PoA = probability-of-approval band (directional only; not FDA guidance).
THE FRAME (APR 6–MAY 10): “BIIB PRINTS → REPL IS NEXT”
Last week cleared the next real FDA clock. BIIB printed approved on March 30 for the high-dose SPINRAZA regimen, so it comes off the forward board. That leaves a tighter April stack: REPL, TVTX, GRCE, MRK, AXSM, and ARGX.
This is a cleaner setup than the last few weeks. The immediate question is no longer whether BIIB gets through. It is what comes next, and that starts with REPL on April 10.
WHAT CHANGED SINCE LAST MONDAY
BIIB / high-dose SPINRAZA was approved March 30 for spinal muscular atrophy. That April 3 clock is now resolved and no longer belongs in the forward queue.
LIVE FDA DECISION BOARD (NEXT ~5 WEEKS)
Date | Ticker | Event | PoA |
|---|---|---|---|
Fri Apr 10 | RP1 | 62% | |
Mon Apr 13 | FILSPARI® / FSGS | 72% | |
Thu Apr 23 | GTx-104 | 70% | |
Tue Apr 28 | doravirine / islatravir | 85% | |
Thu Apr 30 | AXS-05 / Alzheimer’s disease agitation | 78% | |
Sun May 10 | VYVGART® / seronegative gMG | 87% |
NEAR-TERM FOCUS
REPL — $REPL ( ▲ 1.78% ) | RP1 (vusolimogene oderparepvec) | advanced melanoma | PDUFA: Fri Apr 10 | PoA: 62%
This is now the next real hard clock. It remains a real April binary, but not a clean one. This is still an oncology resubmission story after a prior CRL, which keeps the setup more contested than the cleaner lifecycle or franchise-expansion names elsewhere on the board.
TVTX — $TVTX ( ▲ 4.8% ) | FILSPARI® (sparsentan) | FSGS | PDUFA: Mon Apr 13 | PoA: 72%
One of the more interesting debates in the stack. The key question is still whether the evidence package is enough to support full approval in FSGS. If it lands, it is a meaningful regulatory and commercial moment. If it does not, the market will read that as a statement on what the FDA still wants to see in this indication.
GRCE — $GRCE ( ▼ 12.09% ) | GTx-104 | aSAH | PDUFA: Thu Apr 23 | PoA: 70%
Still underfollowed, still real, and now close enough to move into the front half of the issue. This is exactly the type of name that belongs in a PDUFA-focused product: a live FDA decision, not just conference noise.
WATCHLIST JUST BEYOND THE NEXT THREE
MRK — $MRK ( ▼ 0.19% ) | doravirine/islatravir | HIV-1 | PDUFA: Tue Apr 28 | PoA: 85%
Large-cap, comparatively cleaner regulatory setup, and one of the more straightforward late-April clocks.
AXSM — $AXSM ( ▼ 0.14% ) | AXS-05 | Alzheimer’s disease agitation | PDUFA: Thu Apr 30 | PoA: 78%
Priority Review, known asset, and an important label-expansion decision in a closely watched CNS category.
ARGX — $ARGX ( ▲ 0.62% ) | VYVGART® | seronegative gMG | PDUFA: Sun May 10 | PoA: 87%
One of the cleaner clocks on the outer edge of the current window: same franchise, expanded population, strong sponsor.
WEEKLY POSTURE
The board is tighter now.
BIIB has already printed. The next real work shifts to:
REPL → TVTX → GRCE → MRK → AXSM → ARGX
That is the queue.
Disclaimer: informational only; not investment advice; biotech carries risk of total loss.