FDA Shifts to One Pivotal Trial and Moderna Flu Shot Back Under FDA Review – This Week in Biotech #90
Plus Compass psilocybin Phase 3 win and China’s biotech licensing surge (Feb 13-19, 2026).
Welcome back to This Week in Biotech by Biotech Blueprint, edition 90, covering biotech and biopharma news from February 13th to February 19th, 2026.
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VIDEO SUMMARY
THIS WEEK’S KEY TAKEAWAYS 🔑
In a New England Journal of Medicine piece, FDA leadership said the new default for most approvals will be one adequate, well-controlled pivotal trial plus “confirmatory evidence,” rather than two pivotal trials. In theory, that can be a rational modernization. A second trial does not rescue a weak control arm, sloppy endpoints, or a fragile statistical plan. In practice, the market will care less about the philosophy and more about the execution. A policy shift this large, announced without clear implementation guidance, invites the one thing drug developers and investors dislike most - ambiguity about what will be accepted, when, and by whom.
That uncertainty showed up in real time with Moderna. Last week, its mRNA flu vaccine drew a Refusal to File over a comparator dispute. This week, it was accepted back into review after a Type A meeting and an amended application, with an August 5, 2026 target action date. Moderna’s revised path also shifts to an age-tiered approach, starting with adults 50 and older and adding a post marketing trial in older adults. Process and policy are now moving parts, and that will shape how sponsors design trials, allocate capital, and decide which programs are worth the regulatory risk.
Major medical groups asked a federal judge to block the CDC’s ACIP meeting and pause implementation of recent immunization guidance changes. The late-February meeting has been pulled from the calendar, and reporting is mixed on whether it will be rescheduled in mid-March. The plaintiffs are treating this as an emergency, not a routine policy dispute. They argue the committee’s remade composition and process could produce recommendations that further lower vaccination rates, and they want to stop the next round of guidance before it lands.
Clinically, Compass Pathways delivered a Phase 3 win in treatment-resistant depression. COMP360, a synthetic psilocybin, beat a very low dose control (1mg) on the Montgomery Åsberg Depression Rating Scale at week six. The company is talking about rapid onset and a generally tolerable safety profile, and it is now pushing toward FDA discussions and a targeted Q4 filing.
Finally, China is becoming a bigger driver of global biotech deal flow. Out licensing hit a record $137.7B in 2025, and early 2026 is pointing to bigger average deal sizes and higher upfront payments as global pharma shops for pipeline help ahead of major patent expirations. The simplest read is that China is no longer just a bargain source of external innovation. It is becoming a core hunting ground, especially in modalities like antibody-drug conjugates, where the density of licensable assets keeps rising.
BIOTECH/PHARMA NEWS 🧬
🔹 Makary and Prasad just reset the default on FDA evidence standards. In a New England Journal of Medicine piece, they said the agency’s new baseline will be one adequate, well-controlled pivotal trial plus “confirmatory evidence,” not two. They argue two trials can create false confidence if the design is weak, and that focusing reviewer time on one high quality study could speed development and cut costs, with extra studies still required when mechanisms are fuzzy, endpoints are surrogate, or designs are otherwise fragile. Former FDA leaders and industry voices are warning that announcing a major policy shift via an opinion style article without detailed guidance, stakeholder input, or implementation specifics could reduce predictability and rattle investors, payers, and global regulators who usually treat FDA as the reference standard.
🔹 Sensei Biotherapeutics is effectively rebooting via an all stock merger with Faeth Therapeutics plus a $200M private placement, shifting the company’s center of gravity to Faeth’s lead program PIKTOR, an all oral dual node approach in the PI3K–AKT–mTOR pathway (serabelisib + sapanisertib). The near-term focus is a phase 2 study in second-line advanced endometrial cancer and a planned phase 1b in hormone receptor-positive, HER2-negative advanced breast cancer, with key milestones expected before end of 2026. The pitch is simple: multi-node inhibition aimed at avoiding the classic PI3K trap where efficacy gains come with intolerability, supported by early signals that included complete responses in heavily pretreated endometrial cancer. Sensei will also use some of the new capital to finish its ongoing phase 1/2 VISTA antibody study (solnerstotug).
🔹 ImmunityBio jumped after the European Commission granted conditional approval for Anktiva plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. It gives the company commercial access across the full EU (plus Iceland, Norway, and Liechtenstein), and ImmunityBio is pitching it as the first immunotherapy authorized in Europe for this setting, where the fallback has often been radical cystectomy. The label is conditional because the approval leaned on a single arm phase 2/3 dataset, so the company now owes European regulators longer term safety and durability followup to keep the authorization.
🔹 Moderna got a fast reversal at FDA on mRNA-1010. After last week’s Refusal to File over a “best available standard of care” comparator dispute, FDA has now accepted the amended biologics license application for review and set an Aug. 5, 2026 target action date. Moderna says the turnaround followed a Type A meeting and a revised plan that splits the filing by age, with an initial push toward adults 50+ and a post-marketing requirement for an additional trial in older adults.
🔹 The American Academy of Pediatrics, the American Public Health Association, and others asked a federal judge in Massachusetts to block the CDC’s next ACIP meeting and pause recent immunization guidance changes. Since the suit landed, the late-February meeting has been pulled. Reuters reported it will not be held with no new date announced, while Bloomberg reported CDC is considering a mid-March reschedule. The plaintiffs argue HHS Secretary RFK Jr.’s overhaul was unlawful and risks lowering vaccination rates. The Department of Justice has pushed back that the challengers are trying to stifle debate and that HHS has broad discretion, while Judge Brian Murphy flagged the uncomfortably tight timeline for a decision.
🔹 The FDA issued a Complete Response Letter for Disc Medicine’s bitopertin in erythropoietic protoporphyria, effectively saying accelerated approval will have to wait for phase 3. The nuance is FDA agreed the phase 2 trials showed a clear biomarker effect (lowering whole-blood metal-free protoporphyrin), but said the phase 2 package did not demonstrate that the size of that biomarker change tracked with clinical benefit on the sunlight-exposure endpoints used in the studies. Disc now pivots to the APOLLO phase 3 readout expected in the fourth quarter of 2026 as the likely path to traditional approval.
🔹 China biotech out-licensing hit a record $137.7B in 2025, and early 2026 activity points to larger average deal sizes and higher upfront checks as global pharma shops for pipeline replenishment ahead of major patent expirations. The message is that China is increasingly a core sourcing market for innovative assets, with particular strength in high demand modalities like antibody-drug conjugates.
🔹 AC Immune said Janssen (J&J) has temporarily paused enrollment in the [hase 2b ReTain trial of their anti-phospho-tau vaccine (ACI-35.030 / JNJ-2056) in preclinical Alzheimer’s, while Janssen reviews trial logistics including recruitment. The company emphasized the pause is voluntary and not tied to new safety findings, and that the trial’s pre-specified interim immunogenicity threshold was met. AC Immune also said the pause does not change its cash runway, which it still expects to extend into Q3 2027 (excluding any milestones).
CLINICAL TRIAL UPDATES 📊
🔹 Compass Pathways jumped after its second pivotal phase 3 study of COMP360, its synthetic psilocybin therapy, hit the primary endpoint in treatment resistant depression, showing a statistically significant 3.8 point advantage on the Montgomery Åsberg Depression Rating Scale at week 6 versus a very low dose control. The company also highlighted fast onset starting the next day, a generally tolerable safety profile with mostly mild to moderate events, and plans to meet with the FDA on a rolling application ahead of a targeted Q4 filing.
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