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CLVS: Here's the CNBC interview with the CEO Patrick Mahaffy. (They cut off the last part of the interview)
http://video.cnbc.com/gallery/?video=3000280706&play=1
"We do not cause diabetes"
"Game of Shorts" occurred over the weekend.
That's what Clovis CEO said on CNBC just now. Yes, he went there
https://twitter.com/jodigralnick/status/473564229199757313/photo/1
https://twitter.com/search?f=realtime&q=%24clvs&src=typd
Dirk and Adam arguing about Clovis and Adam's article. Adam makes a reference to Yahoo message boards
Dirk Haussecker ?@RNAiAnalyst 4h
After ASCO, wouldn't $CLVS be 1 step closer to blockbuster approval? Is market failing to see forest for the trees.
Steve Musolino Jr ?@stefanomjr 4h
@RNAiAnalyst seems there is a media bias towards $AZN - but then again I've put my money on $CLVS - so there's that....
Dirk Haussecker ?@RNAiAnalyst 4h
@stefanomjr Journos don't want to cross Big Pharmas for fear of losing a big scoop down the line. Easier to go against the small guys. $CLVS
Adam Feuerstein ?@adamfeuerstein 2h
@RNAiAnalyst @stefanomjr Dirk -- stupid comment.
Dirk Haussecker ?@RNAiAnalyst 10m
@adamfeuerstein @stefanomjr Then why are u+ @matthewherper calling data a draw, but value-wise loss to $CLVS and win for $AZN? #makesnosense
Adam Feuerstein ?@adamfeuerstein 3m
@RNAiAnalyst you're bright guy so accusing bright, diligent journos of conspiring for Big Pharma is beneath you. I expect it from msg brds.
MNTA receives orphan status for pancreatic cancer treatment
http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=433314
MNTA receives orphan status for pancreatic cancer treatment
http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=433314
I am surprised that there haven't been any comments.
Two takes on the CO-1686 results:
First by Adam Feursetin:
http://www.thestreet.com/story/12728916/1/clovis-lung-cancer-bravado-falls-flat-with-new-diabetes-revelation.html?puc=yahoo&cm_ven=YAHOO
Clovis' Lung Cancer Bravado Falls Flat With New Diabetes Revelation
Clovis Oncology's (CLVS_) lung cancer drug CO-1686 is turning patients into diabetics.
"Three or four" lung cancer patients in the ongoing phase I/II study of '1686 are now taking insulin to control hyperglycemia (high blood sugar) caused by the experimental drug, Clovis CEO Pat Mahaffay told a roomful of investors and analysts on Saturday night.
The new disclosure ratchets up the seriousness of the link between '1686 and hyperglycemia and should raise more investor concerns about the drug's tolerability. The safety issue is magnified in light of the tight, competitive race between Clovis and AstraZeneca (AZN_), which is developing a similar lung cancer drug known as AZD9291.
...
For Clovis' '1686, the significant side effects include the aforementioned hyperglycemia and Qt prolongation (heart arrhythmia) seen in 15% of patients, with 7% of those reporting more serious grade 3 events.
For AstraZeneca's '9291, 27% of patients reported rash and 3% of patients experienced "interstitial lung disease-like" events. The '9291 presentation also disclosed some "grade 5" adverse events at the lower dose, which means patients died. But it's unclear if these are deaths due to tumor progression or related to '9291 treatment.
He separately tweeted that he didn't say that AZN's drug was superior.
"Adam Feuerstein @adamfeuerstein
@Sophocles44 @capitalinked nowhere do I proclaim $AZN winner over $CLVS. Drugs look very similar. Your bias is showing."
Hmm! the headline makes it look like this is really bad for CLVS.
---------------
Then there is Ohad Hammer's opinion:
http://www.orf-blog.com/drugs-to-watch-at-asco-2014/
"So far not a lot of surprises. Have to admit I don’t have concrete insight on the CLVS vs. AZN debate. Both drugs are AMAZING (median PFS of >9-12 months) and will likely reach the market but the safety profiles are very different with each side claiming victory. Talking with people at CLVS’ analyst event got me even more confused with some claiming Astra are “hiding something” and CLVS talking about a new metabolite which inhibits IGF1R AS the cause for hyperglycemia. (portrayed that as a potential beneficial thing). Turns out that both companies are seeing ILD like symptoms but they look manageable and not problematic like what is observed with Tarceva."
---------------
So, neither Ohad nor Adam is declaring a winner here. Yet, Adam's article might mean that CLVS stock goes down quite a bit tomorrow?
I am curious to see what the analysts have to say about it.
Biotech Option premiums
Some stocks are so volatile that the option premiums are really juicy.
For instance BLUE, I purchased some shares in the 22-23 range and wrote Jun $25 calls for $2.25 and wrote some June $22.5 puts at $2.55. These are incredible premiums. I can't get hurt if it stays in the 20-25 range. If it goes over $25, I am okay with it to lose all my shares as I will have an excellent 3-week profit.
Now if it goes below $20, I will have double the number of shares purchased at around $20 and I can write July calls
If it goes way below $20, then I might have to buy some more since it is on Ohad's watch list
http://www.orf-blog.com/6-stocks-on-my-watch-list/
TKMR premiums have been incredible too. I bought a lot of shares in the 11-12 range and wrote Jun $17.5 calls for 0.55. I also wrote June $12.5 puts for 2.0 - 2.5 on the drop below $11. The shares that I bought at around $15 last month, I wrote June $30 calls for 0.30. I didn't think it would double in a month
FMI premiums are not so good. But since I got shares in the 20-22 range, I didn't mind writing some June $25 calls for 0.75 - 0.90. I have June $15 calls at $5.5 in case the stock takes off next week after the ASCO presentations.
I could have made a lot more money from MNTA if I wasn't pig-headed in not writing covered calls when they were making money from generic lovenox in 2011.
I have been writing some covered calls on 20% of my SRPT holdings. Option premiums are good in SRPT too.
FMI @ ASCO
http://finance.yahoo.com/news/foundation-medicine-announces-initial-data-130000518.html
-- Foundation Medicine Announces Initial Data Demonstrating Clinical Utility of FoundationOne® in Advanced Solid Tumors;
...
-- Physicians Altered Therapy Decisions for 28 Percent of Patients with a Range of Tumor Types Based on FoundationOne Test Results
...
-- A total of 132 patients with refractory metastatic advanced solid tumors of many types were evaluated in this prospective, multi-center, single-arm trial. Nearly half of the patients evaluated had tumors of the breast, lung or colon (20 percent, 16 percent and 14 percent, respectively). The results indicated that physicians recommended a switch in therapy in 36 of the 132 patients (27.3 percent) based on the alterations reported by FoundationOne. Therapy switch rates exceeded 20 percent in all three major tumor types. Of the 98 patients ultimately treated, 27 patients (27.5 percent) received a different therapy from their original treatment. This study was begun in 2011, and it is reasonable to believe that as more targeted therapeutics advance to larger trials and are approved, the therapy switch rate will increase.
“These data, taken together with the 16 additional Foundation-related abstracts presented at the ASCO meeting, demonstrate the growing importance of FoundationOne in informing the treatment decision process of an oncologist practicing in the era of precision medicine,” said Gary Palmer, M.D., J.D., M.P.H., senior vice president, medical affairs, of Foundation Medicine.
...
"With more than 500 new targeted therapies in the development pipeline, we are proud to offer an accurate genomic profiling platform that will enable physicians practicing in a community setting to easily and successfully navigate this rapidly changing landscape to deliver better outcomes for their patients."
-----------------
Looks good. Bought some shares in the 20-22 range and wrote Jun $25 covered calls for 0.75 to 0.90.
I also have June $15 calls at 5.5 or less that I will convert to shares if the covered calls are exercised.
With the biotech stocks being so volatile, I am writing options on a lot of them for extra income
http://www.theflyonthewall.com/permalinks/entry.php/FMIid2015649/FMI-Foundation-Medicine-has-a-conference-call-hosted-by-JPMorgan
Foundation Medicine has a conference call hosted by JPMorgan
JPMorgan Analyst Peterson will host a conference call with CEO Mike Pellini on May 29 at 11 am.
Must have been a good presentation as the stock is up almost 5% Anybody here called in?
Surprising call by Goldman on Teva. I wish they had said buy MNTA or MNTA calls at the same time
http://www.theflyonthewall.com/permalinks/entry.php/TEVA;MYLid2014949/TEVA;MYL-Goldman-says-to-buy-TEVA-puts
Goldman says to buy TEVA puts
Goldman said Teva's (TEVA) '808 Copaxone patent expires this weekend, its biggest earnings driver. Mylan (MYL) has stated it expects to launch despite ongoing litigation and Goldman believes FDA approval is likely with a potential May/June launch. The firm believes Teva options are under-priced for volatility around Copaxone and believes shares could trade down 5-10%.
Surprising call by Goldman on Teva. I wish they had said buy MNTA or MNTA calls at the same time
http://www.theflyonthewall.com/permalinks/entry.php/TEVA;MYLid2014949/TEVA;MYL-Goldman-says-to-buy-TEVA-puts
Goldman says to buy TEVA puts
Goldman said Teva's (TEVA) '808 Copaxone patent expires this weekend, its biggest earnings driver. Mylan (MYL) has stated it expects to launch despite ongoing litigation and Goldman believes FDA approval is likely with a potential May/June launch. The firm believes Teva options are under-priced for volatility around Copaxone and believes shares could trade down 5-10%.
We don't have to wait much longer for the next chapter to reveal itself.
How sure are you that the FDA will do anything?
What if it is days, weeks, or months before we hear anything. Will MNTA then drift slowly into the single digits?
There is nothing in this environment that is holding up biotech stocks.
FPRX had BMY purchasing 1 million shares at $21 last month when they announced their partnership. It has drifted down below $12 today.
TKMR raised $60 million by selling 2 million shares at $30 a couple of months ago. Today it was at 10.45. TKMR and its partner ALNY have released several noteworthy news that should have all helped TKMR. Yet it has done nothing for the stock price.
Companies with good news are getting crushed. What will happen to MNTA if we don't hear from the FDA for a while?
That is my single biggest fear.
What Mr. Market is overlooking
It's no secret that Wall Street squanders long-term opportunities when short-term pain or uncertainty arises -- and that's exactly what I think is happening here.
Yes, I started nibbling when it hit $13 and bought a lot more under $11 and bought a lot of OTM and ITM calls under $10.5. Hopefully, no CRL!
XNPT: Seems like really good news. Yet, the stock went down?
http://seekingalpha.com/news/1753313-xenoport-reckitt-benckiser-in-licensing-deal-for-alcoholism-treatment
XenoPort, Reckitt Benckiser in licensing deal for alcoholism treatment
XenoPort (XNPT) has signed a licensing deal for Reckitt Benckiser (RBGLY) to develop XenoPort's Arbaclofen Placarbil treatment for alcoholism.
XenoPort will receive $20M upfront, $5M after certain technology and materials have been transferred, up to $70M in development and regulatory milestones, and $50M for commercial achievements.
Reckitt Benckiser will also start Phase IIb trials of Arbaclofen Placarbil. (PR)
I don't get the lack of enthusiasm for MNTA. The stock is up just 3% after hours. Maybe it will find a way to finish in the red tomorrow?
The last couple of weeks have been undoubtedly very good.
1. Teva's Citizen petition urging the FDA to not approve Copaxone was denied by the FDA.
2. Teva's subsequent lawsuit against the FDA trying to prevent an approval was dismissed today.
3. Mylan indicating on their earnings calls that they will not get an approval on May 24th.
4. MNTA indicating that they are on track for an approval in 2014 (they didn't commit to the May 24th)
This all but clears the way for an FDA approval for MNTA's generic copaxone and the $35 + 15 million milestone payments from NVS?
If MNTA does get approval and they launch at risk, couldn't MNTA's revenues easily exceed $150-200 million for 2014 and possibly $350-400 million in 2014?
If we add the milestone payments, maybe, we can expect a positive EPS for 2014? (yes, they won't use the revenue..) and a very profitable 2015.
I don't get it.
Let us say that NVS / MNTA gets approval soon and launches at risk.
What revenues can we expect for NVS / MNTA in 2014? How about a full year in 2015?
Will the profit margin be as high as it was for generic lovenox?
Could we be looking at $3-4 EPS for 2015? (just ignoring the lawsuit and the setting aside of the revenues to deal with damages later)
Thanks.
Dew, are you in FMI now?
I started nibbling at 21.50. If $23 was good for jq1234, $21.5 is good enough for me
Teva loses bid to block generic copaxone -- reported by Ian Estepan on Twitter.
MNTA up 5% after market hours
https://twitter.com/search?f=realtime&q=%24mnta&src=typd
I don't see a link though.
Teva loses bid to block generic copaxone -- reported by Ian Estepan on Twitter.
MNTA up 5% after market hours
https://twitter.com/search?f=realtime&q=%24mnta&src=typd
I don't see a link though.
Craig Wheeler is smiling!
http://seekingalpha.com/article/2209703-momenta-pharmaceuticals-ceo-presents-at-deutsche-bank-39th-annual-health-care-conference-transcript
One thing that stood out for me in this DB conference presentation -- Craig Wheeler is smiling because Mylan said that they can't launch on the 24th?
Analyst: Last week Mylan kind of implied that market formation may not start at – on May 24 because of "processes" at the FDA. Could you characterize at least broadly your dialog with the FDA around approvability?
Craig Wheeler - CEO
Yes. So that’s a very good question. And I was smiling when I saw that in a transcript. And because they have taken a very bold stand at being the market creation, May 24 et cetera. And I have always felt that that was not really a wise position to take and we have never taken that position. And let me tell you why.
He has no reason to smile so far as MNTA successes have been non existent. Of course, he has reason to smile for all the money he has been making selling MNTA shares/options and for the performance bonuses etc.
Yes, he suggests that Mylan's stance of approval on May 24th was not a wise one. He goes on to say that there are other parts the FDA has to deal with before approving MNTA's generic copaxone. So, even if he felt that their application is progressing well, he can't be sure when approval happens because he doesn't know how well the FDA is doing in:
1. Handling the citizen petitions from Teva
2. Preparing for the lawsuits from Teva
But even with all that, why smile about Mylan's comment, unless he is sure that they will get approval? He surely can't be smiling because a competitor screwed up by making unreasonable promises. Mylan has done far better than MNTA and have not had gigantic screw-ups that MNTA has had, right from the profit sharing contract with Sandoz on generic lovenox.
http://finance.yahoo.com/q/bc?t=1y&s=MNTA&l=on&z=l&q=l&c=myl&ql=1&c=%5EGSPC&c=%5EIXIC&c=%5EDJI
Or maybe I am just reading too much into that statement?
Craig Wheeler is smiling!
http://seekingalpha.com/article/2209703-momenta-pharmaceuticals-ceo-presents-at-deutsche-bank-39th-annual-health-care-conference-transcript
One thing that stood out for me in this DB conference presentation -- Craig Wheeler is smiling because Mylan said that they can't launch on the 24th?
Analyst: Last week Mylan kind of implied that market formation may not start at – on May 24 because of "processes" at the FDA. Could you characterize at least broadly your dialog with the FDA around approvability?
Craig Wheeler - CEO
Yes. So that’s a very good question. And I was smiling when I saw that in a transcript. And because they have taken a very bold stand at being the market creation, May 24 et cetera. And I have always felt that that was not really a wise position to take and we have never taken that position. And let me tell you why.
He has no reason to smile so far as MNTA successes have been non existent. Of course, he has reason to smile for all the money he has been making selling MNTA shares/options and for the performance bonuses etc.
Yes, he suggests that Mylan's stance of approval on May 24th was not a wise one. He goes on to say that there are other parts the FDA has to deal with before approving MNTA's generic copaxone. So, even if he felt that their application is progressing well, he can't be sure when approval happens because he doesn't know well the FDA is doing in:
1. Handling the citizen petitions from Teva
2. Preparing for the lawsuits from Teva
But even with all that, why smile about Mylan's comment, unless he is sure that they will get approval? He surely can't be smiling because a competitor screwed up by making unreasonable promises. Mylan has done far better than MNTA and have not had gigantic screw-ups that MNTA has had, right from the profit sharing contract with Sandoz on generic lovenox.
http://finance.yahoo.com/q/bc?t=1y&s=MNTA&l=on&z=l&q=l&c=myl&ql=1&c=%5EGSPC&c=%5EIXIC&c=%5EDJI
Or maybe I am just reading too much into that statement?
WTF? They upgrade it two notches from underperform and reduce the price target.
http://www.theflyonthewall.com/permalinks/entry.php/MNTAid2008824/MNTA-Momenta-Pharma-initiated-with-a-Buy-at-Maxim
Momenta Pharma upgraded to Buy from Underperform at BofA/Merrill
BofA/Merrill upgraded Momenta two notches to Buy from Underperform due to valuation, reduced expectations. Price target lowered to $14 from $17.
So, since the earnings call we have:
http://www.analystratings.net/stocks/mnta
1. Maxim: New coverage; Buy; PT = $24
2. BAC: Upgrade to Buy;
3. Canaccord; Reiterated Buy; PT = 17 (lowered from 22)
This is looking like a no-brainer here at 10.35, even with Biotechs out of favor. Surely, MNTA management couldn't screw it up from here? Could they?
So, since the earnings call we have:
http://www.analystratings.net/stocks/mnta
1. Maxim: New coverage; Buy; PT = $24
2. BAC: Upgrade to Buy;
3. Canaccord; Reiterated Buy; PT = 17 (lowered from 22)
This is looking like a no-brainer here at 10.35, even with Biotechs out of favor. Surely, MNTA management couldn't screw it up from here? Could they?
Maxim starts coverage of MNTA with a buy and a $24 price target
Probably good for a 10 cent bump today
http://www.streetinsider.com/Analyst+Comments/Maxim+Group+Starts+Momenta+Pharmaceuticals+(MNTA)+at+Buy/9465973.html
Maxim Group initiates coverage on Momenta Pharmaceuticals with a Buy rating and a price target of $24.00.
Analyst Pamela Bassett comments, "We believe the company has a validated, scientific approach to the analysis and engineering of complex generic drugs that has been proven with the approval and launch of their fully interchangeable enoxaparin generic of Sanofi’s blood-thinner, Lovenox. We expect Momenta’s generic glatiramer acetate injection (M356) of Teva’s Copaxone for the treatment of relapsing remitting multiple sclerosis (RRMS) to follow the regulatory path paved by enoxaparin.
We anticipate FDA approval of M356, partnered with Sandoz, by June 2014 and the launch of an interchangeable version that we expect to rapidly capture market share, a boost to the company’s value and significant catalyst for the stock, in our view."
Maxim starts coverage of MNTA with a buy and a $24 price target
Probably good for a 10 cent bump today
http://www.streetinsider.com/Analyst+Comments/Maxim+Group+Starts+Momenta+Pharmaceuticals+(MNTA)+at+Buy/9465973.html
Maxim Group initiates coverage on Momenta Pharmaceuticals with a Buy rating and a price target of $24.00.
Analyst Pamela Bassett comments, "We believe the company has a validated, scientific approach to the analysis and engineering of complex generic drugs that has been proven with the approval and launch of their fully interchangeable enoxaparin generic of Sanofi’s blood-thinner, Lovenox. We expect Momenta’s generic glatiramer acetate injection (M356) of Teva’s Copaxone for the treatment of relapsing remitting multiple sclerosis (RRMS) to follow the regulatory path paved by enoxaparin.
We anticipate FDA approval of M356, partnered with Sandoz, by June 2014 and the launch of an interchangeable version that we expect to rapidly capture market share, a boost to the company’s value and significant catalyst for the stock, in our view."
jq,
Thanks. I had seen that article. Every one except AGIO is at 52 week lows. I think OHAD likes CLVS too. That may go down to the mid 40s tomorrow.
What to do? So many good stocks down so much. How do we know it won't come down a lot more.
Hopefully, ENTA stays strong and MNTA doesn't go back below $10 and TKMR below $11
The last couple of weeks have been terrible. I thought I was adding a lot of them at 52-week lows and they keep going lower.
Maybe a few Biotech hedge funds are liquidating their entire holdings. Has got to be something going on. Also, ISIS, CLDX, CRIS, ARRY, ARQL are all at 52 week lows.
XOMA, TGTX, XNPT
Any interest in any of these at these prices? XOMA and XNPT have been crushed.
XNPT has $123 million in cash and with 57 million shares and 3.58, its total market cap is just $204 million. Seems cheap.
http://seekingalpha.com/pr/9844683-enanta-pharmaceuticals-announces-submission-of-eu-marketing-authorization-applications-to-the-european-medicines-agency-for-all-oral-interferon-free-hepatitis-c-regimen-containing-abtminus-450
Enanta Pharmaceuticals Announces Submission of EU Marketing Authorization Applications to the European Medicines Agency for All-Oral, Interferon-Free Hepatitis C Regimen Containing ABT-450
Submission Triggers $20 million Payment to Enanta
I am not sure why it sold off in the last couple of days. I purchased some June $25 calls yesterday. I hope to have the cash to exercise it by then. Maybe MNTA will get Copaxone approval by then
I had some orders for the May $35 call. Didn't get filled
So, they will have about $2 EPS for this quarter just from these milestone payments Hopefully, their expenses for the quarter is low and the earnings for this quarter reported in early August will make more people aware of how ridiculously cheap this is.
I was surprised that ABBV rose 3% yesterday while ENTA dropped 5%
Looks like Primecap is now a 5% holder?
http://ih.advfn.com/p.php?pid=nmona&article=62115140&symbol=MNTA
It looks like they held 1.5 million shares before (2.75%) and now hold 2.77 million shares (5.25%)
Canaccord keep buy rating; Lowers price target from $22 to $17
http://www.analystratings.net/stocks/NASDAQ/MNTA/
Time to Pick Up the Momenta Pharmaceuticals Pieces (RDY, TEVA, MNTA)
http://www.smallcapnetwork.com/Time-to-Pick-Up-the-Momenta-Pharmaceuticals-Pieces-RDY-TEVA-MNTA/s/via/1789/article/view/p/mid/3/id/518/
This morning on the drop I did pick up some Sep $7 calls and June $10 and June $12 calls just in case they do get Copaxone approval.
So, you are of the opinion that insiders needn't step in if they believe the stock is ridiculously undervalued? They shouldn't use the cash they got selling the stock at $17 to buy shares at $10-11? What sort of message does that send to the shareholders?
-- That the insiders don't expect Copaxone approval
-- That they don't think the shares are undervalued at these prices
It doesn't have to be large amounts. Just even a token 5k-10k purchase can stop the bleeding. They can sell it later at higher prices
INFN's big insider buy when it dropped below $5 did wonders to the stock. Same with UPL insider buys at 18-19. INFN doubled from there. UPL is at $30+.
http://openinsider.com/search?q=infn
http://openinsider.com/search?q=upl
If ever there was a great time for insiders to step in and buy stock it would be now.
But knowing this management -- they will change their automated plans so they can increase their sales on any spikes on Copaxone approval.