PoA = probability-of-approval band (directional only; not FDA guidance).
THE FRAME (MAR 30–MAY 10): “TWO APPROVALS PRINT → APRIL STACK GOES LIVE”
Last week cleared two real FDA clocks. DNLI printed approved on March 25, and RCKT printed approved on March 27, so both come off the forward board. That leaves a cleaner April setup: BIIB, REPL, TVTX, GRCE, MRK, AXSM, and ARGX.
WHAT CHANGED SINCE LAST MONDAY
DNLI / AVLAYAH™ was approved March 25 for Hunter syndrome. That April 5 date is no longer a forward catalyst.
RCKT / KRESLADI™ was approved March 27 for pediatric severe LAD-I. That clears the March board and shifts attention fully into April.
LIVE FDA DECISION BOARD (NEXT ~6 WEEKS)
Date | Ticker | Event | PoA |
|---|---|---|---|
Fri Apr 3 | high-dose nusinersen / SPINRAZA | 78% | |
Fri Apr 10 | RP1 | 68% | |
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
BIIB — $BIIB ( ▲ 1.88% ) | high-dose nusinersen (SPINRAZA) | SMA | PDUFA: Fri Apr 3 | PoA: 78%
This is now the next real hard clock. Relative to the rest of the board, it reads as one of the cleaner setups: established franchise, familiar regulatory path, and a decision centered on a higher-dose regimen rather than a brand-new asset. The debate is less about whether the drug works at all and more about how much the new regimen improves positioning and durability.
REPL — $REPL ( ▼ 1.45% ) L | RP1 (vusolimogene oderparepvec) | advanced melanoma | PDUFA: Fri Apr 10 | PoA: 68%
A real April binary, but a less straightforward one. This is still an oncology resubmission story, which makes it inherently more contested than the cleaner lifecycle expansions in the queue. Close enough now that it belongs squarely on the core board, but not a setup to treat casually.
TVTX — $TVTX ( ▲ 1.98% ) | FILSPARI® (sparsentan) | FSGS | PDUFA: Mon Apr 13 | PoA: 72%
One of the more interesting debates in the stack. The key question is 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.
WATCHLIST JUST BEYOND THE NEXT THREE
GRCE — $GRCE ( ▼ 4.5% ) | GTx-104 | aSAH | PDUFA: Thu Apr 23 | PoA: 70%
Still underfollowed, still real. The date is close enough now to stay on the main board.
MRK — $MRK ( ▼ 1.56% ) | doravirine/islatravir | HIV-1 | PDUFA: Tue Apr 28 | PoA: 85%
Large-cap, cleaner regulatory setup, and one of the more straightforward late-April names.
AXSM — $AXSM ( ▲ 2.16% ) | AXS-05 | Alzheimer’s disease agitation | PDUFA: Thu Apr 30 | PoA: 78%
Priority Review, known asset, important label-expansion decision in a closely watched CNS category.
ARGX — $ARGX ( ▲ 1.72% ) | 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 cleaner now.
DNLI and RCKT have already printed. The next real work shifts to the April run:
BIIB → REPL → TVTX → GRCE → MRK → AXSM → ARGX
That is the queue.
Disclaimer: informational only; not investment advice; biotech carries risk of total loss.