Farmas USA

http://inbestia.com/analisis/cuanto-hace-falta-para-poder-vivir-de-la-bolsa

Oído cocina. Gracias por la lección de hoy, jejeje.

JUNO

Creo que lo puse antes de su salida a bolsa. Básicamente, esto.

CAR015, demonstrated in an ongoing Phase 1 clinical trial a 91 percent complete remission rate in 22 adult patients with leukemia. Without this treatment, this number has historically been about 10 percent.

La mierda es que yo quería entrar y no lo hice.

PO, looking to raise as much as $191. In a filing with the SEC, the Seattle biotech laid out plans to offer about 9.3 million shares at a range of $15 to $18 each. Juno expects to give its underwriters--Morgan Stanley, J.P. Morgan, Goldman Sachs and Leerink Partners--an option to buy roughly 1.4 million extra shares. At the midpoint of its expected range, Juno would hit Wall Street with a $1.5 billion market cap, making it the most valuable biotech to go public in 2014, according to Renaissance Capital. The principal stockholders in the company before the announcement of the IPO were Arch Venture Fund, CL Alaska L.P. and JT Line Partners and Fred Hutchinson Cancer Research Center.

The company has three advanced product candidates. These drugs are used to remove a patient's cells from his or her body, engineer the cells to boost the body's immune system to better fight cancer, and then put them back into the patient. By the end of 2015, Juno plans to begin testing for at least three more drug candidates.

JCAR015, demonstrated in an ongoing Phase 1 clinical trial a 91 percent complete remission rate in 22 adult patients with leukemia. Without this treatment, this number has historically been about 10 percent. the stellar Phase I results of which led the FDA to grant a breakthrough therapy designation last month (OCTUBRE 2014), promising an expedited regulatory review.
Behind that is JCAR017, in development for ALL and non-Hodgkin lymphoma (NHL), followed by JCAR014, which is undergoing early studies on various B cell malignancies. And last week, Juno expanded its pipeline by licensing another CAR-T candidate developed by the National Cancer Institute and currently in Phase I development for ALL and NHL.

• JCAR015 spurred 24 of 27 (89%) ALL patients to complete remission, and, in a separate study -> Juno plans to start a Phase II trial in mid-2015 exploring JCAR015 in adult r/r ALL that could support accelerated U.S. regulatory approval.

JCAR017 led to a complete remission rate of 85% among 13 pediatric patients with the same cancer. -> We plan to continue the ongoing Phase I/II trial in pediatric r/r ALL in 2015. Based upon data to date, we also plan to initiate a multicenter Phase I trial exploring JCAR017 in relapsed/refractory B cell non-Hodgkin's lymphoma, or r/r NHL, in 2015, with the potential to advance to a registration trial in 2016 that may support accelerated U.S. regulatory approval."

• JCAR014 is in a Phase I/II trial in patients with B cell malignancies, "with the vast majority of patients treated to date having either r/r NHL or r/r ALL. We expect to report data from the Phase I portion of this trial before the end of 2014. We plan to continue enrolling patients in the ongoing Phase I/II trial in 2015 in order to explore various treatment strategies to improve the multiplication and persistence of the CAR T cells in the body. As of the date of this prospectus, we do not plan to advance JCAR014 into registration trials."

And there are plans in place to start 4 more CAR-T and TCR programs by the end of 2015--with "Phase I testing of our first CD19-directed "armored" CAR in one or more B cell malignancies in 2015."

Investigators for Juno have reported cases of severe cytokine release syndrome, a cytokine "storm" that spurs fever and has killed patients. Two patients died while being treated with JCAR015, forcing researchers to change their recruiting profile for patients and alter dosing regimens.

The biotech's chief competitor is Novartis ($NVS), which is developing a similarly promising Phase I CAR-T therapy alongside the University of Pennsylvania. The suddenly crowded space also includes Kite Pharma ($KITE), which grossed more than $140 million in a June IPO on the strength of its approach to T cell modification, and oncology heavyweight Celgene ($CELG), which reached out to gene therapy pioneer bluebird bio ($BLUE) to get to work in CAR-T. Bellicum Pharmaceuticals, angling to raise $115 million in an IPO of its own, is developing preclinical CAR-T assets, and latecomers Johnson & Johnson ($JNJ) and Pfizer ($PFE) shouldered into the space with with high-dollar deals earlier this year.

The company plans to spend $25 million of its IPO windfall on getting JCAR015 to the filing stage, $20 million to take JCAR017 to registration trials, $45 million on internal R&D, $20 million on setting up a manufacturing operation and the rest on general expenses, according to its filing.

Since its founding in August 2013, the company has raised $314 million.

As of Sept. 30, the company has an accumulated deficit of $154.4 million.

CEO Hans Bishop's total compensation in 2013 was $246,630 in a combination of salary, bonus and stock awards. His current annual base salary is $425,000.

Commercializing their products might prove difficult because of how new immunotherapy treatments are. One challenge will be "obtaining regulatory approval from the FDA and other regulatory authorities that have very limited experience with the commercial development of genetically modified T cell therapies for cancer."

JUNO

Parece que la actualización del acuerdo de licencia del lunes con Opus Bio la ha hecho subir más:

"On December 22, 2014, the conditions to the Company’s license agreement with Opus Bio, Inc. (“Opus Bio”) were satisfied, and the Company’s exclusive, worldwide, sublicenseable license under certain patent rights related to a CD22-directed CAR product candidate became effective. In connection with the effectiveness of this license, in accordance with the terms previously disclosed in the Registration Statement, the Company paid Opus Bio $20.0 million in cash and issued to Opus Bio 1,602,564 shares of common stock of the Company."

http://www.streetinsider.com/Corporate+News/Juno+Therapeutics+%28JUNO%29+Advances%3B+Filing+Provides+Update+on+License+Agreement+with+Opus+Bio/10123727.html

BLUE

Roth sube el PO de 90 $ a 120 $.

Confío en que la siguiente que se comporte como JUNO y BLUE sea OCAT :D

ISCO

Conversión de preferentes a ordinarias que supone una dilución 5%. ¿Me equivoco si la leo como una entrada institucional?

http://biz.yahoo.com/e/141229/isco8-k.html

¿Te refieres a Bluebird? La estoy viendo y en el pre marca un +2'22%.

DVAX

Se han dispuesto $10 mill de una linia de crédito de hasta $40 mill para el desarrollo de HEPLISAV. Entiendo que noticia ni buena ni mala. Si al final los estudios no llevan a ningún sitio pues fatal porque hay que devolver la pasta con sus respectivos intereses sin apenas ingresos. Y si el estudio acaba siendo aprobado pues perfecto, se devuelve el dinero con una sonrisa:

http://investors.dynavax.com/secfiling.cfm?filingid=1564590-14-6314&CIK=1029142