PoA = probability-of-approval band (directional only; not FDA guidance).
THE FRAME (APR 13–MAY 10): “REPL FAILS → TVTX IS NOW THE CLOCK”
Last week removed the next April binary from the board. REPL received a complete response letter on April 10, so it drops out of the forward queue. That leaves a tighter FDA stack: TVTX, GRCE, MRK, AXSM, and ARGX.
This is cleaner again. The immediate question is no longer whether REPL can get through on resubmission. It is what the FDA does next, and that starts today with TVTX.
WHAT CHANGED SINCE LAST MONDAY
REPL / RP1 received a complete response letter on April 10 for advanced melanoma. That removes the April 10 event from the forward board and sharpens focus on the remaining April and early-May clocks.
LIVE FDA DECISION BOARD (NEXT ~4 WEEKS)
Date | Ticker | Event | PoA |
|---|---|---|---|
Mon Apr 13 | TVTX | FILSPARI® / FSGS | 68% |
Thu Apr 23 | GRCE | GTx-104 | 70% |
Tue Apr 28 | MRK | doravirine / islatravir | 85% |
Thu Apr 30 | AXSM | AXS-05 / Alzheimer’s disease agitation | 78% |
Sun May 10 | ARGX | VYVGART® / seronegative gMG | 87% |
NEAR-TERM FOCUS
TVTX — $TVTX ( ▲ 6.87% ) | FILSPARI® (sparsentan) | FSGS | PDUFA: Mon Apr 13 | PoA: 68%
This is now the next real hard clock, and it is live today. The core question remains whether the FDA is willing to accept the proteinuria data package as sufficient support for full approval in FSGS despite the persistent debate around long-term renal outcome evidence. If it lands, it is a meaningful first-in-indication moment. If it does not, the message will be that the agency still wants a tighter demonstration of clinical benefit.
GRCE — $GRCE ( ▲ 3.62% ) | GTx-104 | aSAH | PDUFA: Thu Apr 23 | PoA: 70%
Still underfollowed, still real, and now clearly the next date after TVTX. This is exactly the kind of name that belongs in a PDUFA-first product: a defined FDA decision with a tangible regulatory setup, not just conference traffic or speculative development noise.
MRK — $MRK ( ▼ 1.55% ) | doravirine / islatravir | HIV-1 | PDUFA: Tue Apr 28 | PoA: 85%
One of the cleaner late-April setups. Large sponsor, familiar regulatory terrain, and a comparatively straightforward read versus the more contentious small-cap binaries elsewhere on the board.
WATCHLIST JUST BEYOND THE NEXT THREE
AXSM — $AXSM ( ▼ 0.97% ) | AXS-05 | Alzheimer’s disease agitation | PDUFA: Thu Apr 30 | PoA: 78%
Priority Review, known asset, and a meaningful label-expansion decision in a closely watched CNS category.
ARGX — $ARGX ( ▼ 0.55% ) | VYVGART® | seronegative gMG | PDUFA: Sun May 10 | PoA: 87%
Still 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 again.
REPL is off. TVTX is now the live FDA clock, with the rest of the queue lining up behind it:
TVTX → GRCE → MRK → AXSM → ARGX
That is the queue.
Disclaimer: informational only; not investment advice; biotech carries risk of total loss.