CLDX
Yo tengo guardado esto, por si te sirve, por orden cronológico:
The company's cash, cash equivalents, and marketable securities as of June 30 totaled $334.0 million. This reflected a quarterly net cash burn of $25.8 million. Celldex thinks it's in good shape to fund its activities through 2017.
http://www.fool.com/investing/general/2015/08/11/3-key-things-to-know-about-celldex-therapeutics-in.aspx?source=eogyholnk0000001
8-12-2015
Celldex Therapeutics Initiates Phase 1/2 Study of Varlilumab in Combination with Atezolizumab in Renal Cell Carcinoma
investigational combination of varlilumab and Roche's atezolizumab (MPDL3280A) in patients with unresectable stage III or IV renal cell carcinoma (RCC
Patients will be treated with varlilumab until intolerance, disease progression or completion of up to 4 cycles. There is no limit on the duration of treatment with atezolizumab.
20-11-2015
Long-term Survival Benefit Demonstrated in Phase 2 ReACT Study of RINTEGA(R) in Recurrent Bevacizumab-naive Glioblastoma
http://finance.yahoo.com/news/long-term-survival-benefit-demonstrated-193000374.html
1-6-2015
Erdys:
Ayer comenté que los resultados de CLDX eran buenos, aunque la gente (la gente de twitter, no los profesionales de verdad) esperaba unos datos superiores en el brazo de la vacuna y la combinación con Avastin, está mañana mete una caída de cojones, puedo imaginar que para que los cortos cierren posiciones, pues hay muchos cortos abiertos, y ahora sube de manera moderada, pero sube, el que lo aprovechara le salio un intradia de pelotas, yo creo que con esos datos fase 2 les darán la aprobación acelerada, 400 k estimados de ventas, y si la fase 3 que se libera en unos meses sale bien otros 600k, es sólo mi suposición y además un pipeline cojonudisimo.
Celldex Immunotherapy Maintains Survival Benefit for Recurrent Brain Tumor Patients
Bastardo
http://www.thestreet.com/story/13167195/1/asco-15-celldex-immunotherapy-maintains-survival-benefit-for-recurrent-brain-tumor-patients.html
http://finance.yahoo.com/news/randomized-phase-2-react-study-130000611.html
Agosto
brain cancer drug Rintega that could be longer than investors were hoping for, shares in Celldex Therapeutics (NASDAQ:CLDX) lost 37% of their value in August.
Celldex offered up encouraging Rintega's mid stage phase 2 trial results showing that combining it with Avastin helped delay tumor growth, while also extending survival rates, and that led to optimism that Rintega could qualify for an accelerated timeline for approval.
However, those hopes appear dashed by Celldex's August revelation that discussions with regulators leave it believing that it will need to submit complete results from its phase 3 trial to win a regulatory green light.
up to 40% of phase 3 trials fail and that could be why the FDA is approaching Rintega cautiously.
Regardless, the next Rintega interim analysis is expected either later this year or early in 2016
The company is also conducting mid stage trials evaluating glembatumumab vedotin, or glemba, as part of a combination therapy in patients with an amenable genetic make-up and early stage trials of a CD-27 activating drug, varlilumab, that may have promise across a variety of cancers. A phase 2 study of glemba in triple negative breast cancer should complete enrollment next year and another study in metastatic melanoma is also under way. Meanwhile, varlilumab is being studied in phase 1/2 trials as an adjunct treatment for non-small lung cancer, metastatic melanoma, colorectal cancer, and kidney cancer.
The phase 2 data was certainly impressive, but the trial was small enough -- just 72 patients split into two groups -- that it's hard to say whether the longer survival time is real. Patients that received Rintega and Roche's Avastin lived for a median of 12 months compared to 8.8 months for those that just got Avastin.
Shares of Celldex Therapeutics remain in flux because it isn't clear when the ACT IV trial will provide enough data to get Rintega approved. There will be an interim look at the data toward the end of this year or early 2016
DA apparently prefers to wait until Rintega's late-stage trial, ACT IV, wraps up in late 2016 before agreeing to a formal regulatory review. That said, the discussions on Rintega's regulatory pathway are still preliminary at this point
http://www.fool.com/investing/general/2015/09/15/is-celldex-a-bargain-after-losing-a-third-of-its-v.aspx?source=eogyholnk0000001
«Después de nada, o después de todo/ supe que todo no era más que nada.»