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Upfront Briefing
Bristol Myers got its IPF win on Monday, just not the tidy kind: admilparant's 60mg dose hit in Phase 3 while 120mg missed, the sort of dose response that keeps models in pencil. Same morning, RayzeBio's alpha-emitter delivered a Phase 3 win for the $4.1B buyout, and Asahi Kasei's €780M AiCuris bet turned into Hovilpri, the first new herpes mechanism in nearly three decades. Mirum lined up a third Livmarli label, AAO weekend data left Merck's remigromig trailing Lucentis, and Syndax walked away from IPF after the bell. Deal desk: Aspen and Bambusa filed for IPOs, City set terms for ~$175M, and Undecimal launched on an $18M seed. World ADC runs in San Diego through Thursday.
Tape Action
| Instrument |
Last close |
1D % |
YTD % |
| S&P 500 |
7,807.2 |
(0.1%) |
13.8% |
| Nasdaq 100 |
30,664.7 |
(0.7%) |
21.7% |
| Russell 2000 |
2,794.5 |
(0.4%) |
11.4% |
| Healthcare (XLV) |
172.0 |
0.7% |
10.6% |
| Biotech (XBI) |
151.4 |
(1.5%) |
24.6% |
| Nasdaq Biotech (NBI) |
6,927.4 |
(1.0%) |
21.4% |
| Clinical Trials (BBC) |
43.1 |
(2.5%) |
14.4% |
|
- Healthcare (XLV) rose 0.7% while biotech lagged: XBI (1.5%), NBI (1.0%), BBC (2.5%), a 2pp-plus spread with no sector-wide catalyst to pin it on. Bristol Myers' admilparant readout (pre-open) was a single-name story: BMY reversed a 6%-plus premarket gain to trade about 4% lower by late morning, and Contineum fell ~30%.
- Tech (1.25%) was the worst S&P sector in a semis and AI-infrastructure selloff (Lumentum and SanDisk down ~7% intraday) on the day Microsoft unveiled its Maia 300 in-house AI chip; energy (+1.45%) and staples (+1.17%) led after Brent traded up ~1.2% near $106 on Houthi strikes on Riyadh's airport and two tanker attacks. Dow +0.4% was the only major gainer, S&P (0.1%), Nasdaq Comp (0.4%); bond market shut for Columbus Day, with bank earnings today and September CPI Wednesday.
- Market data: U.S. cash close Monday, 12 October 2026.
The Big 3
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1
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Bristol Myers' admilparant hits in IPF at 60mg, misses at 120mg
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- Oral LPA1 antagonist admilparant met the primary endpoint of Phase 3 ALOFT-IPF, slowing 52-week FVC decline vs placebo at 60mg; the 120mg dose did not reach statistical significance. BMS disclosed no effect sizes, said adverse-event discontinuations were low and similar to placebo, and will discuss a filing with regulators.
- Why it matters: The missing dose response is now the whole debate. RBC called the 120mg failure confounding; Leerink thinks the 60mg arm alone could support approval, and William Blair still sees a blockbuster, modeling $1.3B of IPF sales in 2032. Management told William Blair the acute liver-injury case behind May's protocol amendment sat in the 120mg arm and was adjudicated unlikely drug-related, which helps on safety but points to a low-dose-only label. BMY reversed a 6%-plus premarket gain to trade about 4% lower; Contineum, whose LPA1 drug PIPE-791 is in Phase 2, fell roughly 30%. Ofev, Esbriet and Jascayd set the bar, and BMS has yet to show an effect size.
- Source: Endpoints
- More: Fierce Biotech; BioPharma Dive
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2
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Asahi Kasei's AiCuris buy delivers a first-in-class HSV approval
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- FDA approved Hovilpri (pritelivir), an oral helicase inhibitor, late Friday for mucocutaneous HSV lesions refractory to standard antivirals, with or without resistance, in immunocompromised adults. In Phase 3 PRIOH-1 Part C it beat investigator's choice of IV foscarnet, cidofovir or topical imiquimod on complete lesion healing at day 28 (63% vs 34%), with adverse reactions of 22% vs 54%.
- Why it matters: This is the first payoff on Asahi Kasei's €780M (~$920M) AiCuris acquisition and the first new HSV mechanism in nearly three decades. The market is narrow by design: about 15,000 US immunocompromised patients whose lesions fail acyclovir, valacyclovir or famciclovir, with management guiding to peak sales above $400M in the mid-to-late 2030s. The comparators are IV or topical salvage options, so a once-daily pill with 2% vs 20% drug-related discontinuations should win transplant centers quickly. Pricing is undisclosed and launch is slated before year-end. The rest of the deal case rests on AIC468 in BK virus, out of Phase 1, plus the Prevymis royalty.
- Source: Endpoints
- More: Fierce Pharma
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| 3 | RayzeBio's actinium radioligand RYZ101 wins Phase 3 for BMS |
- RYZ101, an actinium-225 radioligand targeting somatostatin receptors, met its PFS primary endpoint (blinded central review) at a planned interim analysis of Phase 3 ACTION-1 vs standard of care in SSTR-positive GEP-NETs that progressed after Lu-177 therapy such as Novartis' Lutathera. BMS released no hazard ratio or medians, called safety consistent with the known profile, and will take the data to FDA; RYZ101 holds orphan designation.
- Why it matters: This is the first pivotal readout from the $4.1B RayzeBio buyout, and it lands in the setting that matters commercially: patients who have already progressed on Lutathera, the beta-emitting SSTR standard. Sequencing behind Novartis avoids a head-to-head, and Curium pricing generic Lutathera 5% below brand on Friday says the earlier-line market is getting cheaper anyway. The blind spot is magnitude, with no hazard ratio or median PFS until a medical meeting, so filing and label timing are unknown. Isotope supply is the other exposure, since ACTION-1 enrollment paused in 2024 when Ac-225 ran short, and a launch would draw on an isotope pool AstraZeneca and Bayer are also contracting for.
- Source: Fierce Biotech
- More: BioSpace
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Everything Else that broke
- AstraZeneca's full Phase 3 HICKORY data at ASBMR showed Strensiq successor efzimfotase alfa missed on six-minute walk in adolescents and adults with HPP (+17.05m vs placebo, p=0.17), with no benefit in adult-onset patients (-2.7m); the BLA, backed by two positive pediatric trials, is under priority review. — Endpoints
- Full one-year BRUNELLO data at AAO left Merck's $1.3B Wnt agonist remigromig behind ranibizumab in DME (9.1 and 8.7 vs 11.8 letters), with proliferative diabetic retinopathy in ~6–7% of patients vs 0.9%; BMO now sees limited potential. — Endpoints
- Roche's intravitreal IL-6 antibody vamikibart held vision and edema gains to week 52 in Phase 3 Meerkat and Sandcat in uveitic macular edema, after one hit and one miss at week 16; FDA decision is set for July 2027. — Fierce Biotech
- Syndax's axatilimab missed the primary FVC endpoint in the 145-patient Phase 2 MAXPIRe IPF trial and won't advance in IPF; the release crossed at 4:01pm ET and SNDX fell about 15% after hours. — GlobeNewswire
- Mirum's IBAT inhibitor Livmarli met the primary endpoint and all five secondaries in the 52-patient Phase 3 EXPAND in cholestatic pruritus from ultra-rare liver diseases (itch 1.81 vs 0.83 points at week 20); a third-indication filing is planned for 1H27. — Endpoints
- Curium priced its generic version of Novartis' radioligand Lutathera at a 5% discount to the brand. — Endpoints
- First Tracks' CD122 blocker ANB033, the same target as argenx's $2.2B FB102, protected the gut lining in a 32-patient celiac gluten-challenge study, hitting significance on mucosal protection and three disease biomarkers with no treatment-related SAEs; a pivotal start is planned for 2027. — BioPharma Dive
- Tortugas' Hansoh-licensed D2/D3 partial agonist obuprazine hit at every dose in a 363-patient Chinese Phase 2b in acute schizophrenia, cutting PANSS by up to 16.7 points vs placebo at day 42; a US trial is next. — Fierce Biotech
- FDA review documents for RevMed's RAS inhibitor Rasonque showed a 24% response rate in G12D pancreatic cancer vs 33% overall and 50% in G12V; RVMD fell more than 6%, with analysts calling the selloff overdone. — BioSpace
- Bausch + Lomb ousted CEO Brent Saunders after three years and named Appio interim CEO. — Endpoints
- GSK will invest $800M in a new Pennsylvania R&D and biologics manufacturing hub. — Endpoints
Deal Flow
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BioBucks 2026 Deal Trackers • Updated weekly ⬇️
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M&A / BD&L
- GSK / Chai Discovery — GSK licensed access to Chai's AI protein-design models after its own wet-lab tests found binders to every target screened; terms undisclosed. Chai's fifth big-pharma pact this year, after BMS, Lilly, Novartis and Pfizer. — Fierce Biotech
VC / Private Financings
- Undecimal Bio, spun out of Eleven Therapeutics, launched with an $18M seed to take siRNA delivery beyond the liver; investors not disclosed in available coverage. — Endpoints
IPOs / Follow-Ons
- City Therapeutics (CTY) set terms: 9.7M shares at $17–$19 (~$175M, ~$1.0B fully diluted at the midpoint), led by Phase 1 Factor XI siRNA CITY-FXI; Goldman, Jefferies, Stifel, Oppenheimer; pricing expected this week. — Renaissance Capital
- Aspen Neuroscience (autologous Parkinson's cell therapy sasineprocel, Phase 1/2a) and Bambusa Therapeutics (IL-4Rα/IL-31 bispecific BBT001, Phase 1 atopic dermatitis) filed for IPOs Friday; no terms yet. — Fierce Biotech
Academic Corner - A Nature Medicine study used data from 52,236 cancer patients to build a multimodal atlas of cachexia. — Nature Medicine
- Nature RDD highlighted the shortage of protein-small molecule binding data for AI drug discovery. — Nature RDD
- Nature Biotech published a look back at the origins of CRISPR-Cas. — Nature Biotech
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Sixty milligrams good, one-twenty milligrams confusing. Dose responsibly.
— BioBucks Team
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