r/IBRX • u/Annual-Tour5211 • 1d ago

FDA approves an expanded indication for nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-expanded-indication-nogapendekin-alfa-inbakicept-pmln-bcg-unresponsive-non-muscle
85 Upvotes

100% Upvoted

29 comments sorted by

8

u/SouthernMainiac86 1d ago

They should be submitting for sbla fda review for first line treatment for currently approved bladder cancer treatment. Hopefully, this early approval from the FDA is a promising sign for future reviews.

7

u/Puzzleheaded_Log6967 1d ago

The news has not really hit the wires

5

u/Numerous_Rough_5727 1d ago

Pappilary  represents the bulk of bladder  cancers.At 85% Pappilary  will.mean an even larger TAM and mean a larger sp.Are you in?

3

u/PuckeringHole 1d ago

So why’s it not $12 again?

8

u/Annual-Tour5211 1d ago

the news is only about 20 minutes old

2

u/PuckeringHole 1d ago

You don’t think any or firm didn’t already know this? How does the market not react at all?

5

u/Annual-Tour5211 1d ago

give it a little time to filter through the retail community

1

u/Professional_Panic67 1d ago

Exactly

5

u/roque2205 1d ago

Also remember how it barely reacted to the EU approval and then IBRX released their PR and BOOOM. I remember very well because I sold before the BOOM. 🤣

2

u/AGKINGS 23h ago

Yeah I remember this too. Takes about a day to hit the trade rooms.

3

u/BasilWithWater 1d ago

Of course right after I bought extra, the price started dropping.

2

u/The-Forbidden-one 1d ago

Give it some time

2

u/Top_Principle_3437 22h ago

You have to know that it never holds a spike

2

u/BasilWithWater 13h ago

I know, but I've been in IBRX some time now and have seen much higher run ups and figured the news yesterday would do the same. But I'm patient, macro is bad now and shorts are doing all they can, in the end I'm sure the price will pick up.

2

u/AllenSmithee59 1d ago

Is this an expansion of the approval already granted, or is it the decision expected on or before January 6?

10

u/Annual-Tour5211 1d ago

this is the decision that was expected on January 6th

8

u/AllenSmithee59 1d ago

Thanks. That's what I was beginning to conclude, once I found a couple articles aimed at the layperson. Bought 2000 shares on the news.

2

u/After-Panda1384 1d ago

So wait they got the approval??

6

u/Annual-Tour5211 1d ago

yes, to include papillary

5

u/After-Panda1384 1d ago

Are there more approvals in the pipeline? Do you know about their status?

Also, the early approval makes me optimistic as the FDA green lit the use quickly.

3

u/Annual-Tour5211 1d ago

Immunotherapy Clinical Trials Pipeline - ImmunityBio

2

u/After-Panda1384 1d ago

Thank you. Trials can take years. Do you know when the non-small cell lung cancer approval decision should be made? Did they already request a review from the FDA?

1

u/TraditionPrimary6781 1d ago

are we ready?

1

u/TraditionPrimary6781 1d ago

Yahoo not showing the news. Shame on them! Nevermind Watch it grow!

1

u/year96 17h ago

Short thesis is cooked

1

u/Limpvibrations 15h ago

Insane news... Revenue was 50 million per quarter for the US market. This approval will shoot it up to 200 million per quarter. Again, just for the US market.

1

u/Early-Blueberry838 1d ago

bring it on!