”
Long $AUPH
$TLOG sm pos – TetraLogic Announces Agreements to Sell SMAC mimetic and HDAC inhibitor assets to Medivir and to Restructure its Convertible Senior Notes and Delisting of Common Stock http://globenewswire.com/news-release/2016/11/02/886000/0/en/TetraLogic-Announces-Agreements-to-Sell-SMAC-mimetic-and-HDAC-inhibitor-assets-to-Medivir-and-to-Restructure-its-Convertible-Senior-Notes-and-Delisting-of-Common-Stock.html
AUPH gets SPA for ph3! Up AH! Long!
Doc for educational purposes how did you determine that $AUPH got a SPA. I have re-read the press release and see nothing about SPA. Thanks. Long $AUPH.
$GiLD $TSRO $INCY – an interesting article from Barrons speculating on Gilead’s M&A strategy
(11/2)
“Gilead Sciences: Is an Acquisition the Right Prescription?”
Following Gilead Sciences’ (GILD) third-quarter earnings, Citigroup’s Robyn Karnauskas and Mohit Bansal argue that the biotech giant doesn’t need M&A to “work.” They explain why:
Gilead ’s 3Q was a miss quarter with sales in-line at ~$7.5B despite help from $332M onetime items and EPS miss at $2.75 vs. $2.84 cons. However, we see these results as in-line as a bigger miss was expected on HCV as pointed by IMS and also the fact that full year guidance remains unchanged should help very negative sentiments. Key takeaways – 1) First signs of US HCV stabilizing and 2) HIV switch happening faster than our expectations to new treatments, 3) The guidance seems to imply stable 4Q US HCV and declining EU HCV.
Key investor question is if M&A is necessary for the stock to work here: Growth investors believe that M&A is necessary. We believe that for the stock to work from here, the base business needs to stabilize. We suspect that inflection point could come sometime in 2017. Given the uncertainty around HCV, guidance with wider error bars for HCV could help investor confidence, in our view. On M&A, the company noted that they are “disciplined but open minded” and “interested in oncology but not limited”.
http://www.barrons.com/articles/BL-SWB-45358
No position in $GILD, but am holding two stocks which are believed by some as GIlead’s buyout targets: $TSRO and $INCY.
$AUPH
While I am happy for AUPH longs, as doc has pointed out before, one must keep in mind the time frame for this Phase3 study:
“The study is expected to commence in Q2 2017 so the NDA should be filed in mid-2018.”
$TTOO (long) – Q3 Conference Call – Q&A – 01Nov2016 (abridged – much):
Key priorities for marketing/sales: 1) Successful customer implementations 2) Continue to close customer base – driven by impact
of customer success stories (CSS), and endorsements (Allergan and potentially other 3rd party relationships). 3) Prepare for Bacteria launch next year.
Market strategy: 1) CSS significantly impacts adoption rates. 2) Learning lessons (of customers and T2) will drive adoption rates within closed accounts. Saw very nice double digit Q to Q growth from closed accounts – manufacturing issues (and recall) end of June (“which is completely behind us”) impacted growth in Q3 (July and August). Back to steady cadence of growth in September. T2 approach to implementation is priority. [Note: T2 helps with the nuts and bolts of the implementation and therefore is able to help define patient selection criteria (how do you spell upsell?)].
More partnerships coming – cultivating pipeline. Some may be public – others not. T2 is used in clinical trial for patient enrollment in a unspecified trial.
Allergan impact to Bacteria panel changes: 1) separately going to build susceptibility panel for gram negative resistance. 2) Expand bacteria panel which has 6 species on it now. Not expanding in time for launch of bacteria panel – no impact to original timeline. Development in parallel to initial bacteria approval process. Will start building probes for species associated with this contract, enter “some kind’ of an FDA trial – perhaps done in a more limited basis – no timeline on that –won’t see it in 2017 – Won’t hear much but working on both. “We’re not done, so much more opportunity beyond what we are talking about”.
Allergan impact near term on commercialization: 1) Endorsement as valuable as customer success stories. 2) Later, but maybe sooner – Allergan will likely be promoting our products around the world. “Allergan is certainly one of the leading institutions for training hospitals in how to treat patients.” [Note: Fact check – anyone?]. T2 panel is identifying pathogens for Allergan drugs.
Why Allergan – They do effective gram negative therapies like Avycaz that are successful in market and have built a very strong channel (one of the largest in the anti-infective space [Note: Fact check anyone?]. Also mentioned Allergan pipeline as evidence of commitments in gram-negative and gram-positive space. Allergan deal moves T2 into world of susceptibility testing.
Henry Ford seeing an 8 times return on investment relative to price of test (based on reagents only –don’t need to buy an instrument up-front). [Note: Razor blade model but the customer still needs to buy the razor! Wonder what is going on – anyone have any information?].
Closings – Target 150,000 high risk patients in the next 12 months – added just under 50k in third quarter. Running between 30-50k high risk patients per quarter. [Note: Does not jive – 50k this quarter even with manufacturing issue, mentioned earlier that they see steady cadence growth, customer success stories to drive adoption rates, endorsements too – doesn’t add up. Perhaps it is because they are awaiting Allergan (and potentially) others to ramp up?]
Lyme disease diagnostic. Objective to enter pre-clinical next year – sets up clinical trial during lyme season in 2018 (probably).
Candida additional distributors (particulary in Europe): Ahead of expectations. Closed another large hospital in Spain during the quarter. Expects “nice” growth in number of accounts in 2017. Should expect to see more distributors coming onboard.
http://investors.t2biosystems.com/phoenix.zhtml?p=irol-eventDetails&c=253528&eventID=5240339
$TTOO, Thanks for this. According to an article on the earnings call, the bacteria panel is already FDA approved but elsewhere it is said to be approved next year. Are there two different panels here?
wmrw – only the candida panel is approved. But yes – there are 2 bacteria panels being developed- the original targeted for filing in mid-2017 and then a version 2 contract with Allergan – no timeline yet provided.
Hello folks.
I just realised something. I’m relatively new here, so I started reading, made myself an Excel of all the stocks Dr KSS spoke well of, and then jumped in on those where the science and/or management sounded most compelling.
Sounds very reasonable at first glance. But what I didn’t do, and should have done, was wait another 3 weeks (thereby avoiding, coincidentally, the recent general bioplunge) and use that time to organise my list by ripeness.
I bought without reference to how close the positive catalysts were for any given stock. Still happy to be holding each and every one, but now the urge to fiddle is getting stronger by the day. With limited funds, the temptation to sell X and buy a bit more of Y keeps rearing its mischievous head.
I’m going to do my best to sit on my hands and find other ways to keep busy. But I also wondered if one of you industrious gummies had compiled a calendar of upcoming catalysts, or if not yet, whether it would be a useful idea.
Ongoing thanks to everyone for everything,
Best wishes,
Ian
lumpified Here ya go, provided by SoGIam ben
http://www.stockgumshoe.com/2015/04/microblog-biotechmedical-catalyst-calender/
I and most here struggle with the feast provided by DR KSS in great leads for investing. I also have bought in too soon as he is far ahead of any other source I have seen. Relax and savour the feast. frank
Ps; The new search box at top of page works great. Just put in word that pertains to what you seek and hit enter. Refine by name more specific subject etc. Here is another link that may be useful.
http://www.stockgumshoe.com/comment-subscriptions/
You can also enter a name or avatar such as HN or HendrixNuzzles.
Try it.
Thanks arch1…Ian the calendar exist and everyone that has asked has update rights. The updating is the most difficult part. Been updating lately to the thread arch1 linked below.
You may also be interested in the dropbox account that was set up and can be found by searching the ‘guidelines’ thread.
We look forward to your input and sharing. Best2You ~ Ben
Guidelines thread: http://www.stockgumshoe.com/2014/11/microblog-guidelines-for-new-members-posting-rules-and-etiquette/
First steps thread: http://www.stockgumshoe.com/2014/11/first-steps-and-favorite-tools-for-new-investors/
$GILD news NP;
http://www.gilead.com/news/press-releases/2016/9/gilead-terminates-phase-23-study-of-gs5745-in-patients-with-ulcerative-colitis
selonsertib (GS-4997), an ASK1 inhibitor in Phase 2 development for the treatment of alcoholic hepatitis, NASH and pulmonary arterial hypertension.
has also been stopped.
Did they make bad choice with Abzena???
$GNFT, $GNFTF np – http://www.stockgumshoe.com/2015/03/the-great-gallic-foie-gras-hack/ $GILD and no one else can compete with $GNFT in NASH Thank you #ZKSS 🙂
NASH first article by #ZKSS and 1st article on his page http://www.stockgumshoe.com/2014/03/microblog-nash-an-all-too-common-liver-disease-and-a-company-aiming-to-treat-it/
$HALO np – FDA Accepts Genentech’s Biologics License Application For Subcutaneous Formulation Of Rituximab http://www.halozyme.com/investors/news-releases/news-release-details/2016/FDA-Accepts-Genentechs-Biologics-License-Application-For-Subcutaneous-Formulation-Of-Rituximab/default.aspx Significance?
$TRIL getting whipped. No idea why….np.
$TRIL long –
https://pbs.twimg.com/media/CwV4X7zXAAAK-eh.jpg
via @AndyBiotech
Dr. KSS – Thank you for this article. I can’t add to what’s been said, but I know you are much more appreciated than you could possibly know. You are an exemplary person.
I’m traveling today, but hope the conference call is followed by a synopsis. Long $PTN
jokin
SUCH A PLEASANT STAY http://www.stockgumshoe.com/2016/11/such-a-pleasant-stay/
Move it or lose it 🙂
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