Last week cleared another real FDA clock. TVTX printed approved on April 13 for FSGS, so it comes off the forward board. That leaves a tighter FDA stack: GRCE, MRK, AXSM, and ARGX.
This is cleaner again. The immediate question is no longer whether TVTX gets through. It is what prints next, and that starts with GRCE on April 23.
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TVTX / FILSPARI® — APPROVED · Apr 13
Approved to reduce proteinuria in patients with FSGS — the first FDA-approved treatment for the condition. This event is now resolved and no longer belongs in the forward queue.
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| Date | Ticker | Event | PoA |
| Thu Apr 23 | GRCE | GTx-104 | 70% |
| Tue Apr 28 | MRK | doravirine / islatravir | 85% |
| Thu Apr 30 | AXSM | AXS-05 / Alzheimer’s agitation | 78% |
| Sun May 10 | ARGX | VYVGART® / seroneg. gMG | 87% |
| GRCE $GRCE · GTx-104 · aSAH | PDUFA: Thu Apr 23 PoA 70% |
This is now the next real hard clock. Still underfollowed, still real, and exactly the kind of name that belongs in a PDUFA-first product: a defined FDA decision with a tangible regulatory setup, not just conference noise or pipeline drift. The appeal here is straightforward — new IV nimodipine formulation, a rare neurocritical-care setting, and a live NDA review this week.
| MRK $MRK · 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 that have moved through the board over the last few weeks.
| AXSM $AXSM · AXS-05 · Alzheimer’s agitation | PDUFA: Thu Apr 30 PoA 78% |
Priority Review, known asset, and a meaningful label-expansion decision in a closely watched CNS category. It stays squarely on the core board as one of the higher-interest names on the outer edge of April.
| ARGX $ARGX · VYVGART® · seronegative gMG | PDUFA: Sun May 10 PoA 87% |
Still one of the cleaner clocks at the far edge of the current window: same franchise, expanded population, strong sponsor, and an already disclosed May 10 action date.
The board is tighter again. TVTX is off. The next real work shifts to:
| GRCE | → | MRK | → | AXSM | → | ARGX |
That is the queue.
Informational only · Not investment advice · Biotech carries risk of total loss