watching biotechs, gold & silver
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Another SLE failure- "Sanofi’s Ablynx reports PhII lupus flop"
https://endpts.com/failed-again-sanofis-ablynx-reports-phii-lupus-flop/
and this one from January 2018
"Xiidra®* (Lifitegrast Ophthalmic Solution 5%) Approved by Health Canada To Treat the Signs and Symptoms of Dry Eye Disease"
"Canada approval represents Shire's first international market authorization for Xiidra outside of the United States."
VOS should be a lock in Canada
https://globenewswire.com/news-release/2018/01/03/1281454/0/en/Shire-plc-Xiidra-Approved-by-Health-Canada-To-Treat-the-Signs-and-Symptoms-of-Dry-Eye-Disease.html
I like this DES story from October 2017
"Restasis is Allergan’s largest drug other than Botox, with sales of $1.49 billion in 2016 and $676.4 million in the first six months of 2017, regulatory filings show. Shire has said Xiidra sales totaled $96 million from January to June."
I'm thinking this means Merck, Shire, and Allergan are naturals to bid on VOS.
https://www.reuters.com/article/legal-allergan-shire-dryeye/shire-sues-allergan-in-u-s-over-dry-eye-drug-idUSKCN1C727Q
Luna, thanks for the feedback. Sounds excellent.
Couple more questions:
1. VCS chemistry question: Re the "reverse effect" seen in AURA where the LD outperformed the HD; I know VCS is more potent than cellcept, but wonder if the combination of the two drugs could create an interaction that could cause that? Is the effect a concern or ???
2. Have you looked at Retrophin (RTRX) science re their FSGS drug?
Thanks again
Luna, Jess, others- Do you think "tolerability" is enough to get a bid from BP for their DES program?
"Aurinia also plans to begin a Phase IIa tolerability study of VOS versus the standard of care for the treatment of DES by the second quarter of 2018, with data available in the second half of 2018. Calcineurin inhibitors are a mainstay in the treatment for DES, and the goal of this program is to develop a best-in-class treatment option."
(above from Q4/Full Year 2017 AUPH report)
"5 Big Biotech Stocks to Buy Under $10
Small biotech stocks can pack a wallop"
"Big Biotech Stocks to Buy Under $10 #4: Aurinia Pharmaceuticals (AUPH)"
https://investorplace.com/2018/03/5-big-biotech-stocks-buy-10/?sid=A6N816&cp=IPIE&ct=20180320&cc=eletter&en=5581793&auth=nonbuyer&cpp=IPIE&enn=5581793&num=01
"2nd half of this year could get really interesting."
Hoping that is a severe understatement!
If somehow VCS could actually repair kidney damage, all of the current valuation models become shredded.
Very exciting times for AUPH- hope they are rewarded as financial gain aside, what a boon and hope for the sufferers of these illnesses.
a little more from that Q3 2017 Q&A:
Joseph Schwartz: "And then last one from me, in terms of the long-term goal of FSGS, how should we think about in terms of kidney function, is it stabilization that should be looked at or more improvement of the kidney function?"
Richard Glickman: "You know, that's a really fair question and then Rob I will let you jump in on that, but you know in listening to Dr. Tumlin [ph] at [indiscernbile] where he gave his presentation, he really does believe that you can see some regeneration at the podocyte level and the improvement in performance of kidney function as a consequence of podocytes being protected. But do you want to add to that Rob?"
Robert Huizinga: "Certainly, I think breakthrough into lupus nephritis in the short term we are looking for stabilization of renal function, but Rich made a really important point that these are all podocytopathies and we know from more recently that's come out this year that if you are able to interact on the pococyte directly soon you may actually be able to see repair of that podocyte. So that's an encouraging long term view for us"
Thanks. Please keep the board posted on your thoughts on Aurinia. Always appreciate your knowledge and insights.
cheers
Unless they've recently changed the trial- it's monotherapy- (VCS alone).
The following is from a transcript from the Q&A part of the Q3 2017 earnings call.
This is a followup question from analyst Joseph Schwartz re the FSGS trial:
"And is there any reason to believe that since you are including corticosteroid free patients into your open label trial, if you were to have patients on a concurrent immunosuppressant therapy that there would be any drug-drug interaction and are you including any patients that are on immunosuppresant therapy at baseline?
Response from Robert Huizinga: "The plan for the study is voclosporin monotherapy, so it is just voclosporin on its own. So any patients that are on other immunosuppressants coming into this treatment period would have to stop those other immunosuppressants to be cleared of those before they could be entered into the study."
Response from Richard Glickman: "I also want to comment and you are dealing with these diseases that are really part of cytotophies [ph] and I think when you really look at the mechanism of action of voclosporin, I think one of the things that excites me most is that dual nature, at first people were actually concerned of the dual nature of voclosporin, one being an immunosuppressant and reducing- in IL-2 and T-cell activation, but the other being its direct impact on the podocyte. And I think that combination gives us potential for a really quick response on that disease, but also over time a real impact on the disease from a immunological perspective. So I think it is exactly an ideal type therapy for FSGS and minimal change disease."
"Lupus nephritis remission predicts long-term renal survival"
They are using a test developed by Dr. Glickman's team at Aspreva.
https://www.healio.com/rheumatology/lupus/news/online/%7B01997c2b-b6b0-4753-ac31-9e03243db3db%7D/lupus-nephritis-remission-predicts-long-term-renal-survival
Luna, question for you re FSGS trial-
It's intriguing to me that this trial is monotherapy vs. VCS layered on top of cellcept & steroids.
I've wondered what kind of efficacy VCS would have as a standalone so now wonder if this trial will give some clues regarding that.
What do you think?
Thanks in advance for any response.
Correct. It's dated March 28, 2017. I posted it because I think it's relevant to the query to Luna from Jess.
I'm thinking that in 8 weeks of VCS for FSGS, something valuable can be learned.
Looking forward to what Luna has to say.
"Aurinia Says Biomarkers Help Predict Response to its Voclosporin Therapy for Lupus Nephritis"
The team also found that a 25 percent reduction in UPCR after eight weeks of treatment predicted a good outcome in kidney response at 24 and 48 weeks. On the other hand, if proteins C3 and C4 (which are low in LN) were not at normal levels by week eight, a positive kidney response at later points in the study was very unlikely.
“Results from AURION demonstrated that an early UPCR reduction of 25 percent is the best predictor of renal response at 24 and 48 weeks,” Neil Solomons, MD, Aurinia’s chief medical officer, said in a news release. “In addition, the use of C3 or C4 improves the precision of predicting if a patient will achieve a clinical response. This exploratory study is supportive of the successful AURA Phase 2b study and continues to inform us of optimal ways to evaluate renal response in future LN trials.”
https://lupusnewstoday.com/2017/03/28/lupus-nephritis-resonse-voclosporin-therapy-predicted-biomarkers-aurinia/
"...we should know sooner rather than later with data coming out this year."
That fact makes me wonder why the 11% of the float that is short seems so blase re covering here. What are they waiting for?
Wondering if the major holders playing this both ways are indifferent since they're using it as a hedge.
If somehow all 3 indications succeed, this could likely be at least a 10 bagger from here, as Restasis sales alone are at a $1B+ run rate. If VOS proves superior, I think Aurinia sells it or partners it for a big number.
"This will be just as big as LN if it works: "
Mike says, "FSGS a nice indication. 40k US prevalence, ..."
I think LN is something like 200K+ in USA, so how could it be as big?
I think a bonus of the FSGS upcoming trial is that AUPH will be getting interim looks, which may indicate something about their P3 in LN.
I love Lucy!
R@Lucy3370
4h4 hours ago
$auph Glickman has been dropping little hints of what he knows about the ph3 trial without coming out & saying. Language has changed 2 done w/LN enroll 4th QTR vs EOY. I also picked up on him talking bout DSMB in CC on constant monitoring & no safety issues. All is going well
another interesting comment from Lucy:
R@Lucy3370
18h18 hours ago
R Retweeted Tom Silver
$auph What jumps out in Leerinks comments is the $14 PT is only for LN. Said there could b significant upside IN THE NEAR TERM if FSGS or DES programs show supportive data
Aurinia Pharmaceuticals' (AUPH) CEO Richard Glickman on Q4 2017 Results - Earnings Call Transcript
https://seekingalpha.com/article/4156960-aurinia-pharmaceuticals-auph-ceo-richard-glickman-q4-2017-results-earnings-call-transcript?part=single
Can it crack the $6 wall today?
@YVR_Trader
35m35 minutes ago
As soon as $AUPH hits 5.98 a big dump of shares appear.....they will eventually run out of shares then its (graphic of 3 rockets blasting off)
lido, what is the gist of the article and implications for AUPH?
I don't have PRO so can't read it.
Thanks in advance.
Thanks! Love the sound of it- onward and upward from here hopefully.
"(“many interested parties”)" And we know it's on the level because Dr. Glickman has that elusive quality (in bio-land anyway) of credibility.
1st class organization all the way!
Also like the sound of this:
KSS, MD, PhD
@KSSMDPhD
$AUPH: Cantor Fitzgerald reiterates overweight and raises PT to $16. #voclosporin AURORA may complete enrollment by 4Q18.
Maybe you should cheer up. I like this argument:
R@Lucy3370
21m21 minutes ago
$auph Many folks think they have plenty of time 2 get in cause ph 3 results not til nxt yr. now u have other programs. Someone’s gonna buy Auph & many folks going to regret not getting in
The conference call and webcast is scheduled for March 15, 2018 at 4:30pm EST. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events” through the “Investors” section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.
Hilarious! cheers
I guess I could ask if my pledge to LivingTheDream ("don't rock the boat") has an expiration date.
I hate to disappoint a fellow Red Sox/Patriots fan.
Maybe the pain forged from the crucible of being a follower of New England sports teams for decades has clouded my thinking on this subject.
Another factor could be my relatively short history/experience while you and others here are seasoned veterans.
Thanks for your well intentioned advice.
Interesting AUPH comment from SA article ("Altum Is Launching Biotech Insider") touting birth of new bio publication.
"The forgotten IPO is everywhere in biotech, but usually comes after a questionable P1 or P2 where the data is simply not compelling enough to hold shares for multiple years, waiting for that fateful Phase 3. These companies tend to slide downwards in price until their catalyst comes closer. While not an IPO, Aurinia pharmaceuticals (AUPH) is a good example. The company had posted excellent data for Lupus, but has since lost about half of its value since then due to a very long time line for completion of its phase 3."
https://seekingalpha.com/article/4155521-altum-launching-biotech-insider
That's a tough situation! The ability to take things seriously but not ourselves too seriously is a wonderful gift. I like to hope and never give up, even when it seems hopeless. He did seem to appreciate the humor of the past carbuncle episode, so just maybe....
BR....maybe lighten up a little- it's just joking around
(but there's always at least a tiny element of truth to jokes)
I'm sure if you step back just a bit you can appreciate the comedic expression.
What a difference a year makes!
Fundamentals are stronger, yet we're at $5
Looking forward to the future reversal
Mar 14, 2017 8.03 8.60 7.65 7.90 7.90 38,892,100
Mar 13, 2017 8.70 10.54 8.55 10.54 10.54 39,105,700
"I’ll have to ponder that one for awhile.."
Not necessary- here's the answer:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=136222080
"... generic response that was for colonoscopy results..."
Not really, it's about the danger of loss of credibility in the trial results due to bias. Here is what the FDA says about the same subject:
"Knowledge of unblinded interim comparisons from a clinical trial is generally not necessary for those conducting or sponsoring the trial; further, such knowledge can bias the outcome of the study by inappropriately influencing its continuing conduct or the plan of analyses. Unblinded interim data and the results of comparative interim analyses, therefore, should generally not be accessible by anyone other than DMC members or the statistician(s) performing these analyses and presenting them to the DMC (see id.). "
And also:
"We recommend that any part of the interim report to the DMC that includes comparative effectiveness and safety data presented by study group, whether coded or completely unblinded, be available only to DMC members during the course of the trial, including any follow-up period—that is, until the trial is completed and the blind is broken for the sponsor and investigators. If interim reports are shared with the sponsor, it may become impossible for the sponsor to make potentially warranted changes in the trial design or analysis plan in an unbiased manner"
https://www.fda.gov/RegulatoryInformation/Guidances/ucm127069.htm
It appears that Aurinia is using a far higher standard than the other biotechs you reference, so you may want to make inquiries and investigate why that is the case.
Is this relevant to your question?
"In order to preserve the integrity of a trial and safeguard the interests of patients, interim data, including complete data on short-term outcomes, should remain confidential to the DMC and the statistical group responsible for preparing interim reports until the trial has achieved its primary objectives."
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2703711/
"...it will not be from the AURORA p3 trials."
Not directly, but we could get news re quicker enrollment than expected, which might provide a boost.
"In Two Months, Biotech Startups Raised More Money Than In All Of 2013"
"In the year-to-date, venture capitalists have poured $2.8 billion into biotechnology startups. That means that in the first two months of 2018, venture capitalists have invested more in biotechnology firms than they did in all of any year before 2014."
"In 2013, the VC community spread $2.4 billion among 287 companies. The $2.8 billion spent in two months of 2018 went to just 60 start-up firms."
https://www.forbes.com/sites/matthewherper/2018/03/05/in-two-months-biotech-startups-raised-more-money-than-in-all-of-2013/#42bc24b27be7
It appears that biotech is heating up, which I'm thinking can't hurt us.
"I hope you didn’t take my post as argumentative or confrontational.."
Never! You rank among the best of the best here!
I appreciate different views- I like to argue with people (to my wife's chagrin, as I get lectured by her [lovingly] quite frequently).
The way I look at it, It's a learning opportunity for me when people disagree with me- my goal is simply to try to ascertain what is the truth of the matter in question. I've found it's true that knowledge is power. It seems I don't learn as much when people agree with me, so the value of seeing other sides intrigues me.
Feel free to differ with me anytime as you're actually doing me a favor. No worries my friend.
Have a good one!
Luna, thanks for your feedback. As a human myself, my impression of AF could easily be wrong. I had thought the accusations re AF being a short were sour grapes. I need to check out the current situation you described re NVAX.
Thanks for the heads up on this.
"AF is a massive FUDster himself..."
I find him a very interesting character in the world of biotech. Very bold, brash, controversial but also thoughtful and intelligent with the ability to express himself well.
He certainly makes a lot of enemies as he has no qualms about absolutely skewering bio bigwigs (CEO's) that he thinks are committing treacherous acts against shareholders. He's part of a rare breed.
He's also very human as well- he was way off the mark on ARIA as you and others here well know. I like the fact that he reviews his biggest blunders at the end of every year as I don't see a lot of people who admit when they are mistaken- it's somewhat refreshing.
I know a lot of AUPH holders probably hate him as well for his series of tweets that you referenced during their fundraising last year, but I think Adam got it right despite the offering being 36% below the close of $10.54.
I still believe that gift opportunity given to the institutions is what created the massive jump in short interest (still very sizeable)- they couldn't possibly lose by shorting right after the offering.
I liked these tweets from that series:
"When $AUPH day traders become $AUPH shareholders…
Relax, you own a good company.
2:08 PM - 13 Mar 2017"
"Yes. Long-term, fundamental investors buying $AUPH deal aren’t paying a premium for your momentum-fueled trading.
3:46 PM - Mar 13, 2017"
"$AUPH upsized its offering to 22.3M shares. Priced at $6.75. Brings in $150M.
Excellent work, guys.
7:02 AM - Mar 14, 2017"
Luna- Thanks for all your insights and input
Hope all is well with you and yours