CEPI Rescues Moderna’s Bird Flu Vaccine and Takeda’s Delivers in Psoriasis — This Week in Biotech #82
From pandemic preparedness to late stage clinical wins, plus key FDA approvals and trial readouts that will shape 2026 (Dec 12-18, 2025).
Hi and welcome to This Week in Biotech by Biotech Blueprint, edition 82, covering biotech and pharma news from December 12-18, 2025.
📣 This is the final This Week in Biotech edition of 2025. Happy holidays from Biotech Blueprint! We’ll be back on January 2, 2026, covering everything from December 19 through January 1.
Instead of recapping the biggest biotech developments of 2025 here, I’ll be publishing an article over the holiday break, alongside a podcast recorded with Biotech Capital Compass. With so much news breaking in the past week, I didn’t want to overload this issue.
🎙️ 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.
In the latest episode, I sat down with NImmune founder and CEO Josep Bassaganya-Riera to talk about omilancor, the gut-restricted oral Inflammatory bowel disease drug now in phase 3. We cover LANCL2 biology, their biomarker aimed at boosting response rates, and the TITAN-X platform that helps guide real development decisions. A really interesting look at how you build an oral immunology company in 2025.
VIDEO SUMMARY
THIS WEEK’S KEY TAKEAWAYS 🔑
The clearest scientific win came from Takeda, which delivered convincing late stage data for its once daily psoriasis pill, zasocitinib. For Takeda, the timing is critical. Major patent expirations loom later this decade, and zasocitinib now looks less like a pipeline asset and more like a future growth engine.
In oncology, J&J showed how incumbents defend leadership without reinventing the science. FDA approval of a subcutaneous formulation of Rybrevant doesn’t change survival curves (those were already strong) but it meaningfully improves how care is delivered. Shorter administration times and fewer infusion reactions matter to patients and health systems alike. As competition in lung cancer intensifies, differentiation is increasingly about how drugs are used, not just whether they work.
The most consequential policy signal came from CEPI stepping in to fund Moderna’s pandemic influenza vaccine after U.S. federal support evaporated. The science never faltered but the political environment did. CEPI’s investment keeps the world’s first mRNA-based pandemic flu vaccine moving toward phase 3. Pandemic preparedness is becoming more international, more distributed, and less dependent on U.S. government leadership. That has long term implications for how future outbreak responses are financed and governed.
Public health policy also took a more uncertain turn. The CDC’s decision to relax universal newborn hepatitis B vaccination guidance marks a notable departure from decades of prevention messaging. While officials stress informed choice and unchanged access, past experience shows that weakening universal recommendations often leads to lower vaccination rates in practice.
Finally, a quieter but deeply important update: newborn screening will now include Duchenne muscular dystrophy. Earlier diagnosis won’t cure the disease, but it fundamentally alters the clinical trajectory by enabling earlier monitoring and access to therapy before irreversible damage sets in. This is public health working as intended by shifting care upstream, where it has the most impact.
BIOTECH/PHARMA NEWS 🧬
🔹 CEPI will invest up to $54.3M to fund a pivotal phase 3 trial of Moderna’s mRNA-based H5 avian influenza vaccine, mRNA-1018, effectively reviving the program after the U.S. government terminated a much larger BARDA contract earlier this year. The study is expected to begin in early 2026 and would be the first mRNA vaccine to enter a phase 3 trial for pandemic influenza, leveraging prior positive phase 1/2 immunogenicity data in healthy adults. As part of the agreement, Moderna committed to reserving 20% of manufacturing capacity for affordable supply to low- and middle-income countries in the event of a pandemic, underscoring CEPI’s push for rapid, equitable access amid growing uncertainty around U.S. federal support for pandemic preparedness.
🔹 J&J won FDA approval for a subcutaneous version of its EGFR-targeting antibody Rybrevant, developed with Halozyme, enabling a much faster, injection-based alternative to IV dosing for first line EGFR mutant non small cell lung cancer when combined with lazertinib. The approval is supported by phase 3 MARIPOSA data showing a statistically significant overall survival benefit versus AstraZeneca’s Tagrisso, with J&J projecting median survival beyond four years in this chemotherapy-free regimen. The new formulation cuts administration time from hours to minutes and sharply reduces infusion-related reactions, reinforcing J&J’s push to differentiate on convenience and durability as competition in EGFR mutant lung cancer intensifies.
🔹 Incyte said the European Commission approved Minjuvi (tafasitamab), partnered with Xencor, as a new late-line option for adults with relapsed or refractory follicular lymphoma, expanding the drug’s footprint beyond its earlier EU approval in diffuse large B cell lymphoma. The decision clears Minjuvi for use alongside lenalidomide and rituximab after at least one prior systemic therapy, based on Phase 3 inMIND data showing a statistically significant and clinically meaningful improvement in progression-free survival versus standard therapy alone. The approval marks a second European indication for the CD19 antibody and reinforces Incyte’s strategy of incrementally broadening Minjuvi’s role across B cell lymphomas using combination regimens rather than standalone monotherapy.
🔹 The CDC formally adopted a shift in its newborn hepatitis B vaccination guidance, ending its decades-long recommendation that all infants receive a birth dose if their mothers test negative for the virus. Under the new policy, vaccination for these newborns moves to shared clinical decision making between parents and healthcare providers, with the first dose deferred until at least two months of age if the birth dose is skipped, while infants born to hepatitis B-positive or untested mothers will still receive immediate vaccination. The change has sparked significant controversy among public health experts, who warn it could reverse hard won declines in pediatric hepatitis B infections, even as federal officials emphasize informed consent and note that insurance coverage and vaccine access remain unchanged.
🔹 Sarepta shares rose after HHS announced it will add Duchenne muscular dystrophy (DMD) and metachromatic leukodystrophy to the recommended newborn screening panel, a move that could shift diagnosis from around age 4-5 years to shortly after birth. Earlier detection is seen as clinically meaningful in DMD, where irreversible muscle damage begins in infancy, and could accelerate access to care and approved therapies. The decision also has commercial implications for Sarepta, which has marketed and pipeline DMD therapies.
🔹 BioCryst won approval for an oral pellet formulation of Orladeyo, extending its hereditary angioedema franchise to children ages 2 to 12 and making it the first targeted oral prophylactic option for pediatric patients who previously relied on injections or infusions. Meanwhile, Amgen secured FDA approval to expand Uplizna into generalized myasthenia gravis, adding a third U.S. indication for the CD19-targeting antibody and positioning it as a twice yearly option for durable symptom control in a difficult autoimmune disease. Both approvals meaningfully widen access by extending proven therapies to new patient groups.
🔹 Last Friday, reports briefly suggested the FDA might add a “black box” warning to Covid vaccines, but follow up from Bloomberg says the agency has no such plans. Officials emphasized that earlier stories were premature, even as the FDA continues routine safety reviews already reflected in existing labels. While the episode is concerning and highlights growing uncertainty around vaccine policy under new leadership, there is no immediate change to vaccine labeling, recommendations, or the underlying safety data.
CLINICAL TRIAL UPDATES 📊
🔹 Takeda reported strong late stage results for zasocitinib, a once daily pill for plaque psoriasis developed using AI. In two large phase 3 studies, more than half of treated patients had skin that was clear or almost clear after 16 weeks, and about 30% achieved completely clear skin, with responses continuing to improve over time. The drug was generally well tolerated and outperformed placebo and an existing oral competitor. Takeda plans to file for regulatory approval in 2026, positioning zasocitinib as a potential oral alternative in a market still dominated by injectable biologics, and a key revenue opportunity as the company approaches major patent expirations later this decade.
🔹 Pyxis Oncology fell nearly 47% after releasing phase 1 data for its ADC micvotabart pelidotin (MICVO) in recurrent/metastatic head and neck cancer. While the company highlighted a 46% response rate and 92% disease control at the selected monotherapy dose, investors appeared focused on the safety profile, with Grade ≥3 treatment-related adverse events in 56% of patients and a 28% discontinuation rate. Early combination data with Keytruda looked numerically stronger (71% ORR in seven patients), but remains highly preliminary. With durability data not expected until mid-2026, the readout reinforced how unforgiving the market remains for early stage oncology programs where efficacy comes paired with meaningful toxicity.
🔹 Insmed fell after abandoning brensocatib in chronic rhinosinusitis without nasal polyps, following a phase 2b miss where the drug failed to beat placebo on symptom improvement despite a clean safety profile. The program was discontinued immediately, though brensocatib remains approved for bronchiectasis and in development for other indications. Insmed paired the setback with the acquisition of a phase 2-ready monoclonal antibody, INS1148, to rebuild its respiratory and inflammation pipeline.
🔹 DBV Technologies surged after its phase 3 VITESSE trial showed that the VIASKIN Peanut patch significantly desensitized children aged 4-7 with peanut allergy, with 46.6% meeting responder criteria at 12 months versus 14.8% on placebo, easily clearing the pre-specified efficacy bar. The treatment demonstrated a favorable safety profile consistent with prior studies, driven mainly by mild to moderate local skin reactions and very low rates of treatment related anaphylaxis. With the largest food allergy immunotherapy trial to date now positive and Breakthrough Therapy Designation already in hand, DBV plans to submit a BLA in the first half of 2026, positioning VIASKIN Peanut as a potentially first-in-class, noninvasive option for pediatric peanut allergy. The stock (DBVT) is up 25% on the news.
🔹 Vistagen shares collapsed after its phase 3 PALISADE-3 trial showed that intranasal fasedienol failed to significantly reduce anxiety versus placebo in a public speaking challenge for social anxiety disorder, missing both its primary and secondary endpoints despite earlier positive signals in phase 2 and a prior phase 3 study. The drug’s safety and tolerability remained consistent with past trials, but the lack of efficacy erased the investment case, prompting Vistagen to announce cost-cutting measures to extend its cash runway into 2027 and triggering an analyst downgrade as the company reassesses next steps with regulators.
🔹 Gilead said its investigational single-tablet HIV regimen combining lenacapavir (capsid inhibitor) with bictegravir (INSTI) hit its mark again: in the phase 3 ARTISTRY-2 switch study, moving virologically suppressed patients from Biktarvy to the BIC/LEN combo was statistically non-inferior at week 48, with secondary endpoints also supporting comparable control. With ARTISTRY-1 already positive, Gilead is now framing the two trials as the package for regulatory submissions, positioning BIC/LEN as a “next step” option for suppressed adults that pairs a high resistance barrier backbone with a first-in-class mechanism, without introducing new safety surprises.
🔹 argenx will discontinue its phase 3 UplighTED trials of subcutaneous efgartigimod in thyroid eye disease after an independent monitoring committee recommended stopping for futility at a pre-specified interim analysis. The decision was driven by a lack of efficacy rather than safety, with the company noting a favorable tolerability profile and no new safety signals. Shares fell modestly on the news, but the setback is contained: efgartigimod remains a cornerstone asset for argenx in approved indications like generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.
🔹 Arcus Biosciences halted its phase 3 anti-TIGIT program after failing to improve survival in gastric cancer, adding another late stage strike against the TIGIT class as the company pivots capital to its HIF-2 alpha and inflammation pipeline.
Have a great rest of your week and thanks for reading Biotech Blueprint!
The CEPI rescue of Moderna's H5 vaccine is a bigger deal than it seems on the surface. When federal pandemic prep funding becomes politically unreliable, you need distributed backup systems, and CEPI stepping in shows that model working in practice. The 20% capacity reservation for LMIC supply is smart policy engineering, because the whole point of pandemic prep is avoiding the vaccine nationalism mess we saw early in COVID. One thing I'm curious about: does CEPI funding change Moderna's timeline or trial design compared to what the BARDA contract would've looked like, or is it basically a straight subsitution? The Takeda zasocitinib data looks solid too, especially with oral dosing in a space dominated by injectables, though convincing derms to switch from proven biologics to a neworal TYK2 will probaby be an uphill battle initially.