PDUFA Pulse: Monday (Jan 5)

The lights are back on. After two weeks of holiday thinning, institutional desks fully return today. Expect liquidity to normalize rapidly, which means the thin, timing-driven moves we saw in late December will be replaced by sharper, volume-driven reactions.

This week is unusual: it is a Data Week first, followed by a PDUFA Cluster into the weekend.

Tuesday–Friday: A dense stack of clinical readouts, including multiple pancreatic cancer programs ($IMRX, $RNXT, $ACTU).
Saturday: A rare weekend PDUFA for $ATRA.

We are watching $ATRA closely. Saturday PDUFAs often result in “press release limbo”—news dropping Friday night or Monday morning. Position accordingly.

Final 2025 FDA decisions resolved into year-end.

Corcept Therapeutics $CORT ( ▲ 2.38% ) — Relacorilant
Outcome: CRL (Dec 31)

Context: The FDA indicated it could not reach a favorable benefit–risk determination without additional evidence of effectiveness. The outcome reflects regulatory disagreement on efficacy framing rather than late-cycle safety or CMC issues. Focus now shifts to FDA engagement on next steps and path forward.

Outlook Therapeutics $OTLK ( ▼ 2.41% ) — ONS-5010 (Lytenava)
Outcome: CRL (Dec 31) (third CRL)

Context: The FDA stated the BLA cannot be approved in its current form. This remains a repeat-cycle outcome for a program with persistent execution risk, including known sensitivity around submission quality and CMC expectations.

Desks return to a cluster of clinical readouts, with a heavier focus on pancreatic cancer assets later in the week.

Gain Therapeutics $GANX ( ▼ 14.14% ) — Phase 1b Results (KOL Discussion)
Date: Jan 6 (Tuesday) | Virtual KOL Event @ 10:00 AM ET
Event: KOL discussion of previously announced Phase 1b Parkinson’s data (GBA1 & idiopathic), including exploratory biomarker signal.

Watch for: Safety remains the primary hurdle, but attention will center on biomarker validation—specifically CSF substrate reduction (GluSph/GCase pathway)—as support for the proposed mechanism of action.

Immuneering $IMRX ( ▲ 1.66% ) — Phase 2a Update
Date: Jan 7 (Wednesday) | Call @ 4:00 PM ET
Event: 12-month overall survival (OS) update in first-line pancreatic cancer.

The bar: Prior 9-month OS was ~86% versus ~45–50% reported historical benchmarks. Durability at the 12-month mark is the key validator as the program advances toward Phase 3.

RenovoRx $RNXT ( ▲ 7.37% ) — Phase 3 Interim
Date: Jan 9 (Friday)
Event: Interim data for RenovoCath in locally advanced pancreatic cancer.

Actuate Therapeutics $ACTU ( 0.0% ) — Phase 2 Data
Date: Jan 9 (Friday)
Event: Data for elraglusib in metastatic pancreatic cancer.

The first regulatory wave of 2026.

Atara Biotherapeutics $ATRA ( ▼ 13.58% ) — Tab-cel
Date: Jan 10 (Saturday) | PDUFA
PoA: 77 (High)

Setup: First-in-class allogeneic T-cell immunotherapy for EBV+ PTLD. Priority Review.
Risk: Saturday timing. If the FDA does not issue the action letter by Friday close, risk is carried over the weekend.

Travere Therapeutics $TVTX ( ▼ 6.06% ) — Filspari
Date: Jan 13 (Tuesday) | PDUFA
PoA: 70 (High)

Setup: sNDA for traditional approval in FSGS.
Context: Volatility is generally lower than a first-cycle NCE, but label language and post-marketing commitments still matter. DUPLEX Phase 3 proteinuria data supports conversion from accelerated approval.

Fortress Biotech $FBIO ( ▼ 1.41% ) — CUTX-101
Date: Jan 14 (Wednesday) | PDUFA
PoA: 80 (High)

Setup: Pediatric treatment for Menkes disease.
Context: Class 1 resubmission following a CRL. The turnaround suggests resolution of discrete issues, more consistent with CMC or administrative items than clinical efficacy.

An exercise in risk framing. Not a prediction.

Atara Biotherapeutics $ATRA ( ▼ 13.58% )
Asset: Tab-cel (Ebvallo)
Event: PDUFA — Jan 10 (Saturday)

Bull case: Tab-cel addresses a setting with no approved alternatives. The pivotal trial showed ~50% ORR and durable survival (median OS 18.4 months) in a population with very limited survival. Priority Review reflects unmet need.

Bear case: A negative outcome would most likely stem from CMC or REMS complexity rather than efficacy.

The “cell therapy” tax: Allogeneic T-cell programs face a high bar for manufacturing consistency and potency assays. A CRL would likely cite information gaps around stability, comparability, or facility inspection.

Saturday risk: Clean approvals often clear on Friday. Silence extending into Saturday can reflect last-minute negotiation on label language or post-marketing requirements.

Survival check: Atara has transferred development and commercialization costs to Pierre Fabre but retains a $40M milestone upon approval.

We are watching the $IMRX ( ▲ 1.66% ) readout on Wednesday closely. Pancreatic cancer is a graveyard for biotech; 12-month survival that holds up against historical benchmarks would represent a rare durability-validated signal in the space.

— PDUFA Pulse