$IBRX -- The FDA accepted the sBLA to expand Anktiva to include the treatment of MNBIC papillary. The PDUFA date is Jan. 6, 2027. Standard review. A positive development for ImmunityBio, but like all things, details matter. Approval is not a given. In fact, the FDA reiterated its "concerns relating to single-arm trials in papillary disease alone..." ImmunityBio acknowledged. I'd love to read the entire FDA letter, and not just the company's curated excerpt. If ImmunityBio wins approval to expand Anktiva's use based on single-arm study data, the agency will establish a new approval standard that can, and likely will, be used by other companies to seek the same. The same competitive risks that are impacting ImmunityBio and Anktiva in bladder cancer today will remain because $JNJ, for instance, can accelerate expanded approval of Inlexzo.
Second $JNJ ex-Halda "riptac", HLD-0117, goes into phase 1. Previously only known as "breast cancer riptac", target still undisclosed https://t.co/aJRe55AgYH
"Extended-release chemotherapy"? $JNJ 🧐 https://t.co/YNyf9f6GP1
J&J $JNJ wins approval for first-of-its-kind psoriasis pill https://t.co/i3nkTz8mi1 via @damiangarde $PTGX
Who knew $REGN was developing an anti-GPRC5D T-cell engager? https://t.co/jyL1PAS0y5 $JNJ $PFE $BMY
FDA approved $JNJ Tecvayli, multiple myeloma treatment https://t.co/7JX80XjYy9
Why is $BCAX testing a ficera dose in phase 3 that it now says isn't optimal (and other uncomfortable questions)? Via @ApexOnco -> https://t.co/mLWKP6AAZ9 $JNJ $GMAB
MK-2750 has been in the clinic since 2024. JNJ-95437446 started phase 1 in July 2025 https://t.co/PYUnhSJogA $MRK $JNJ
With a tipoff from a friend, and some info that probably shouldn't have been posted in a trial registry, the mechanisms of ADCs JNJ-95437446 $JNJ & SKB571/ MK-2750 $MRK have been revealed. Quite amazing given the recent $GMAB news. Via @ApexOnco -> https://t.co/WT8gNUvT83
Qilu appears to be aping $JNJ in trispecific T-cell engagers. First BCMA x GPRC5D, now CD79b x CD20. Via @ApexOnco -> https://t.co/d4pBcl0MuF
@SweetStocks22 @DrPatrick The glioblastoma data (scant) come from single arm combination trials. None of the data prove Anktiva is having any effect at all. And yes, Anktiva is approved in bladder cancer, but $JNJ recently approved drug is taking significant market share away from $IBRX.
It's $JNJ Tecvayli https://t.co/83ezqcZxm8
If you enjoyed #ASH25 you can catch up on all @ApexOnco coverage, including previews, here -> https://t.co/XIQrEeKMwY $TERN $JNJ $LLY $CGEM $ONC $NRIX $PFE $REGN $KURA
@avidresearch OS, even with slightly fugly crossover, gives HR=0.46 $JNJ #ASH25 As ever, infection risk is very real with CD3-targeting T-cell engagers.
$JNJ Tecvayli (& $LEGN Carvykti) "entering a new era of resetting survival expectations in a cancer historically described as incurable". @ByMadeleineA @ApexOnco from #ASH25 on Majestec-3 https://t.co/yUP2j9tJjj $ACLX $BMY
Wow, check out the $JNJ Tecvayli survival curves in Majestec-3 #ASH25
$LLY Jaypirca looks best... up to a point. Via @ApexOnco from #ASH25 https://t.co/SgHJrraNrI $ONC $AZN $JNJ $ABBV $NRIX
New data from Gilead, Arcellx multiple myeloma CAR-T suggest benefit over rival treatment https://t.co/h2TMrtrufE $GILD $ACLX $JNJ $LEGN #ASH25
@bigpharmaguy Not insane. You're correct. The competitive hit to $ACLX y'day was present (that $JNJ abstract) and future (the in vivo CAR-T) I didn't see the former until later.
#ASH25 late-breakers are now up (links don't work though): $JNJ $LLY + Kelonia in vivo Car-T! https://t.co/O9NqyOuXya
Halda turns $202m into $3bn from $JNJ (plus a #sadtrombone for $ARVN). Via @ApexOnco -> https://t.co/7zXwDOTMS6
Who knew?! $ARVN $JNJ
Halda's HLD-0915 is an oral, heterobifunctional small molecule that induces prostate cancer death by binding AR and the essential protein BRD4 $JNJ #ASCO25 https://t.co/lhEAQL1Gnb
$JNJ acquiring Halda Therapeutics, cancer drug developer, for $3.05B
$JNJ just acquired Halda for $3.05bn. Earlier story from @BatirtzeAreitio -> https://t.co/7nxuN3Oykj $JANX $CTMX
Big uh-oh for $BMY $JNJ Factor X1a anticoagulant program. Ph3 study halted for futility. https://t.co/amVbO86N6o
@jq1234t No clue, sorry. I'm amazed $JNJ goes as far as admitting that this is an anti-ENPP3 ADC.
Amazing similarities (& differences?) between Flaura2 vs Mariposa $AZN $JNJ
Here's another oncology company going from ph1 straight into ph3: $JNJ anti-KLK2 T-cell engager pasritamig https://t.co/KpW7G2wNs0 cc @BowTiedBiotech
If you're catching up with #WCLC25 news, @ApexOnco coverage can be found here: https://t.co/Jl2xGAtcZw $SMMY $IDYA $AZN $JNJ $BMY $ZLAB $BNTX
Guess who just went into the clinic with a new menin inhibitor $SNDX $KURA $JNJ $AZN https://t.co/J1NxKIddpD
Quite a few (redacted) oncology CRLs released then: $REGN odronextamab x3 SC Rybrevant $JNJ $REPL $ATRA Patri-dxd $MRK $DSNKY Camrelizumab + rivoceranib x2
$JNJ first announced TAR-200 filing on 15 Jan, but never announced the acceptance. Today's PR likely result of mention of priority review dribbled out at GS conf in June & on yesterday's earnings call. Still no idea when filing was actually accepted!
Admirable effort by FDA's Deepti Telajara to present the current treatment paradigm for multiple myeloma $JNJ $BMY $GSK https://t.co/VfdzITcqRY
Ichnos Glenmark's BCMA x CD38 bispecific ISB 2001 was covered by @ByMadeleineA at #ASCO25. Today licensed to $ABBV for $700m up front $JNJ https://t.co/eRXwEbxky9
Zegfrovy gets its US approval, but don't expect an imminent launch. Via @ApexOnco -> https://t.co/bCDzI4zzSQ $CGEM $JNJ
@justaname2u JNJ-88549968 appears to be the only other CALRmut project in clinical development apart from the two at $INCY. Ph1 started in Dec 2023, but has anyone seen any data from $JNJ?
$JNJ anti-KLK2 T-cell engager pasritamig (JNJ-78278343) #ASCO25
