PDUFA Pulse: Monday (Mar 23, 2026)

PoA = probability-of-approval band (directional only; not FDA guidance).

This week is simpler than the last few. RYTM already printed approved on March 19 for acquired hypothalamic obesity, while GSK’s linerixibat also already printed approved on March 19, so neither belongs in the forward queue anymore. LNTH-2501 was pushed out to June 29, 2026, so it drops out of the immediate 6-week stack. That leaves RCKT as the next hard FDA clock, followed by a denser April run: BIIB, REPL, TVTX, GRCE, MRK, AXSM, and ARGX.

RYTM / IMCIVREE was approved March 19 for acquired hypothalamic obesity, becoming the first FDA-approved treatment for that indication.

GSK / linerixibat was also approved March 19 in PBC-associated cholestatic pruritus, so that Mar. 24 PDUFA is no longer an upcoming event. GSK had also disclosed its Alfasigma transaction earlier in March.

LNTH / LNTH-2501 was extended three months to June 29, 2026 for added manufacturing review time, with the company saying the extension is not related to efficacy or safety.

The next real hard clock. This remains a rare-pediatric gene-therapy review with a small but striking data package and potential PRV upside if approved. Main risk remains the same one flagged in prior review cycles: CMC / manufacturing execution, not clinical signal.

Biogen continues to describe the high-dose regimen as under FDA review with an April 3, 2026 action date. This is a relatively de-risked label-expansion style setup around an already established drug, with the real question being how much the higher-dose regimen improves competitive positioning and durability versus standard dosing and rivals.

The FDA accepted Replimune’s BLA resubmission with an April 10, 2026 PDUFA date. This remains a more contested setup than the cleaner label expansions in the queue because it is a resubmission story in oncology, but it is close enough now that it belongs firmly in the core watchlist.

Travere’s FSGS sNDA was pushed to April 13, 2026 after the FDA asked for more review time around additional clinical-benefit characterization. This is still a meaningful hard clock, but it is not a totally clean one; the key debate is whether the evidence package is sufficient for full approval in FSGS.

This is exactly the kind of name your reader was asking for: a date that is still a few weeks out, but close enough to matter now. Grace continues to state the April 23, 2026 target date, and the company just used March conference appearances to reinforce the unmet-need/commercial-angle framing.

Merck reiterated that the FDA set an April 28, 2026 action date for the once-daily two-drug regimen in virologically suppressed adults. The setup remains comparatively clean: large Phase 3 package, no visible review drama, big sponsor, familiar regulatory path.

The FDA accepted the sNDA and granted Priority Review, setting April 30, 2026 as the action date. Because AXS-05 is already marketed in another indication, this has some obvious de-risking from a manufacturing/safety-history standpoint, though the commercial question is how it stacks up in a market already opened by Rexulti.

argenx’s supplemental filing was accepted with Priority Review and a May 10, 2026 PDUFA date. This is one of the cleaner late-spring clocks in the queue: same franchise, expanded population, strong sponsor, clear strategic importance.

This Monday issue is back to a forward decision map. The near-term stack is now cleaner because RYTM and GSK are off the board and LNTH has been pushed out. That leaves RCKT as the next immediate FDA event, with the real work now shifting to the April calendar: BIIB → REPL → TVTX → GRCE → MRK → AXSM → ARGX.

Disclaimer: informational only; not investment advice; biotech carries risk of total loss