Farmas USA

Madre mia, ni respiran. Yo guardo 120$ y no me quedo las 265 que si les da por corregir con las 259 ya llevo mucho. A ver si procesan a Trump o algo jajaja

Que todas las noticias son buenas, hasta las malas jjjjjjjjjjjjjjjjjjjjjjjjjj

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/

 

 

 

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.

os dejo esto jo jo jo

 

 

Con eso y si dejo las cputs hasta 240 hago el año jjjjjjjjj
Pero vamos, los q hayan ido poniéndose cortos les habrán dejado "el lado oscuro" 🇯🇵. 😂😂😂
Q procesen a T o algo..ya!

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..

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.

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