uniQure Wins a Surprise FDA Path in Huntington's, Moderna's mRNA Flu Vote, and a Record IPO Run – This Week in Biotech #105
The FDA reverses course on two products it had previously blocked, Lilly closes its fifteenth deal of 2026, and Kardigan pops 38% on debut to extend the year's biggest IPO streak since 2021 (6/12-18).
Welcome back to This Week in Biotech by Biotech Blueprint, edition 105, covering biotech and pharma news from June 12 to June 18, 2026.
🎙️ Biotech Blueprint brings you weekly video updates on the latest biotech and pharma news, plus in-depth podcast interviews with industry leaders. You can find us on YouTube, Spotify, and Apple Podcasts. If you want to be featured on our podcast, get in touch.
🌐 For consulting inquiries, please email us or visit BiotechBlueprintConsulting.com.
👥 If you haven’t already, please connect with me or follow me on LinkedIn.
VIDEO SUMMARY
THIS WEEK’S KEY TAKEAWAYS 🔑
The most interesting thing that happened this week wasn’t a clinical readout or a deal. It was the FDA reversing itself on two products in two days. On Wednesday, uniQure said the agency will accept three year data from a roughly 50 patient Phase 1/2 study as the primary basis for an accelerated approval filing of AMT-130, its gene therapy for Huntington’s disease. The FDA had previously asked for more. A day later, the agency’s vaccines advisory committee voted unanimously that Moderna’s mRNA flu vaccine has a favorable benefit-risk profile, for a product the same agency had refused to even review earlier this year. Both reversals came after Marty Makary and Vinay Prasad left.
It would be easy to read this as the FDA going soft. It’s not. Under acting commissioner Kyle Diamantas, the agency is being selectively flexible on programs where there’s no current alternative. There’s nothing approved for Huntington’s, which is a uniformly fatal disease. mRNA gives the US a faster way to update flu vaccines as strains drift. But in other areas, the bar hasn’t moved at all. Fulcrum’s sickle cell program got sidelined last week on a safety question, and AstraZeneca’s camizestrant in breast cancer is still frozen after a negative advisory vote in April. So the agency isn’t lowering its standards across the board but it seems to be making case by case decisions about where unmet need is high enough to accept less data. For developers, that makes regulatory strategy harder to plan, because the rules now depend on which category your program lands in.
The other big theme is that M&A keeps happening every single week. Biogen bought an immunology startup for up to $1 billion. Jazz signed a T cell engager deal worth up to $4.1 billion. Lilly bought a non-opioid pain developer in what’s now their fifteenth deal of 2026. PwC reported first quarter pharma deal value above $65 billion and called the biopharma ecosystem “back to full health.” Large caps are buying discovery speed and modality breadth instead of building it in house, and they’re doing it before Section 232 pharma tariffs kick in on July 31.
The IPO market is the cleanest bull signal in biotech right now. Kardigan raised $400 million in an upsized offering this week and closed up 38% on its first day of trading. That makes four biotechs to raise at least $400 million via IPO in 2026, the most in any single year since 2021.
BIOTECH/PHARMA NEWS 🧬
🔹 uniQure said the FDA will accept three year data from its Phase 1/2 study of AMT-130 as the primary basis for a Biologics License Application under accelerated approval. The company plans to file in Q3 2026. AMT-130 is an AAV gene therapy delivered directly into the striatum via neurosurgery, designed to lower the mutant huntingtin protein that drives Huntington’s disease. There is no approved therapy for Huntington’s, which makes a filing on a roughly 50 patient dataset a clear signal that the agency will accept a small package when the disease is fatal and untreated. The FDA also indicated it’s open to a concurrent standard of care control in the confirmatory study rather than a sham surgical arm, which is a meaningful concession given the ethics and cost of sham neurosurgery. Shares jumped on the news. The open questions are durability of effect and whether a 50 patient base can carry a label in a heterogeneous, slowly progressing disease.
🔹 The FDA’s vaccines advisory committee voted unanimously that the benefit-risk profile of mFluSiva, Moderna’s mRNA trivalent seasonal flu vaccine, is favorable. The FDA target decision date is August 5. This completes a striking turnaround. The same agency declined to review the same shot earlier this year, and the briefing documents released ahead of the meeting were supportive. If approved, mFluSiva would be the first mRNA-based seasonal influenza vaccine in the US. The practical implication is that mRNA’s core advantage, speed of reformulation against drifting strains, finally gets a US regulatory anchor in flu, the largest vaccine market by volume. For Moderna, this is the proof point that the platform extends beyond COVID. Vaccine politics remain the wild card between a unanimous panel and a final signature.
🔹 Jazz Pharmaceuticals and AbCellera signed a collaboration to discover next-generation T cell engaging multispecific antibodies for gastrointestinal and other solid tumors. AbCellera takes $56M upfront across the first two programs, plus $28M on initiation of a third, with up to $792M per program in option and milestone payments and tiered royalties, totaling up to $4.1B across as many as five programs. T cell engagers have largely worked in blood cancers and struggled in solid tumors, where the targets are less clean and the toxicity harder to manage. Jazz is paying for AbCellera’s antibody engineering platform to solve that problem rather than buying a finished asset. The small upfront and heavily backloaded structure is the standard template for platform deals where the science still has to prove itself.
🔹 Biogen agreed to acquire RayThera, a private developer of small molecule anti-inflammatory drugs, for up to $1B in upfront and primarily clinical and regulatory milestones. The lead candidate is expected to enter Phase 1 in early Q3 2026. This is Biogen’s second sizable deal of the year after the roughly $5.6B Apellis acquisition in March, and it continues a deliberate push into immunology as the company diversifies away from a neurology franchise that has produced two Phase 2b misses in twelve months. The deal structure, small disclosed upfront with most of the value contingent, fits a preclinical stage asset. What Biogen is really buying is optionality in immune-mediated disease at a price that limits downside if the lead program stalls.
🔹 Lilly acquired 4E Therapeutics, an Austin neuroscience company developing oral MNK inhibitors for chronic pain, on undisclosed terms. The lead compound, 4ET1103, targets the MNK-eIF4E signaling pathway in peripheral sensory neurons and is the first MNK inhibitor for pain to reach the clinic. This is Lilly’s second non-opioid pain acquisition in as many years, following the up to $1 billion SiteOne deal in May 2025, which targeted sodium ion channels. It’s also their fifteenth or so deal of 2026 and pushes the year’s committed acquisition capital past $18B. The chronic pain market has been waiting two decades for a credible alternative to opioids, and Lilly is now building optionality across multiple non-opioid mechanisms.
🔹 Kardigan, a cardiovascular drug developer founded by former MyoKardia executives, raised $400M in an upsized IPO, selling 25M shares at $16, the top of its range. Shares closed up 38% at $22, giving the company a market value near $2B. MyoKardia developed Camzyos and was acquired by Bristol Myers Squibb for $13B, so the founder pedigree is direct. Kardigan has now raised close to $1B total in two years, including a $254M Series B in October. It’s the fourth biotech to raise at least $400M via IPO this year, the most in a single year since 2021. The 38% pop on debut is the signal worth watching. The 2026 IPO class is holding its value in the aftermarket, which is what separates a real funding window from a temporary one.
Have a great rest of your week and thanks for reading Biotech Blueprint!
DISCLAIMER: This publication is for informational and educational purposes only and does not constitute investment, legal, medical, or tax advice, a solicitation, or an offer to buy/sell any security. Information is believed reliable but no warranty is made as to accuracy or completeness; views may change without notice. Do your own research and consult qualified professionals.
DISCLOSURE & CONFLICTS: The author may hold positions in securities mentioned and may change positions at any time without notice. No compensation is received from companies mentioned, and there are no known material business relationships unless explicitly stated. Content may reference clinical data and regulatory events; always consult primary sources and a licensed clinician for medical decisions. Past performance is not indicative of future results.
LIABILITY: Use of this content is at your own risk. The author assumes no responsibility for any losses arising from reliance on this material.
Image source: pharmaphorum.com