Monday · October 5, 2026

Information checked through October 4. Target action dates are not guaranteed announcement times. A dash in the PoA column means no numerical estimate is published in this issue.

Editor’s Note: Changes to Beehiiv’s plans have prompted me to reconsider the future of PDUFA Pulse. Maintaining the recent newsletter design now requires a paid platform subscription. For a free publication, that adds another expense to the time spent researching, verifying sources and producing each issue.

I’m considering whether to wrap up this experiment or continue with a reader-supported version. Before deciding, I’d like to know whether a paid PDUFA Pulse would interest you.

If you would consider subscribing, reply and tell me what would make it worth paying for, whether that’s the weekly decision board, deeper analysis or something else. Honest feedback is useful; there’s no commitment involved.

Thank you for reading and helping me assess where this goes next.

Daiichi Sankyo and Merck withdrew I-DXd’s accelerated-approval BLA September 25 after FDA discussions concluded the supporting data did not satisfy that pathway’s requirements. Its former October 10 target is no longer live. Withdrawal announcement

Emcitate and pediatric CAMZYOS have resolved with approvals. The October 5–17 board now has three reviews: Tecentriq after colon-cancer surgery on October 9, Enspryng for thyroid eye disease on October 15, and phentolamine for presbyopia on October 17.

This issue covers October 5–17. As of writing, the three listed reviews remain pending in the public sources checked. The October 17 Saturday target does not promise a Saturday announcement. Tecentriq’s two formulations represent one clinical event; Viatris and Opus share one presbyopia application.

Date and filing sources: Tecentriq, Enspryng, phentolamine.

✓ EGTX · EMCITATE — APPROVED SEP 28. The U.S. indication covers peripheral thyrotoxicosis in adults and pediatric patients with MCT8 deficiency. It does not make a claim for improved neurodevelopment. FDA also granted a rare pediatric disease Priority Review Voucher; Egetis expects to explore monetization, potentially in Q4, subject to market conditions. A voucher grant is a separate milestone from a completed sale. Egetis is entitled to 50% of net proceeds from an Emcitate-related voucher sale; the other half is payable as an earnout to the former Rare Thyroid Therapeutics owners. U.S. label, section 1 · Egetis announcement · Proceeds-sharing terms

✓ BMY · CAMZYOS — EXPANDED SEP 30. The approved indication uses a weight threshold: adults and pediatric patients weighing at least 30 kg with symptomatic obstructive HCM, to improve functional capacity and symptoms. SCOUT-HCM enrolled adolescents aged 12 to under 18, but that trial age range is not the indication's wording. The heart-failure boxed warning and REMS remain. BMS decision · Updated label, sections 1 and 8.4

× MRK / DAIICHI SANKYO · I-DXd — WITHDRAWN SEP 25. The sponsors withdrew the BLA seeking accelerated approval for previously treated extensive-stage SCLC. Their disclosed reason is that the supporting data, including IDeate-Lung01, did not satisfy accelerated-approval requirements. The release does not identify lung toxicity, durability or manufacturing as the specific cause, and does not describe a CRL. Enrollment in the randomized Phase 3 IDeate-Lung02 continues and was described as near completion. Sponsor explanation

→ OCTOBER WINDOW. One oncology review on October 9, followed by two eye-treatment reviews on October 15 and 17.

Adjuvant benefit — Tecentriq. The relevant outcome is preventing recurrence or death after surgery in the selected colon-cancer population. The biomarker and disease stage define the application.

Evidence consistency — Enspryng. One pivotal study met the proptosis-response primary endpoint; the other missed statistical significance. FDA must assess the combined TED evidence for the requested new use. Filing and trial results

New-use evidence — phentolamine. The 0.75% solution is already approved as RYZUMVI for reversal of pharmacologically induced pupil dilation. Presbyopia is a separate proposed use. Viatris says VEGA-2 and VEGA-3 met their primary and key secondary endpoints. Read any approved near-vision claim and safety instructions before drawing commercial conclusions. Viatris filing

PDUFA: Friday, October 9

Setup: Priority Review sBLA; IV Tecentriq and subcutaneous Tecentriq Hybreza

Risk: Adjuvant benefit and biomarker-defined label

PoA: No numerical estimate published

The clean read: ATOMIC randomized 712 patients with resected stage III dMMR colon cancer. Three-year disease-free survival was 86.3% with Tecentriq plus mFOLFOX6 versus 76.2% with mFOLFOX6 alone (HR 0.50 for recurrence or death). The trial publication calls the regimen mFOLFOX6; Genentech’s filing release uses FOLFOX6. This result is disease-free survival, not an overall-survival finding. Trial publication · Filing

What matters:

PDUFA: Thursday, October 15

Setup: Priority Review sBLA for thyroid eye disease

Risk: Evidence consistency and label scope

PoA: No numerical estimate published

The clean read: For the Week 24 proptosis-response primary endpoint, SatraGO-2 reported 53% with Enspryng versus 23% with placebo and met statistical significance. SatraGO-1 reported 49% versus 31% and did not. The primary endpoint assessed at least a 2 mm reduction in eye bulging in active, moderate-to-severe TED. Filing and trial results

What matters:

CAMZYOS was tested in SCOUT-HCM adolescents aged 12 to under 18. Its new U.S. indication is framed around pediatric patients weighing at least 30 kg. Emcitate's indication names peripheral thyrotoxicosis rather than every consequence of MCT8 deficiency. Those boundaries are the starting point for interpreting either approval. CAMZYOS label · Emcitate label

Apply the same discipline to October: the proposed use, the trial population and the eventual approved indication can differ. Read all three before updating the thesis.

Questions to ask after an adverse action, not claims about undisclosed FDA findings.

MRK / Daiichi Sankyo / I-DXd: Accelerated-approval BLA withdrawn September 25; the former October 10 target is no longer live. Merck

EGTX / Emcitate: Approved September 28; peripheral-thyrotoxicosis indication and voucher grant now replace the pending FDA decision. FDA · Approval letter

BMY / CAMZYOS: Pediatric expansion approved September 30; the next read is implementation under the updated label and REMS. BMS

MRK / Eisai / WELIREG + LENVIMA: The former October 4 target was already resolved by FDA approval September 24. FDA decision

First clock: Tecentriq on October 9.

Next evidence-consistency test: Enspryng on October 15.

Next new-use decision: Phentolamine on October 17.

I-DXd’s withdrawal makes evidence adequacy the resolved oncology lesson. Tecentriq is the next live decision, followed by Enspryng’s mixed pivotal record and phentolamine’s new-use application. Emcitate and CAMZYOS remain reminders to read the actual label after the headline.

That is the queue.

Follow the FDA decision board. Forward this issue to someone tracking the October dates who also needs to know what each decision must establish.

Informational only. Not investment advice. Biotech investing carries the risk of total loss.