Expensive AI Therapy Robot Might End Up Dishwasher
What if @DrPatrick builds an expensive AI robot to make NK cell therapies and then those therapies don’t work? I guess the robot could be reprogrammed to wash his dishes.
INBX to Release INBRX‑106 Phase 2 Data Monday
$INBX reporting INBRX-106 ph2 data on Monday. This is the ox40 cancer drug that reportedly drew interest from Merck and others?
Episode 400: Daphne Zohar on Seaport’s IPO Success
On this week’s Readout LOUD podcast, @daphnezohar was our very special guest. We chatted about Seaport and its successful IPO. Also, this week is Episode No. 400! https://t.co/5o02LIjjD6
CAPR Sues NS Pharma over Launch Delays, Pricing Disputes
$CAPR is suing NS Pharma, its deramiocel commercial partner. Capricor alleges NS Pharma is not doing enough to prepare for commercial launch + some pricing mishegas. 8K https://t.co/7iFyLRhKsq
STAT Live Event in SF Featuring INSM and BBIO CEOs
Today is an opportune moment to mention STAT's next live event in San Francisco on May 19. I will be chatting on stage with $INSM CEO Will Lewis and $BBIO CEO Neil Kumar. Full agenda and registration here: https://t.co/YtXTTuz1Nv
INSM Q1 Sales Beat Consensus, Miss Whisper Target
$INSM Q1 Brinsupri sales $208 million, above sell-side consensus but below the buyside "whisper" expectation that has moved around from the $2-teens to $220-ish.
AVXL CEO Chris Missling Fired for Cause
$AVXL CEO Chris Missling - fired. The 8K spells it out. Terminated for cause. https://t.co/HzBCPfX0gV One of biotech's worst peddlers of bullshit is gone. I might actually miss him. https://t.co/ZbDslD7jGj
Myqorzo ACACIA Study Achieves Dual Primary Endpoint Success
$CYTK Here we go! Myqorzo ACACIA study results in nHCM --> BOTH co-primary endpoints hit with statistical significance. There may be debate about magnitude of improvements for Myqorzo via KCCQ-CSS and peak V02. But, if you were dreaming for a...
Full Asset Acquisitions Avoid Margin Drag of Royalties
Seedy is not long enough $ABVX, however I’m old enough to remember when $ABBV spent $21B to buy half of ibrutinib.
FDA Approves Early, yet ARVN, PFE Lack Partner
FDA approves vepdegrestrant one month early. $ARVN and $PFE still haven't found (or disclosed) a third-party company to commercialize it. What a world...
Interim Data Hint Weaker PFS; Selloff Caps Losses
Leerink's Daina Graybosch on $SMMT "... In our base case scenario of the company’s likely statistical design choices and enrollment timing, not hitting statistical significance at this interim suggests a degradation in PFS Hazard Ratio (HR) of ~10 percentage points...
Interim PFS Review Confirms Study Continuation
$SMMT ivo HARMONi-3 update on squamous subgroup interim PFS analysis: "At this early interim PFS analysis reviewed exclusively by the Independent Data Monitoring Committee (iDMC), the iDMC recommended that the study continue as planned."
Akeso’s ASCO Plenary Raises Questions on Lung Cancer Data
This week's Biotech Scorecard: An #ASCO26 mystery: What does Akeso’s primo plenary spot say about its ivonescimab lung cancer survival data? $SMMT If the news was good, we'd have heard by now, right? Or, is Akeso just being ultra conservative?...
FDA Partners with AZN, AMGN to Accelerate AI-Driven Trials
FDA launches effort with $AZN $AMGN to speed up clinical trials, using AI https://t.co/k4LjxnDLmq via @LizzyLaw_
ERAS-0015 Linked to Fatal Pneumonitis After Care Withdrawal
$ERAS safety update, from tonight's slides. One Grade 3 TRAE of pneumonitis progressed to Grade 5 after withdrawal of supportive care per patient decision. The patient was a 66 year-old male with heavily pretreated metastatic pancreatic adenocarcinoma who received 24 mg of ERAS-0015. The patient had...
ERAS Slides 10
$ERAS -10% AH. Reason(s), anyone? Chime in, please. Sell the news, or red flag in the data?
Erasca Shows Promising 40% PDAC, 62% NSCLC Responses
$ERAS Erasca touts strong, though preliminary, results in trial of pancreatic and lung cancer therapy $RVMD 40% uORR in PDAC; 62% uORR in NSCLC https://t.co/90BkD7tBeN
ERAS Pan‑Ras Data Released; RVMD Alleges Patent Infringement
$ERAS pan-Ras data update this afternoon after market close. also, $RVMD sent Erasca a letter claiming ERAS-0015 violates certain RevMed patents. https://t.co/QTmyUhT89n
NTLA's HAE Results Fall Short, Funding Needed for Weak Launch
$NTLA HAE study results were both expected and unimpressive relative to current treatments. The company will need to raise a lot of money to sell a therapy that is not going to launch well.
Unverified Tips Can Mislead: False Compass Data
Interesting side note on today's disappointing $CMPX results: Yesterday, I received a message on Signal from someone claiming to be a Compass employee. He gave me the purported tovecimig PFS and OS data. I didn't do anything with the supposedly material...
CRISPR Therapy Cuts Swelling Attacks 87%, 60% Attack‑Free
$NTLA Intellia says CRISPR-based treatment for rare disease reduced swelling attacks in pivotal trial Attack rates dropped 87%, relative to placebo. Just over 60% were entirely attack-free over the period, compared to 11% for the placebo patients. https://t.co/ljPC7Lww0D via @Jasonmmast
Oruka's Long-Acting Psoriasis Drug Achieves 63% PASI‑100
$ORKA Oruka’s long-acting psoriasis therapy posts strong results in mid-stage study 63% PASI 100 score at 16 weeks, very strong data. https://t.co/RJxnbuU0e3 via me
Veradermics' Hair Loss Drug Clears Late-Stage Trial
Ok, here we go... $MANE Veradermics' hair loss drug succeeds in late-stage trial. A report from @ADeAngelis_bio https://t.co/jtSB36sPGO
Readout LOUD Interview Explores Kelonia and Eli Lilly
Our Readout LOUD interview with @BRobertsVC about Kelonia and $LLY in print form. https://t.co/DsfGxwcvS3 via @statnews
CAR‑T Turnaround: Kelonia’s LLY Deal Signals New Pharma Play
A VERY SPIRITED interview w/ Venrock VC Bryan Roberts re: Kelonia Therapeutics and its $LLY deal on this week's Readout LOUD podcast. A CAR-T biotech’s dramatic turnaround, and drugmakers’ tactics to drive more scripts https://t.co/600DsE1cBm via @statnews
Regeneron Approves Free Gene Therapy, Sparks Industry Precedent Worries
$REGN wins FDA approval for its gene therapy to treat a very rare genetic form of hearing loss. The company is giving away the therapy for free. OTOF-related hearing loss affects approx. 50 newborns per year, so really rare, but......
First Personalized CAR‑T Shows Mobility Gains in Stiff Person Syndrome
$KYTX Kyverna Therapeutics cell therapy improves mobility in patients with stiff person syndrome. If cleared, the medicine would be first personalized CAR-T therapy for an autoimmune disease https://t.co/B28Zp9IA2O
ASCO26 Unveils Pancreatic
#ASCO26 abstract titles were released today: $RVMD RASolute Ph3 study in pancreatic cancer will be presented during the plenary session. Also, Akeso $SMMT ivonescimab HARMONi-6 trial in lung cancer. China-only data.
Tortugas Neuroscience Launches to Develop Brain Disorder Drugs
Tortugas Neuroscience launches with hopes to develop drugs for brain disorders, other conditions https://t.co/zoM69VEQtV via @ADeAngelis_bio
Anktiva Needs Trial Data Before FDA Approval
For the umpteenth time, these posters have zero relevance to Anktiva unless, or until, $IBRX conducts/completes randomized clinical trials that demonstrate the drug improves outcomes for cancer patients w/ lymphopenia. @LoriMills4CA42 and the rest of you can idolize @DrPatrick ...
KRAS Targeting Fuels $30B Valuation for RVMD
The race to catch KRAS, pancreatic cancer’s ‘greasy ball,’ and create the most promising drug in decades Or, how $RVMD is now worth $30B https://t.co/iFilUpezjn via @angRchen #AACR26
Beware: X DMs Vulnerable to Hacking Attacks
I almost fell victim to an @X hacking attempt. Likely, the same people who got @SharkAlertsBio. Folks, be REALLY careful these days, especially with DMs.
FDA Requires Influencer Advocacy for Huntington’s Treatment
I guess people living and dying with Huntington’s disease need an influencer/podcaster to text Trump. That’s how the FDA works these days.
FDA Approves Kidney Drug Despite No Functional Benefit
This week's Biotech Scorecard newsletter: $TVTX Travere Therapeutics' drug for a rare kidney disease doesn’t improve kidney function. The FDA approved it anyway. https://t.co/63hDsPfOcT
Roche Initiates New Elevidys Trial Targeting EU Approval
Roche to launch another Elevidys trial, with eyes on European approval https://t.co/eAANNiihpt via @DrewQJoseph $SRPT
FDA Panel to Consider Expanding Peptide Access
FDA panel will meet to discuss allowing broader access to certain peptides https://t.co/PDWKvmvvUH via @LizzyLaw_
Dan Rosenblum's Twitter Hacked; Follow SharkAlertsBio for Updates
Hey folks - For those who follow Dan Rosenblum @sharkbiotech -- his account was hacked and he's currently locked out of it. @nikitabier -- any help here? There doesn't seem to be an @X person to contact about regaining control...
Rigorous Trials, Not Hype, Prove Cancer Drug Value
Today's $RVMD study outcome in pancreatic cancer is a good lesson for all the $IBRX @DrPatrick fans. Stop with all the hand-waving "cancer cure" podcasting social media nonsense. Shut up and run well-designed clinical trials with definitive endpoints. If you have...
Second‑line RVMD Improves Pancreatic Cancer Survival over First
As noted by others, the $RVMD dara mOS in 2nd line PDAC is better than mOS for current first-line regimens.
Daraxonrasib Halves Pancreatic Cancer Mortality, Doubles Survival
Finally, best news of the morning (and something you didn't expect so soon)... Revolution Medicines $RVMD daraxonrasib Ph3 results in second-line pancreatic cancer. Median overall survival in ITT patients (KRAS mutants + wild type combined) Dara 13.2 months vs chemo 6.7...
Allogeneic CAR‑T Achieves 42% MRD Boost, Safe Profile
Allogene $ALLO cema-cel interim ALPHA3 results just reported: B-cell lymphoma MRD negativity: cema-cel 58% vs observation 16% A 42% absolute difference in MRD clearance is better than expected. Clean safety profile, too. Allogeneic CAR-T may have found its role. Nice...
Spyre's SPY001 Achieves 40% Remission in UC Trial
Spyre $SYRE just reported SPY001 (long-acting alpha4beta7 antibody) ulcerative colitis induction data. Here's the efficacy chart, notable for a 40% clinical remission rate at week 12, albeit with small number of patients. https://t.co/aEoLWPRjEL
OCE's Objections Caused Rejection, Not Vinay Prasad
$REPL my read of the RP1 CRL suggests OCE (CDER) took the lead in the review. Their objections led to the first rejection, as I previously reported, and nothing Replimune submitted for the second review was enough to support...
Replimune's FDA‑targeted Skin Cancer Drug Faces Another Rejection
Replimune $REPL skin cancer drug that became FDA flashpoint is rejected again https://t.co/7aOfKy8vC7 via @Jasonmmast
Patients Favor Peptides over Statins, Exposing Medical Bias
My patient would rather take a peptide than a statin. That reveals an uncomfortable truth in medicine https://t.co/vCtJj2O6vq via @statnews
FDA's Future: New CBER Chief & Rare Disease Flexibility
On this week’s pod, we chatted with @docrodwong about the FDA, the next CBER chief and regulatory flexibility for rare diseases https://t.co/f6L7gwcNsr via @statnews
Paragon Launches Korsana Biosciences, Targeting Alzheimer's
Paragon launched its 7th company today -- Korsana Biosciences, merging into the $CYCN public shell. New ticker will be $KRSA. Lead drug candidate is a shuttled anti-amyloid beta antibody for Alzheimer's disease in early studies. https://t.co/RcJ8adMakm
FDA Hurdles Stall Academic Scaling of Custom Gene Editor
Baby KJ scientists hit speed bump in quest to scale custom gene editor. Stringent FDA requirements could prove stumbling block for academics https://t.co/HsaK7lSuh1 via @Jasonmmast
Allogene's Interim Data Hints at Off‑Shelf CAR‑T Breakthrough
This week's Biotech Scorecard: Allogene $ALLO: A preview of its April interim analysis. Very interesting (to me, at least) There just might be a path forward for off-the-shelf CAR-T therapy in B-cell lymphoma. Frontline consolidation. Read all about it: https://t.co/tcPFelUH3C
Analysts Bullish on MAZE, yet Pre‑market Price Drops
$MAZE - Analysts pitching tent poles over the AMKD data, yet stock is down pre market. What's the disconnect?