Durata Therapeutics, Inc (DRTX)

[maytepper]

$DRTX Durata Therapeutics: Moving To Neutral On Likely Closure Of Actavis Takeout, Says Roth Capital http://www.smarteranalyst.com/2014/10/15/durata-therapeutics-moving-neutral-likely-closure-actavis-takeout-says-roth-capital/

[136]

Hey bud, remember when I introduced you to DRTX ??

;)

[136]

DRTX nice one!!!! Started this board last year under $8 as a buyout target .

[dshade]

appears someone knew 2 days ahead. anyways nice move

[maytepper]

$DRTX $MDCO Durata Therapeutics: We Recommend Adding To Positions At These Levels, Says Roth Capital http://www.smarteranalyst.com/2014/09/17/durata-therapeutics-we-recommend-adding-to-positions-at-these-levels-says-roth-capital/

[MiamiGent]

DRTX met and as I suspected, appears to need to do a secondary offering.
With its recently approved intravenous antibiotic drug, a $150M by 2021 mkt will be split three ways.
A "sell the Earnings news" likely to ensue. It has been up on baseless buyout rumours to begin with.
MG
http://stockcharts.com/h-sc/ui?s=DRTX


news of one of the three competitors:

FDA approves The Medicines Co's acute skin infection drugBY Reuters — 6:23 PM ET 08/06/2014
By Natalie Grover

Aug 6 (Reuters) - The U.S. Food and Drug Administration approved The Medicines Co's (MDCO) single-dose intravenous drug to treat acute bacterial skin infections, the agency's third approval for the same condition this year.

Drugmakers need to constantly devise new therapies to fight bacterial infections as patients build up resistance to older antibiotics.

All the three drugs target acute bacterial skin and skin structure infections (ABSSSI), caused by the Gram positive strain of bacteria. These infections involve deep tissue or are associated with an underlying disease such as diabetes.

Medicines Co's (MDCO) treatment, Orbactiv, is in the same class of drugs as generic vancomycin, the standard-of-care for methicillin-resistant Staphylococcus aureus (MRSA), a serious Gram-positive infection.

ABSSSI, which leads to hospitalization of about 5.2 million patients in the United States and Western Europe each year, often involves intravenous therapies that require hospitalization over multiple days, the company said.

A single 1200 mg dose of Orbactiv comprises a full course of therapy - unlike vancomycin which requires twice-daily intravenous infusions for seven to 10 days - giving it an edge over competition.

The regulator in recent months approved Cubist Pharmaceuticals Inc's (CBST) Sivextro and Durata Therapeutics Inc's Dalvance for the same condition.

Sivextro, available for intravenous and oral use, is administered once daily for six days. Dalvance, an intravenous drug, is given in two doses, eight days apart.

Jefferies & Co analyst Biren Amin told Reuters he expects Orbactiv to be launched in the fourth quarter and estimated peak U.S. sales of $150 million by 2021.

Orbactiv, known generically as oritavancin, was found to be non-inferior to vancomycin in 1,959 patients in late-stage trials. Patients on the drug most frequently reported adverse events that included nausea, headache, vomiting and diarrhea.

The antibiotic received an expedited review by the FDA and was designated a qualified infectious disease product, qualifying it for an extra five years of marketing exclusivity. (Additional reporting by Anjali Rao Koppala in Bangalore)

[redharocosmo]

This board is dead.... Not sure why after the last two weeksoif solid green..... Took a starter position here today, any other ihubers in on this one?

[koman]

At this point it seems that they are focusing on manufacturing and going solo. This does not mean that there won't be an offer by big pharma later on but I doubt we see such announcement anytime soon. Either scenario of going alone or future sale of co will most likely mean a higher pps so at this level it is a bargain. I would like to see pps of 30 but I can't predict when such target will be met if ever. Everyone will want to look at sales number and product launch expense but that data won't be until next year, so if you want to get the most benefit from this stock you will have to really hold this one til next summer. GL Also, let's hear what management plans to do about future growth etc ie will they buy another product?

[ResourceBaller]

What is next for this co. Sales or do we think they will sell the Co?

[koman]

Almost no way to tell accurately on daily fluctuations but I can guess like anyone else out there. This was a sell on the news but not much pop in the after hours. I am looking for a initial sell off followed by a retrace hopefuly close to 17pps. If there is a pop up at open I'm guessing the opposite and a close at around 16. But it doesn't matter to me since I'm not day trading this one but holding it until it gets bought out or my target price is reached.

[bullmarket2222]

I can't tell yet, but I'm pouring over the data now....
Might make a play AM....

BULL

[ResourceBaller]

What is this thing going to close at tomorrow?

[koman]

Can't tell if shorts are shorting this as longs are rushing to lock in profit. Unfortunately my shares got locked up in a GTC order that I can't seem to cancel. I might as well hold out for all this volatility to settle and see what management has to say about their future plans. I hope they plan on selling to maybe Astrazeneca as they may want to do an acquisition to thwart PFE takeover. This sell on the news will hopefully be short lived as this is an approved drug and not just some pII data results.

[mathew633]

thanks!

[koman]

News have to be first spread in the major outlets first before this halt is lifted. IMO AH will be best time to trade out unless you are holding out for sale of co. GL

[mathew633]

Thanks...wonder if we'll trade AH today?

[koman]

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm398724.htm

[faxedreceipts]

TOS says on its newstream. Weeeeeeeeeeeeeee

[mathew633]

and you know because?

it's till halted

[koman]

it is approved

[mathew633]

DRTX...halted!

[akamaii]

Yeah I hope some folks discover ctix. Are you still there

[centillion]

Spreading the good word are you?

[akamaii]

Try looking a ctix brialacidin one day pill half of trial so far so good. Phase 2b it's other pipe is kevetrin activating p53 at Df for mtd. Brialacidin I'm sure will work on 3 day regimen but if one day pill works watch out including

[ImOnABoat]

I was. But, to be honest with you, there is nothing to moderate around here :) I have been in DRTX since last July, and was lucky to get in at $7. But I have parted ways with this stock today as I find my 130% percent gain to be sufficient, and would rather not take my chances on that 9% chance of a CRL.

Best of luck to all!

[deniseann]

Hi itmd...

I don't know if i' going crazy here, but weren't you just the moderator of this board yesterday...?

If not, I apologize...

denise.

[ImOnABoat]

I expect around 20%.

[ResourceBaller]

I hope we get a good pop if we get the approval.

[ImOnABoat]

DRTX has moved up marvelously ahead of the decision date.

[fam401]

I'd love it also we can only wait and see!! Exciting times ahead!!

[ResourceBaller]

I would love to see this thing hit $20.00 plus a share on approval. I think it is very possible IMO.

[ImOnABoat]

I expect a 20-30% pop. Everyone expects the drug to be approved after the 12:0 AdCom vote, so that is somewhat built into the price already. On the other hand, if something were to go wrong, DRTX would get crushed into non-existence. 90/10 are the chances...

[ResourceBaller]

I think we should get a pretty good pop on approval. 50%?

[Badger2]

IMO, it is very good. They are on a fast track "Priority Review" per FDA. This means the FDA feels there is an urgent need for their product. I am watching and not in yet. Would like to get a better deal. That may not happen. Good luck!

[fam401]

None that I have heard I was just curious to see everyone else's opinion in the future of this company

[Badger2]

Watching for the May 8th Q1 results. Any rumors?

[fam401]

Any opinions on how how we will climb leading up the May 26?? What if we get that approval??

[ImOnABoat]

75.6% institutional ownership as of March 31 2014 - pretty impressive, if you ask me.

[ImOnABoat]

Over 91% Chance of Approval On or Before May 26, 2014.

http://seekingalpha.com/article/2129313-over-91-percent-chance-of-approval-for-mannkind-and-durata-therapeutics

[ImOnABoat]

Is there anyone lurking around here who could provide an insight in regards to such precedent? Thanks!

[mathew633]

I don't have answer for that

[ImOnABoat]

Nice.

[ImOnABoat]

Bought in big time today. I believe $12.20 was the bottom heading into the approval next month.

I have a question for you -- given the recent ADCOM's unanimous recommendation to approve, how likely is it that the FDA will choose to go against it? Do you know of any precedents in which the FDA went AGAINST the UNANIMOUS recommendation of ADCOM?

Thanks!

[TheFinalCD]

FDA Advisory Committee Unanimously Recommends Approval of Dalvance(TM) for the Treatment of Acute Bacterial Skin and Skin Str...







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Alert



Durata Therapeutics, Inc. (MM) (NASDAQ:DRTX)
Intraday Stock Chart

Today : Tuesday 1 April 2014
Click Here for more Durata Therapeutics, Inc. (MM) Charts.
Durata Therapeutics, Inc. (Nasdaq:DRTX) announced today that the U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee voted 12 to 0 that the Company has provided substantial evidence of the safety and effectiveness of its investigational drug, DalvanceTM (dalbavancin) for injection, for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). While not bound by the guidance provided by the Committee, the FDA will consider the Committee's deliberations as part of its review of the New Drug Application (NDA) for Dalvance, which was accepted for priority review by the FDA in November 2013 with an action date of May 26, 2014.

"We are pleased with the positive outcome of today's Advisory Committee meeting, and the confidence that was expressed regarding the safety and effectiveness of Dalvance," said Paul R. Edick, Durata Therapeutics Chief Executive Officer. "If approved by the FDA, Dalvance would be the first once-weekly antibiotic for ABSSSI, providing an alternative to current once- or twice-daily treatments. We look forward to continuing to work with the FDA on its evaluation of our product."

A total of 21 clinical trials have been conducted with dalbavancin in the entire clinical program, with the five Phase 3 trials evaluating nearly 3,000 patients. Two Phase 3 trials, DISCOVER 1 and DISCOVER 2 ("Dalbavancin for Infections of the Skin COmpared to Vancomycin at an Early Response"), were conducted under a Special Protocol Assessment (SPA) with the FDA and included more than 1,300 patients with ABSSSI.

ABOUT ABSSSI

For the six-month period of January to June 2010, a projected 9.2 million patients were treated in U.S. hospitals for infections of any type, and nearly 17 percent of the diagnostic category presentations were for skin and skin structure infections (SSSIs). Of these presentations for SSSI, approximately 74 percent were disease types included in ABSSSI. This category of infection increased by 176 percent from 1997 to 2009 in hospitalized patients. The majority of skin and soft tissue infections in hospitalized patients are caused by Staphylococcus aureus, and approximately 59 percent of these infections are estimated to be caused by MRSA in the U.S. Effective early treatment of ABSSSI is critical to prevent wound expansion and to avoid lengthy and costly hospital stays. Failure to successfully treat ABSSSI may result in hospital readmissions.

ABOUT DALVANCE

Dalvance is a second generation, semi-synthetic lipoglycopeptide, which consists of lipophilic side-chains attached to glycopeptides. If approved, Dalvance would be the first drug for ABSSSI requiring only two once-weekly 30-minute intravenous doses (1000 mg on Day 1 and 500 mg on Day 8). Dalvance demonstrates bactericidal activity in vitro against a broad range of bacteria, such as Staphylococcus aureus (including methicillin-resistant strains) and Streptococcus pyogenes, as well as certain other streptococcal species.

ABOUT DURATA THERAPEUTICS, INC.

Durata Therapeutics is a pharmaceutical company focused on the development and commercialization of new therapeutics for patients with infectious diseases and acute illnesses. Durata has completed two global Phase 3 clinical trials with its lead product candidate, Dalvance, under investigation for the treatment of patients with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria. For more information about the company, visit www.duratatx.com.

DALVANCE is a trademark of Durata Therapeutics Holding C.V.

[mathew633]

Many folks looking towards a favorable vote

[ImOnABoat]

Interesting. Should spike up nicely after the halt. I think the outcome of the meeting is bound to be positive.

[mathew633]

AdCom

[ImOnABoat]

Why was trading halted?

[mathew633]

My guess would be late or AH today...guess only in watching others

[CGough08]

Anyone know how long these Adcoms typically take? Hope we get great news today!