Two approvals cleared the front of the board last week. Neither eliminated every evidence question.
FDA approved Moderna’s mFLUSIVA through two pathways: traditional approval for adults ages 50–64 and accelerated approval for adults 65 and older, with a postmarketing study required for the older group. One application produced two different levels of regulatory certainty.
FDA then granted accelerated approval to REPL’s TUDRIQEV with nivolumab after two prior complete response letters and a 10–3 advisory vote on a narrower question. FDA used 91 evaluable patients from the 140-patient study and reported a 24.2% objective response rate with a 14.1-month median duration of response. Confirmatory evidence is still required.
The board now rotates from therapeutic controversy to diagnostic performance. Lantheus is next on Thursday with MK-6240, a tau PET imaging agent. The asset is also part of the neurology franchise covered by Curium’s newly announced Lantheus acquisition and its contingent-value-right structure. Bristol Myers Squibb follows four days later with an iberdomide filing built on minimal residual disease while progression-free-survival follow-up continues.
Approval can settle the market-access question while moving the remaining uncertainty somewhere else: into a narrower population, a confirmatory trial, or the final label.
| Date | Sponsor / Event | Setup / Main Risk | PoA |
| THU AUG 13 | LNTH MK-6240 tau PET | Fast Track NDA Diagnostic performance / label | 88% |
| MON AUG 17 | BMY iberdomide combo / RRMM | Priority / BTD / Orbis MRD endpoint / pathway | 79% |
| SAT AUG 22 | CAPR deramiocel / DMD | Class 2 / negative AdCom Evidence / CMC status | 10% |
| SUN AUG 23 | RARE DTX401 / GSDIa | Priority Review BLA Durability / CMC | 76% |
| TUE AUG 25 | JAZZ Ziihera combos / HER2+ GEA | Priority / RTOR / Orbis Regimen / label scope | 83% |
| THU AUG 27 | GILD BIC/LEN / suppressed HIV | Priority Review NDA Resistance / regimen / label | 89% |
| FRI AUG 28 | ITM PRIVATE 177Lu-edotreotide | NDA / GEP-NETs Efficacy / CMC / supply | 82% |
| SUN AUG 30 | PharmaEssentia BESREMi / ET | Standard Review sBLA Label / safety / execution | 87% |
| THU SEP 3 | Advicenne Sibnayal / dRTA | 505(b)(2) NDA U.S. bridge / CMC / label | 78% |
| FRI SEP 11 | Telix Pixclara / glioma PET | Resubmitted NDA / FT / ODD Evidence / resubmission | 75% |
Board dates reflect current company and FDA disclosures. Private and non-U.S.-listed sponsors are identified by sponsor name. PoAs are PDUFA Pulse editorial estimates rounded to whole numbers.
| LNTH$LNTH · MK-6240 | Aug 13 88% |
MK-6240 is an F18-labeled PET imaging agent designed to detect tau neurofibrillary-tangle pathology in cognitively impaired patients being evaluated for Alzheimer’s disease. Lantheus says both pivotal Phase 3 trials met their co-primary sensitivity and specificity endpoints.
That is a strong filing posture, and Lantheus has 70 years of radiopharmaceutical operating experience. But the public filing announcement does not disclose the detailed performance results. FDA’s decision still depends on the full reader-study package, truth standard, reproducibility, manufacturing and the exact clinical-use language the data can support.
There is now a corporate overlay. On Aug. 3, Curium agreed to acquire Lantheus for $102.50 per share in cash plus non-transferable contingent value rights worth up to $12.00 per share. The CVR includes up to $3.00 tied to global neurology-diagnostics sales thresholds measured in any one of fiscal 2028, 2029 or 2030, and its defined portfolio expressly includes MK-6240. The transaction is expected to close in the first half of 2027; Lantheus remains an independent public company until closing. The FDA decision therefore arrives before the merger but can directly affect the value of the neurology franchise Curium is acquiring.
| BMY$BMY · iberdomide | Aug 17 79% |
BMS is seeking approval for iberdomide with daratumumab and dexamethasone in relapsed or refractory multiple myeloma. The filing is based on a planned analysis of minimal residual disease negativity from the randomized Phase 3 EXCALIBER-RRMM trial. PFS—the trial’s other primary endpoint—remains under follow-up.
This is not a conventional mature-PFS filing. It is a live test of how FDA will use MRD in myeloma when the randomized trial continues. Breakthrough Therapy, Priority Review and Project Orbis show substantial regulatory engagement; none substitutes for the approval standard.
MRNA and REPL both received approvals. The unresolved questions moved downstream.
For mFLUSIVA, FDA separated the evidence by age group: traditional approval for ages 50–64, accelerated approval for ages 65 and older, plus a postmarketing study in the older population.
For TUDRIQEV, blinded independent central review reported a 33.6% ORR and 24.8-month median DOR across 140 patients. FDA restricted its label-supporting analysis to 91 patients with at least one non-injected lesion, producing a 24.2% ORR and 14.1-month median DOR. FDA granted accelerated approval on that narrower population and required confirmation of clinical benefit.
The approval did not resolve which population definition best represented the broad IGNYTE cohort. It defined the population and efficacy evidence FDA was willing to put into the label.
The post-decision question is not only “approved or rejected?” It is: what population, what pathway, what evidentiary obligation and what label survived the review?
| LNTH | Did sensitivity, specificity, reader reproducibility, manufacturing or the proposed diagnostic label fail to support approval? |
| BMY | Was MRD insufficient for action before PFS matured, 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 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? |
| ITM PRIVATE | Did efficacy interpretation, isotope supply, CMC or inspection risk break the radiopharmaceutical package? |
| PharmaEssentia TWSE | Did FDA narrow the ET population, require additional safety controls or find an execution issue in the sBLA? |
| Advicenne EURONEXT | Did the European-data bridge, 505(b)(2) basis, CMC package or proposed U.S. label fail to close? |
| Telix ASX | Did the resubmission fail to resolve FDA’s diagnostic-evidence concerns, or did label, manufacturing or distribution remain open? |
The front of the board has changed categories.
Resolved: MRNA / mFLUSIVA and REPL / TUDRIQEV.
Live: LNTH → BMY → CAPR → RARE → JAZZ → GILD → ITM → PharmaEssentia → Advicenne → Telix.
Next hard clock: LNTH on Aug. 13.
Next therapeutic clock: BMY on Aug. 17.
Highest-drama name: CAPR. A 10% PoA leaves a non-zero path, but approval would require FDA to move against the public posture of both its review team and the advisory committee.
Informational only · Not investment advice · Biotech carries risk of total loss