Genmab — September 2020

[kkjoel]

Genmab Announces that Janssen has Submitted a Supplemental Biologics License Application to U.S. FDA for use of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in Patients with Light-chain (AL) Amyloidosis.

[kkjoel]

https://ir.genmab.com/news-releases/news-release-details/genmab-announces-janssen-has-submitted-supplemental-biologics

[kkjoel]

Sådan! Mon ikke kursen vil udvise en stigende tendens resten af dagen...!?

[E_L]

Jan dodged the question on increasing the participation in Cami-T last Q&A, but i expect with data out, they will have to make a decision soon?

[Plimsoller]

Det startede den med kl. 13:54 da E L postede nyheden første gang

[kkjoel]

Ups. Nyheden var kommet her allerede. Sorry.

[kkjoel]

Dejligt, Plims!

[Plimsoller]

Det var blot en joke

[E_L]

it is great news, and worthy of repeating a few times

[kkjoel]

Absolutely

[kkjoel]

Og ja, nu må GEN da have en begrænset periode at melde tilbage til ADC. Oprindeligt havde de hvor lang tid efter data-release?

[kkjoel]

Og vedr. AL) Amyloidosis: "The U.S. FDA will review the application under their Real-Time Oncology Review (RTOR) pilot program and Project Orbis."

[kkjoel]

Meget positivt - giver jo kortere behandlingstid: "About the RTOR Pilot Program1 and Project Orbis2
The aim of the RTOR pilot program is to explore a more efficient review process for supplemental New Drug Applications (sNDAs) and sBLAs to provide safe and effective treatments to patients as early as possible. Inclusion in the RTOR pilot program does not guarantee or increase the probability of approval of this sBLA."

[kkjoel]

.. "Project Orbis is an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology products among international partners."

[E_L]

from the SEC document,
i thought they should have made the decisoin already on Cami in aug, but may be delayed by the temporary trial halt or Covid. Jan did not answer that question.

[E_L]

Now all we need is Lagarde to tell us they now will start buying biotech stocks to stimulate the economy. Specially Danish ones

[gentogen]

The Cami article looks very interesting but it is based on preclinical models so not as such new data

[E_L]

Genmab’s inaugural appearance in Forbes’ annual ranking of the world’s 2000 largest public companies https://twitter.com/Genmab/status/1304057290086125568

[KWC]

Er denne allerede postet ?

[KWC]

Takeda's Ninlaro Stumbles in Latest Multiple Myeloma Trial

Published: Sep 10, 2020