@Jstidd Great news. $IMAB Now it’s official they will be skipping Phase 2 and going to Phase 3 by year end, fast tracked by the FDA because of great results from their drug Givastomig. This will save them a lot of time and money.
$IMAB Givastomig fast track designation this AM https://www.globenewswire.com/news-release/2026/06/16/3312417/0/en/novabridge-biosciences-receives-fda-fast-track-designation-for-givastomig-in-first-line-her2-negative-metastatic-gastric-cancer.html
$IMAB HC Wainright reiterates buy with target to $9. Accelerated Givastomig to phase 3 possibly by last quarter 2026. Already have a position, but getting interesting to add more. Once good results in phase 3, the risk reduces to make this a true biotech.
$IMAB Nice that they look like they are skipping to phase 3 for Givastomig. Possibly by year end.
“Givastomig, a potential best-in-class/first-in-class Claudin 18.2-directed bispecific antibody for gastric cancer, has shown robust and durable responses with broad CLDN18.2 activity, favorable safety, as well as potential eligibility for FDA’s Accelerated Approval Pathway with potential initiation of a registrational Phase 3 trial as early as Q4 2026.”
$IMAB Even though Nova is not at ASCO, there are still potential triggers.
https://www.asco.org/annual-meeting/search?filters=%7B%22mediaTypes%22:%5B%22Abstracts%22%5D%7D&userInput=Claudin%2018.2&sortBy=AbstractBrowse&contentKey=ANNUAL_MEETING&contentKeyYear=2026
Multiple presentations of Claudin 18.2 ADCs, combinations and Bispecifics. I checked them quickly, benefits for Giva in PFS, ORR, safety and low claudin concentration depending on competitors. Hope with quarterly report we receive an update from 12mg cohort, especially on PFS which will most likely exceed the 16.9 months from 8mg cohort based on 6 month landmark. As reminder:
https://www.novabridge.com/news-releases/news-release-details/novabridge-presents-positive-givastomig-dose-expansion-data
Overall it looks like Giva prooves to be best in class with broadest spectrum.
$IMAB Worth listening to HC Wainwright fireside chat with focus on Giva
Nova finalizes Giva Phase 3 design and intends to start in Q4. Interesting comment from Sean, I expect a partnering after design approval and update of running extension cohorts.
Interesting as well: They are evaluating to start a Claudin 18.2 negativ cohort given the strong performance of Giva in low CLD 18.2 patient and test inaccuracy in extreme low settings. This would add additional 25-30% of total market opportunity.
Double low, BTC and PDAC chorts recruiting well with data expected YE.
$IMAB @Tika1 @jayshree4201Twits Unless nobody cares. I am not seeing any huge differentiator with their data...looks good but going to need more than that IMO.
And this opinion applies to many biotechs - while it might seem early, some of these that have drifted down since the beginning of the year I see more downward movement motivated by:
Summer doldrums (sell in May then go away)
Blips in June (ASCO conference spiking 1 or 2)
Drifting down more
Spikes in Sept (transient for a few)
Nov. Tax loss selling
I could see NBP IMAB getting down to 1.2 by then.
Dec - Feb 2027 some up 100-200% if one times the bottom perfectly + a bit of luck
$IMAB Anyone still around for this stock? Since NBP is taken, seems like no one is holding this. Anyone has any thought they can share regarding current movement?
$IMAB “Givastomig, a potential best-in-class/first-in-class Claudin 18.2-directed bispecific antibody for gastric cancer, has shown robust and durable responses with broad CLDN18.2 activity, favorable safety, as well as potential eligibility for FDA’s Accelerated Approval Pathway with potential initiation of a registrational Phase 3 trial as early as Q4 2026”
Accelerated Phase 3? This sounds like a very promising development.
