PDUFA Pulse July 26th 2026

FDA Catalyst Intelligence · Biotech Investors

PDUFA Pulse

MONDAY · JULY 27, 2026

PoA = directional probability-of-approval estimate; not FDA guidance. Advisory committee recommendations are non-binding. Weekend target dates can produce an earlier Friday or subsequent Monday public announcement.

► The Board · Jul 27 – Aug 27

MNKD AND OTLK PRINTED EARLY. NOW THE PUBLIC RECORD TAKES OVER.

CAPR and REPL go before the same FDA committee on consecutive days. VTRS carries Thursday’s hard action date, and REPL’s Aug. 2 weekend clock follows immediately.

As of Sunday, FDA had not posted either briefing package. Under FDA’s stated two-business-day schedule, CAPR’s package is expected Monday and REPL’s Tuesday. Either may reset the board before the vote.

► Live FDA Board

Date	Ticker / Event	Setup / Risk	PoA
Wed Jul 29	CAPR deramiocel CTGTAC PDUFA Aug 22	Class 2 / AdCom Cardiac evidence; CMC status	ADCOM
Thu Jul 30	VTRS MR-100A-01 weekly patch	505(b)(2) NDA Efficacy / BMI / adhesion	90%
Thu Jul 30	REPL RP1 + nivolumab CTGTAC	Post-2nd-CRL Class 1 Evidence adequacy	ADCOM
Sun Aug 2	REPL RP1 + nivolumab / melanoma	Post-2nd-CRL Class 1 Evidence adequacy	19%
Wed Aug 5	MRNA MFLUSIVA / mRNA-1010	Post-AdCom BLA Age-split pathway	85%
Thu Aug 13	LNTH MK-6240 tau PET imaging	Fast Track NDA Performance / label	88%
Mon Aug 17	BMY iberdomide + dara/dex	Priority / Breakthrough MRD pathway	79%
Sat Aug 22	CAPR deramiocel / DMD cardiomyopathy	Class 2 resubmission Cardiac evidence; CMC status	TBD
Sun Aug 23	RARE DTX401 / GSDIa	Priority Review BLA Durability / CMC execution	76%
Tue Aug 25	JAZZ Ziihera / first-line HER2+ GEA	Priority sBLA / RTOR Regimen / label scope	83%
Thu Aug 27	GILD bictegravir/lenacapavir / HIV	Priority Review NDA Resistance / label execution	89%

Board dates reflect current company, SEC and FDA disclosures. PoAs are PDUFA Pulse editorial estimates, rounded to whole numbers.

CAPR is intentionally unscored before the briefing package and July 29 vote. The raw 77% estimate does not adequately price a public evidence review after FDA lifted the prior CRL and resumed review without erasing the evidentiary question.

► Board Delta · Since Last Monday

✓ MNKD / FUROSCIX READYFLOW — APPROVED EARLY · JUL 24

FDA approved the ReadyFlow autoinjector for edema in adults with heart failure or chronic kidney disease, two days before the July 26 target. The next read is launch execution and whether the faster format expands use beyond the existing on-body infusor.

✓ OTLK / LYTENAVA — APPROVED EARLY · JUL 24

FDA approved bevacizumab-vikg for wet AMD five days before the July 29 target, making it the first FDA-approved ophthalmic formulation of bevacizumab for this indication. Launch execution and reimbursement now replace approval risk.

✓ GSK / JIDEYTRO — APPROVED · JUL 22

FDA approved zidesamtinib for previously treated ROS1-positive locally advanced or metastatic NSCLC roughly two months ahead of the goal date. GSK completed its acquisition of Nuvalent on July 15, so this is a GSK asset rather than a live NUVL ticker event.

→ CAPR / REPL — THE ADCOMS ARE NOW FRONT BOARD

CTGTAC reviews deramiocel Wednesday and RP1 plus nivolumab Thursday. CAPR brings a new randomized Phase 3 repair package. REPL returns after a second efficacy CRL; FDA’s public record still describes the randomized evidence as an early analysis from about 10% of planned enrollment.

! BRIEFING-DOCUMENT WATCH · EXPECTED MONDAY / TUESDAY

As of Sunday, neither FDA package was posted. FDA says background material is intended no later than two business days before each meeting: Monday for CAPR and Tuesday for REPL. Until the documents appear, any claim about FDA’s current framing is premature.

→ RARE / JAZZ / GILD — NOW ON THE EXTENDED BOARD

DTX401 enters as the first potential disease-modifying treatment for GSDIa. Ziihera brings randomized Phase 3 PFS support and a positive triplet OS result. BIC/LEN brings two positive switch studies in virologically suppressed adults.

× RAW-CALENDAR CORRECTIONS

SVRA moved from Aug. 22 to Nov. 22 after a major amendment. BIIB’s Aug. 24 row is stale after the Jul. 13 LEQEMBI IQLIK approval. Raw OTLK dates are superseded by the Jul. 24 approval. Both MRK Aug. 17 rows remain stale after the Jul. 10 approval.

► Risk Types On This Board

ADCOM / EVIDENCE ADEQUACY

The vote is not the approval decision. It exposes the question FDA believes the application must answer. CAPR and REPL reach the same committee with very different repair packages.

CLASS 1 IS A CLOCK, NOT A THESIS

OTLK’s Class 1 followed an OND decision that effectiveness had been established and ended in early approval. REPL’s Class 1 follows a second CRL while trial-adequacy and contribution-of-components objections remain live. Same 60-day label, opposite evidence setups.

505(b)(2) / LABEL MECHANICS

VTRS uses a familiar contraceptive framework and a single-arm Phase 3 program. Efficacy, the BMI-limited population, adhesion, pharmacokinetics and safety language still have to close.

POST-POSITIVE-ADCOM EXECUTION

MRNA has two 9–0 benefit-risk votes. Residual questions are the full-versus-accelerated age split, labeling, manufacturing and postmarketing requirements.

FIRST-CYCLE EFFICACY + EXECUTION

RARE, JAZZ and GILD have positive pivotal packages. Their remaining risk is whether FDA accepts the endpoint, regimen, label and application execution presented.

► Top Two Setups

CAPR$CAPR · deramiocel

AdCom Jul 29

PDUFA AUG 22 · CLASS 2 RESUBMISSION · PoA TBD

FDA lifted CAPR’s July 2025 CRL on March 10 after the company submitted HOPE-3 data, resumed review of the original BLA and classified the response as a Class 2 resubmission. Review restarted, but the public reasoning in the original CRL still frames the evidence question.

HOPE-3 was randomized, double-blind and placebo-controlled. PUL v2.0 reached p=0.029 and the prespecified LVEF key secondary reached p=0.041. The CRL had recommended an adequate controlled study whose primary objective was cardiac outcomes, while HOPE-3’s primary endpoint was upper-limb function.

Filed indication: Treatment of cardiomyopathy in Duchenne muscular dystrophy.

FDA question: Does the randomized HOPE-3 package, including the prespecified LVEF endpoint, provide substantial evidence of clinically meaningful cardiac benefit even though cardiac function was not the primary endpoint?

If the vote is favorable: The Aug. 22 setup improves, but the vote remains non-binding and the public CRL also contains redacted CMC and facility sections.

If the vote is negative: Determine whether the panel rejected the endpoint, clinical meaningfulness or totality-of-evidence argument. Do not automatically recast that as a disclosed manufacturing failure.

What can change: FDA and sponsor briefing materials, the July 29 discussion and vote, and any subsequent labeling or review update.

REPL$REPL · RP1 + nivolumab

AdCom Jul 30 PoA 19%

PDUFA AUG 2 · COMPLETE CLASS 1 RESPONSE AFTER SECOND CRL

FDA’s April CRL said the single-arm RPL-001-16 study was not adequate and well-controlled and could not isolate RP1’s contribution to the combination. The early RP1-104 randomized data covered only about 10% of planned enrollment and lacked mature duration-of-response evidence.

Replimune’s May ASCO update reported 32.9 months median overall survival, 47.8% three-year overall survival and 24.8 months median duration of response. Those signals strengthen the benefit case, but the single-arm update does not by itself solve FDA’s control and contribution-of-components objections.

Filed indication: RP1 with nivolumab for adults with advanced melanoma previously treated with an anti-PD-1-containing regimen.

FDA question: Can the response overcome objections involving response reliability, patient heterogeneity, lack of a concurrent control and RP1’s contribution to the combination?

Sponsor’s strongest counterpoint: Mature IGNYTE survival and response-duration data support a durable treatment effect, even though they do not create a concurrent control.

Longer path: FDA’s CRL says Replimune may ask whether a revised RP1-104 protocol and statistical analysis plan can address the deficiencies; FDA also provided recommendations on using Phase 3 data to potentially support accelerated approval.

If the vote is favorable: The setup can improve sharply, but FDA is not bound by the panel and the Aug. 2 action follows immediately.

If the vote is negative: A third CRL remains the base-case read unless FDA identifies a narrower approvable path.

What can change: The FDA briefing package, exact voting question, Thursday’s discussion and vote, and weekend disclosure timing.

► Failure Mode Of The Week · The Briefing Book Resets The Base Rate

An AdCom is not just a vote. FDA’s briefing document defines the problem before the panel answers it.

For CAPR, the question is whether FDA treats the prespecified LVEF result as sufficient to repair a cardiomyopathy-specific evidence gap. For REPL, it is whether the latest response changes FDA’s two prior conclusions about trial adequacy and contribution of components.

If the documents change the question, the PoA should change before the vote. As of Sunday, they are expected—not posted.

► If This Fails, What Broke?

CAPR	Did HOPE-3 fail to close the cardiomyopathy evidence gap, or did redacted CMC/facility or other deficiencies remain open?
VTRS	Did contraceptive efficacy, the BMI-limited population, adhesion, PK or safety language prevent approval?
REPL	Did the Class 1 response fail to overcome FDA’s adequacy, control and contribution-of-components objections?
MRNA	Did the older-adult accelerated pathway, labeling, manufacturing or postmarketing plan fail despite two 9–0 votes?
LNTH	Did sensitivity, specificity, image interpretation or the proposed diagnostic label fail to support approval?
BMY	Was MRD negativity insufficient for the proposed pathway or regimen, or did effect size, safety or execution fail?
RARE	Did FDA reject the cornstarch-reduction endpoint or encounter gene-therapy CMC, inspection or durability concerns?
JAZZ	Did FDA narrow the filing to one regimen, or did label, safety or application execution prevent approval?
GILD	Did resistance, population definition, regimen composition or manufacturing/label execution prevent approval?

► Resolved / Removed

× MNKD / FUROSCIX READYFLOW — APPROVED JUL 24

The July 26 delivery-format binary is resolved.

× OTLK / LYTENAVA — APPROVED JUL 24

The July 29 wet-AMD application printed five days early after OND resolved the efficacy dispute.

× GSK / JIDEYTRO — APPROVED JUL 22

The previously treated ROS1-positive NSCLC application printed roughly two months early. GSK completed its acquisition of Nuvalent one week earlier.

× SVRA / MOLBREEVI — AUG 22 REMOVED

FDA extended the PDUFA date to Nov. 22 after treating a response to information requests as a major amendment.

× BIIB / LEQEMBI IQLIK — AUG 24 REMOVED

FDA approved the at-home starting regimen on Jul. 13.

× MRK / KEYTRUDA + PADCEV — AUG 17 REMAINS REMOVED

FDA approved both formulations with Padcev on Jul. 10.

► Weekly Posture

The board is front-loaded. By Thursday afternoon, two public discussions may have changed the two highest-variance names.

Resolved: MNKD / FUROSCIX ReadyFlow; OTLK / Lytenava; GSK / Jideytro.

Live: CAPR AdCom → VTRS / REPL AdCom → REPL → MRNA → LNTH → BMY → CAPR → RARE → JAZZ → GILD.

Highest-drama name: REPL remains the lowest-PoA action date. CAPR is the most elastic setup because its FDA framing and vote are still ahead.

That is the queue.

Forward this to someone who plans to read the vote before reading the question FDA asked.

Informational only · Not investment advice · Biotech carries risk of total loss

PDUFA Pulse July 26th 2026

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