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#38961

Re: Farmas USA

Amén @framus, ademas pienso que parte de la pasta ha estado entrando en ARIA que ha eclipsado al resto de farmas hoy (a la que por cierto conviene dar un repaso porque debería subir todavía mucho más).

La semana que viene se tocarán esos 2,45 en AMRN estoy convencido.
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Buen finde!

#38963

Re: Farmas USA

1. Ariad returns Iclusig to market but with more restrictions and smaller patient pool

By Eric Palmer Comment | Forward | Twitter | Facebook | LinkedIn

Ariad Pharmaceuticals ($ARIA) is back in the market with Iclusig. The FDA is allowing the Cambridge, MA-based company to again sell the leukemia drug, but with tighter restrictions to face. Ariad has a lot of ground to regain to return to its former glory.

While CEO Harvey Berger said the company is starting 2014 where it left off, that is not entirely accurate. Iclusig is now approved for a smaller patient population. The company also has post-marketing requirements including a trial testing other doses of the drug.

And as for the size of the company, he said it would add some sales reps, but not nearly the 160 that it let go in November after the FDA had it yank the drug from the market because of blood clot risks, Bloomberg reports. Those 160 represented 40% of the company's U.S. workforce, and Ariad expected to save about $26 million through 2014 with the cuts. At the time, it did not touch its EU sales group because it had not limited use of the drug. But since then, the EU has added tighter restrictions as well.

The company also saw its market cap plunge after questions first arose in the fall. Its shares were up as much as 31% to $7.25 in mid-morning trading, but that is off from about $18.25 a share in September.

The FDA is now allowing Iclusig to be used for adult patients with a mutation called T315I and for patients for whom no other tyrosine-kinase inhibitors are indicated. Previously, it could be for adult patients when that therapy didn't work or was intolerable. Under the old label, the company said 640 patients were taking the drug. The FDA has so far approved on a case-by-case basis 350 who would qualify.

It has been a rollercoaster ride for Ariad and Iclusig, a drug the FDA granted accelerated approval to less than a year ago, approving it to treat both patients with chronic myeloid leukemia who have stopped responding to other drugs and patients with Philadelphia chromosome-positive acute lymphoblastic leukemia. The company quickly rolled the drug out, putting a $115,000-a-year price tag on it, and touted how the drug had been brought to market in 5 years, turning Ariad into a commercial oncology company in the process. Analysts believed there was a blockbuster in the making.

- here's the announcement
- more from Bloomberg

Related Articles:
Ariad's Iclusig further restricted by EMA
Ariad canning 40% of U.S. workers as troubled Iclusig gathers dust
Flailing Ariad swallows poison pill to fend off takeovers
Ariad shares plunge again after safety fears force halt to Iclusig sales
Ariad halts Iclusig trial enrollment on blood-clot worries

#38964

Re: Farmas USA

Ariad storms back with an FDA nod to get Iclusig back on the U.S. market

By Damian Garde Comment | Forward | Twitter | Facebook | LinkedIn


Ariad Pharmaceuticals CEO Harvey Berger
Losing more than $2.5 billion in market value didn't kill Ariad Pharmaceuticals ($ARIA), and now the biotech is set to relaunch the once-spurned cancer drug Iclusig in the U.S. as the FDA has approved a new label and indication for the company's only product.

Ariad surged more than 30% on the news, announcing it would reintroduce the leukemia treatment by mid-January now that the FDA has OK'd the drug for T315I-positive patients and amended the label to include warnings about Iclusig's risk of blood clotting and heart failure. Those same safety concerns prompted the FDA to ask Ariad to take its drug off the market in October, the heaviest blow in a downward spiral that blasted the company's shares by more than 70%. But that's all in the past, CEO Harvey Berger said.

"We are back on track," Berger told Bloomberg. "We'll enter 2014 largely where we were as we started off the fall in September."

"Largely" being a relative term, of course. Ariad's hellish October led it to lay off about 160 U.S. employees in an effort to save $26 million, and while the company plans to piece together another U.S. sales force, it won't have the same marketing heft as before, Berger said. Furthermore, while the European Medicines Agency hasn't ordered Iclusig off the market, the group's Pharmacovigilance Risk Assessment Committee has reopened the books on the drug's safety profile, putting Ariad's overseas sales in jeopardy.

Still, Iclusig's exit from the tomb is undoubtedly good news for Ariad, as many analysts speculated it might take a year to win over the FDA if it ever happened at all. The company's shares leapt as high as $7.74 on the Friday announcement, by far their highest mark since an October freefall.

"In less than two months of suspending marketing and commercial distribution of Iclusig in the U.S., we addressed the issues raised by the FDA and now are able to market and distribute Iclusig again in the U.S.," Berger said in a statement.

- read the announcement
- check out the Bloomberg story

Related Articles:
Ariad faces fresh woe as EMA takes a harder look at Iclusig
Ariad canning 40% of U.S. workers as troubled Iclusig gathers dust
Flailing Ariad swallows poison pill to fend off takeovers

Read more about: Ariad Pharmaceuticals

#38965

Re: Farmas USA

Hace un mes la ponían a parir. Lo q dijeron siempre positivo es q tenían ctas saneadas. Cortaron el personal como en AMRN, suspendieron la vta del producto en USA , fda dijo q el producto estava muerto. En Las dos semanas q la tenia a full a 2,x, por los commentarios d stoctwits/SA parecía q perdería la camisa. Al primer intento frustrado de superar los 3 me salí ( fuck me!!). Muy fácil a toro pasado! me dió la impresion q quería irse arriba en su día.

ARIA

#38966

Re: Farmas USA

En mi pueblo,la chica mas guapa nunca te decia que no al baile,siempre te citaba para ultima hora,las ultimas canciones.....
creeme que pocas veces llegaba,pero ese subidon con los amigos,didiendoles que lo tenias hecho....
Con Amrn estoy sitiendo lo mismo...ellla no dijo que no...pero no bailamos por ahora :P

#38967

Re: Farmas USA

Gran sesion con maximos anuales y con un tecnico que apunta muy arriba.

NVAX

Buen finde crack

#38968

Re: Farmas USA

Así me siento yo!! ;).