FDA launches effort with $AZN $AMGN to speed up clinical trials, using AI https://t.co/k4LjxnDLmq via @LizzyLaw_
Next, why not run a trial combining Imdelltra + zoci-P + obrixtamig? Any scientific reason not to? $AMGN $ZLAB
Ha ha, great April Fool's joke from $ZLAB $AMGN! https://t.co/HlXz61yXa9
$MRK's PD-1 x VEGF bispecific reveal, & other key #AACR26 presentations, via @APEXONCO -> https://t.co/ob1eswxCWF $RVMD $AMGN $GILD $BCYC $SDGR
$AMGN's likely discontinued anti-CCR8 MAb #AACR26
Since my 2024 look at CCR8 a lot has happened: $BMY $GILD $ABBV upsized; $ONC Bayer $ZLAB (& soon $AMGN?) discontinued. @BatirtzeAreitio investigates, via @ApexOnco -> https://t.co/hUweyScpAN $CHRS $RHHBY
$RVMD was collaborating with $TNGX in PRMT5, but now it's working with $BMY (remember that ex MRTX project?). Via @ByMadeleineA @ApexOnco -> https://t.co/mGZjKOiB7p (And $AMGN still dose optimising.)
$AMGN Tavneos update. FDA wants it pulled from the market. On January 16, 2026, the U.S. Food and Drug Administration (FDA) requested that ChemoCentryx voluntarily withdraw TAVNEOS from the U.S. market. The FDA raised concerns about the process followed by ChemoCentryx to re-adjudicate primary endpoint results for 9 of the 331 patients in its pivotal clinical trial. Hepatotoxicity, which is a known infrequent risk of TAVNEOS treatment for AAV, was also raised in the context of the benefit-risk profile of the medicine. Amgen is not aware of any issue with the underlying patient data from the ChemoCentryx clinical trial. And after review of the relevant clinical data and years of real-world evidence, Amgen is confident that TAVNEOS demonstrates effectiveness and a favorable benefit–risk profile. On January 28, 2026, following FDA regulatory process, Amgen informed the Agency that it did not intend to withdraw TAVNEOS from the market. Amgen is evaluating next steps with the FDA to determine a path forward, while keeping patient safety, needs and support at the forefront.
Another OX40 update, and it's not good. On an analyst call Sunday, Kyowa Kirin disclosed a case of Karposi's sarcoma with rocatinlimab in a "high risk" patient, according to a Jefferies note. Recall, last week, $AMGN returned roca to Kyowa.
And now $AMGN returns its OX40 drug candidate rocatinlimab to Kyowa.
What's this about? EMA re-reviewing $AMGN Tavneos due to "data integrity" issues in study that supported approval. https://t.co/lg9eh7qSmJ
Leerink's David Risinger on the $SNY amlitelimab Karposi's sarcoma case: "As a result, we see risk of a potential black box warning on amlitelimab’s label." Would be same for $AMGN $APGE and any other company with an OX40 drug, right?
Perhaps I am over-reacting, but doesn't the reported case of Kaposi's sarcoma in the $SNY amlitelimab atopic dermatitis study basically end any hope for the entire OX40 drug class? $AMGN included. Why would any patient or physician take the risk with an OX40 drug when there are so many other better treatment options?
Dark Blue Therapeutics pipeline, via OncologyPipeline $AMGN https://t.co/WM4ft5n2c8
Funny $ABBV saying absolutely nothing about paying Zelgen $100m for a DLL-3 T-cell engager (H/T @chuminhua432). @ByMadeleineA earlier take on this biparatopic T-cell engager -> https://t.co/nm9YAZ3DUF $AMGN
$AZN follows $LLY $PFE $AMGN $ONC & $ALPMF into pan-KRAS, but should it be looking more to pan-RAS approaches like $RVMD & $ERAS? Via @ApexOnco -> https://t.co/MioOWziuSt
@NotGenentech @bioinvestor24 Here's a list of just the clinical pan-RAS & pan-KRAS assets from Oncologypipeline $RVMD $LLY $ONC $RHHBY $PFE $ERAS $AZN $AMGN $ALPMF https://t.co/oeb4Yr2nzo
#AHA25 reporting all weekend Amgen’s $AMGN cholesterol shot prevented first heart attacks and strokes, more detailed data affirm https://t.co/1RX6TrfU6l via @cooney_liz
Apparently #SITC25 is hosting a webinar on development of anti-CCR8 MAbs - mechanisms & clinical results. 22 Oct 2025 $CHRS $BMY $ABBV $RHHBY $AMGN $GILD $BGNE $FGEN $BNTX
This week's Biotech Scorecard newsletter: - $SGMO 's Fabry therapy partner search looks futile - Geoff Porges is back on Wall Street, taking a banking role at Lazard - Don't get rid of FDA adcomms, make them better. I have a few ideas, including: Eliminate the public hearing where patients and advocates basically intimidate experts into voting yes, even when the data say otherwise. - Comments from Peter Marks and $AMGN at a recent conference. Link to web version of the newsletter below.
But it's not clear how bad the OS decline has been from interim -> final analysis. $AMGN Paul Burton @ W Fargo: "at a recently completed final analysis the magnitude of the survival benefit has decreased". That's all we know $ZLAB
Story from @ByMadeleineA from when Fortitude-101 was toplined in June. Clearly tox is now a major factor https://t.co/Ha0bNZinlY $AMGN $ZLAB
Wow, so $AMGN slipped out that bemarituzumab's positive final OS analysis slipped into negative territory at longer follow-up. $ZLAB off 6% yesterday, -4% premarket today https://t.co/W6TdNDHlzj
$AMGN Fortitude-101 study of bemarituzumab (ex $FPRX) + chemo is stat sig "& clinically meaningful" for OS vs chemo alone. FGFR2b overexpression (≥10% @ IHC 2+/3+) was enrolment criterion, I believe, so this is a hit on ITT. $TYRA
