ARQT resolved as the label-expansion win. FDA approved ZORYVE® cream 0.3% for plaque psoriasis in children down to age 2, moving the franchise another step deeper into pediatric dermatology.
UNCY went the other direction. FDA issued another complete response letter for oxylanthanum carbonate. The agency again cited deficiencies at a third-party manufacturing facility and did not identify new safety or effectiveness concerns or ask for additional clinical data. That moves UNCY out of the live queue and into the CMC-reset bucket with ACHV and LNTH.
The board now moves to July. VERA is the next hard clock tomorrow. CELC carries the mid-July oncology date. MNKD and VTRS remain the lower-drama late-July rows. OTLK is back to the July 29 Class 1 labeling-review setup after its dispute-resolution win, and REPL now has a late-July AdCom watch before its Aug. 2 action date.
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ARQT / ZORYVE® — APPROVED · Jun 29
FDA approved ZORYVE cream 0.3% for plaque psoriasis in children ages 2 and older. This was the cleaner late-June label-expansion setup: approved product, commercial dermatology franchise, pediatric expansion, high PoA.
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UNCY / OLC — CRL · Jun 30
FDA declined to approve oxylanthanum carbonate for hyperphosphatemia in CKD patients on dialysis. This is the second manufacturing-driven CRL for the program. FDA did not identify new safety or effectiveness concerns and did not request additional clinical data.
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CORT / RELACORILANT — STILL EXCLUDED
CORT remains off the live July board. FDA already approved relacorilant with nab-paclitaxel for the relevant platinum-resistant ovarian cancer indication. There is no active July 11 PDUFA to track for this board.
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OTLK / LYTENAVA — CORRECTED BACK TO JUL 29
OTLK belongs on the live board as a July 29 Class 1 review. This remains a scarred file, but after the formal dispute-resolution win the near-term question is narrower: labeling, final review mechanics, and whether the Class 1 clock resolves cleanly.
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REPL / RP1 — ADDED TO OUTER BOARD · ADCOM WATCH
Replimune is on the outer board with RP1 plus nivolumab in advanced melanoma. The Aug. 2 action date matters, but the late-July advisory committee is the real intermediate catalyst.
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| PDUFA | Window | Ticker | Event | PoA |
| 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 |
| Sun Jul 26 | Fri 24 / Mon 27 | MNKD | FUROSCIX ReadyFlow Autoinjector | 73% |
| Wed Jul 29 | Wed Jul 29 | OTLK | LYTENAVA / wet AMD | 72% |
| Thu Jul 30 | Thu Jul 30 | VTRS | MR-100A-01 / low-dose-estrogen CHC weekly patch | 92.5% |
| Sun Aug 2 | Fri 31 / Mon Aug 3 | REPL | RP1 + nivolumab / advanced melanoma | 18.5% |
| VERA $VERA · atacicept · IgA nephropathy | PDUFA: Tue Jul 7 PoA 78% |
VERA is now the main live FDA clock. Atacicept is under review for IgA nephropathy on an accelerated-approval path, with the file built around proteinuria reduction. Priority Review, Breakthrough Therapy designation, and a defined confirmatory sequence keep it at the top of the board.
The decision itself is only the first step. If FDA approves, the next question is label and postmarketing language. Then the focus moves to ORIGIN 3 eGFR data expected in Q3 2026 and the potential Q4 2026 sBLA path toward full approval.
| CELC $CELC · gedatolisib · HR+ HER2- PIK3CA WT BC | PDUFA: Fri Jul 17 n/s |
CELC is the next oncology date after VERA. FDA accepted the NDA and granted Priority Review for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer. The key discipline remains the same: keep the filed indication separate from broader breast-cancer read-throughs. This is not a general “gedatolisib in breast cancer” action date.
| MNKD $MNKD · FUROSCIX ReadyFlow Autoinjector | PDUFA: Sun Jul 26 PoA 73% |
MNKD remains more device / delivery execution than new-drug efficacy. FUROSCIX is already an established subcutaneous furosemide product. ReadyFlow is an autoinjector / delivery-format sNDA, with a weekend action date that may resolve Friday July 24 or Monday July 27.
| OTLK $OTLK · LYTENAVA / ONS-5010 · wet AMD | PDUFA: Wed Jul 29 PoA 72% |
OTLK remains a scarred file, but the risk has changed. The old risk was whether FDA would accept the effectiveness package at all. After the formal dispute-resolution win, the review has moved into a narrower Class 1 resubmission / labeling setup. That does not make approval automatic, but it is not the same low-probability “FDA still needs a new efficacy trial” story.
| VTRS $VTRS · MR-100A-01 · low-dose-estrogen CHC weekly patch | PDUFA: Thu Jul 30 PoA 92.5% |
VTRS remains the lower-volatility late-July item. This is a 505(b)(2) combined hormonal contraceptive weekly patch application, not a high-drama novel-mechanism biotech binary. The watch item is label language around BMI, adhesion, estrogen exposure, and use population.
| REPL $REPL · RP1 + nivolumab · advanced melanoma | PDUFA: Sun Aug 2 PoA 18.5% |
REPL is the messier outer-board story. RP1 has already run into FDA resistance over the adequacy of the evidence package, especially reliance on single-arm data. The expected late-July advisory committee now becomes the key setup event before the Aug. 2 action date. A favorable panel tone could change the setup quickly. A skeptical panel would likely harden the bear case before the action date.
CORT / relacorilant — already approved for the relevant ovarian cancer indication. Off the live board.
ARQT / ZORYVE — resolved approval. Off the live board.
UNCY / OLC — resolved CRL. Off the live board until resubmission timing becomes clear.
The late-June board turned into another clean lesson in FDA catalyst sorting.
ARQT printed. UNCY reset. IONS was already the clean win. LNTH and ACHV remain CMC / manufacturing-reset examples.
The live board now starts with VERA.
| VERA | → | CELC | ||||
| MNKD | → | OTLK | / | VTRS | → | REPL |
The cleanest live setup is VERA. The next oncology clock is CELC. The lower-drama late-July rows are MNKD and VTRS. OTLK is now a Class 1 labeling-review setup after the dispute-resolution win. REPL is the highest-drama outer-board name because the late-July AdCom may matter more than the Aug. 2 date itself.
That is the queue.
Informational only · Not investment advice · Biotech carries risk of total loss