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http://seekingalpha.com/news/1829395-teva-files-a-citizen-petition-regarding-approvability-of-generic-versions-of-copaxone?uprof=45
Teva files a citizen petition regarding approvability of generic versions of Copaxone
In response to a request from the FDA, (TEVA) files a citizen petition (CP) on the approvability of generic versions of Copaxone (glatiramer acetate injection). The agency wanted a CP in order to facilitate public review and comment on new scientific data on gene expression. This will allow Teva to comment publicly on the views and opinions of others and will create an administrative record that the FDA may use as a basis for future decisions.
Teva's CP provides new scientific data on gene expression and evidence to support arguments that active ingredient sameness, immunogenicity and bioequivalence in generic offerings are similar but not the same as Copaxone. The company says that competitive offerings should use the same gene expression markers and biological pathways to demonstrate sameness and be evaluated in full-scale clinical trials.
Teva is doing everything it can to hold on. Looks like Citi's call that Copaxone approval won't happen until the end of the year is looking more and more reasonable.
Generic Copaxone approval likely later than expected, says Citigroup
Citigroup says the FDA has recently requested incremental data from the Copaxone generic filers, including both gene expression and immunogenicity data. Citi expects the first generic approval towards the end of 2014 at the earliest, later than the current Street expectations of Q3. Citi reiterates a Buy rating on Teva shares with a $70 price target.
http://www.theflyonthewall.com/permalinks/entry.php/TEVAid2032869/TEVA-Generic-Copaxone-approval-likely-later-than-expected-says-Citigroup
Generic Copaxone approval likely later than expected, says Citigroup
Citigroup says the FDA has recently requested incremental data from the Copaxone generic filers, including both gene expression and immunogenicity data. Citi expects the first generic approval towards the end of 2014 at the earliest, later than the current Street expectations of Q3. Citi reiterates a Buy rating on Teva shares with a $70 price target.
http://www.theflyonthewall.com/permalinks/entry.php/TEVAid2032869/TEVA-Generic-Copaxone-approval-likely-later-than-expected-says-Citigroup
I know that the volume is low. But the bid/ask is so much higher than yesterday's close of 26.96.
FMI -- Bid / Ask at 28.01 / 29.00.
I don't see any news that could explain this pre-market move
GSK caught with their pants down
http://finance.yahoo.com/news/sex-video-twist-gsk-china-214205519.html
Sex video is new twist in GSK China bribery scandal
I hate GSK for several reasons. I am glad to see them get in trouble. Hopefully we will have a lot of people getting fired at the top for the bribery scandal. I wonder if they have done a lot of bribing in the US? I wouldn't be surprised.
That is because ENTA got added to the Russell 3000.
http://www.streetinsider.com/Insiders+Blog/Preliminary+Russell+3000+Addition+Pushing+Stocks+Around/8422632.html
As did ARWR. Hence a lot of shares traded in these and any others that got added to the Russell indexes
http://uk.reuters.com/article/2014/06/16/ca-arrowhead-research-idUKnBw165489a+100+BSW20140616?type=companyNews
FMI: Next Generation of Cancer Diagnostics and Informatics; Initiating at Neutral
http://www.janney.com/File%20Library/Unassigned/JMS_LS_Newsletter_6-25-14.pdf
June 25, 2014 – Foundation Medicine is developing the most comprehensive molecular diagnostics and bioinformatics platform in the cancer diagnostics market. With a seasoned management team from Clarient and a compelling approach to match cancer patients with the right treatment, we believe that Foundation Medicine is properly aligned to benefit from this new era of personalized medicine. Selling at 6.2x 2015 revenue and 3.5x our 2016 sales estimate, our fair value is $28 per share or 18% above the current share price. We initiate with a Neutral rating.
Reason for MNTA weakness: Teva gets FDA approval for generic lovenox
https://twitter.com/search?f=realtime&q=%24mnta&src=typd
I think this is a buying opportunity. Yes, there have been lots and lots of those
Reason for MNTA weakness: Teva gets FDA approval for generic lovenox
https://twitter.com/search?f=realtime&q=%24mnta&src=typd
I think this is a buying opportunity. Yes, there have been lots and lots of those
Hopefully, we don't get a bigger dump when Mike Havrilla and his biorunup subs unload their losing position that they initiated this morning. I hate it when Mike gets involved with a stock. His silly trading works for him, I guess.
https://twitter.com/search?f=realtime&q=%24mnta&src=typd
Mike added 1K $MNTA @$11.62 (own 5K @$11.90 average)
Mike added 1K $MNTA @$11.82 (own 4K @$11.96 average)
Mike: $MNTA expect FDA approval for generic Copaxone by next quarter; could be any day now since 5/24 patent expiration for $TEVA
Mike bought 3K $MNTA @$12.01 for ST swing trade (+5-10% tgt) looking for bounce off the 50-day moving average
Baird Downgrades Enanta Pharmaceuticals (ENTA) to Neutral
http://www.streetinsider.com/Analyst+Comments/Baird+Downgrades+Enanta+Pharmaceuticals+%28ENTA%29+to+Neutral/9607317.html
Baird downgraded Enanta Pharmaceuticals (NASDAQ: ENTA) from Outperform to Neutral with a price target of $41.00 on valuation.
Analyst Brian Skorney said, "At this price, we are firm believers that, fundamentally, ENTA is at fair value. However, we do note that the MRK/IDIX deal has injected some life into the HCV M&A game and Enanta offers one of the few remaining tickets into the space."
Baird Downgrades Enanta Pharmaceuticals (ENTA) to Neutral
http://www.streetinsider.com/Analyst+Comments/Baird+Downgrades+Enanta+Pharmaceuticals+%28ENTA%29+to+Neutral/9607317.html
Baird downgraded Enanta Pharmaceuticals (NASDAQ: ENTA) from Outperform to Neutral with a price target of $41.00 on valuation.
Analyst Brian Skorney said, "At this price, we are firm believers that, fundamentally, ENTA is at fair value. However, we do note that the MRK/IDIX deal has injected some life into the HCV M&A game and Enanta offers one of the few remaining tickets into the space."
Article on EXEL's Cabo in the Australian Herald Sun
http://www.heraldsun.com.au/news/strangers-rally-on-facebook-to-help-pay-for-experimental-cancer-drug-for-girl-with-cancer/story-fni0fiyv-1226954748406
Strangers rally on Facebook to help pay for experimental cancer drug for girl with cancer
Anybody here think EXEL is a good pick up in the $3.5 range?
Here is the facebook page -- Looks like the drug is working in a little over 10 days?
https://www.facebook.com/EvasFightforLife
June 1st entry:
Such a big improvement over the weekend, though there is still quite a way to go. Sleeping less during the day, eating more and laughing lots! The tumour is visibly shrinking at last.
May 21st entry:
A few more smiles today and a few more mouthfuls. Hopefully a sign of things turning in the right direction.
We FINALLY have our capsules from Exelixis! Will see doc again tomorrow to obtain specifics of plan for next 8 weeks
Article on EXEL's Cabo in the Australian Herald Sun
http://www.heraldsun.com.au/news/strangers-rally-on-facebook-to-help-pay-for-experimental-cancer-drug-for-girl-with-cancer/story-fni0fiyv-1226954748406
Strangers rally on Facebook to help pay for experimental cancer drug for girl with cancer
Anybody here think EXEL is a good pick up in the $3.5 range?
Here is the facebook page -- Looks like the drug is working in a little over 10 days?
https://www.facebook.com/EvasFightforLife
June 1st entry:
Such a big improvement over the weekend, though there is still quite a way to go. Sleeping less during the day, eating more and laughing lots! The tumour is visibly shrinking at last.
May 21st entry:
A few more smiles today and a few more mouthfuls. Hopefully a sign of things turning in the right direction.
We FINALLY have our capsules from Exelixis! Will see doc again tomorrow to obtain specifics of plan for next 8 weeks
People who sold options booked a very decent profit this month for sure.
I did quite well with purchased calls in the 10-11 range as I had indicated here.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=102994895
I bought some July 11/12/13/14 calls today in the last 15 minutes. I will sell half and roll the rest to Aug on a move back to 13.50 or so (hopefully it does and today was just op-ex behavior like some of you said)
3rd Friday of the month. Options expiration.
I know that. But those were huge blocks for sale. I purchased some July calls in the last 10 minutes. Hopefully that pays off
MNTA -- Looks like somebody liquidated their holdings in the last half an hour. Hence the drop from 12.65 to 12.25 in the last 30 minutes. Huge blocks sold at 12.30 including one block of 224k
http://www.nasdaq.com/symbol/mnta/time-sales?pageno=2
http://www.nasdaq.com/symbol/mnta/time-sales
Copaxone rejection coming?
MNTA -- Looks like somebody liquidated their holdings in the last half an hour. Hence the drop from 12.65 to 12.25 in the last 30 minutes. Huge blocks sold at 12.30 including one block of 224k
http://www.nasdaq.com/symbol/mnta/time-sales?pageno=2
http://www.nasdaq.com/symbol/mnta/time-sales
Copaxone CRL coming?
Araidndndough,
Thanks for the updates. I have benefited from the ones on TGTX and hopefully from these
Thanks to Dirk (RNAIAnalyst) who has been relentless tweeting about ARWR (and putting it down at every possible chance), I was able to accumulate some shares below $11.5.
Do you follow RTRX? Any analyst updates on that? I got some between 10.50 and 11 knowing that it is very speculative.
Martin's tweets caused such a meltdown, including in his own portfolio. I guess he will think twice now about making smart aleck comments on Twitter.
Also, is Patrick working for RTRX now?
I guess the accelerated assessment was expected?
ABBV up $1 pre-market on low volvume. Maybe the market was not expecting it?
Price target of $18?
http://www.analystratings.net/stocks/NASDAQ/ENTA/?RegistrationCode=SocialMedia-Twitter
I am so glad that it is an outperform with a price target of $18. Imagine what the target would have been if it was an underperform rating?
http://finance.yahoo.com/news/enanta-pharmaceuticals-announces-european-medicines-060300921.html
Enanta Pharmaceuticals, Inc. (ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today announced that AbbVie has reported that the Marketing Authorization Applications (MAAs) for AbbVie’s investigational, all-oral, interferon-free regimen primarily for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection have been fully validated and are now under accelerated assessment by the European Medicines Agency (EMA).
I guess the accelerated assessment was expected?
Accelerated assessment, which is a review process designated for new medicines of major public health interest, was granted in May 2014 by the EMA for AbbVie’s investigational HCV regimen. Validation of the MAAs confirms that the submissions are complete and starts the EMA's centralized review process. If approved, AbbVie expects that its regimen could be available for marketing in the European Union in the first quarter of 2015.
So, could EMA approval happen in late Dec 2014? It would be nice to get almost all of the $155 million milestone payment in 2014.
http://finance.yahoo.com/news/enanta-pharmaceuticals-announces-european-medicines-060300921.html
Enanta Pharmaceuticals, Inc. (ENTA), a research and development-focused biotechnology company dedicated to creating small molecule drugs in the infectious disease field, today announced that AbbVie has reported that the Marketing Authorization Applications (MAAs) for AbbVie’s investigational, all-oral, interferon-free regimen primarily for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection have been fully validated and are now under accelerated assessment by the European Medicines Agency (EMA).
I guess the accelerated assessment was expected?
Accelerated assessment, which is a review process designated for new medicines of major public health interest, was granted in May 2014 by the EMA for AbbVie’s investigational HCV regimen. Validation of the MAAs confirms that the submissions are complete and starts the EMA's centralized review process. If approved, AbbVie expects that its regimen could be available for marketing in the European Union in the first quarter of 2015.
So, could EMA approval happen in late Dec 2014? It would be nice to get almost all of the $155 million milestone payment in 2014.
New Ohad Hammer Blog
http://www.orf-blog.com/clovis-oncology-still-a-long-term-core-holding/
Anybody have any thoughts on the whole ALNY / ARWR / TKMR patent issue?
I am beginning to get really annoyed by Dirk. He may be a good blogger but he seems to have undue influence on TKMR and ARWR. His goal was to push down ARWR and promote TKMR with his latest blog article yesterday. It backfired on him in that both finished down 10%.
ARWR just put out a press release on the patent issue:
http://finance.yahoo.com/news/arrowhead-issues-statement-intellectual-property-214100462.html
So, does this guarantee approval by the end of 2014 and the receipt of the bulk of the $155 million milestone in 2014?
Is priority review good enough to push this and keep it over $40? It had a failed attempt this week.
Thanks.
jq1234,
Thanks again for your input on CLVS, FMI and others.
I picked up some CLVS in the 45-46 range on the way down. However, I picked up a lot more in the 36-37 range
I am still waiting for Ohad's blog for his portfolio update. I am curious to know if he added to CLVS at the lows.
I also got a lot of FMI in the 20-22 range and TKMR in the 11-12 range. I got some BLUE in the 22-23 range as well (wrote Jun $25 covered calls for $2+).
Surprising that ENTA has gone down since the IDIX and ACHN news. If it goes down some more, I might have to buy more.
So, if IDIX is worth $3.8 Billion, shouldn't ENTA be valued at $5 billion or more?
http://www.fiercebiotech.com/press-releases/merck-acquire-idenix
https://twitter.com/search?f=realtime&q=%24idix&src=typd
So, if IDIX is worth $3.8 Billion, shouldn't ENTA be valued at $5 billion or more?
https://twitter.com/search?f=realtime&q=%24idix&src=typd
June calls are up nicely
Selling some of the June $10/11/12/13 calls here for close to double or better on most of them.
I will keep some / roll the rest of the June calls to July for potential Copaxone approval.
I have a lot of July/Sep $6/7/8/9 calls also picked up when MNTA dropped below $11. Sold some of them for a nice profit.
Hmm! Maybe I may yet recover some of the losses in MNTA from 2011.
Of course, I do have lots of shares in the 10-13 range which I will keep for now. I will use those to write covered calls when we get approval or if it hits $15, whichever comes first
t57,
The flyonthewall got it wrong.
http://www.analystratings.net/stocks/mnta
I don't know how Maxim can initiate coverage in May with $24 target and then again in June with $17 target.
Looks like Maxim kept a buy on MNTA but lowered price target to $17 from $24 (which they set just last month)
http://www.streetinsider.com/Analyst+Comments/Maxim+Group+Assumes+Momenta+Pharmaceuticals+%28MNTA%29+at+Buy/9556965.html
Analyst Jason Kolbert said, "We believe Momenta is well positioned to benefit from the launch of generic Copaxone (M356). We continue to expect generic Copaxone to follow the same regulatory path paved by Momenta’s enoxaparin. We anticipate FDA approval of M356, partnered with Sandoz (generic arm of Novartis – NVS - $88.44-NR) this month. Even if delayed, we believe the company’s valuation is reasonable. Once launched M356 should, not only rapidly take share from Copaxone, but also from other brand products as managed care forces drive cost efficiency in the marketplace."
MNTA finally released a PR about the orphan status for M402 (now Necuparanib):
http://finance.yahoo.com/news/momenta-pharmaceuticals-receives-orphan-drug-120100667.html
Looks like the orphan news is good for 10-15 cents (pre-market) as I had suggested
Looks like Maxim kept a buy on MNTA but lowered price target to $17 from $24 (which they set just last month)
http://www.streetinsider.com/Analyst+Comments/Maxim+Group+Assumes+Momenta+Pharmaceuticals+%28MNTA%29+at+Buy/9556965.html
Analyst Jason Kolbert said, "We believe Momenta is well positioned to benefit from the launch of generic Copaxone (M356). We continue to expect generic Copaxone to follow the same regulatory path paved by Momenta’s enoxaparin. We anticipate FDA approval of M356, partnered with Sandoz (generic arm of Novartis – NVS - $88.44-NR) this month. Even if delayed, we believe the company’s valuation is reasonable. Once launched M356 should, not only rapidly take share from Copaxone, but also from other brand products as managed care forces drive cost efficiency in the marketplace."
MNTA finally released a PR about the orphan status for M402 (now Necuparanib):
http://finance.yahoo.com/news/momenta-pharmaceuticals-receives-orphan-drug-120100667.html
Looks like the orphan news is good for 10-15 cents (pre-market) as I had suggested
I am curious as to why was there no PR about the orphan status for the cancer drug?
If anything it would have allowed Wheeler, Shea and others to sell their next batch of shares 10-20 cents higher.
http://openinsider.com/search?q=mnta
Momenta's reasoning for abandoning the development of an alternative, non-infringing process. Momenta decided to file its ANDA using Teva's patented process because it "[e]nable[d] a first to-file approach" and "[m]itigate[d] risk regarding chemical equivalence." (PTX 172 at MMT01287394.) In other words, as Dr. Iyer explained, Momenta decided to copy Teva's patented process for making copolyrner-1 instead of developing its own process because it provided the quickest route to a regulatory filing. (PTX 960>>
If the above is indeed true, then MNTA is just a generic company no different from other generic companies. Is it a pretender who may have fooled Baxter? Can we expect anything then to come to fruition with their collaboration with Baxter?
I have had a very low opinion of their management and their legal team for quite a while now. Now, it goes even lower. Also, should we hold their scientists in such high esteem? All this while we had figured that they had done brilliant work in creating generic lovenox and generic copaxone.
In retrospect, they may have been better off doing the clinical trials in 2009 like Teva wanted and they may have had their approval by now (on the 24th). It wouldn't have taken 5 full years for the trials, would it?
Maybe the delay in the approval is because of a tussle in the FDA between people who want to approve it without trials and those who want the trials?
Sorry, if I seem to be rambling here I was hurt by MNTA before. I am trying to figure out if I should just exit a second time and never touch MNTA again.
Clovis Oncology (CLVS) PT Reduced to $50 at Goldman Sachs Due to Competition
http://www.streetinsider.com/Analyst+Comments/Clovis+Oncology+%28CLVS%29+PT+Reduced+to+%2450+at+Goldman+Sachs+Due+to+Competition/9550690.html
Goldman Sachs maintained a Neutral rating on Clovis Oncology (NASDAQ: CLVS) and reduced its price target to $50.00 (from $85.00). '1686 estimates were lowered to account for increased competition.
Analyst Terence Flynn said, "Last night, AZN (NYSE: AZN) hosted an analyst event at ASCO and provided more clarity on the profile of ‘9291, its plans in the front-line (FL) setting, its combination strategy, as well as filing timelines. As a result we are lowering our ‘1686 front-line market penetration to 50% from 75%, which reduces our estimates and price target. Our new ‘1686 adjusted peak estimate is $1.3bn from $2bn."
Piper Jaffray's note on Clovis
Link to YMB -- Note is in 3-parts. Since it is YMB, I can't be sure that is what Piper said.
http://finance.yahoo.com/mbview/userview/;_ylt=Ao3Rfu5kp5H174PBdfZk2hfeAohG;_ylu=X3oDMTB1MDcxc2toBHBvcwM1BHNlYwNNZWRpYU1zZ0JvYXJkc1hIUlVsdA--;_ylg=X3oDMTBhYWM1a2sxBGxhbmcDZW4tVVM-;_ylv=3?_media.modules.msgboards.switches._enable_mbv2=1&u=villaborinquen&bn=e626e6c2-6945-3eb8-966f-7a5f49473d3d
CONCLUSION