Last week changed the board again. ARGX printed approved on May 8, ahead of its May 10 action date. BIIB did not print; the FDA extended the LEQEMBI IQLIK action date from May 24 to August 24 after requesting additional information that was classified as a major amendment to the sBLA.
That leaves the next live PDUFA stack as: MNKD, CING, AZN, ACHV, and ARQT.
The immediate question is no longer whether VYVGART expands into seronegative gMG, or whether LEQEMBI IQLIK is still a late-May event. The board now rolls forward to MNKD on May 29.
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ARGX / VYVGART® + VYVGART HYTRULO® — APPROVED · May 8
Approved to expand use to all adult patients living with generalized myasthenia gravis, regardless of antibody status. That May 10 clock is now resolved and no longer belongs in the forward queue.
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BIIB / LEQEMBI IQLIK — PDUFA EXTENDED · New date: Aug 24
The FDA extended the review after requesting additional information that was classified as a major amendment to the sBLA. This is not a rejection, and Biogen/Eisai said the FDA has not raised approvability concerns to date, but it removes BIIB from the near-term May board.
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| Date | Ticker | Event | PoA |
| Fri May 29 | MNKD | Afrezza / pediatric T1D & T2D, ages 4–17 | 72% |
| Sun May 31 | CING | CTx-1301 / ADHD | 75% |
| Tue Jun 2 | AZN | DATROWAY® / 1L mTNBC, IO-ineligible | 86% |
| Sat Jun 20 | ACHV | cytisinicline / smoking cessation | 82% |
| Mon Jun 29 | ARQT | ZORYVE® cream / plaque psoriasis, ages 2–5 | 100% |
| MNKD $MNKD · Afrezza · pediatric T1D & T2D, ages 4–17 | PDUFA: Fri May 29 PoA 72% |
This is now the next real hard clock. The setup is a pediatric label expansion for an already approved inhaled insulin product, covering children and adolescents ages 4–17 with type 1 or type 2 diabetes. The commercial hook is obvious: needle-free mealtime insulin. The regulatory risk is more specific than the delivery story, though — INHALE-1’s HbA1c noninferiority read is the key scrutiny point, alongside the familiar pulmonary-safety monitoring that comes with inhaled insulin.
| 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. The story is straightforward: known active ingredient, differentiated timed-release platform, and an attempt to carve out a full-day symptom-control position in a crowded stimulant market. Smaller cap, but now close enough to belong in the main board.
| AZN $AZN · DATROWAY® · 1L mTNBC, IO-ineligible | PDUFA: Tue Jun 2 PoA 86% |
Large-cap, Priority Review, and a real early-June FDA decision. The sBLA is for adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy — the defining feature of this setup. This is a cleaner large-cap review than the small-cap binaries around it, but still worth watching because the label-expansion stakes are meaningful.
| ACHV $ACHV · cytisinicline · smoking cessation | PDUFA: Sat Jun 20 PoA 82% |
A later-June NDA with a public-health angle and two Phase 3 smoking-cessation studies behind it. This is close enough now to enter the forward board, but not yet the main event.
| ARQT $ARQT · ZORYVE® 0.3% · psoriasis, ages 2–5 | PDUFA: Mon Jun 29 PoA 100% |
A pediatric label expansion around an already approved and commercialized dermatology franchise. The “100%” PoA should be read as a dataset/model flag for an already-marketed product, not a literal guarantee.
The board rotates again. ARGX is off by approval. BIIB is off the near-term board by PDUFA extension. The next real work shifts to:
| MNKD | → | CING | → | AZN | → | ACHV | → | ARQT |
That is the queue.
Informational only · Not investment advice · Biotech carries risk of total loss