Moderna Flu Filing Rejected, Sanofi Replaces CEO, AbbVie Sues Over Botox Medicare Pricing – This Week in Biotech #89
CBER’s Refusal to File jolts FDA predictability, Sanofi swaps CEOs, AbbVie sues over Botox Medicare pricing, and BridgeBio’s Phase 3 win contrasts with Regenxbio’s CRL (Feb 6-12, 2026).
Welcome back to This Week in Biotech by Biotech Blueprint, edition 89, covering biotech and biopharma news from February 6th to February 12th, 2026.
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VIDEO SUMMARY
THIS WEEK’S KEY TAKEAWAYS 🔑
This week’s biggest signal came from FDA. Moderna’s flu vaccine received a Refusal to File not for safety or efficacy, but for a comparator dispute. The company used a licensed standard dose flu shot, which it says FDA initially accepted, and it also included older adult evidence, including a separate phase 3 comparison against a high dose vaccine in those 65 and older. When a filing can turn on shifting views of what counts as the best available standard of care, the regulatory bar starts to feel like a moving target. Reports that leadership overruled career reviewers only deepen the impression that the rulebook is getting less predictable.
Hims’ $49 compounded semaglutide pill came and went almost instantly, but the signal it sent is more durable. The company briefly reset what people think an obesity pill should cost to under $100 a month, then got hit from both sides. FDA and HHS escalated scrutiny of compounded GLP-1 ingredients and mass marketing, and Novo filed a patent suit that aims to shut down copycat versions in both pill and injectable forms. Novo and Lilly now have to explain why the real thing costs more after a $49 almost version showed up overnight, and FDA has to decide if compounding is still a temporary shortage fix or if it is turning into a permanent side door to the same drugs.
BridgeBio’s Phase 3 in achondroplasia is the cleanest win this week. Statistically strong growth data plus a meaningful nudge toward body proportionality, packaged as an oral, mechanism-targeted option that fits real life better than injections. Upstream’s asthma data is the opposite lesson. The drug worked, but the stock collapsed because the best result points to more frequent dosing, which weakens the long acting convenience thesis investors were underwriting. And Regenxbio’s CRL is the sobering counterpoint to all of it. In ultra rare diseases, regulators can still demand cleaner population definition, better controls, and more convincing surrogate endpoints, even when the human need is obvious and the development story is a decade long.
BIOTECH/PHARMA NEWS 🧬
🔹 Sanofi pushed out CEO Paul Hudson, with his last day set for Feb. 17, and named Merck KGaA chief Belén Garijo as the next CEO, effective after the Apr. 29 shareholder meeting, with Olivier Charmeil serving as interim. The board is effectively admitting the R&D reboot has been too slow, with Dupixent still doing the heavy lifting after underwhelming pipeline updates and with vaccine sales facing added pressure in the U.S. Shares were down about 3.5% on the day as investors weighed Garijo’s lower profile and mixed R&D track record against the clock ticking on the next growth engine.
🔹 AbbVie sued HHS after CMS picked Botox for the next round of Medicare Part D price negotiations, arguing the agency crossed a statutory line rather than just picking another political fight. AbbVie’s cleanest hook is plain text. Botox contains human serum albumin sourced from human blood plasma, so it should qualify as a plasma-derived product that Congress excluded from the IRA negotiation program. The company is also repeating familiar constitutional arguments that have largely failed for other drugmakers, including that the program compels speech by forcing companies to describe the negotiated price as fair and that it amounts to an unlawful taking. Botox is not just a cosmetic vanity line item either, it is used in migraines and other therapeutic indications and generated about $4.7B in U.S. sales in 2025, which helps explain why AbbVie is willing to litigate even as it has already modeled some pricing pressure into longer term forecasts.
🔹 Regenxbio shares slid after FDA issued a complete response letter for RGX-121 (clemidsogene lanparvovec), its one time gene therapy for Hunter syndrome, knocking the accelerated approval bid off track and sending the stock down about 15% premarket. The agency questioned whether the study eligibility criteria cleanly captured the neuronopathic population, whether the natural history external control was truly comparable, and whether the cerebrospinal fluid biomarker CSF HS D2S6 is an acceptable surrogate endpoint reasonably likely to predict clinical benefit. The letter lays out a menu of painful options in an ultra rare disease, including a new study, dosing more patients with longer follow up, or adding an untreated control arm, and the company says it will request a Type A meeting and try to resubmit with additional expert input and longer term clinical data.
🔹 Moderna said FDA’s CBER issued a Refusal to File letter for its investigational mRNA flu vaccine mRNA-1010, meaning the agency will not even start reviewing the BLA, despite Moderna using a Priority Review Voucher and despite no cited safety or efficacy concerns. CBER’s stated reason was the phase 3 comparator. Moderna used a licensed standard dose flu shot, and FDA said that did not reflect the “best available standard of care” in the US, which Moderna argues contradicts earlier FDA feedback and the fact that it also submitted supportive older adult data including a separate phase 3 comparison versus a high dose vaccine in 65+. Moderna has requested a Type A meeting to clarify the path forward, says its 2026 guidance is unchanged, and notes mRNA-1010 has been accepted for review in the EU, Canada, and Australia. If comparator standards can shift this late, sponsors either overbuild trials to avoid getting bounced, or they stop taking the risk at all and shift investment elsewhere. On Wednesday, STAT added an important detail. Three FDA officials told STAT that career reviewers were prepared to proceed and that David Kaslow, head of the vaccine office, wrote a memo arguing the agency should start the review, but CBER director Vinay Prasad overruled staff and signed the refusal memo himself, which is unusual and shifts this from a routine filing dispute to a signal about who is setting the bar and how predictable that bar is.
🔹 Hims pulled its $49 compounded semaglutide pill almost immediately, and now Novo is escalating the fight in court. Novo filed a patent infringement lawsuit against Hims tied to Wegovy in both pill and injectable forms, asking for a permanent ban on compounded versions that Novo says infringe its patents and seeking damages. The legal move lands on top of the regulatory squeeze already building: the FDA signaled a broader crackdown on compounded GLP-1 ingredients and mass marketed “copycats,” and the U.S. HHS said it referred Hims to the Department of Justice for potential violations. Hims is trying to flip the politics, calling the suit a “blatant attack” on Americans who rely on compounded meds and framing it as Big Pharma using the courts to limit choice. Novo rose about 5% and Hims dropped roughly 18% to 20%.
🔹 Eli Lilly and Innovent just signed a new oncology and immunology R&D partnership. Innovent will run discovery through phase 2 proof of concept in China, then Lilly gets an exclusive license to develop and commercialize worldwide outside Greater China, while Innovent keeps Greater China rights. The money is big: $350M upfront plus up to about $8.5B in milestones, plus tiered royalties. It is also their seventh deal together, which reads less like a one off and more like Lilly formalizing Innovent as a repeatable early development engine. The tell will be how many programs are actually included and how quickly they move from China phase 2 into global phase 3.
CLINICAL TRIAL UPDATES 📊
🔹 BridgeBio popped after its pivotal phase 3 PROPEL 3 trial of oral infigratinib in children with achondroplasia hit its primary endpoint at 52 weeks, improving annualized height velocity vs placebo with a least squares mean treatment difference of +1.74 centimeters per year and a mean treatment difference of +2.10 centimeters per year. The study also cleared a key secondary endpoint on height Z-score (achondroplasia reference population), and the more interesting nuance is the exploratory readout on body proportionality. In children under 8 years old, infigratinib showed the first statistically significant improvement versus placebo on an upper to lower body proportionality measure, which gets closer to the real lived burden of the disease than raw height alone. Safety looked clean for a year long pediatric study with no discontinuations or serious adverse events tied to drug, and only three mild, transient hyperphosphatemia cases without dose changes. BridgeBio is now aiming for second half of 2026 submissions in the U.S. and EU and is accelerating a phase 3 path in hypochondroplasia, positioning this as a potentially best in class, needle free, mechanism targeted option in a market currently defined by injections and tradeoffs.
🔹 Upstream Bio shares got cut in half even as its phase 2 VALIANT trial in severe asthma because the efficacy landed hardest on the more frequent dosing schedule investors were not hoping for. Verekitug, a monoclonal antibody that blocks the thymic stromal lymphopoietin receptor, met the primary endpoint by reducing the annualized asthma exacerbation rate, with a 56% reduction on 100 mg every 12 weeks and a 39% reduction on 400 mg every 24 weeks versus placebo, plus clinically meaningful improvements in lung function and exhaled nitric oxide on both regimens. The market issue is the product profile because the company has been selling verekitug as a long acting, low burden biologic, so the read through is that the most compelling efficacy may come with quarterly injections rather than a true twice yearly convenience story. Safety looked clean, with adverse events mostly mild to moderate and more than 90% of eligible patients rolling into the long term extension.
🔹 Priovant Therapeutics, the Pfizer and Roivant-created autoimmune biotech, posted unusually clean phase 2 data for brepocitinib in cutaneous sarcoidosis, a disfiguring inflammatory skin disease with no FDA-approved therapies. In the 31-patient BEACON trial, the drug drove a 22.3 point mean improvement at week 16 on the Cutaneous Sarcoidosis Activity and Morphology Instrument Activity score versus a 0.7 point change on placebo, and every patient on brepocitinib hit at least a 10 point improvement versus 14% on placebo (with separation showing up as early as week 4). On a tougher clinician bar, 69% reached “clear” or “almost clear” on the Investigator’s Global Assessment compared with 0% on placebo, with all adverse events graded mild to moderate. Management plans to take the package to the FDA and start a phase 3 program in 2026, adding a third pivotal track for a dual TYK2 and JAK1 inhibitor that is already further along in dermatomyositis and non-infectious uveitis.
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