Last week resolved the open Sunday clock. CING / CTx-1301 received a complete response letter on June 2. The FDA did not identify current clinical safety or efficacy concerns, but the agency did request additional chemistry, manufacturing, and controls information. That moves CING off the live approval board and into the reset bucket.
That leaves SPRO / tebipenem HBr as the next clean hard clock on June 18.
The next live stack is now: SPRO, ACHV, ARQT, LNTH, IONS, VERA, and CELC. The board is quieter than late May, but not empty: one CMC-driven CRL, one high-confidence antibiotic review, one expected CRL, then a concentrated late-June cluster.
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CING / CTx-1301 — CRL · Jun 2
The FDA issued a complete response letter for CTx-1301 in ADHD. The letter focused on CMC information requests and did not identify current concerns with clinical safety or efficacy. That removes the May 31 action-window item from the forward board.
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CORT / relacorilant — EXCLUDED FROM BOARD
The raw file still showed a July 11 PDUFA for relacorilant in platinum-resistant ovarian cancer, but that entry appears stale. FDA has already approved relacorilant with nab-paclitaxel for this indication, so CORT is not included in the live board.
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| PDUFA | Window | Ticker | Event | PoA |
| 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 exp. |
| 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% |
| Fri Jul 17 | Fri Jul 17 | CELC | gedatolisib / HR+ HER2- PIK3CA WT BC | n/s |
| SPRO $SPRO · tebipenem HBr · cUTI, incl. pyelo | PDUFA: Thu Jun 18 PoA 92.5% |
This is now the next clean hard clock. 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. If approved, tebipenem changes the outpatient and step-down treatment conversation for a class that has historically been IV-only.
| ACHV $ACHV · cytisinicline · smoking cessation | PDUFA: Sat Jun 20 CRL expected |
This remains an FDA event, but not a clean approval watch. Achieve has already said it expects a CRL by the June 20 PDUFA date tied to manufacturing/inspection issues at a prior third-party manufacturer. The clinical package still matters, but the trade has shifted from “approval binary” to “how quickly can they reset the file and resubmit?”
| ARQT $ARQT · ZORYVE® 0.3% · 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. The main question is less about whether roflumilast works and more about whether FDA is comfortable extending the plaque psoriasis label down to ages 2–5.
| 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. 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 still 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 commercial stakes are larger here because sHTG is a broader addressable population.
| VERA $VERA · atacicept · IgA nephropathy | PDUFA: Tue Jul 7 PoA 78% |
Now moving closer to the front of the board. Priority Review, Breakthrough Therapy designation, and a Phase 3 package built around proteinuria reduction make this one of the more important early-July renal catalysts.
| CELC $CELC · gedatolisib · HR+ / HER2- / PIK3CA WT BC | PDUFA: Fri Jul 17 not scored |
Now inside the outer edge of the window. The FDA granted Priority Review for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, with a July 17 action date. The recent data noise makes this worth monitoring, but without a PoA in the current dataset, it stays unscored for now.
The board rotates again.
CING is off by CRL. CORT is excluded as a stale raw-data entry. SPRO becomes the next real approval clock. ACHV remains a likely CRL/reset story.
| SPRO | → | ACHV | → | ARQT | / | LNTH |
| IONS | → | VERA | → | CELC |
That is the queue.
Informational only · Not investment advice · Biotech carries risk of total loss