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Sunday, 12/04/2022 9:33:12 PM

Sunday, December 04, 2022 9:33:12 PM

Post# of 8606
Here's another, shorter post that gets to the point a bit faster.


Racing Merck and Pfizer, Roche readies to file subcutaneous Tecentriq after posting phase 3 data

Roche thinks the data set is strong enough to support approval of the subcutaneous formulation, leading it to submit the results to health authorities globally. If approved, Roche plans to roll out the formulation across multiple tumor types.
The subcutaneous launch may give Roche a point of differentiation in the congested checkpoint inhibitor space. While Chinese authorities approved a locally developed subcutaneous checkpoint inhibitor last year, Roche is leading the charge in the West. Merck’s phase 3 trial of subcutaneous Keytruda is on track to reach primary completion early next year, while Bristol Myers Squibb is targeting late 2023 and Pfizer is looking at a 2024 end date.
Roche claimed its spot at the front of the race with the support of Halozyme Therapeutics’ Enhanze drug delivery technology. The approach uses a recombinant enzyme to temporarily degrade hyaluronan in the subcutaneous space, thereby increasing permeability and enabling the drug to enter the bloodstream quickly.


Source: https://www.fiercepharma.com/pharma/racing-merck-and-pfizer-roche-readies-file-subcutaneous-tecentriq-after-posting-phase-3-data
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