Pharma Tariffs on Ice, FDA Limits Filings, Amgen’s PCSK9 Win — This Week in Biotech #72
Plus $8B Genmab-Merus deal, Metsera's monthly GLP-1 score, Novavax/Sanofi & Vaxcyte/Thermo shore up U.S. capacity, and AbbVie sets U.K. Elahere price to match U.S. (Sept 26–Oct 2, 2025).
Hi and welcome to This Week in Biotech by Biotech Blueprint, edition 72, covering biotech & pharma news from September 26th to October 2nd, 2025.
📢 Next week, I will be traveling back to the U.S. next week and might have to postpone publishing edition #73 until Friday (10/10) afternoon ET or Saturday (10/11) morning. Apologies in advance! In the meantime, I’ll publish an article and a podcast I recorded in July with Sensible Bio about their work in mRNA manufacturing.
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THIS WEEK IN BIOTECH VIDEO SUMMARY
THIS WEEK’S KEY TAKEAWAYS 🔑
Tariffs paused. 100% drug tariff threat paused while price talks proceed.
FDA in shutdown mode. No new NDA/BLA/biosimilar/device filings tied to FY’26 fees. Expect filing delays and timeline slippage.
Genmab → Merus ($8B). Genmab buys petosemtamab and shifts to wholly owned launches.
Amgen VESALIUS-CV hits. Repatha cuts major adverse cardiovascular events in primary prevention.
Halozyme + Elektrofi. $750M upfront (+$150M) for Elektrofi’s Hypercon to enable ultra-high-concentration, small-volume SC injections. Partner trials as soon as late 2026, royalties in 2030.
Metsera monthly GLP-1. Up to 14.1% placebo-adjusted loss with low GI burden & high retention. Phase 3 slated for late 2025. MET-097i is monthly, tolerable, could wedge incumbents.
Capacity is strategy: Novavax/Sanofi + Vaxcyte/Thermo. Matrix-M cleared for Sanofi’s BARDA-backed pandemic flu program through phase 2. Vaxcyte locked U.S. fill-finish (up to $1B) in Greenville, NC. Fewer late-stage bottlenecks and smoother launch logistics.
AbbVie U.K. pricing. Elahere launches at the U.S. list (~$6.5k/100 mg) while the U.K. gov decides access.
BIOTECH/PHARMA NEWS 🧬
🔹 Donald Trump is pausing the threatened 100% tariffs on branded/patented drug imports to give pharma time to cut price deals similar to Pfizer’s. The White House says tariffs remain “in play” under Section 232 but enforcement will wait while negotiations proceed. Pfizer reportedly got a three-year grace period, and the administration also rolled out “TrumpRx,” a DTC site to find discounted drugs.
🔹 🏛️ FDA + government shutdown impact: with funding lapsed, the agency is only running “mission critical” work (e.g., outbreak response, high risk recalls, import screening, urgent safety surveillance) and will not accept any submissions that require FY’26 user fees, including NDAs, ANDAs, BLAs, biosimilars, animal drug and device filings, until an appropriation/CR is passed. About 86% of FDA staff continue working (many on carryover funds or excepted for safety of human life), while 14% are furloughed. Some regulatory science and routine activities are curtailed. Expect delays in new filings and potential ripple effects on approvals/timelines.
🔹 Fortress Biotech and its subsidiary Cyprium said the FDA issued a Complete Response Letter for CUTX-101 (copper histidinate) for pediatric Menkes disease, citing cGMP deficiencies at the manufacturing site. No new efficacy or safety issues were raised. The NDA had Priority Review and is backed by survival data in early-treated patients. Shares of Fortress fell ~30% on the news.
🔹 Halozyme is buying Boston-based Elektrofi for $750M upfront (plus up to $150M in milestones) to add Hypercon, a tech that packs biologics into ultra-high concentrations so the same dose can be given in a much smaller subcutaneous injection, which is ideal for at home use. The strategy is to license Hypercon to pharma and collect royalties. Two partner programs could start clinical testing by late 2026, with first royalties around 2030. Halozyme will use cash and some debt (ending near 2x leverage), expects <5% EPS dilution near term, and kept its 2025 outlook unchanged. Big picture: this broadens Halozyme’s drug delivery toolkit and positions it for the shift toward convenient biologics with long-dated IP into the 2040s.
🔹 Genmab will acquire Merus for $8B, adding late-stage petosemtamab and accelerating Genmab’s shift to a wholly owned model with potential multiple launches by 2027. The tender offer is expected to close by early Q1 2026. Financing is a mix of cash and $5.5B in non-convertible debt. Genmab targets <3× gross leverage within two years. The deal is expected to be EBITDA-accretive by end of 2029, with petosemtamab viewed as a potential $1B+ seller by 2029 and multi-billion after, pending clinical and regulatory outcomes.
🔹 💡 Supply chain and preparedness: Novavax and Sanofi amended their deal so Sanofi can use Matrix-M in its BARDA-backed pandemic flu program through phase 2 (new terms if phase 3 proceeds). Novavax remains eligible for up to $200M tied to the first four Matrix-M products, up to $210M per additional product, plus royalties. Vaxcyte and Thermo Fisher signed a long-term U.S. fill-finish pact (valued up to $1B) at Greenville, NC, to support commercial supply for Vaxcyte’s PCV franchise, including VAX-31 (phase 3 in adults; phase 2 in infants). Why it matters: Both moves de-risk late-stage manufacturing and strengthen U.S. pandemic and vaccine readiness ahead of pivotal/launch timelines.
🔹 AbbVie is taking an unusual stand in the UK: it says ovarian-cancer drug Elahere will launch at the same list price it carries in the U.S., about $6,487 per 100-mg vial, while talks with the National Institute for Health and Care Excellence determine whether the drug actually reaches NHS patients. The move mirrors BMS’s plan to price schizophrenia drug Cobenfy at U.S. levels in Britain, a stance that aligns with ongoing “most-favored-nation” pressure from Washington. Elahere won MHRA approval in July and AbbVie’s pricing gambit signals big pharma’s willingness to raise ex-U.S. prices rather than cut U.S. list prices as global scrutiny intensifies.
CLINICAL TRIAL UPDATES 📊
🔹 Nanobiotix reported first phase 1 data for JNJ-1900 (NBTXR3), its J&J-partnered, intratumoral radioenhancer, in locally advanced esophageal adenocarcinoma. In 13 patients treated with either photon- or proton-based chemoradiation plus NBTXR3, treatment was feasible via endoscopic ultrasound–guided injection and generally well tolerated. The photon cohort’s RP2D was set at 33% of gross tumor volume. Efficacy signals were encouraging: 85% disease control (11/13) and 69% objective response (9/13), including six complete and three partial responses. Among six surgical patients, two achieved pCR and four had major pathologic responses (≤10% viable cells). Enrollment continues (5 more for proton dose escalation, then 12 for expansion). Data were presented at ASTRO 2025.
🔹 Anavex unveiled a once-daily, modified-release oral tablet for ANAVEX®3-71 that showed superior pharmacokinetics vs the immediate-release capsule in a phase 1b head-to-head, meeting its primary endpoint of safety/tolerability in healthy adults. Separately, a placebo-controlled phase 2 in schizophrenia on top of stable antipsychotics hit its safety/tolerability primary endpoint and showed encouraging exploratory biomarker signals. The new formulation supports once daily dosing as ANAVEX®3-71 advances in CNS indications.
🔹 Amgen’s landmark phase 3 VESALIUS-CV trial met both primary endpoints, showing that adding Repatha (evolocumab) to optimized lipid-lowering therapy significantly reduced major adverse cardiovascular events in 12,000 high-risk adults without prior heart attack or stroke over a 4.5-year median follow up. No new safety signals were seen, making Repatha the first PCSK9 inhibitor with outcomes benefit in both primary and secondary prevention and potentially opening earlier use to tens of millions of patients. Full data will be presented at the American Heart Association Scientific Sessions on Nov. 8.
🔹 Metsera (to be acquired by Pfizer as of last week) reported strong mid-stage data for MET-097i, its ultra-long acting GLP-1 RA aimed at monthly dosing. In VESPER-1, placebo-subtracted weight loss reached up to 14.1% at 28 weeks (with some outliers >25%) and an exploratory 36 week look suggested no plateau yet. VESPER-3’s interim tolerability read showed minimal diarrhea and modest GI burden after a two-step titration (13% nausea, 11% vomiting vs placebo), alongside high retention (2.9% discontinuations in VESPER-1). The dose response plus cleaner tolerability profile underpins phase 3 starts in late 2025 and positions MET-097i as a credible, scalable rival in obesity care, potentially matching weekly market leaders at far lower doses.
🔹 Enanta’s phase 2b RSV readout was mixed but directionally encouraging: zelicapavir missed the primary endpoint, yet delivered statistically significant gains on patient-reported severity, faster resolution of total RSV symptoms, lower hospitalizations, and clear antiviral effects (quicker time to undetectable viral load). Investors initially bought the “secondary wins + safety” story as shares jumped from about $9.30 to $15.10, then cooled as the primary miss sank in, with the stock settling the next day around $12.15.
🔹 📈 Market movers: KALA BIO’s CHASE phase 2b in persistent corneal epithelial defect (eye condition) was a clean miss on primary and key secondaries, prompting termination of KPI-012/the MSC-secretome platform, headcount cuts, and a pivot to “strategic options” as the equity repriced 90% to residual optionality. MoonLake’s hidradenitis suppurativa update was mixed: VELA-1 hit HiSCR75 and key secondaries, while VELA-2 narrowly missed the composite primary on an unusually high placebo. The pre-specified treatment-policy analysis was positive in both, safety clean, but the market still slammed the stock nearly 90%.
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Good catch on the financing structure here. I think the shift to wholly owned launches is really the kicker becuase it lets Genmab keep more economics if petosemtamab does hit the multi billion range. The timeline to EBITDA accretion by 2029 seems reasonble given they're already talking about a billion plus in sales by then. Wonder how much upside there is in the non H&N indicatons if the LGR5 mechanism works broadly.