Last week cleared two more FDA clocks. IRWD / LINZESS® printed approved on May 27, expanding use in pediatric functional constipation to children ages 2 and older. MNKD / Afrezza® printed approved on May 29 for children aged 6 and older with type 1 or type 2 diabetes.
That leaves CING / CTx-1301 as the immediate unresolved item. Its posted PDUFA date was Sunday, May 31. As of this issue being prepared, no public approval or CRL announcement had been found.
The next live stack is now: CING, SPRO, ACHV, ARQT, LNTH, IONS, and VERA. The board is cleaner, but not quiet.
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IRWD / LINZESS® — APPROVED · May 27
Approved for pediatric patients 2 years of age and older with functional constipation. Removes the May 24 weekend clock from the forward board.
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MNKD / Afrezza® — APPROVED · May 29
Approved for children aged 6 and older with type 1 or type 2 diabetes. Resolves the May 29 pediatric Afrezza setup; MNKD is off the near-term board.
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CING / CTx-1301 — STILL IN WINDOW · PDUFA: May 31
As of this issue being prepared, no public approval or CRL announcement had been found. Because the posted PDUFA date fell on a Sunday, this remains an open action-window item heading into Monday.
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| PDUFA | Window | Ticker | Event | PoA |
| Sun May 31 | Mon Jun 1+ | CING | CTx-1301 / ADHD | 75% / open |
| Thu Jun 18 | Thu Jun 18 | SPRO | tebipenem HBr / cUTI, incl. pyelo | 92.5% |
| Sat Jun 20 | Thu 18 / Mon 22 | ACHV | cytisinicline / smoking cessation | CRL expected |
| Mon Jun 29 | Mon Jun 29 | ARQT | ZORYVE® cream / psoriasis, ages 2–5 | 95%+ |
| Mon Jun 29 | Mon Jun 29 | LNTH | LNTH-2501 / SSTR+ NET imaging | 92.5% |
| Tue Jun 30 | Tue Jun 30 | IONS | TRYNGOLZA® / severe HTG | 92.5% |
| Tue Jul 7 | Tue Jul 7 | VERA | atacicept / IgA nephropathy | 78% |
| CING $CING · CTx-1301 · ADHD | PDUFA: Sun May 31 PoA 75% |
This is now the immediate unresolved clock. The setup is a 505(b)(2) NDA for a once-daily extended-release dexmethylphenidate product designed to provide rapid onset and full active-day coverage. The clinical pitch is straightforward: known active ingredient, differentiated release profile, and an attempt to reduce the need for afternoon booster dosing. The key regulatory nuance remains manufacturing and CMC, where the company has previously said it was responding to agency information requests. Because the PDUFA date fell on a Sunday, the practical action window likely carries into Monday.
| SPRO $SPRO · tebipenem HBr · cUTI, incl. pyelo | PDUFA: Thu Jun 18 PoA 92.5% |
One of the cleaner smaller-cap setups on the board. The asset is partnered with GSK, the PIVOT-PO package supports the resubmission, and the core pitch remains simple: a potential first oral carbapenem option for complicated urinary tract infections, including pyelonephritis. This is not just another antibiotic review; if approved, it changes the outpatient/step-down conversation for a class that has historically been IV-only.
| ACHV $ACHV · cytisinicline · smoking cessation | PDUFA: Sat Jun 20 CRL expected |
The clinical story remains strong, but the regulatory setup has already changed. Achieve has said it expects a CRL by the June 20 PDUFA date tied to manufacturing/inspection issues at a prior third-party manufacturer. This remains an FDA event, but it is now a timing/reset story rather than a clean approval watch.
| ARQT $ARQT · ZORYVE® 0.3% · plaque psoriasis, ages 2–5 | PDUFA: Mon Jun 29 PoA 95%+ |
A pediatric label expansion around an already approved and commercialized dermatology franchise. The capped PoA reflects a heavily de-risked label-expansion setup, not a guarantee.
| LNTH $LNTH · Ga 68 edotreotide · SSTR+ NET imaging | PDUFA: Mon Jun 29 PoA 92.5% |
The FDA previously extended the review by three months to June 29 to review manufacturing-related information. Importantly, the company said the extension was not related to efficacy or safety data. This remains a high-confidence diagnostic-imaging setup, but CMC/manufacturing review is the thing to watch.
| IONS $IONS · olezarsen / TRYNGOLZA® · severe HTG | PDUFA: Tue Jun 30 PoA 92.5% |
A high-confidence late-June label-expansion setup. Olezarsen is already approved in familial chylomicronemia syndrome, and the current Priority Review is for severe hypertriglyceridemia. The label-expansion stakes are meaningful because sHTG is a much broader commercial opportunity.
| VERA $VERA · atacicept · IgA nephropathy | PDUFA: Tue Jul 7 PoA 78% |
Now close enough to enter the outer edge of the board. Priority Review, Breakthrough Therapy designation, and a Phase 3 package built around proteinuria reduction make this a major early-July renal catalyst. Not the next hard clock yet, but it belongs in the reader’s field of view.
The board rotates again.
IRWD is off by approval. MNKD is off by approval. CING remains the live open action-window item after a Sunday PDUFA. The next real work shifts to:
| CING | → | SPRO | → | ACHV | → | ARQT | → | LNTH |
| IONS | → | VERA |
That is the queue.
Informational only · Not investment advice · Biotech carries risk of total loss