PDUFA Pulse August 3rd, 2026

FDA Catalyst Intelligence · Biotech Investors

PDUFA Pulse

MONDAY · AUGUST 3, 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 · Aug 3 – Sep 3

THE SCOREBOARD IS USEFUL ONLY AFTER READING THE BALLOT.

CAPR received a 3–9 vote against deramiocel’s effectiveness for Duchenne cardiomyopathy. REPL received a 10–3 vote that IGNYTE’s results were evaluable and clinically meaningful—but the panel was not asked whether RP1 was approvable.

VTRS resolved early with approval of Gwyn Lo. REPL’s Aug. 2 action remains pending. The next scheduled hard clock is Moderna’s mRNA flu vaccine on Wednesday.

► Live FDA Board

Date	Sponsor / Event	Setup / Risk	PoA
PENDING Aug 2 goal	REPL RP1 + nivolumab advanced melanoma	Class 1 / post-AdCom Evidence / timing	PENDING
Wed Aug 5	MRNA mFLUSIVA / mRNA-1010	Post-AdCom BLA Age group / label	85%
Thu Aug 13	LNTH MK-6240 tau PET	Fast Track NDA Performance / label	88%
Mon Aug 17	BMY iberdomide + dara/dex	Priority / Breakthrough MRD pathway	79%
Sat Aug 22	CAPR deramiocel / DMD	Class 2 / negative AdCom Evidence / CMC	10%
Sun Aug 23	RARE DTX401 / GSDIa	Priority Review BLA Durability / CMC	76%
Tue Aug 25	JAZZ Ziihera / 1L HER2+ GEA	Priority sBLA / RTOR Regimen / label	83%
Thu Aug 27	GILD bictegravir/lenacapavir	Priority Review NDA Resistance / label	89%
Fri Aug 28	ITM PRIVATE 177Lu-edotreotide	NDA Efficacy / CMC / supply	82%
Sun Aug 30	PharmaEssentia TWSE-LISTED BESREMi / ET	Standard sBLA Label / safety	87%
Thu Sep 3	Advicenne EURONEXT-LISTED Sibnayal / dRTA	505(b)(2) NDA U.S. bridge / CMC	78%

Dates reflect current company, SEC and FDA disclosures. Private and non-U.S.-listed sponsors are named because none has a U.S.-listed equity ticker. PoAs are editorial estimates, rounded to whole numbers. REPL is marked pending rather than rescored after its goal date.

Takeda’s oveporexton is not assigned an Aug. 10 row. Takeda has disclosed only a third-quarter 2026 PDUFA date, which is not precise enough for the hard-date board.

► Board Delta · Since Last Monday

✓ VTRS / GWYN LO — APPROVED EARLY · JUL 29

FDA approved the once-weekly combined hormonal contraceptive patch one day before its Jul. 30 goal date. The label is limited to women with BMI below 30 kg/m². Commercial launch is expected later in 2026.

✓ CAPR ADCOM — 3 YES, 9 NO · JUL 29

CTGTAC voted that the evidence did not support deramiocel’s effectiveness for cardiomyopathy in DMD. The vote was non-binding, but it aligned with FDA reviewers. The Aug. 22 clock remains live; PoA falls to 10%.

✓ REPL ADCOM — 10 YES, 3 NO · JUL 30

The committee voted that IGNYTE’s results were evaluable and clinically meaningful. It did not vote on approval or substantial evidence. FDA’s methodology and contribution-of-effect objections remain unresolved, and no action had been announced Sunday morning.

→ MRNA — NEXT SCHEDULED HARD CLOCK · AUG 5

VRBPAC voted 9–0 in adults 50–64 and separately 9–0 in adults 65 and older. Remaining questions are label, regulatory pathway by age group, manufacturing and postmarketing execution.

+ THREE CONFIRMED CLOCKS ADDED

The supplied calendar omitted 177Lu-edotreotide on Aug. 28, BESREMi’s essential-thrombocythemia sBLA on Aug. 30 and Sibnayal on Sep. 3. Each date is confirmed by the sponsor.

× RAW-CALENDAR CORRECTIONS

MRK’s two Aug. 17 rows are stale after the Jul. 10 approval. SVRA’s MOLBREEVI moved to Nov. 22. BIIB’s Aug. 24 LEQEMBI IQLIK row is stale after the Jul. 13 approval.

► Risk Types On This Board

POST-ADCOM LABEL + EXECUTION

MRNA brings two unanimous votes, but FDA still owns the final indication, pathway, manufacturing assessment and postmarketing package.

EVIDENCE ADEQUACY AFTER A NEGATIVE VOTE

CAPR now needs FDA to depart from both its review team and a 3–9 committee vote. The residual upside case depends on unusually broad totality-of-evidence flexibility.

DIAGNOSTIC PERFORMANCE + ENDPOINT ACCEPTANCE

LNTH must translate sensitivity, specificity and image interpretation into an approvable tau-PET label. BMY asks FDA to accept an MRD-centered myeloma package.

GENE THERAPY + RADIOPHARMA EXECUTION

RARE and ITM have positive clinical packages, but modality-specific manufacturing, inspection, durability and supply-chain questions remain binary.

LABEL EXPANSION + 505(b)(2) BRIDGING

BESREMi is an approved product seeking a new indication. Sibnayal uses European clinical studies in a U.S. 505(b)(2) application.

► Top Two Setups

MRNA$MRNA · mFLUSIVA

Aug 5 85%

POST-ADCOM BLA · AGE-GROUP PATHWAY / LABEL / EXECUTION

FDA’s vaccine committee voted 9–0 that mRNA-1010’s benefits outweigh its risks in adults 50–64 and separately 9–0 in adults 65 and older. The BLA seeks prevention of influenza disease in adults 50 and older.

The efficacy debate is substantially de-risked. FDA can still separate the age groups or attach different evidentiary and postmarketing requirements. Manufacturing and final label execution remain the principal binary risks.

Filed population: Adults 50 years and older.

Panel signal: Two unanimous 9–0 benefit-risk votes.

If approved: The U.S. gets its first mRNA seasonal influenza vaccine; exact age-group language determines the read-through.

If CRL: The surprise is more likely to involve execution, manufacturing or the age-group pathway than panel-level benefit-risk.

CAPR$CAPR · deramiocel

Aug 22 10%

CLASS 2 RESUBMISSION · NEGATIVE ADCOM · EVIDENCE / CMC

Only three committee members voted yes and nine voted no on whether the evidence supported deramiocel’s effectiveness for cardiomyopathy in Duchenne muscular dystrophy.

FDA’s prespecified HOPE-3 analyses were not statistically significant for PUL 2.0 or LVEF. The agency said later significant analyses depended on post-study changes and lacked robustness and clinical interpretability.

FDA position: The submitted analyses do not provide substantial evidence of effectiveness.

Residual bull case: FDA applies exceptional totality-of-evidence flexibility across functional and cardiac measures.

If approved: The decision would depart materially from the review team and committee posture.

If CRL: Evidence adequacy is the leading failure mode. The public record does not identify a specific current manufacturing deficiency.

► Focus Card · MRNA

THE VOTE IS STRONGER THAN THE LABEL READ

Known: Two 9–0 benefit-risk votes and an Aug. 5 goal date.

Unknown: Whether FDA treats both age groups identically in the final action.

Do not confuse: A unanimous panel with a guaranteed full-population label.

Fastest invalidator: A review extension, manufacturing disclosure or age-specific postmarketing requirement.

► Failure Mode Of The Week · The Vote Is Only As Broad As The Question

CAPR and REPL appeared before the same committee on consecutive days and produced opposite tallies.

CAPR’s question asked whether the evidence supported effectiveness for Duchenne cardiomyopathy. The committee said no, 3–9.

REPL’s question asked whether IGNYTE’s efficacy results were evaluable and clinically meaningful. The committee said yes, 10–3. It was not asked whether RP1 was approvable, whether the application met the substantial-evidence standard or whether RP1’s contribution had been isolated.

The scoreboard is useful only after reading the ballot.

► If This Fails, What Broke?

REPL	Did the Class 1 response fail to overcome FDA’s response-reliability, systemic-activity and contribution-of-effect objections?
MRNA	Did manufacturing, final labeling or the age-group pathway prevent approval despite two unanimous votes?
LNTH	Did sensitivity, specificity, image interpretation or the proposed diagnostic label fail?
BMY	Was MRD insufficient for the proposed pathway or regimen, or did safety or execution fail?
CAPR	Did the evidence fail to establish effectiveness, or did another application, CMC or facility issue remain open?
RARE	Did FDA reject the endpoint or encounter gene-therapy CMC, inspection or durability concerns?
JAZZ	Did FDA narrow the filing to one regimen, or did label, safety or execution prevent approval?
GILD	Did resistance, population definition, regimen composition or label execution prevent approval?
ITM PRIVATE	Did efficacy interpretation, isotope supply, CMC or inspection risk break the radiopharma package?
PharmaEssentia TWSE	Did FDA narrow the ET population, require more safety controls or find an sBLA execution issue?
Advicenne EURONEXT	Did the European-data bridge, 505(b)(2) basis, CMC package or U.S. label fail to close?

► Resolved / Removed

× VTRS / GWYN LO — APPROVED JUL 29

The Jul. 30 weekly contraceptive-patch binary resolved one day early.

× MRK / KEYTRUDA + PADCEV — APPROVED JUL 10

Both raw Aug. 17 entries remain removed.

× SVRA / MOLBREEVI — MOVED TO NOV 22

The Aug. 22 row is superseded by the major-amendment extension.

× BIIB / LEQEMBI IQLIK — APPROVED JUL 13

The raw Aug. 24 row is resolved.

► Weekly Posture

The board has rotated from public-review risk toward execution risk, with REPL still carrying an unresolved evidence question beyond its weekend goal date.

Resolved: VTRS / Gwyn Lo.

Live: REPL pending → MRNA → LNTH → BMY → CAPR → RARE → JAZZ → GILD → ITM → PharmaEssentia → Advicenne.

Next scheduled hard clock: MRNA on Aug. 5.

Highest-drama name: CAPR. Approval would require FDA to move against the public posture of both its review team and the advisory committee.

That is the queue.

Forward this to someone who reads the voting question before trading the tally.

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

PDUFA Pulse August 3rd, 2026

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