BREAKING $ROIV - $MRNA reached a $2.5B settlement in LNP delivery tech lawsuit. Agreement comes just days before jury trial was to start in Delaware.
The FDA’s Moderna $MRNA pirouette is one more sign of chaos at the agency https://t.co/zThJqhT2BS via @matthewherper
$MRNA says FDA will now review its flu vaccine. PDUFA date is Aug. 5. https://t.co/npZzeEa5nk
$MRNA -- FDA reverses course, agrees to review Moderna’s flu vaccine https://t.co/ZqZXrDC7aP via @LizzyLaw_
Moderna’s $MRNA president weighs in on FDA’s decision not to review its flu vaccine Transcript of our interview w/ Stephen Hoge. You can listen to the interview as part of this week's Readout LOUD podcast, available on all pod platforms. https://t.co/8VgzfDlATp via @statnews
$MRNA expects Interpath-001 data "potentially in 2026". $MRK https://t.co/GgJ6F33AG7
We just finished recording this week's Readout LOUD podcast, focused entirely on the FDA (Vinay Prasad) decision to block a review of $MRNA 's flu vaccine. You'll hear directly from Moderna President Stephen Hoge and former FDA official Jesse Goodman. @matthewherper and @LizzyLaw_ also joined us. The episode will drop later today!
BREAKING: FDA refuses to review Moderna’s $MRNA influenza vaccine https://t.co/df6oAfeEhO via @matthewherper
$MRK confirming that Interpath-001 study of $MRNA partnered intismeran autogene is "ongoing & fully enrolled". No further guidance as to timing of results, due some time in 2026. My earlier take on what to expect: https://t.co/9Pk3JK8TLs
Investor behind Moderna $MRNA says U.S. policy is ‘taking a sledgehammer to our miracle machine’ https://t.co/B9MGLzxfZO via @matthewherper #JPM26
$MRNA making biotech debt great again.
This week, STAT welcomed the great @damiangarde back to the family! On Thursday, Damian and the equally great @Jasonmmast are getting together for a special virtual chat to discuss Moderna $MRNA Exepect a wide-ranging discussion about what’s ahead for a history-making company that now faces political, social, and scientific headwinds. Bring your questions! Register for free here: https://t.co/V1rpMvdbTu
$MRNA just confirmed what I speculated in August re mRNA-2808.
Moderna $MRNA, the biotech that helped save the world with its Covid-19 vaccine, is facing a crisis unlike any other in its 15-yr history. Cratering sales, the vilification of its mRNA technology, profligate spending and clinical setbacks have all contributed to Moderna's financial and stock troubles. My colleague @Jasonmmast interviewed more than a dozen current former Moderna employees to tell the story of Moderna's great unraveling, where it goes from here. https://t.co/TNcvsUNNYn
Moderna $MRNA says key study of its CMV vaccine, expected to be its next big win, failed https://t.co/G91fKsWV2V via @matthewherper @Jasonmmast
Fun facts from the #ESMO25 exhibition hall: $BNTX booth is almost next to $SMMT $IOBT booth is at least twice as big as $MRNA Menarini booth is FREAKIN HUGE
#ESMO25 regular abstracts are now live, with first-in-human data being revealed by $LLY $INCY $DSNKY $MRNA $NVS Parabilis & others. Preview via @ApexOnco https://t.co/4oZFL7a5bt
@avidresearch One caveat is $IOBT is 1st-line, whereas $MRNA is checkpoint-refractory, but PD-L1-negative comps are probably accurate #ESMO25
So... no $MRNA activity in PD-L1-negatives looks like a win for $IOBT, no? #ESMO25 https://t.co/fbyK3FLgPH
$MRNA mRNA-4359 at #ESMO25: ORR 67% (n=9), but no activity at all in PD-L1 non-expressers (n=13) $IOBT
The gov't shutdown means FDA is not accepting drug-approval applications. I did quick scan of potentially affected drug makers, defined by me as companies that have guided to filings by EOY. $VRDN $RNA $MRNA $COGT $VERA Any others, add in replies.
Interesting take on the FcRH5 landscape, which seems to be one of $RHHBY's main oncology R&D areas of interest. $MRNA & $LEGN active here https://t.co/87JPjuwyu5
$PFE $MRNA dip on WaPo report that FDA is going to link Covid shots to 25 child deaths, based on unverified VAERS data.
No mention of Trump deserving the Nobel Peace Prize. Tactical mistake? $MRNA https://t.co/SFtVtJxZiI
In this week's Biotech Scorecard newsletter: The case for Invivyd $IVVD and why the RFK Jr. anti-Covid vax agenda is a boost for the company's monoclonal antibody approach to Covid prevention. I spoke with Invivyd Chairman Marc Elia. Also interesting: The FDA's post-approval study requirements for covid vaccines ( $PFE $MRNA etc) are more onerous than the study parameters suggested to Invivyd to support filing and potential approval of VYD2311. Kinda makes you go, hmmmm.... Read the online version of the newsletter at link below.
Remember that $MRNA mRNA-encoded triple T-cell engagers therapy vs BCMA, FcRH5 & GPRC5D, from #ASH24? It could be mRNA-2808
$IOBT comes agonisingly close, but now cash runs out in Q1 2026. Via @ApexOnco -> https://t.co/g6lHLyBiE6 $MRNA
$IOBT fail, but these data don't look terrible at first sight. Comparator mPFS is in line, and curves look decent. Did they basically underpower the trial?? https://t.co/QYFZSOfYj4 $MRNA
Also this, from $MRNA https://t.co/d2MFKGTnEF $IOBT
$CVAC in with a bang, out with a whimper. Via @ApexOnco -> https://t.co/AkH71vUJrg $BNTX $MRNA
