Last week resolved two more real FDA clocks. AXSM printed approved on April 30, and ARVN printed approved early on May 1 ahead of its June 5 action date. That leaves the next live stack as: ARGX, BIIB, MNKD, CING, and AZN.
This is the kind of week where the board rotates forward cleanly. The immediate question is no longer whether Axsome gets through, or whether Arvinas can convert its first PROTAC review into approval. The next real hard clock is now ARGX on May 10.
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AXSM / AUVELITY® — APPROVED · Apr 30
Approved for the treatment of agitation associated with dementia due to Alzheimer’s disease. That April 30 clock is now resolved and no longer belongs in the forward queue.
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ARVN / VEPPANU™ — APPROVED EARLY · May 1
Approved ahead of its June 5 PDUFA date for ESR1-mutated, ER-positive, HER2-negative advanced or metastatic breast cancer after prior endocrine therapy. That is now off the forward queue.
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| Date | Ticker | Event | PoA |
| Sun May 10 | ARGX | VYVGART® / seroneg. gMG | 87% |
| Sat May 24 | BIIB | LEQEMBI IQLIK / Alzheimer’s disease | 88% |
| Thu May 29 | MNKD | Afrezza / pediatric diabetes | 72% |
| Sat May 31 | CING | CTx-1301 / ADHD | 75% |
| Tue Jun 2 | AZN | DATROWAY® / metastatic TNBC | 86% |
| ARGX $ARGX · VYVGART® · seronegative gMG | PDUFA: Sun May 10 PoA 87% |
This is now the next real hard clock. Still one of the cleaner setups on the board: same franchise, expanded population, strong sponsor, and a label-extension profile that reads more like execution than reinvention.
| BIIB $BIIB · LEQEMBI IQLIK · Alzheimer’s disease | PDUFA: Sat May 24 PoA 88% |
The key question here is not whether lecanemab works. It is whether the subcutaneous autoinjector format gets through cleanly and helps make administration meaningfully more practical outside the infusion-center model.
| MNKD $MNKD · Afrezza · pediatric diabetes | PDUFA: Thu May 29 PoA 72% |
This is the first genuinely debatable late-May setup on the board. The attraction is obvious: pediatric label expansion and a needle-free delivery angle. The question is whether that is enough to outweigh the familiar caution around inhaled insulin.
| CING $CING · CTx-1301 · ADHD | PDUFA: Sat 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.
| AZN $AZN · DATROWAY® · metastatic TNBC | PDUFA: Tue Jun 2 PoA 86% |
Now close enough to enter the board. Large-cap, Priority Review, and a meaningful expansion decision in an area where treatment sequencing still matters.
The board rotates again. AXSM is off by approval. ARVN is off by early approval. The next real work shifts to:
| ARGX | → | BIIB | → | MNKD | → | CING | → | AZN |
That is the queue.
Informational only · Not investment advice · Biotech carries risk of total loss