Phaseline @phaseline_bio

FDA decision dates it is. Our free weekly Brief starts Monday with this week’s FDA dates ($INO , $AGIO ) and the next 30 days. phaseline.beehiiv.com

Which biotech catalyst do you track most closely? Helps us decide what to cover more. Not investment advice.

Real example from this week: GSK/Ionis’ bepirovirsen had a PDUFA date of 26 Oct. The FDA approved it (as Hibsago) on 20 Oct, 6 days early. $IONS $GSK

What is a PDUFA date? 🧬 It’s the deadline the FDA sets itself to decide on a drug application. 1. Company applies (NDA or BLA) 2. FDA accepts it and sets the target date 3. Review: ~10 months standard, ~6 months priority 4. Decision: approval, or a Complete Response Letter (CRL) Worth knowing: the FDA can decide early, the date can be extended by 3 months, and the company usually announces the result itself. Next on our list: $INO, FDA decision on INO-3107 due Fri 30 Oct. Not investment advice.

$BOLT closed +49.6% on Friday at $6.27 (prev. close $4.19). What happened: Bolt Biotherapeutics merged with private company Prana Therapies and raised $120M in a private placement. The details that matter: • Placement price: $8.57/share (as-converted), above Friday’s close • Ownership after the deal (fully diluted): pre-deal Bolt holders ~6.9%, Prana holders ~51.7%, placement investors ~41.4% • New lead drug: PRA-216, an IL-4Rα/TSLP bispecific antibody in Phase 2 for asthma, COPD and atopic dermatitis • Up to $60M more if warrants are exercised • Company says cash runway now reaches into 2028 What’s next: • Placement expected to close 26 Oct • PRA-216 Phase 2 data expected Q2–Q4 2027 Source: Bolt Biotherapeutics press release, 23 Oct 2026; Nasdaq close. Not investment advice.

Also this week: $BHVN ~+31% (22 Oct). FDA accepted the resubmitted Vyglxia (troriluzole) NDA for spinocerebellar ataxia; goal date Q1 2027. Not investment advice.

This week in biotech catalysts (19–23 Oct): $SLN +125.6% (19 Oct): Merck KGaA agreed to acquire Silence for $20/ADS cash $IRON +38.9% (19 Oct): Ph3 APOLLO met all endpoints; $350M offering $MRNA $MRK (22 Oct): INTerpath-001 melanoma data, RFS HR 0.58 Not investment advice

What does “HR 0.58” mean? Moderna/Merck’s melanoma vaccine data at #ESMO26: HR 0.58 for recurrence-free survival. HR = hazard ratio. 0.58 = 42% lower risk of recurrence or death with vaccine + Keytruda vs Keytruda alone, over the follow-up studied. Not investment advice $MRNA

@ADeAngelis_bio @Bloomberg Congrats, Allison. Looking forward to reading what you cover next.

@AdamWilsonFI Per Dyne’s 20 Jul release: Priority Review, PDUFA target 21 Jan 2027. Filing seeks Accelerated Approval for z-rostudirsen (DMD exon 51) based on dystrophin production as a surrogate endpoint, from the DELIVER trial expansion cohort. Not investment advice.

Same day: $350M underwritten offering announced, plus a $52.5M underwriter option. Next: NDA resubmission targeted by end of 2026. FDA decision estimated mid-2027. Not investment advice.

Primary endpoints vs placebo: • Metal-free PPIX: −41.4% (p<.0001) • Time in light without pain, month 6: +12.2 h/month (p=.0010) Most common AE: dizziness, 50% vs 11%, mostly mild. No AEs above Grade 3.

$IRON +38.9% on Mon 19 Oct, close $78.93. Catalyst: Phase 3 APOLLO (bitopertin, EPP) met all primary and secondary endpoints. 183 patients, 60 mg once daily vs placebo, 6 months. Source: company press release, 19 Oct.

$MRNA $MRK INTerpath-001 (intismeran + Keytruda, resected stage IIB–IV melanoma), per company releases 22 Oct: • RFS vs Keytruda alone: HR 0.58 (95% CI 0.45–0.75), p<0.001 • After month 6: piecewise HR 0.42 (sensitivity analysis) Full data at ESMO. Not investment advice.

$MRNA $MRK INTerpath-001 (intismeran + Keytruda, resected stage IIB–IV melanoma), per company releases 22 Oct: • RFS vs Keytruda alone: HR 0.58 (95% CI 0.45–0.75), p<0.001 • After month 6: piecewise HR 0.42 (sensitivity analysis) Full data at ESMO. Not investment advice.

Moderna @moderna_tx

2 days ago

Today we announced detailed positive results from the Phase 3 INTerpath-001 study evaluating intismeran autogene (mRNA-4157 or V940), an investigational mRNA-based individualized neoantigen therapy, in combination with KEYTRUDA® (pembrolizumab), @Merck's anti-PD-1 therapy, in

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Today we announced detailed positive results from the Phase 3 INTerpath-001 study evaluating intismeran autogene (mRNA-4157 or V940), an investigational mRNA-based individualized neoantigen therapy, in combination with KEYTRUDA® (pembrolizumab), @Merck's anti-PD-1 therapy, in patients with high-risk melanoma (stage IIB-IV) following complete resection. These late-breaking results will be presented during a Presidential Symposium at the 2026 European Society for Medical Oncology (@myESMO) Congress. Read more: feeds.issuerdirect.com/news-release.h…

@daphnezohar It's now official: ESMO said the LBA1 embargo was breached and released the data, and Merck put out a release today (HR 0.58, 95% CI 0.45–0.75, p<0.001 vs Keytruda alone). Full presentation still at ESMO.

#ESMO26: The embargo on LBA1, “INTerpath-001: Phase 3 study of the mRNA-based individualised neoantigen therapy intismeran autogene plus pembrolizumab versus pembrolizumab alone for adjuvant treatment of resected stage IIB-IV melanoma”, has been breached. As the data are now publicly available, ESMO has released the information contained in the abstract and has lifted the embargo on the full dataset.

@yaireinhorn Per Merck's release today: RFS HR 0.58 (95% CI 0.45–0.75), p<0.001 vs Keytruda alone in resected stage IIB–IV melanoma. After month 6, piecewise HR 0.42 in a pre-specified sensitivity analysis. Full data: ESMO Presidential Symposium.

@WSJ For context: the companies said in August that the Phase 3 met its primary endpoint. The leak adds the effect size (reported 42% vs 49% in Phase 2b). Full INTerpath-001 data are scheduled for ESMO, Sat 24 Oct.