Last week resolved two more real FDA clocks. MRK printed approved on April 21, while GRCE came off the board after a complete response letter on April 23. That leaves the next live stack as: AXSM, ARGX, BIIB, MNKD, and CING.
This is the kind of week where the product gets cleaner by subtraction. The immediate question is no longer whether Merck gets through, or whether Grace can sneak through a small-cap neuro setup. The next real hard clock is now AXSM on April 30.
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MRK / IDVYNSO™ — APPROVED · Apr 21
Approved as IDVYNSO™, a once-daily oral two-drug regimen for certain virologically suppressed adults with HIV-1. That April 28 clock is now resolved.
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GRCE / GTx-104 — COMPLETE RESPONSE LETTER · Apr 23
Issues were not efficacy-driven. Disclosed problems tied to chemistry, manufacturing, and controls — including packaging-related leachables, toxicology risk assessment, and manufacturing deficiencies. GRCE is out of the forward queue for now.
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| Date | Ticker | Event | PoA |
| Thu Apr 30 | AXSM | AXS-05 / Alzheimer’s agitation | 78% |
| Sun May 10 | ARGX | VYVGART® / seroneg. gMG | 87% |
| Sun May 24 | BIIB | LEQEMBI IQLIK / Alzheimer’s | 88% |
| Fri May 29 | MNKD | Afrezza / pediatric diabetes | 72% |
| Sun May 31 | CING | CTx-1301 / ADHD | 75% |
| AXSM $AXSM · AXS-05 · Alzheimer’s agitation | PDUFA: Thu Apr 30 PoA 78% |
This is now the next real hard clock. Priority Review, known asset, and a meaningful label-expansion decision in a closely watched CNS category. The story here is not blue-sky mechanism risk. It is whether the FDA is willing to extend an already known drug into a commercially and clinically important agitation label in Alzheimer’s disease.
| ARGX $ARGX · VYVGART® · seronegative gMG | PDUFA: Sun May 10 PoA 87% |
Still one of the cleaner clocks on the board. Same franchise, expanded population, strong sponsor, and a setup that reads more like a franchise extension than a speculative first shot. It belongs near the front of the queue.
| BIIB $BIIB · LEQEMBI IQLIK · Alzheimer’s disease | PDUFA: Sun May 24 PoA 88% |
This is the first name on the outer edge that starts to matter now. The key question is not whether lecanemab works. It is whether the subcutaneous autoinjector format gets through cleanly and helps make administration more practical at home.
| MNKD $MNKD · Afrezza · pediatric diabetes | PDUFA: Fri May 29 PoA 72% |
Pediatric label expansion, needle-free delivery angle, and a real late-May FDA date. Not as central as AXSM or ARGX, but absolutely on the board.
| CING $CING · CTx-1301 · ADHD | PDUFA: Sun May 31 PoA 75% |
A 505(b)(2) ADHD setup with a live FDA date at month-end. Smaller cap, but now close enough to count as a real calendar item rather than distant watchlist material.
The board changes again.
MRK is off by approval. GRCE is off by CRL. The next real work shifts to:
| AXSM | → | ARGX | → | BIIB | → | MNKD | → | CING |
That is the queue.
Informational only · Not investment advice · Biotech carries risk of total loss