$PRME
The FDA published a draft guidance on June 2: “Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing”. Relevant to every gene-editing platform.
It sets out how sponsors may rely on existing knowledge (CMC, nonclinical and clinical data, plus established platform knowledge) to streamline regulatory submissions for therapies that edit human somatic cells, without lowering the evidentiary standard.
The read-through for $PRME is
structural. Its thesis rests on a single Prime Editing platform feeding multiple programs — PM577 in Wilson, PM647 in AATD, PM359 in CGD. A framework that explicitly credits reused platform data across products favors that model, and it lands as Prime approaches its first regulatory filings (IND/CTA for Wilson in H1’26, AATD mid-year), with the agency encouraging early engagement via pre-IND and INTERACT. For a company operating on runway into 2027, cutting redundant testing is a material cost lever.
It is a draft under a 90-day comment period, not a final rule. And it benefits the whole class: Intellia (rolling BLA for lonvo-z) and Beam (BEAM-302 in AATD, on an FDA-aligned accelerated pathway) are further along and better positioned to act on it near-term.
fda.gov/news-events/pr…
Great news for CGD patients with the NCF1 deltaGT mutation.
$PRME is planning for the commercial launch of the PM359 in CGD in 2027+ (hopefully that's 2027).
$PRME shared strong dose-escalation preclinical data for its Wilson’s Disease program in mice models:
0.4 mg/kg ➡️ >40% hepatocytes editing/protein expression (carrier status)
0.8 mg/kg ➡️ 55~75% hepatocytes editing/protein expression
Previous data at an undisclosed dose (1
I own 1/800 of $PRME. I contacted the team multiple times and they never responded back to me. This is what lack of care for the shareholders look like @PrimeMedicine time to resign
$PRME will be a lackluster company until @Allan_Reine and his team finds funding, but their incompetent team is literally incapable of doing deals. @PrimeMedicine. So we are stuck with a group of mediocre executives
One of the most amazing things I’ve ever seen: a standing ovation for the full Daraxonrasib results
I feel inspired and energised, to put it mildly — we have a targeted therapy for pancreatic cancer now, and nothing is undruggable anymore
I would like to state here very clearly that if $PRME is not above $7 by next year. I am selling all the stock. I own 1/900 of the company. I cannot wait bunch of incompetent people to do the right thing forever. Get it together @PrimeMedicine
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