full-time investing; total portfolio up over 130% in 2009; but 2010 sucks!
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PEIX: Great DD by kel3. Exercised Warrants will probably be a real headwind, as 6.2 million could all be exercised below $8 and sold into the market (slowing the upward move of the stock)! It seems like it will be hard getting PEIX over $9-$10, even with the generous corn spread.
Keith Shaefer's summary was very good!
Just wondering how much uncertainty about the China bond default game is impacting world markets.
http://www.bloomberg.com/news/2014-01-24/ubs-says-market-wants-default-as-risks-to-pile-up-china-credit.html
PEIX down hard today as "uncertainty is king".
An excerpt from your article:
And, as spring planting season gets closer, analysts are speculating whether farmers will move more acres into soybeans and away from corn, potentially lifting corn prices. Or, will corn acres stay at the recent record levels producing more record corn crops. That, of course, hinges on Mother Nature cooperating. Given recent extreme weather events, the markets – corn, ethanol, energy – are all facing uncertainty.
ps> Thanks, cartonet! As they say, "There are a million stories in the naked city, and this has been one of them".
PEIX... bought some a little higher than it is now.
Of course now that I own it, I'm beginning to become leary of the rosy picture painted by your newsletter writing pal Schaefer. Particulaly, why should we expect bumper crops of low-priced corn in 2014? I mean 2013 was an outlier with large harvests of corn, but predicting the future can be dangerous. We have no idea what the growing season will bring to the cornbelt, but the weather has been a bugger this winter, so we might easily expect significnat rough weather this spring-fall as well. Our PEIX hopes and dreams are subject to such abominations as floods, droughts, hurricanes and locusts.
Have a nice day (gulp), fellow PEIX longs!
'peeker
China stocks got spanked for bad auditors!
Chinese stocks seeing notable weakness this morning, following SEC actions on auditors
Yesterday the SEC issued a ruling related to the auditing of certain Chinese companies. The SEC document indicates that the "Initial Decision censures and denies the privilege of practicing or appearing before the Commission for a period of six months to Respondents Ernst & Young Hua Ming LLP (E&Y), KPMG Huazhen (Special General Partnership) (KPMG), Deloitte Touche Tohmatsu Certified Public Accountants Ltd. (DTTC), and PricewaterhouseCoopers Zhong Tian CP As Limited (PwC), and censures Respondent BDO China Dahua CPA Co., Ltd. (Dahua)."
Chinese stocks/ADRs are moving lower this morning, potentially being impacted by this news (China also had disappointing PMI data last night): KONG -8.9%, QIHU -8.6% (planning to adjust revs sharing policies to attract small and medium-sized game developers , according to Marbridge ), CCIH -18.5%, WBAI -7.9%, STV -6.9%, SFUN -5.6%, DANG -4.5%, CYOU -3.1%, YY -4.2%, YOKU -5.8%, BORN -4.8%, TSL -4.2%, ATHM -4.2%, EJ -4.1%, SINA -1.8%, CTRP -3.6%, CHU -3.5%, BIDU -3.4% (partners with Jingdong for hardware development open platform, according to Marbridge ), JRJC -3%, SOHU -2.6%, PTR -2.4%, RENN -1.2%
CDXC (Chromadex) is an interesting company that could become profitable by next year. They manufacture and sell specialty chemicals used in nutritional and pharmaceutical products. For instance they have a specialty chemical that is bonded to caffeine and makes the caffeine-based energy boost last longer. It's biggest shareholder is Philip Frost, the CEO of Opko.
The stock has done very well (up ~80% over the last two months).
I just thought I'd throw it out here to see if anyone has looked into it.
OT: Could it be time for you to sponsor a party in Boulder to celebrate your MDBX (smokin' hot) payoff? As for the invitee list, maybe you'll cover travel expenses for your fellow BCC.ax (up in smoke) investors. I mean ... afterall, we need it for the "pain management".
Best Regards,
'peeker
PRY.v down hard perhaps due to their not drilling new wells until they improve production from their existing ones. The thing that jumped out at me was they've borrowed $130million against their $150milion credit line, making me think the banks may be saying they won't loan any more so PRY.v has to manage their cashflow better than they have.
Another prediction about potential 2014 downward pressure on oil prices.
http://www.bloomberg.com/news/2014-01-14/oil-price-forecasts-cut-by-deutsche-bank-on-u-s-supply.html
Well it is "cold as a witch's teat" here in the sunny south, so the heater just keeps on hummin'.
This board has been hijacked.
BCC.ax/BCGYF: Anyone hearing anything about the financing and asset sales, that is, what to expect when it starts trading again in a couple of days? I thought it was interesting that the latest comment by the company did not mention a JV, just financing and asset sales.
It looks to me like someone just hacked their website during the holiday with that phrase "therapy testosterone human growth hormone hgh".
14:41 PVG
Pretium Resources: Mineral resource estimate adds measured gold resources, increase grade at Valley of the Kings (stock halted) (5.07 -0.25)
Co reports the NI 43-101-compliant 2013 Valley of the Kings Mineral Resource estimate for its Brucejack Project, completed by Snowden Mining Industry Consultants. Measured and Indicated Mineral Resources total 8.7 million ounces of gold at a grade of 17.6 grams of gold per tonne.
Valley of the Kings High-Grade Gold Mineral Resources; High-grade gold resources in the Valley of the Kings (5.0 g/t gold-equivalent cut-off) total:
8.7 million ounces of gold in the Measured and Indicated Resource categories (15.3 million tonnes grading 17.6 grams of gold per tonne); and
4.9 million ounces of gold in the Inferred Mineral Resource category (5.9 million tonnes grading 25.6 grams of gold per tonne).
HNR finalizes first phase of deal to sell Venezuelan assets:
Harvest Natural announces share purchase agreement to sell interests in Venezuela for aggregate of $400 mln in cash
Briefing.com - 6:40 AM ET
Co announced that it and its wholly-owned subsidiary, HNR Energia B.V., have entered into a Share Purchase Agreement with Petroandina Resources and Pluspetrol Resources to sell, in two separate transactions, all of the co's interests in Venezuela, for an aggregate of $400.0 mln in cash. The Buyer will purchase Harvest's 32% interest in Petrodelta, S.A. by purchasing HNR Energia's 80% interest in Harvest-Vinccler Dutch Holding B.V. in two transactions of 29% and 51%, respectively. Harvest Vinccler owns, indirectly through wholly-owned subsidiaries, a 40% interest in Petrodelta, S.A.
HNR Energia and Buyer closed the first transaction today for a cash purchase price of $125 mln. The closing of the second transaction for a cash purchase price of $275 mln is subject to, among other things, approval by the holders of a majority of the Company's common stock and the Government of the Bolivarian Republic of Venezuela. Net proceeds after taxes and transaction-related costs from the two transactions are estimated to be approximately $122 mln and $208 mln, respectively. Proceeds from the first transaction will be used to pay Harvest's long-term debt with the remaining proceeds used for working capital.
09:15
Alert
HNR
Harvest Natural: First Venezuelan transaction closes; provides ample cash with more on the way - Wunderlich (3.94)
Wunerlich notes HNR this morning announced it had closed the first transaction in the sale of its Venezuelan assets for $125 million gross ($122 million net), essentially putting the near-term liquidity issues to bed for good, allowing the nearly $80 million in long-term debt to be repaid in full and providing a nice line of sight for Harvest to completely exit Venezuela with a second transaction of $275 million gross ($208 million net). Both deal prices are now expected to net about $10 million more than previously expected and with the first deal now closed, they believe there is a great chance the co can unlock the value in Venezuela, which should lead to considerable stock price appreciation given the second deal is worth $5/share in cash alone; Buy.
HNR is at $4.63 in the premarket.
SFY down again today, but here's another positive SFY article at SA:
http://seekingalpha.com/article/1897121-swift-energy-co-drilling-for-value-and-performance?source=email_rt_article_readmore
OT: That's right up there with that UK Whale.
"He's dead but he beckons".
Salutations!
'peeker
Somebody gave up and took their lumps (losses) today, I assume.
Of course we US-based longs took our lumps with that action as well.
Can anyone suggest any GOOD news on the way?
Briefing.com Value Leaders :
The following table contains a list of stocks that we believe should be particularly attractive to value and yield investors who want to avoid "value traps." Value Leaders components are derived from a quantitative screen and ranking system that is designed to uncover companies that possess a combination of low valuations across a variety of metrics, healthy 6-month Relative Strength, and shareholder-friendly managements that pay dividends and/or have active share buybacks in place. There are no growth or market cap criteria applied to this list.
Value Leaders: November 27, 2013
Mkt Cap RS Value EV/ EV/ FCF Buyback Div Cash/
Rank Name Ticker Price Sector (mln) Rank Rank EBITDA Sales Yield Yield Yield Share
1 United Online UNTD $15.56 Technology Services $209 96 100 2.9 0.4 7.5% 85.5% 3.8% $53.24
2 Western Refining WNR $39.23 Energy Minerals $3,080 92 100 3.9 0.4 5.8% 7.5% 2.3% $3.96
3 Southwest Airlines LUV $18.80 Transportation $12,917 93 98 6.6 0.7 7.5% 3.0% 0.9% $4.68
4 Marathon Petroleum MPC $84.57 Energy Minerals $24,549 82 100 5.6 0.3 9.1% 6.6% 2.1% $6.49
5 Alaska Air ALK $78.27 Transportation $5,353 92 96 4.5 1.0 7.2% 0.9% 1.0% $20.72
6 Apollo Education APOL $26.55 Consumer Services $2,961 92 96 2.5 0.5 18.8% -0.1% 0.0% $15.71
7 Kindred Healthcare KND $16.95 Health Services $914 84 98 6.2 0.4 5.9% -0.5% 2.8% $2.72
8 Lear LEA $82.81 Producer Manufacturing $6,612 84 98 6.2 0.4 3.6% 14.9% 0.8% $10.81
9 Cardinal Health CAH $64.55 Distribution Services $22,162 89 96 9.1 0.2 6.7% 0.3% 1.9% $8.00
10 ITT Educational ESI $38.83 Consumer Services $906 93 94 5.2 0.7 11.8% -0.1% 0.0% $7.16
11 Exelis XLS $17.79 Electronic Technology $3,325 83 97 5.5 0.7 6.5% -0.1% 2.3% $1.60
12 Northrop Grumman NOC $113.52 Electronic Technology $24,856 86 96 7.1 1.0 5.6% 3.5% 2.2% $21.26
13 Safeway SWY $34.67 Retail Trade $8,522 89 95 7.2 0.3 4.9% -0.8% 2.3% $2.01
14 Hewlett-Packard HPQ $27.27 Electronic Technology $48,219 72 100 4.7 0.6 13.6% 1.2% 2.3% $6.27
15 Global Cash Access GCA $9.63 Consumer Services $632 93 93 9.3 1.0 21.3% 1.8% 0.0% $2.15
16 Phillips 66 PSX $70.36 Energy Minerals $41,218 80 97 10.5 0.3 8.5% 2.6% 2.3% $9.67
17 McKesson MCK $164.37 Distribution Services $37,753 92 93 11.7 0.3 5.9% 2.6% 0.6% $12.70
18 R.R. Donnelley RRD $18.14 Commercial Services $3,289 73 99 5.4 0.6 7.2% -0.6% 5.7% $2.52
19 Western Digital WDC $75.89 Electronic Technology $17,706 76 98 4.7 1.0 12.4% 1.3% 1.6% $20.12
20 Tesoro TSO $58.53 Energy Minerals $7,566 79 97 6.4 0.3 3.6% 1.8% 1.8% $10.91
21 Best Buy BBY $39.63 Retail Trade $13,531 76 97 5.0 0.3 5.4% -0.7% 1.7% $6.22
22 Macy's M $53.15 Retail Trade $19,487 75 97 6.9 0.9 5.3% 2.5% 1.9% $3.08
23 Men's Wearhouse MW $50.67 Retail Trade $2,418 93 91 7.7 1.0 3.2% 1.9% 1.4% $0.65
24 Hyatt Hotels H $48.47 Consumer Services $2,137 65 100 4.0 0.5 11.3% 3.5% 0.0% $7.94
25 Archer-Daniels ADM $41.68 Process Industries $27,372 74 97 8.5 0.3 18.9% 0.0% 1.8% $15.20
26 CBIZ CBZ $8.89 Commercial Services $422 86 93 7.1 0.8 4.8% 1.8% 0.0% $0.58
27 Delta Air Lines DAL $29.22 Transportation $24,845 95 90 6.9 0.9 5.3% -0.4% 0.8% $4.87
28 Arrow Electronics ARW $51.80 Distribution Services $5,226 72 97 8.1 0.3 4.4% 4.9% 0.0% $2.48
29 Unisys UIS $27.31 Technology Services $1,188 68 98 3.3 0.3 9.4% 0.6% 0.0% $12.69
30 Tyson Foods TSN $31.71 Consumer Non-Durables $8,677 71 97 6.0 0.3 5.6% 0.6% 0.9% $3.09
31 Brocade Comms BRCD $8.67 Electronic Technology $3,847 86 92 6.9 1.5 12.5% 1.2% 0.0% $2.14
32 Arkansas Best ABFS $32.38 Transportation $830 95 89 10.0 0.4 9.8% -0.4% 0.4% $5.37
33 Seagate STX $48.85 Electronic Technology $15,916 67 98 5.7 1.1 8.6% 0.3% 3.5% $6.85
34 Xerox XRX $11.35 Electronic Technology $13,862 75 95 6.8 1.0 12.1% -0.9% 2.0% $0.74
35 Harris HRS $64.55 Electronic Technology $6,894 77 94 7.9 1.6 6.7% 3.8% 2.6% $3.14
36 Pitney Bowes PBI $23.39 Producer Manufacturing $4,712 95 88 8.3 1.8 5.8% -0.3% 3.2% $3.84
37 Dillard's DDS $92.47 Retail Trade $3,873 72 95 6.6 0.7 3.4% 3.7% 0.3% $2.46
38 Raytheon RTN $89.23 Electronic Technology $28,238 84 91 8.6 1.2 4.3% 1.5% 2.5% $12.05
39 Foot Locker FL $38.93 Retail Trade $5,726 71 95 6.6 0.8 3.9% 1.1% 2.1% $5.32
40 TIM Participacoes TSU $24.16 Communications $11,716 71 95 5.0 1.3 5.0% 0.0% 2.7% $3.11
41 Green Plains GPRE $17.13 Process Industries $522 63 97 6.5 0.2 14.0% -0.9% 0.9% $10.36
42 Bridgepoint Education BPI $18.28 Consumer Services $995 72 94 3.9 0.7 16.5% -0.4% 0.0% $8.28
43 Heartland Pay. Sys. HPY $45.08 Technology Services $1,648 81 91 7.7 0.8 6.4% 0.0% 0.6% $4.83
44 Spirit AeroSystems SPR $32.69 Electronic Technology $3,945 95 86 5.4 0.8 5.1% -0.3% 0.0% $3.04
45 Convergys CVG $20.61 Technology Services $2,091 64 96 6.4 0.7 3.8% 2.6% 1.2% $6.11
46 Smith & Wesson SWHC $11.93 Producer Manufacturing $736 64 96 4.2 1.1 8.6% 1.4% 0.0% $2.23
47 Chico's FAS CHS $18.74 Retail Trade $2,999 70 94 7.2 1.1 3.4% 3.9% 1.6% $1.61
48 AmerisourceBergen ABC $70.63 Distribution Services $16,243 82 90 13.0 0.2 6.2% 0.6% 1.3% $5.24
49 L-3 Comms LLL $103.37 Electronic Technology $9,129 69 94 8.0 1.0 5.8% 0.8% 2.1% $4.13
50 Computer Sciences CSC $52.66 Technology Services $7,754 53 99 4.0 0.6 5.3% 4.2% 1.5% $13.88
Data source: FactSet
11:45 CAMT
Camtek clarifies its position on 3D printing: 'now in advanced stages of the development of GreenJet, a 3D printing system used for the deposition of solder mask designated for the printed circuit board industry' (5.48 +0.92)
Co announced that in light of the high trading volume of the Company's shares and rumors that have been circulating in the media over the course of the past few days, it wishes to clarify that, as reported previously, it is now in the advanced stages of the development of the GreenJet, a digital 3D printing system used for the deposition of solder mask designated for the printed circuit board industry. The first installation of the GreenJet System for evaluation in a customer's manufacturing environment is expected to take place in the beginning of 2014 and, subject to the results, the Company expects the first commercial sales of the GreenJet System to take place during 2014.
In addition, the Company wishes to inform that it has decided to focus on its two primary markets (products for the printed circuit board industry and inspection products for the semi-conductor market), and will not continue with development of future models of its Xact product line designed for the sample preparation of models for the characterization and failure analysis in the semi-conductor industry. The Company will continue to sell and support the existing Xact products. Therefore, as a future growth engine, in addition to the existing products lines, the Company will focus its activity in the field of digital 3D printing for the printed circuit board industry, including the GreenJet System.
HNR (~$4.00) was very strong yesterday; I assume the deal to sell Venezuelan assets is nearing finalization. HNR should get about 1/3 of the $400million price next month.
Wunderlich came out this morning with target of $8
My greatest fear about Mart is that you are being too optimistic! 2013 has turned out to be the "lost year" for Mart investors (due noncompletion of Umugini pipeline). Somehow I am still optimistic, as I doubt Mart can put together 2 lost years in a row.
Camtek Ltd (CAMT) Denies Rumors as Momos Engulf the Name
8:01 AM ET, 11/25/2013 - Street Insider
Momos have Camtek Ltd (NASDAQ: CAMT) on their radar related to a 3D-printing connection and rumors of a tender offer. However, the parent company set the record straight this morning saying there is no basis to the rumor about a tender offer on behalf of Priortech for the purchase of Camtek shares.
After gaining 39.5% on Friday, shares are up another 19% this morning to $3.15.
From the Company: Camtek Ltd. (NASDAQ and TASE: CAMT) ('The Company') hereby informs that yesterday the Company's parent company, Priortech Ltd. (TASE: PRTC), issued, at the request of the Israel Securities Authority, an immediate report to the effect that Priortech does not know of any information that is unavailable to the public that may have caused the sharp increase in the share price of Priortech or of Camtek during the last two days. Priortech clarified further that there is no basis to the rumor about a tender offer on behalf of Priortech for the purchase of Camtek shares.
HNR selling Venezuelan assets; keeping Gabon assets:
Harvest Natural Resources Announces Revised Proposal from Pluspetrol for Company's Interests in Venezuela; Termination of Negotiations with Vitol
14 hours 8 minutes ago - DJNF
HOUSTON, Nov. 19, 2013 /PRNewswire/ -- Harvest Natural Resources, Inc. (NYSE: HNR) today announced updated information about its continuing discussions with Pluspetrol Venezuela S.A. to sell Harvest's 32% interest in Petrodelta, S.A., its Venezuelan equity affiliate.
In response to a new proposal by Pluspetrol, Harvest and Pluspetrol have agreed, subject to negotiation of definitive agreements, to enter into two independent transactions. Under the proposal, Pluspetrol would purchase Harvest's 32% interest in Petrodelta, S.A. by purchasing HNR Energia B.V.'s 80% interest in Harvest-Vinccler Dutch Holding B.V. (HVDH) in two separate and independent transactions. The total consideration for both proposed transactions would be $400 million.
In the first proposed transaction, which is expected to close in December 2013, Harvest would sell 29% of HVDH for $125 million. Net proceeds from this first transaction are estimated to be approximately $120 million after deductions related to transaction expenses and taxes. These net proceeds would be used to pay Harvest's long-term debt with the remaining proceeds used for working capital.
In the second proposed transaction, Harvest would sell its remaining interest in HVDH for $275 million. Closing of the second transaction is expected to occur in the first half of 2014 and would be subject to, among other things, receipt of approvals from Harvest's stockholders and the Government of the Bolivarian Republic of Venezuela. Net proceeds from the second transaction are estimated to be approximately $200 million after deductions related to transaction expenses and taxes.
While Harvest and Pluspetrol have agreed to negotiate to enter into these transactions, there can be no assurance that these negotiations will result in the currently proposed transactions or any other transaction.
James A. Edmiston, President and CEO of Harvest, said: "After extended negotiations with Pluspetrol, we have come to believe this structure affords the parties a much less complex transaction structure while at the same time providing Harvest with the near-term liquidity required to fund the Company and complete the previously announced sales processes."
Harvest also announced today that negotiations toward definitive agreements with Vitol S.A. for the sale of the Company's 66.667% interest in the Dussafu Marine Permit PSC, offshore Gabon, as announced September 30, 2013, have terminated as the parties failed to reach definitive agreements.
Mr. Edmiston continued: "In spite of our best efforts, we were unable to reach an agreement on the terms of a transaction with Vitol that would meet Harvest's requirements on timing and certainty. As evidenced by Gabon's recent deepwater bid round, industry interest is very high in the Gabonese deepwater area. We have just completed our 1,130 square kilometer 3-D seismic acquisition covering Harvest's discoveries as well as the highly prospective outboard area of the block. Our discoveries on the block, our substantial prospect inventory, and the excellent prospectivity of our outboard area should continue to draw substantial industry interest."
OT: Is that house located in Buccaneer Estates, and does the boat include a bucket?
.
.
.
.
No wonder Aussies drink so much beer!
Energy stocks I hold and like are:
SFY (Great call by Bobwins; recently touted by Jimbo Cramer)
TGA (Great management with growing production in Egypt)
HNR (in negotiations to sell assets in Venezuela and Gabon)
POE.v/POEFF (Chen pick that hasn't worked worth a toot so far, but Indonesian assets should take it higher in the longer term)
MMT/MAUXF (My biggest holding; should move upward in 2014 if they can finish the dagburn Umugini pipeline and continue to deliver thru AGIP's way-too-leaky pipeline)
PRY/PNCGF article was pretty good summary, especially about the risk associated with price of oil. IMHO that downside risk due falling oil&gas prices is VERY real for all Canadian energy stocks and US shale-derived energy stocks! Canadian companies are already suffering with big discounts to WTI for instance. The US companies have to move their product a long way to get it to refineries on the Gulf Coast.
Disclosure: I do own some PNCGF, as I have for a long time, so I have a bad taste in my pocketbook from it.
14:23 SFY Swift Energy CEO disclosed buying 10K shares at $14.11 on 11/4, worth ~$140K (14.92 +1.96)
BCC.ax investors may have some concern about cash levels as well, since CAPEX plans are aggressive, yet delays have been costing them. I don't know their monthly spend rate, and I'm not savvy enough to quantify the risk regarding cash on hand, but they did a rather large PP earlier this year at .04 (painful news at the time, similar to the painful feeling I am getting now).
Good luck!
'peeker
BCC.ax got whacked, and like you say, not sure why.
Negative factors for all oils are lower trending oil prices, but Buccaneer operational performance seems to be disappointing vs. investor expectations which the company set too high.
The considerable delay of drilling plans on the expired lease may be contributing to the falloff in Australia (if they can work things out with the DNR).
Basically investors seem to be losing patience with any stock that does not measure up to expectations (e.g., MMT.v, POE.v, PNY.v, etc).
Might as well just "hang in there", since that's about all you can do (besides cursing like a sailor/buccaneer while taking the losses) when a company leaves you hanging.
'peeker
TGA outlook brightens:
RBC International E&P Daily excerpt about TGA:
TransGlobe Energy (TGL.V): On the South Alamein block, Egypt, a rig has been contracted to target the West Manar (11mmbbl) and Taef (25mmbbl) prospects; we include an upside/risk of +C$1.20/-C$0.30 and +C$2.90/-C$0.51 per share for the wells in our NAV, respectively.
TGA Q3 results are due 6 November!
https://rbcnew.bluematrix.com/docs/pdf/60a1b490-37bf-4b69-99bb-cd79b4bcda2d.pdf
Bob, did BCC.ax lose their lease at their Southern Cross unit?
... or have you heard another reason for the slide? It seems this one should still be at $0.06 or higher, but I suppose yearend Aussie/Yank/Canuck tax-loss selling could take it below $0.04 before it is ready to rebound.
Anyway, I added some today "just because".
'peeker
PVG: dr_airtime, thanks, as Brent Cook's analysis is bothersome. Well thought out though. Thanks for passing it along; I'll be looking for a small pop rather than continuing to add if it goes lower.
Much appreciated!
'peeker
OPK: ... and today they just touched $12, just a short few days since breaking out above $10; not sure what is going on with this company but the CEO is a smart guy. Could it be about the potential for RAYALDY (see previous post) or some other ill-defined catalyst that the retail investor is not yet privy to?
Anyway, it's nice to own one when it breaks out...
'peeker
PVG: Bought a re-starter position at $4.65 today; hoping for the patience to hold til it goes over $8, maybe longer.
Risk: Concern over the resignation of the independent consultant conducting a gold sampling program.
Opinions? I'd certainly appreciate any +/- opinions of PVG.
Regards to All,
'peeker
OT: Bob has decided that when you die you should be buried in Oklahoma in your smelevator. What's your favorite flower?
OT: No, further south, so we missed the deluge.
Spend most time between Atlanta and Savannah.
... and you need it.
Ain't no sunshine ...
...
...
...
...
... in your elevator !!!
OPK just broke $10 and they have been on a roll for awhile (up >100% this year). Philip Frost is the longtime CEO billionaire who runs it. If you are into Pharma/Biotech, this is worth looking into; you might want to wait for a pullback (or not).
They are currently developing many drugs, but this note is about their work on RAYALDY, a medication to help people with Vitamin D deficiency. This article is very interesting as it is written by a researcher who has done research on Vitamin D for over 10 years.
Worth the read! I promise! Vitamin D is involved in many bodily functions and promotes wellness. Opko's drug RAYALDY helps the body utilize Vitamin D.
OPKO Health Inc. And Rayaldy by John Cannell, MD
This article was published at 8:14pm ET on 10 October 2013.
http://seekingalpha.com/article/1739772-opko-health-inc-and-rayaldy?source=email_rt_article_readmore
(cut & pasted below):
_______________________________________________________________
OPKO Health Inc. And Rayaldy
Disclosure: I am long OPK. (More...)
Three weeks ago, I invested all my available funds in OPKO Health Inc. (OPK). I did that when I learned about its new drug, Rayaldy.
I am not a stock analyst, adviser, or investment expert. Instead, I am a physician and an expert on vitamin D. Ten years ago, I established the Vitamin D Council, a non-profit dedicated to educating the public and health professionals about vitamin D. I have written more than 15 peer-reviewed scientific articles on vitamin D. I have been reading, writing, and lecturing about vitamin D for the last 12 years.
Vitamin D (cholecalciferol) is not a vitamin in that it is not contained in any appreciable quantity in the food we eat, including milk. Instead, it is a prohormone made in the skin upon exposure to sunlight -- something that most of us have come to avoid during the last 30 years. Vitamin D is the only known building block for a potent seco-steroid hormone known as calcitriol. Vitamin D is metabolized to calcitriol in two steps via a more active prohormone intermediate known as calcifediol, the circulating form of vitamin D. Like corticosteroids and other steroid hormones, calcitriol directly regulates hundreds if not thousands of human genes. In calcitriol's case, those genes are involved with the repair and maintenance of the human body. It is crucial to realize that steroid hormones have as many mechanisms of action in various diseases as genes they regulate.
Science has discovered much about vitamin D in the last ten years, almost all of it promising. If they know anything about vitamin D, most people think of it as something that may protect against various diseases. Indeed, the evidence is so strong for prevention of disease, four large and very expensive phase 3 trials are currently underway around the world to see if vitamin D prevents common diseases like cancer and heart disease. The largest of these trials is the VITAL study at Harvard where scientists are conducting a randomized controlled trial of vitamin D in 20,000 Americans. Obviously, these large studies would never have been funded unless solid reasons exist indicating these vitamin D trials will be positive. For more on vitamin D, go to Harvard School of Public Health's website on vitamin D.
While everyone seems intent on studying vitamin D's preventative effects, few have noticed that scientists have published dozens of small randomized controlled trials in the last few years, documenting that vitamin D has treatment effects, not just preventative effects. These small "phase 2" trials show over-the-counter (OTC) vitamin D has a treatment effect in several diseases, especially autoimmune diseases like multiple sclerosis. In addition, "phase 2" trials exist, showing vitamin D has efficacy in treating diseases as diverse as major depression, falls in the elderly, atopic dermatitis, congestive heart failure in infants, hypertension in African Americans, and tooth loss in the elderly. Treatment effects are not cures; rather, they are simply clinical or laboratory improvements. Besides the randomized controlled trials, hundreds, if not thousands, of epidemiological studies now exist, suggesting that vitamin D will have treatment effects in an even wider variety of human disease.
OPKO Health's new drug, Rayaldy, is the first and only modified-release formulation of calcifediol, protected by newly issued patents (see, for example, US Patent No. 8,361,488). It is currently in phase 3 trials for the treatment of secondary hyperparathyroidism in vitamin D insufficient patients with chronic kidney disease (CKD). Its phase 2 trials for this indication were very positive. Rayaldy is much more potent than OTC vitamin D and it corrects vitamin D insufficiency more effectively and reliably than does OTC vitamin D. Also, Rayaldy is less prone to degradation in the body than is OTC vitamin D because of gradual delivery of calcifediol from its modified-release formulation.
If the FDA will eventually approve Rayaldy; OPKO Health will certainly study more indications for its new drug than just secondary hyperparathyroidism in CKD. According to the current medical literature, phase 3 trials targeting new indications could confirm treatment effects in a wide variety of human diseases.
Of course, risks exist. I may be wrong about vitamin D; similar enthusiasm for other vitamins in the past did not pan out. Larger randomized controlled trials may fail to find treatment effects with vitamin D. Also, Rayaldy's current phase 3 trials may turn out to be negative. Eventually, other companies may enter the market with different modified-release formulations of vitamin D. OPKO Health may not aggressively seek other indications, settling only for the multibillion-dollar CKD market.
Rayaldy is currently the only product of its type in development by any drug company, as far as I am aware. Currently available prescription vitamin D hormone therapies have significant limitations or side effects, something not seen with Rayaldy. Physicians will soon have a choice: tell their patients to go to the corner drug store to buy OTC vitamin D or prescribe the more potent and reliable and less degradable Rayaldy.
Again, it is important to realize that steroid hormones like calcitriol and corticosteroids have as many mechanisms of action as genes they regulate. The number of genes directly regulated by corticosteroids is estimated to be around 100, almost all having to do with inflammation. However, calcitriol regulates 1,000 human genes. Calcitriol's genetic mechanism of action not only includes anti-inflammatory actions, but extends to mechanisms involving DNA repair, anti-autoimmune actions, mechanisms involving brain development and functioning, profound effects on the immune system, cardiovascular functioning, lung function, liver function, and pancreatic function, to name a few.
In my opinion, sales of Rayaldy-like drugs will eventually easily outstrip the sales of corticosteroids.
Pharma/Biotech company summary (sorry, original format not retained):
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Weekly Biotech/Pharma Volatility Tracker -- ARIA crashes; Multiple catalysts expected next week
ARIA shares crashed approximately 70% after the company announced poor safety data from a clinical trial of Iclusig. Next week should see volatility due to two PDUFA dates and an FDA Advisory Committee Meeting. Check out the "Recent Events" section and Anticipated Movers list below for more information on these catalysts and to identify others in the coming weeks. Finally, be sure to use our Calendar of Upcoming Events to prepare for the many catalysts scheduled for 2013.
Recent Events
Arrowhead Research (ARWR) has gained over 25% this week. On Tuesday the company announced that it completed enrollment in a Phase 1 clinical trial of ARC-520, its RNAi-based candidate against chronic hepatitis B virus infection. Initial data indicate that ARC-520 is generally safe and well tolerated at all six dose levels studied, enabling the company to proceed with plans to initiate a Phase 2a pilot efficacy study in chronic HBV patients. The company also announced that it priced a private offering with net proceeds of $60 million. The offering was priced at $5.86 per share. Arrowhead Research was listed on our Anticipated Movers table last week.
Ariad Pharmaceuticals (ARIA) was one of this week's sharpest decliners, losing nearly 70%. Yesterday the company announced results of its review of updated clinical data from the pivotal PACE trial of Iclusig (ponatinib) for the treatment of certain types of difficult to treat leukemia. The key takeaway was that non-serious and serious arterial and venous adverse events combined occurred in approximately 20% of patients. Patient enrollment in all clinical studies of Iclusig is being paused, and subject to agreement with the FDA, will be resumed with anticipated changes in dose and other modifications. A number of analysts firms have issued downgrades as a result of the news, including Stifel, Brean Capital, BofA/Merrill, Barclays, JMP Securities, Citigroup, Chardan Capital Markets, and Summer Street Research. Chardan believes that Ariad will be able to reach an agreement with the FDA but believes the timing of a potential resolution is unpredictable. Oppenheimer adds that it now sees very little potential for Iclusig as a first-line treatment.
Discovery Laboratories (DSCO) jumped over 35% last Friday after announcing that the FDA agreed to the company's updated product specifications for SURFAXIN (lucinactant) Intratracheal Suspension which was approved for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. The Company has initiated manufacturing of SURFAXIN for its planned commercial introduction in the fourth quarter of 2013.
Atossa Genetics (ATOS) revealed after the close last Friday that it initiated a voluntary recall to remove the ForeCYTE Breast Health Test and the Mammary Aspiration Specimen Cytology Test (MASCT) device from the market. Shares opened lower by over 50% on Monday morning. The recall was issued to address concerns raised by the FDA in a warning letter received by Atossa in February 2013. The FDA raised concerns about (1) the current instructions for use (IFU); (2) certain promotional claims used to market these devices; and (3) the need for FDA clearance for certain changes made to the Nipple Aspirate Fluid specimen collection process identified in the current IFU. Atossa will remove existing product from the market until FDA's concerns are addressed. Analysts at Sidoti downgraded the company in reaction to the recall.
Acura Pharmaceuticals (ACUR) traded higher by as much as 32% this morning. The company announced that it entered into agreements with Par Pharmaceutical and Impax Laboratories (IPXL) to settle ongoing patent disputes. The settlement provides Acura with protection against generic competition for its drug Oxecta through 2021.
Trading Ideas, Anticipated Movers & Upcoming Events
Anticipated Movers:
Volatility remains high in several stocks on our Anticipated Movers list, most notably CNDO and VNDA. New additions to the list include PSDV, XOMA, MACK, and KERX. Volatility moderated or near term catalysts have been eliminated in ARWR and CRIS, which have been removed from the list.
Looking at the bigger list, implied volatility is elevated in a large number of biotech/pharmacy stocks, including the following: CNDO, VNDA, PSDV, XOMA, AMRN, ONCY, ATRS, MACK, ANAC, and KERX. These elevated volatility levels are indicative of expectations for greater volatility in these stocks in the future.
Anticipated Movers Table:
Ticker Price Implied Volatility Historical Volatility Implied vs. Historical 1-day move based on historical Current implied 1-day event SD Event Date
CNDO 7.00 222% 66% 3.3x 4.2% 14.6% Coronado Biosciences' two principal pharmaceutical product candidates in clinical development are: TSO (Trichuris suis ova or CNDO-201), a biologic for the treatment of autoimmune diseases; and CNDO-109, a biologic that activates natural killer cells, for the treatment of acute myeloid leukemia, multiple myeloma and solid tumors. On July 1, 2013 the company announced it completed enrollment of TRUST-I, its Phase 2 clinical trial with TSO in 250 Crohn's disease patients. Coronado expects to report top-line data in the fourth quarter of 2013. A second interim analysis of data from the TRUST-II trial in Europe is also expected in the second half of 2014. By 12/31/2013
VNDA 9.81 212% 52% 4.1x 3.3% 13.8% Vanda Pharmaceuticals is focused on the development and commercialization of products for the treatment of central nervous system disorders. On July 29, 2013 the FDA accepted and granted a priority review to Vanda's NDA for tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder in the totally blind. An FDA Advisory Committee will discuss the application on November 14, 2013. The PDUFA date for tasimelteon is January 31, 2014. 11/14/2013
PSDV 4.79 207% 95% 2.2x 6.0% 14.4% pSivida has licensed ILUVIEN for the treatment of chronic diabetic macular edema (DME) to Alimera Sciences. On May 1, 2013 the FDA acknowledge receipt of an NDA resubmission for ILUVIEN and stated that it was considered a complete, class 2 response to the FDA's November 2011 Complete Response letter. The PDUFA date for ILUVIEN is October 17, 2013. 10/17/2013
XOMA 4.66 205% 69% 3.0x 4.4% 13.6% XOMA's flagship candidate, gevokizumab, is a humanized antibody to interluekin beta in clinical development for the treatment of conditions associated with inflammation. Gevokizumab currently is being evaluated in over a dozen trials involving 10 different indications, six of which are rare diseases. The company's Phase 2 erosive osteoarthritis of the hand with elevated CRP study is expected to deliver top-line results in October. By 10/31/2013
AMRN 6.36 186% 56% 3.3x 3.5% 12.2% Amarin received FDA approval of Vascepa capsules as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia on July 26, 2012. An FDA Advisory Committee will review Amarin's sNDA for Vascepa for the treatment of patients with mixed dyslipidemia and high triglyceride levels on October 16, 2013. The PDUFA date for the sNDA is December 20, 2013. 10/16/2013
ONCY 2.79 164% 73% 2.2x 4.6% 11.3% Oncolytics Biotech develops oncolytic viruses as potential cancer therapeutics. The company's lead product, REOLYSIN, a broadly active novel cancer therapy, is in multiple ongoing clinical trials, including seven randomized studies. In May the company announced positive results from REO 020, a Phase 2 clinical trial in patients with metastatic melanoma. The company is prepared to commence the data analysis stage of its randomized head and neck clinical study (REO 018) once sufficient patient events have occurred. Ongoing
ATRS 4.36 147% 40% 3.6x 2.5% 9.6% Antares Pharma focuses on self-administered parenteral pharmaceutical products and topical gel-based medicines. On February 27, 2013 the FDA accepted the company's NDA for OTREXUP, a potential new product for the subcutaneous delivery of methotrexate (MTX) using Medi-Jet technology. OTREXUP is being developed for self-administration of MTX to enhance the treatment of rheumatoid arthritis, poly-articular-course juvenile RA and psoriasis. The PDUFA date for OTREXUP is October 14, 2013. 10/14/2013
MACK 3.54 134% 51% 2.6x 3.2% 9.0% Merrimack currently has six oncology therapeutics in clinical development. The company recently completed enrollment in the second cohort of a Phase 2 clinical trial of MM-121, also known as SAR256212, for the treatment of breast cancer. The first cohort was fully enrolled in April 2013, with final results expected in fall 2013. By 12/31/2013
ANAC 11.00 121% 43% 2.8x 2.7% 8.1% Anacor's two lead product candidates are topically administered dermatologic compounds — tavaborole, an antifungal for the treatment of onychomycosis, and AN2728, an anti-inflammatory PDE-4 inhibitor for the treatment of atopic dermatitis and psoriasis. The comapny expects a resolution to its arbitration with Valeant Pharmaceuticals, who is seeking to launch a generic version of tavaborole, in the second half of 2013. The company also expects results from the MUSE and thorough QT studies of AN2728 for the treatment of atopic dermatitis in the second half of 2013. By 12/31/2013
KERX 9.56 101% 43% 2.4x 2.7% 6.9% KERX announced on October 8, 2013 that the FDA accepted its NDA for Zerenex (ferric citrate) as a treatment for elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease (CKD) on dialysis. Zerenex is also in Phase 2 development in the U.S. for the management of elevated phosphorus and iron deficiency in anemic patients with Stage 3 to 5 non-dialysis dependent CKD. Results from the Phase 2 trial are expected by the end of the year. By 12/31/2013
*The Current implied 1-day standard dev. is the 1-day, 1-standard deviation move in the stock, based on the implied 1-day event volatility. Based on current options prices, the underlying stock is expected to remain within a +/- 1 standard deviation range, about 2/3 of the time, and within a +/- 2 standard deviation range about 95% of the time.
Calendar of Upcoming Biotech/Pharmacy Events
= Highly Anticipated
October 2013
Date Ticker Company Optionable Event Product Treatment Briefing Notes/Links
10/3/2013 LGND, PFE Ligand Pharmaceuticals and Pfizer Y PDUFA (NDA) Bazedoxifene / conjugated estrogens Vasomotor symptoms and vulvar and vaginal atrophy APPROVED
On October 3, 2013 the FDA approved approved DUAVEE (conjugated estrogens/bazedoxifene) 0.45mg / 20mg tablets, a novel therapy for women with a uterus, for the treatment of moderate-to-severe vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis. Pfizer anticipates that DUAVEE will be available in the U.S. in the first quarter of 2014. DUAVEE is part of a broader research collaboration with Ligand Pharmaceuticals.
10/8/2013 BAYRY Bayer N PDUFA (NDA) Adempas (riociguat) Chronic thromboembolic pulmonary hypertension APPROVED
On October 8, 2013 the FDA approved Adempas (riociguat) to treat adults with two forms of pulmonary hypertension.
10/14/2013 ATRS Antares Pharma Y PDUFA (NDA) Otrexup Rheumatoid arthritis On December 17, 2013 Antares Pharma announced the submission of an NDA to the FDA for OTREXUP, a combination product for the delivery of methotrexate (MTX) using Medi-Jet technology. OTREXUP was developed for easy subcutaneous administration of MTX to enhance the treatment of rheumatoid arthritis, poly-articular-course juvenile RA and moderate to severe psoriasis. The PDUFA date is October 14, 2013.
10/16/2013 AMRN Amarin Y Advisory Committee Meeting Vascepa High triglycerides The FDA will convene an advisory committee on October 16, 2013 in connection with its review of the sNDA seeking approval for the use of Vascepa (icosapent ethyl) capsules as an adjunct to diet in the treatment of adult patients with high triglycerides (TG =200 mg/dL and <500 mg/dL) with mixed dyslipidemia. The FDA has assigned a PDUFA date of December 20, 2013 for completion of its review of the sNDA.
10/17/2013 PSDV, ALIM pSivida, Alimera Sciences Y PDUFA (NDA) Iluvien Chronic diabetic macular edema On May 1, 2013 pSivida announced that the FDA acknowledged receipt of the resubmission of the NDA for ILUVIEN for treatment of chronic diabetic macular edema (DME) and stated that the resubmission was considered a complete, class 2 response to the FDA’s November 2011 complete response letter. The new PDUFA date is October 17, 2013. pSivida has licensed ILUVIEN to Alimera Sciences.
10/21/2013 AMAG AMAG Pharmaceuticals Y PDUFA (sNDA) Feraheme Iron deficiency anemia AMAG Pharmaceuticals' sNDA for Feraheme seeks approval for a broader indication for the treatment of iron deficiency anemia. On September 23, 2013, AMAG Pharmaceuticals received a notification from the FDA stating that it identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments. The FDA stated that the Notification does not reflect a final decision on the information under review. The Company plans to work with the FDA to resolve any outstanding issues. The PDUFA date is October 21, 2013.
10/21/2013 CBST Cubist Pharmaceuticals Y PDUFA (sNDA) Entereg GI recovery On December 21, 2012 Cubist announced that it submitted an sNDA to the FDA requesting approval for the use of ENTEREG (alvimopan) to accelerate GI recovery following any surgery that includes a bowel resection with primary anastomosis; expanded from the current indication in patients requiring surgery for colorectal disease. The estimated PDUFA date is October 21, 2013.
10/31/2013 (estimated) SGEN Seattle Genetics Y PDUFA (sBLA) ADCETRIS (brentuximab vedotin) Hodgkin lymphoma and systemic anaplastic large cell lymphoma On May 14, 2013 the FDA accepted Seattle Genetics' sBLA supporting the use of ADCETRIS (brentuximab vedotin) for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma. The FDA was expected to take action on the application by September 14, 2013, however, no determination has been made.
10/31/2013 (estimated) ZGNX Zogenix N PDUFA (NDA) Zohydro ER Chronic pain On October 1, 2013 Zogenix was informed by the FDA that an action letter on the NDA for Zohydro ER (hydrocodone bitartrate) extended-release capsules could follow after a further delay of short duration. The FDA had previously informed the company that it expected to issue an action letter over the summer. The original PDUFA goal date was March 1, 2013. Zogenix and the FDA have completed the final labeling and reached agreement on the post-marketing requirements for Zohydro ER. The FDA has also reconfirmed there are no deficiencies in the NDA.
November 2013
Date Ticker Company Optionable Event Product Treatment Briefing Notes/Links
11/4/2013 BIIB Biogen Idec Y PDUFA (BLA) Alprolix (recombinant factor IX Fc fusion protein) Hemophilia B On March 4, 2013 the FDA accepted Biogen's BLA for the marketing approval of ALPROLIX (recombinant factor IX Fc fusion protein, or rFIXFc) for the treatment of hemophilia B and granted the company a standard review timeline. Based on a January 4, 2013 submission date the expected PDUFA date is November 4, 2013.
11/11/2013 BIIB Biogen Idec Y PDUFA (sNDA) Tysabri Multiple sclerosis On January 16, 2013 Biogen Idec and Elan submitted an application to the FDA requesting updates to the TYSABRI (natalizumab) labels. The application requests an expanded indication that would include first-line use for people living with certain relapsing forms of multiple sclerosis who have tested negative for antibodies to the JC virus. Biogen completed a purchase of full rights and control of TYSABRI from Elan on April 2, 2013. The expected PDUFA date is November 11, 2013.
11/14/2013 VNDA Vanda Pharmaceuticals Y Advisory Committee Meeting Tasimelteon Non-24-Hour disorder On July 29, 2013 the FDA accepted the filing and granted a priority review classification to Vanda Pharmaceuticals' NDA for tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind. The PDUFA date is January 31, 2014 and the the FDA has tentatively scheduled an advisory committee meeting to discuss the application on November 14, 2013.
11/27/2013 BMY / AZN Bristol-Myers Squibb, AstraZeneca Y PDUFA (BLA) Metreleptin Metabolic disorders associated with lipodystrophy On June 4, 2013 the FDA accepted and granted a Priority Review designation for the Biologics License Application (BLA) for metreleptin, an investigational agent for the treatment of metabolic disorders associated with inherited or acquired lipodystrophy (LD). The expected PDUFA date is November 27, 2013.
By
11/28/2013 (estimated) JNJ Johnson & Johnson (via Janssen R&D) and Medivir (private) Y PDUFA (NDA) Simeprevir (TMC435) Hepatitis C On March 28, 2013 Janssen R&D (a JNJ company) and Medivir submitted an NDA to the FDA seeking approval for simeprevir (TMC435), an investigational NS3/4A protease inhibitor administered once daily with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients. The application was granted a priority review on May 13, 2013. The FDA is expected to make a determination by November 28, 2013.
By 11/28/2013 (estimated) SNY Sanofi Y PDUFA (sBLA) Lemtraded Relapsing multiple sclerosis On January 28, 2013 the FDA accepted for review Genzyme's sBLA seeking approval of LEMTRADA (alemtuzumab) for the treatment of relapsing multiple sclerosis. Genzyme is a Sanofi company. The company said it expects FDA action in late 2013.
December 2013 & Beyond
Date Ticker Company Optionable Event Product Treatment Briefing Notes/Links
12/6/2013 AUXL, BSTC Auxilium and BioSpecifics Technologies Y PDUFA (sBLA) XIAFLEX Peyronie's disease On December 27, 2012 the FDA accepted for filing and granted standard review status to Auxilium's sBLA for XIAFLEX (collagenase clostridium histolyticum or CCH), a novel, in-office biologic therapy for the potential treatment of Peyronie's disease. On August 28, 2013 the PDUFA date was extended to December 6, 2013 from September 6, 2013 following the submission of revisions regarding the company's proposed REMS program. BioSpecifics is partnered with Auxilium for XIAFLEX.
12/8/2013 GILD Gilead Sciences Y PDUFA (NDA) Sofosbuvir Hepatitis C On June 7, 2013 the FDA granted a priority review to Gilead's NDA for sofosbuvir, a once-daily oral nucleotide analogue inhibitor for the treatment of chronic hepatitis C virus infection. The FDA set a PDUFA date of December 8, 2013.
12/18/2013 THRX, GSK Theravance and GlaxoSmithKline Y PDUFA (NDA) ANORO ELLIPTA Chronic obstructive pulmonary disease On August 1, 2013 Theravance announced that the FDA's Pulmonary-Allergy Drugs Advisory Committee will discuss the new molecular entity NDA for umeclidinium bromide and vilanterol dry powder for inhalation (proposed trade name ANORO ELLIPTA), sponsored by Glaxo Group for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The PDUFA date is December 18, 2013.
12/18/2013 (estimated) SNY Sanofi Y PDUFA (NDA) Lixisenatide Type 2 diabetes On February 19, 2013 the FDA accepted for review Sanofi's NDA for lixisenatide, the first once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes mellitus. The estimated PDUFA date is December 18, 2013.
12/20/2013 AMRN Amarin Y PDUFA (sNDA) Vascepa High triglycerides An FDA Advisory Committee is scheduled to review Amarin's sNDA for Vascepa on October 16, 2013. See above for details. The FDA has assigned a PDUFA date of December 20, 2013 for completion of its review of the sNDA.
12/25/2013 (decision likely by 12/24/2013) BAYRY, ONXX Bayer, Onyx Pharmaceuticals Y PDUFA (sNDA) Nexavar (sorafenib) Thyroid cancer On August 27, 2013 Bayer and Onyx announced that the FDA granted Priority Review designation to the sNDA for the oral multi-kinase inhibitor Nexavar (sorafenib) tablets under evaluation for the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer. The PDUFA date for completion of review by the FDA of the sNDA is December 25, 2013.
12/26/2013 (estimated) BAX Baxter Y PDUFA (BLA) FEIBA NF Hemophilia A and B On February 26, 2013 Baxter submitted a BLA supplement to the FDA for the approval of prophylaxis treatment of FEIBA NF [Anti-Inhibitor Coagulant Complex], Nanofiltered and Vapor Heated, in patients with hemophilia A or B and inhibitors. The estimated PDUFA date is December 26, 2013.
12/27/2013 ACT Actavis Y PDUFA (NDA) Norethindrone Transdermal Delivery System Contraception On May 13, 2013 the FDA accepted Actavis' NDA for a progestin-only transdermal contraceptive patch (Norethindrone Transdermal Delivery System) for use by women to prevent pregnancy. The PDUFA date is December 27, 2013.
1/8/2014 GSK GlaxoSmithKline Y PDUFA (sNDA) Mekinist (trametinib) Unresectable or metastatic melanoma On September 16, 2013 Glaxo announced that the FDA granted Priority Review designation to its sNDA for combined use of Tafinlar (babrafenib) and Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 E or K mutation. The PDUFA date for Mekinist is January 8, 2013.
1/9/2014 GSK GlaxoSmithKline Y PDUFA (sNDA) Tafinlar (dabrafenib) Unresectable or metastatic melanoma On September 16, 2013 Glaxo announced that the FDA granted Priority Review designation to its sNDA for combined use of Tafinlar (babrafenib) and Mekinist (trametinib) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 E or K mutation. The PDUFA date for Tafinlar is January 9, 2013.
1/11/2014 AZN, BMY AstraZeneca, Bristol-Myers Squibb Y PDUFA (NDA) Dapagliflozin Type 2 diabetes On July 25, 2013 AstraZeneca and Bristol-Myers Squibb announced that the FDA acknowledged receipt of the NDA resubmission for investigational drug dapagliflozin for the treatment of adults with type 2 diabetes. The FDA assigned a PDUFA goal date of January 11, 2014.
1/12/2014 BIIB Biogen Idec Y PDUFA (BLA) ELOCTATE (recombinant factor VIII FC fusion protein) Hemophilia A On May 13, 2013 the FDA accepted Biogen's BLA for ELOCTATE (recombinant factor VIII Fc fusion protein) for the treatment of hemophilia A. Based on a March 12, 2013 submission date the expected PDUFA date is January 12, 2014.
1/14/2014 CHTP Chelsea Therapeutics Y Advisory Committee Meeting NORTHERA (droxidopa) Neurogenic orthostatic hypotension On October 9, 2013 Chelsea Therapeutics announced that the FDA's Cardiovascular and Renal Drug Advisory Committee will review the company's NDA for NORTHERA (droxidopa) for the treatment of symptomatic neurogenic orthostatic hypotension. The meeting is tentatively scheduled for January 14, 2014. The PDUFA date for NORTHERA is February 14, 2014.
1/24/2014 POZN POZEN Y PDUFA (NDA) PA32540/PA8140 Prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers On May 29, 2013 POZEN announced that the FDA accepted its NDA for PA32540/PA8140. Both products are a coordinated-delivery tablet combining immediate-release omeprazole (40 mg), a proton pump inhibitor (PPI), layered around a pH-sensitive coating of an aspirin core. Pending FDA review and approval, an indication is sought for PA tablets for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers. The PDUFA date is January 24, 2014.
1/27/2014 (estimated) MRK Merck Y PDUFA (BLA) Timothy grass pollen (Phleum pratense) Allergy immunotherapy tablet On March 27, 2013 Merck announced that its BLA for investigational Timothy grass pollen (Phleum pratense) allergy immunotherapy tablet (AIT) was accepted for review by the FDA. The estimated PDUFA date is January 27, 2013.
1/29/2014 (estimated) DEPO, MNK Depomed, Mallinckrodt Y PDUFA (NDA) MNK-795 Acute pain On July 29, 2013 Depomed announced that the FDA accepted for filing an NDA from Mallinckrodt for MNK.795. MNK-795 is a controlled-release oral formulation of oxycodone and acetaminophen that has been studied for the management of moderate to severe acute pain where the use of an opioid analgesic is appropriate. MNK-795 is formulated with Depomed's Acuform drug delivery technology. The estimated PDUFA date is January 29, 2014.
1/31/2014 VNDA Vanda Pharmaceuticals Y PDUFA (NDA) Tasimelteon Non-24-Hour disorder On July 29, 2013 the FDA accepted the filing and granted a priority review classification to Vanda Pharmaceuticals' NDA for tasimelteon, a circadian regulator for the treatment of Non-24-Hour Disorder (Non-24) in the totally blind. The PDUFA date is January 31, 2014 and the the FDA has tentatively scheduled an advisory committee meeting to discuss the application on November 14, 2013.
-- Tyler Desmond
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