FDA Approves Moderna's mRNA Flu Vaccine, Takeda's Orzeyful, and Replimune's Tudriqev – This Week in Biotech #112
Three first-in-class approvals in seven days, Lilly's $23B quarter crushes Novo again, and a rumored $400B AstraZeneca-Bristol Myers merger knocks 9% off AZ (Jul 31–Aug 6, 2026).
Welcome back to This Week in Biotech by Biotech Blueprint, edition 112, covering biotech and pharma news from July 31 to August 6, 2026.
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VIDEO SUMMARY
THIS WEEK’S KEY TAKEAWAYS 🔑
The FDA approved three first-in-class drugs this week. Moderna’s mFluSiva is the first licensed influenza vaccine built on mRNA. Takeda’s Orzeyful (oveporexton) is the first orexin receptor 2 agonist, and the first drug that treats narcolepsy type 1 by restoring the signal patients have lost rather than just stimulating them around it. Both open new categories, not just single product approvals. And in Moderna’s case, the FDA had issued a refusal to file on this exact program only 18 months ago.
The FDA also granted accelerated approval to Replimune’s Tudriqev (vusolimogene oderparepvec-wtpg) on August 6, four days after the August 2 decision deadline and one week after its advisory committee voted 10-3 that the efficacy data are evaluable and clinically meaningful. This is Replimune’s third review cycle after rejections in July 2025 and April 2026.
The second story is obesity, and the race isn’t close anymore. Lilly booked $23B in the quarter, up 48% and raised full year guidance to $85B to $87B, driven by tirzepatide alone. Novo missed on the oral Wegovy line and, more damaging, disclosed that CagriSema failed to prove non-inferiority to tirzepatide on blood sugar in the head-to-head REIMAGINE 4 trial. That’s the second direct loss to Lilly’s molecule in six months, after CagriSema missed on weight in REDEFINE 4. Novo’s CEO spent the earnings call talking about small acquisitions to fill pipeline gaps, which usually means the company can’t fix things with its own pipeline.
Capital markets had a busy week too. Five biotechs went public and raised more than $1 billion combined, bringing 2026 to 17 IPOs and 12 that raised at least $250 million each. All of 2025 only produced 11. Meanwhile, the Financial Times mentioned a rumored $400 billion merger between AstraZeneca and Bristol Myers Squibb, which knocked about 9% off AstraZeneca’s stock before the whole story was denied by an insider. So investors are happy to pay premium prices for fresh science and clearly don’t want to pay for consolidation between two aging pipelines.
BIOTECH/PHARMA NEWS 🧬
🔹 The FDA approved Moderna’s mFluSiva on August 5 for seasonal influenza in adults 50 and older. Standard approval in the 50 to 64 group, accelerated approval in 65 and older contingent on a confirmatory trial running across two flu seasons. The pivotal data showed a 27% relative reduction in influenza-like illness compared with a standard dose flu shot in adults 50 and over, with no new safety signals. What matters here almost as much as the approval itself is the regulatory part of it. Moderna received a refuse-to-file decision on this exact program under Marty Makary and Vinay Prasad. Both are gone from the agency, a June advisory committee voted unanimously in favor, and the product is now approved in time for the 2026-2027 season. The commercial case rests on manufacturing speed. Conventional flu vaccines require a strain call months ahead of the season and a production run that can’t be revised, but an mRNA process can. If the confirmatory data hold in the 65+ population, strain match becomes the whole commercial argument against Sanofi, GSK, and CSL.
🔹 Takeda’s Orzeyful (oveporexton) was approved August 5 for narcolepsy type 1 in adults, the first medicine to target the biology of the disease directly. Narcolepsy type 1 is caused by loss of orexin-producing neurons, and existing therapy is stimulants and sodium oxybate, which manage symptoms without touching the deficit. Jefferies puts the annual price between $142k and $250k, and roughly $2B in peak sales at the low end. Launch waits on the Drug Enforcement Administration, which has up to 90 days to assign a control schedule. The phase 3 FirstLight and RadiantLight data behind the approval were clean. Mean sleep latency on the Maintenance of Wakefulness Test improved by 13.83 minutes at 1 mg and 17.2 mins at 2 mg against placebo, both at p<0.001. Weekly cataplexy rate fell more than 80% from baseline relative to placebo, with patients reporting four to five cataplexy free days a week at week 12 against none at entry. The interesting question is where the class goes, not the specific drug. Alkermes is running alixorexton across narcolepsy type 1, type 2, and idiopathic hypersomnia, explicitly to arrive with a broader label than Takeda’s. Lilly bought into the mechanism through the $6.3B Centessa acquisition. Eisai has its own candidate. Takeda gets first mover pricing in the smallest of the three indications, and the larger populations are still open and that’s where the class gets decided.
🔹 The FDA granted accelerated approval to Replimune's Tudriqev (vusolimogene oderparepvec-wtpg) on August 6 for advanced melanoma in patients who have progressed on anti-PD-1 therapy, in combination with nivolumab. Tudriqev is a genetically modified oncolytic viral therapy based on herpes simplex virus type 1, injected directly into tumors every two weeks for eight doses. In the pivotal single arm trial of 91 evaluated patients, 24% achieved an objective response with a median duration of 14.1 months. The approval landed four days after the August 2 decision deadline and one week after the Cellular, Tissue and Gene Therapies Advisory Committee voted 10-3 that the efficacy data are evaluable and clinically meaningful. This is Replimune's third review cycle. The FDA had previously rejected the application in July 2025 and April 2026, and briefing documents released two weeks before the panel meeting had called the trial "not interpretable" on the grounds that a single arm intratumoral injection study couldn't separate RP1's contribution from Opdivo's. The panel disagreed and the FDA, eventually, agreed with the panel. Two weeks produced a briefing document that took 30-40 % off the stock, a panel vote that doubled it, a deadline that passed, and finally an approval four days late.
🔹 Lilly reported $23.0B in Q2 revenue, up 48%, against a $20.6B consensus. Mounjaro rose 91% to $9.94B worldwide, US Zepbound rose 44% to $4.9B, non-GAAP earnings per share rose 33% to $8.38, and full year guidance moved to $85.0B to $87.0B from $82.0B to $85.0B. Foundayo, the oral GLP-1, brought home $98M in its first reported quarter against $104M expected, which nobody punished because expectations were already low. Novo’s oral Wegovy came in at DKK 3.2B, about $494M, versus DKK 3.6B expected, and the shares fell 6%. Novo did raise its own full year sales forecast, from a range of down 4% to down 12% to a narrower range of flat to down 6%. But the direction of the franchise isn’t really in question. Lilly is growing at 48% on an injectable that has now beaten Novo’s next generation combination twice head to head.
🔹 Novo Nordisk’s CagriSema was compared head-to-head against Lilly’s tirzepatide 15 mg in about 1,000 adults with type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor, over 68 weeks. On weight, CagriSema was non-inferior at 15.2% versus 15.8%. On glycemic control, it wasn’t. HbA1c fell 1.9 percentage points versus 2.2 for tirzepatide, missing the non-inferiority margin. A 1.9-point HbA1c reduction is a strong result in absolute terms and would have been a big headline against placebo three years ago. But Novo chose the comparator, chose the dose, and lost on the primary endpoint. Combined with REDEFINE 4, where CagriSema missed non-inferiority on weight in obesity, the amylin+semaglutide combination has now been tested directly against Lilly’s molecule twice and come up short on both axes that matter commercially. So CagriSema’s launch case has to be built on tolerability or price rather than efficacy.
🔹 The Financial Times reported on August 3 that AstraZeneca and Bristol Myers Squibb had held early talks about combining, which would have created a roughly $400B company and one of the largest deals in the industry’s history. AstraZeneca’s shares fell as much as 7-9%. On Aug. 5, a senior source told Reuters there never was a deal and there are no discussions. The London listing recovered about 3%. Whether talks actually happened is unresolvable from the outside. The shareholder reaction, however, is not ambiguous. AstraZeneca has a functioning oncology and cardiometabolic pipeline, and the mere suggestion that it would spend its equity on Bristol Myers, whose Revlimid and Eliquis patent cliffs are the reason it would want the deal, cost it nearly a tenth of its market value in a day.
🔹 Braveheart Bio raised $382.5M, pricing 21.25M shares at $18 for BHB-1893, a cardiac myosin inhibitor licensed from Hengrui Pharma for hypertrophic cardiomyopathy and aimed at Bristol Myers’ Camzyos. Hengrui is running Phase 3 in the obstructive form in China. Braveheart plans global trials in both obstructive and non-obstructive disease starting late 2026. Attovia raised $289M at $17 for a $767M valuation on ATTO-1310, an antibody against interleukin-31, the itch cytokine, in Phase 1 for chronic pruritus and severe eczema. Braveheart is the 17th drugmaker to go public in 2026 and Attovia the 12th to raise at least $250M, against 11 offerings in all of 2025. Median deal size this year is around $300M. Braveheart is also the second listing of 2026 built on a Hengrui-licensed molecule, which means the China licensing arbitrage model has now moved from private deal rooms into the public markets.
🔹 Tarsus Pharmaceuticals is acquiring Alkeus for about $450M upfront, $270M cash and $180M stock, plus up to $350M in milestones and a low to mid single digit revenue share. The asset is gildeuretinol (ALK-001), a daily oral in Phase 3 for Stargardt disease, an inherited retinal degeneration with no approved treatment. The mechanism is deuteration of vitamin A to slow the dimerization that produces toxic retinal byproducts, and the drug has been studied in more than 400 individuals. Tarsus is spending the balance sheet from its marketed eye care product on a late stage rare disease program in an indication where any approval is the first.
🔹 Intellia disclosed that an analysis of more than 600 patient samples across the nex-z program identified a specific human leukocyte antigen allele associated with the largest liver transaminase elevations seen in the trials. The company will return HLA genotyping results to investigators and to patients already enrolled or entering screening in the phase 3 studies, and is discussing the finding with regulators. Enrollment, which had been paused after a grade 4 transaminase and bilirubin elevation in a patient who later died, has been restarted. MAGNITUDE-2 in hereditary ATTR with polyneuropathy should complete enrollment in the second half of 2026. This is arguably the most useful thing to happen to in vivo gene editing safety this year. The standing problem with the field is that a one time, irreversible edit leaves no way to de-risk an individual patient after the fact. An inherited immune genetic marker that flags who’s likely to mount the hepatic response converts an unpredictable platform risk into a screening step, if regulators accept it.
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