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Farmas USA

114095 respuestas
  1. Triskis

    Re: Farmas USA

    IMMU

    ¿alguien la sigue? 

    https://ca.finance.yahoo.com/news/immunomedics-receives-complete-response-letter-011253093.html

     

    La FDA no aprueba el fármaco por un tema de producción (no se sabe exactamente de un se trata) pero dicen que no harán falta más datos en el NDA filling y “solo” subsanar lo que pide la FDA. Hoy 25% down pero me estoy planteando entrar en unos días con poca carga.

    Ni idea de lo que llevan ni pipeline ni nada...seria una entrada puramente especulativa para rebote.

     

    Edito-Pipeline:

    https://www.immunomedics.com/our-science/pipeline/

     

     

     

  2. framus_morrigan

    Re: Farmas USA

    Bueno, hoy he hecho los deberes pronto … dejo por aquí una ristra de semanales … los tipos de velas ya los conocéis y lo que puede implicar … 

    Shooting stars … 

    HZNP

    ACAD

    ACHN

    NVAX confirmación del aviso de reversal de la shooting star de la semana pasada

    Rechazos de resistencias ...

    La bajista en TGTX

    EXEL

     

    Dejo una con muy buen cierre, RDUS, por encima de su MM20 semanal, cosa que no se veía desde Abril. Aun le queda esa bajista por superar y los 17,90 como obstaculos inmediatos para poder siquiera aspirar a cotas superiores. Ya se vera ...

    Buen finde a todos :)

    Recordad que el Lunes es festivo en USA.

  3. Investing_saints
    en respuesta a lgonber

    Re: Farmas USA

    Ver mensaje de lgonber

    SGMO

    Post en IV de eventos para el próximo año:

    https://www.investorvillage.com/smbd.asp?mb=1933&mn=118875&pt=msg&mid=19050726

    SGMO in one year

     Where will we be in 1 year

    Nice combination of stages of trials and variety of products and mechanisms and partners

     MPS II- IVPRP in vivo gene editing

    Finishing extension of phase I/II trial with 6 months of ERT withdrawal data and filing for early approval based on this data in adults..

    Several adolescents dosed and some are beginning ERT withdrawal..

    Several children dosed 

    MPS I- IVPRP in vivo gene editing

    Finishing phase I/II extension trial with ERT withdrawal with plans to file in near future for early approval based on these results and MPS II trial results helping accelerate this trial.

    Several adolescents dosed

    Hemo B- IVPRP in vivo gene editing

    Finishing phase I/II trial and heading towards a phase 3 trial ( this one may require a larger phase 3 trial due to adequate and safe alternatives and multiple competitors)

    patients also dosed in Europe 

    Hemo A- gene therapy

    Trial has been handed over to Pfizer and they have chosen cohort 4/5 for expansion to phase 3 and have dosed multiple patients with up to 6 months of data

    Beta thal- cell therapy

    In phase ii after initial dosing trial and has been handed over to Sanofi

    Sickle cell- cell therapy

    in phase ii after initial phase I dosing study- run by Sanofi

    Fabrys- gene therapy

     Dosed several patients with accelerated/prompt patient recruitment due to proven safety of platform and starting from higher cohort since safety and dose response of protein production from Hemo A trial is known

    TxCell - cell therapy/CAR T reg

    First in class T reg trial- dosing in phase I

    SGMO edited CAR- T reg  IND filed 

    GILD- cell therapy/ CART

    two phase I trials

    Allogenic CART-possibly Allogenic Yescarta

    Autologous CART-possibly something similar to a  PD1 knockout Yescarta 

    Pfizer ALS- gene regulation

    Decision to advance has been made ..and SGMO has solved CNS delivery to make it possible to advance

    Takeda Huntingtons- gene regulation

    Decision about product has been made after acquiring Shire..likey will proceed with trial since they "own" it and will have to pay SGMO very little to advance it..and by then SGMO will have solved CNS delivery

    Tau- gene regulation

    pre- IND data shown for SGMO owned small population tauopathy trial and this data used to gain large population tau partnership.

     

    SGMO "solves" CNS delivery.. 

    2 additional IVPRP IND/phase I- gene editing

    ? Gauchers and PKU? ( kept secret with no data shown until IND since multiple gene therapy and gene editing companies going after same targets)

     

     HIV- cell therapy

    early data on enhanced trial with better T cell management and ZFN than earlier trial

     Advances and data on ZFN 2.0

    Advances and data on AAV delivery for both liver an CNS and possibly other organs..and possibly other forms of delivery 

    And a few secret surprises since SGMO will keep quiet until last second due to massive competition from the multiple gene therapy/gene editing/CRSPR companies out there..

  4. trantor
    en respuesta a Investing_saints

    Re: Farmas USA

    Ver mensaje de Investing_saints

    SGMO

    Investing, leyendo su web, entiendo que se dedican a la terapia genética, pero usando un método distinto a Crispr/Cas9, algo que no había oído nunca antes llamado zinc finger nuclease (ZFN) technology... ¿tienes idea de las diferencias entre una y otra tecnología? ¿si alguna de ellas se considera superior a la otra? etc.

    Sangamo leads the therapeutic genome editing field, with multiple clinical  trials underway in the United States. Our zinc  finger  nuclease  (ZFN) technology is based on a naturally occurring class of proteins called zinc finger DNA-binding proteins (ZFPs) which recognize and bind to specific sequences of DNA. We engineer ZFNs for precision, efficiency and specificity, which we believe are the critical parameters for a therapeutic  genome  editing technology.

  5. trantor
    en respuesta a trantor

    Re: Farmas USA

    Ver mensaje de trantor

    CRSP EDIT NTLA SGMO

    Este de la edición genética es un sector al que le veo gran potencial, pero la verdad es que no sé distinguir el grano de la paja, así que de momento no me he atrevido a invertir en el mismo.

    Por cierto, el otro día leía que la FDA está siguiendo 800 medicamentos de esta área, y que espera que le entren 200 más cada año de aquí a 2025, por lo que está contratando personal especializado.

    FDA to beef up cell and gene therapy staff

    https://seekingalpha.com/news/3423193-fda-beef-cell-gene-therapy-staff

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