Last Week Tonight in BioPharma: Week of July 7th, 2026
Vertex swings big for Crinetics, Ionis' results boost BridgeBio, and a Vera introduces TRUTAKNA to the IgAN market
Welcome back to Last Week Tonight in BioPharma (LWTB)!
This week: AstraZeneca and Ionis see disappointing results in ATTR Cardiomyopathy, Vera sees accelerated approval of TRUTAKNA ahead of eGFR data in Q3, the FDA pauses CRLs but then restarts them, and Vertex acquires Crinetics for nearly $10B.
All that and more below!
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📡 PRESS RELEASE DECODER
What the press releases actually mean
AstraZeneca and Ionis WAINUA Misses in CARDIO-TTRansform ATTR-CM
📅 July 9, 2026 | 🏢 AstraZeneca (AZN),IonisPharmaceuticals(IONS) | 💊 Wainua (eplontersen), TTR antisense silencer | 🏷 Phase 3 Failure / ATTR-CM | 🔗 Ionis press release, FiercePharma, Alnylam Q1 2026 results, FiercePharma on ATTRUBY
WAINUA missed the primary endpoint in CARDIO-TTRansform (n=1,432, largest ATTR-CM trial ever run), a composite of CV mortality and recurrent CV events through Week 140 versus placebo on top of standard of care. In a pre-specified subgroup of patients on eplontersen monotherapy without a stabilizer at baseline, the hazard ratio was a nominally significant 0.71. In patients already on a stabilizer, no treatment effect was observed. 57% of patients in each arm were on a stabilizer at baseline and another 24% initiated one during the trial. WAINUA produced large sustained TTR reductions, safety was clean, and multiple secondary imaging and biomarker endpoints favored eplontersen. AZN shares fell around 7% and IONS around 21% on the news. Full data will be presented at ESC Congress August 2026. Wainua remains approved and marketed in ATTRv-PN in 20-plus countries.
🧠 BPS Take: Ionis CEO Brett Monia attributed the miss to the rapidly evolving treatment landscape in ATTR-CM. When CARDIO-TTRansform started enrolling, ATTR-CM patients were not universally on tafamidis. By the time the trial read out, 81% of participants were either on a stabilizer at baseline or initiated one during the study. Basically, adding a TTR silencer on top a stabilizer didn’t add any benefit. The monotherapy subgroup hazard ratio of 0.71 tells you the drug is probably working when it isn’t competing with a background stabilizer drug that is already lowering TTR levels upstream.
BridgeBio’s ATTRUBY (acoramidis) feels like the real winner here. Ionis’ study is evidence that combination therapy doesn’t add value, and that the stabilizer MOA is a powerful therapeutic anchor as a monotherapy. It looks to be comparatively better than Pfizer’s VYNDAMAX, which is a first-generation stabilizer. ATTRUBY put up $37M in its first full quarter and just closed a $1B Sixth Street and KKR preferred equity raise last week that I covered in depth.
Alnylam’s AMVUTTRA generated $889.9M in Q1 2026, up 187% year over year and the stock price rallied a bit on this news. AMVUTTRA has its own positive HELIOS-B data supporting the silencer approach, but there was far less background stabilizer use when that study ran. Payers now have evidence to point to to say they’d rather have patients on a stabilizer first before moving to a silencer.
This also puts added pressure on the development of Alnylam’s next-gen silencer, nucinersen. Alnylam is moving nucresiran into a pivotal Phase 3 trial called TRITON-CM to test it in cardiomyopathy. The problem? In 2026, finding a newly diagnosed ATTR-CM patient who isn't already taking a stabilizer is incredibly difficult. An nucinersen is probably the drug Alnylam wants to quickly overtake Amvuttra, as the companies owed double-digit royalties to Blackstone on sales of Amvuttra, thus compressing its margin.
Vera Therapeutics TRUTAKNA Wins FDA Accelerated Approval. Seventh IgAN Drug, First Dual BAFF/APRIL Inhibitor Enters a Competitive Nephrology Market
📅 July 7, 2026 | 🏢 Vera Therapeutics ( VERA 0.00%↑ ) | 💊 TRUTAKNA (atacicept-vymj), dual BAFF/APRIL inhibitor | 🏷 FDA Accelerated Approval / IgA Nephropathy | 🔗 Vera press release, BioSpace, NEJM ORIGIN 3
The FDA granted accelerated approval to TRUTAKNA for adults with primary IgA nephropathy at risk of disease progression, based on ORIGIN 3 Phase 3 data showing a 46% reduction from baseline in proteinuria (24-hour urine protein-to-creatinine ratio) at Week 36 versus placebo. Dose is 150 mg subcutaneous weekly, self-administered. Full approval is contingent on eGFR data at Week 104 as the confirmatory endpoint. TRUTAKNA is the first B-cell modulator targeting both BAFF and APRIL to reach the market. The approved IgAN armamentarium now includes Tarpeyo (Calliditas), Filspari (Travere TVTX 0.00%↑ ), FABHALTA and VANRAFIA (Novartis, NVS 0.00%↑ ), VOXYACT (Otsuka), and now TRUTAKNA. Vera has already begun launch execution.
🧠 BPS Take: IgAN went from an unmet-need orphan indication five years ago to a multi-drug commercial slugfest in 2026. How each drug differentiates from its competitors and what patients they aim to compete for will be key to monitor as this market matures. For Vera and TRUTAKNA that main competitor is Otsuka’s VOXYACT, an anti-APRIL mAb. TRUTAKNA’s label looks pretty clean relative to VOXYACT, with broader patient eligibility language and no prominent warnings for neutralizing antibodies.
The real tests will come in the second half of the year once both drugs’ long-term eGFR numbers are made available for cross trial comparison. Otsuka already reported “significant stabilization and improvement in annualized eGFR slope”, leaving the field waiting for specific numbers to be reported at an upcoming conference. Vera has moved up its eGFR data readout to Q3 2026. Numerically stronger numbers should drive TRUTAKNA’s commercial uptake significantly and support a smooth sBLA filing (expected Q4’26) to convert the accelerated approval into a full approval.
Lurking around the corner is Vertex, which has a PDUFA date for its own BAFF/APRIL inhibitor, povetacicept on November 30th, 2026. Povetacicept looked numerically better than TRUTAKNA on UPCR change, the main surrogate endpoint for accelerated approval. If TRUTAKNA looks better than VOXYACT on eGFR, that starts to speak to a potential advantage dual BAFF/APRIL inhibition has over single target inhibition. It also may raise physicians expectations for povetacicept’s eGFR results since it registered a numerically higher UPCR change than TRUTAKNA. We won’t know the full eGFR numbers for Vertex until 2027, but that perception is something Vera may have to contend with if they achieve the eGFR numbers they are hoping for.
Kailera and Hengrui HRS-7535 Oral GLP-1 Delivers 10.9% Weight Loss in Chinese Phase 3. 70% Nausea Rate Is the Story
📅 July 7-8, 2026 | 🏢 Kailera Therapeutics (private), Jiangsu Hengrui Pharmaceuticals | 💊 HRS-7535, oral small-molecule GLP-1 receptor agonist | 🏷 Phase 3 Topline / China | 🔗 Kailera press release, FierceBiotech, BioPharma Dive
Hengrui reported topline data from two Phase 3 China trials of HRS-7535 in obesity/overweight and Type 2 diabetes. In the obesity trial, mean weight loss at Week 44 was 10.9% at the 180 mg dose and 9.8% at 120 mg. Both doses hit primary endpoints. Nausea was reported in 70.3% of patients on 120 mg and 70.0% on 180 mg versus 16.2% on placebo. Discontinuation rate not broken out at topline. Kailera holds ex-China rights via the 2024 Hengrui licensing deal, was co-founded by Atlas Venture and Bain Capital, and is running a parallel US development program. Kailera stock dropped approximately 10% on the release.
🧠 BPS Take: 10.9% weight loss with an oral small molecule is a solid result and puts HRS-7535 in the same efficacy neighborhood as oral semaglutide at higher doses and Lilly’s orforglipron. The nausea number is the problem.
Orforglipron ATTAIN-1 reported nausea rates in the mid-30s at the highest dose with a well-managed titration schedule. A 70% nausea rate is not competitive with what the field has already established as a manageable tolerability profile. If those numbers hold in western studies with KAI-7535, it doesn’t bode for a competitive profile. Perhaps Kailera looks to explore a more aggressive titration schedule to blunt the GI side effects, but that too comes with the trade off of time, cost, and inconvenience.
This readout doesn’t totally nuke the thesis behind Kailera’s massive IPO earlier in the year. They have multiple assets in P2 and P3 studies for obesity. If they don’t see a viable path to making KAI-7535 commercial competitive, they can easily pivot to one of their three other clinical stage programs.
🌐 CONNECTING THE DOTS
When the outside world meets biopharma
FDA’s CRL Transparency Push Wobbles, Then Doesn’t
📅 July 10-11, 2026 🏢 FDA / HHS, Acting Commissioner Kyle Diamantas 📄 Policy pause reversed within days after 16 new CRLs released 🔗 FierceBiotech | BioCentury | Proposed rule
FDA quietly paused real-time release of Complete Response Letters in April after a Covington & Burling citizen’s petition on behalf of an undisclosed pharma company challenged the policy over unredacted confidential information. The petition cited specific unredacted material in the Lykos and Stealth BioTherapeutics CRLs. Days after the pause was reported, FDA released 16 new CRLs, including the Hengrui/Elevar camrelizumab plus rivoceranib rejection. HHS is simultaneously advancing a proposed rule to eliminate the presumption that a marketing application’s existence is confidential commercial information.
🧠 BPS Take: Marty Makary’s tenure will not be remembered fondly, but CRL transparency was the one policy he championed that the industry should actively want to keep. CRL transparency can help drive learning that leads to more successful FDA submissions — i.e not repeating mistakes others have made and also getting a clearer sense of regulatory precedent and expectation.
The right posture for Big Pharma is to support codification with sensible guardrails, sponsor pre-review of redactions, a short embargo window to prepare a response, and clear standards for what stays confidential. Fighting the policy outright is a losing PR fight, but I guess you could argue Big Pharma has nothing to lose on the PR front. Getting behind it and shaping the redaction rules is the move that protects trade secrets and builds trust at the same time.
💰 FOLLOW THE MONEY
Deals, dollars, and what they signal
Vertex Pays $10B for Crinetics. Endocrinology Becomes the Fifth Vertex Pillar, but the 102% Premium Is the Story
📅 July 6, 2026 | 🏢 Vertex Pharmaceuticals (VRTX), Crinetics (CRNX) | 💊 Palsonify (paltusotine, oral acromegaly), atumelnant (CAH/Cushing’s, Phase 3) | 🏷 M&A / Endocrinology| 🔗 BioPharma Dive, BioWorld, Reuters
Vertex agreed to acquire Crinetics for $85 per share in cash, $10B equity value and approximately $8.8B net of cash. This is Vertex’s largest deal ever. The premium is 102% to Crinetics’ pre-deal price, second only to the Biogen/Apellis 140% premium among 2026 buyouts. Closes Q3 2026. PALSONIFY (paltusotine), an oral once-daily somatostatin analog for acromegaly, was FDA-approved September 2025 and generated $10M in Q1 2026, beating consensus in its first full quarter of launch. Atumelnant is a Phase 3 oral ACTH receptor antagonist for congenital adrenal hyperplasia and Cushing’s syndrome. Vertex claims combined peak sales potential of $5B-plus. Endocrinology becomes Vertex’s fifth therapeutic pillar alongside cystic fibrosis, sickle cell/beta-thalassemia (CASGEVY), pain (JOURNAVX), and kidney disease (povetacicept, PDUFA November 2026).
🧠 BPS Take: Vertex has been gradually building the “other legs of the stool” so to speak, to diversify beyond its seemingly impenetrable moat in Cystic Fibrosis. With their biggest acquisition, ever, what the other legs of the stool are have come into clear view: cystic fibrosis, non-malignant hematology, pain, rare renal, and now with the addition of Crinetics — endocrine. You don’t see any oncology, obesity, IBD, derm-immunology, or rheumatology on that list. Vertex has nicely spread its bets across several relatively lower competition segments that (save for pain) command premium pricing. IgAN as I mentioned before is going to be a war zone, but pain has been a graveyard for Pharma for decades. And CF will always attract challengers, but Vertex has long-seemed to have the magic formula in that space. Now adding endocrine to the mix, and Vertex all of a sudden looks like the king of the jungle in this space largely competing against specialty players like Neurocrine, Ipsen, and Ascendis.
Outside of CF though, Vertex’s other approved products, particularly CASGEVY and JOURNAVX have been slow to turn into commercial growth engines. CASGEVY launch has been notoriously slow, with heavy friction throughout the patient journey wiht it taking anywhere between 6 to 9 months for Vertex to recognize revenue. JOURNAVX has also been slow to ramp, not due to a lack of demand, but due to mainly seeing resistance with commercial access and pricing relative low-cost generic opioids. These are still really good products, but the commercial launch expectations were perhaps too aggressive. It will take time.
The 102% premium has some sticker shock built into it, but all that won’t mean much if PALSONIFY and atumelnant achieve blockbuster status. The upside case rests on atumelnant in CAH. Neurocrine’s ( NBIX 0.00%↑ ) CRENESSITY sets a high safety bar and is a strong market incumbent, however Phase 2 data for atumelnant suggests a once-daily profile that avoids strict food restrictions and offers superior efficacy by way of absolute biomarker normalization and increased steroid sparing, alongside a massive secondary expansion runway in Cushing's.
Novartis Pays $1.1B Upfront for Myricx Bio’s Preclinical ADC Payload Platform
📅 July 6, 2026 🏢 Novartis ($NVS) acquiring Myricx Bio (private, UK-based) 💰 $1.1B upfront, up to $400M in milestones ($1.5B total) 🧬 NMTi ADC payload platform, two lead assets against B7-H3 and HER2 | 🔗 Novartis press release | BioWorld coverage | GEN coverage
Novartis $NVS agreed to acquire UK-based Myricx Bio for $1.1 billion upfront and up to $400 million in milestones, with close targeted for H2 2026. Myricx is preclinical. What Novartis is buying is a payload platform built around N-myristoyltransferase inhibitors (NMTi), a mechanism distinct from the topoisomerase-1 payloads (deruxtecan and its variants) that anchor the current ADC leaderboard, plus two lead programs directed against B7-H3 and HER2. Fiona Marshall, President of Biomedical Research at Novartis, framed the deal around addressing “limitations of commonly used ADC payload classes such as TOPO-1 inhibitors” in the company statement.
🧠 BPS Take: To me, the main reason that explains why Novartis is choosing to pull the trigger now is payload differentiation. The ADC space has consolidated around Dxd chemistry, from Enhertu through datopotamab deruxtecan through the wave of TROP2 and B7-H3 assets in development at Daiichi Sankyo, Merck, AstraZeneca, and a lot of China ADCs that have been licensed by the west over the last two years. Payload resistance is the emerging bottleneck. Novartis is saying it wants a payload that works in TOPO-1 resistant models, which is a real clinical problem in patients cycling through multiple ADCs sequentially. NMT inhibition disrupts protein lipidation across broad substrate classes rather than triggering DNA damage, so the mechanistic case for non-cross-resistance is credible on paper.
Clinical validation is the major big hanging outstanding question. $1.1 billion upfront for a preclinical platform is aggressive by any historical benchmark, and the milestone tail of $400 million is unusually small relative to the upfront, which tells you Myricx negotiated hard on cash certainty over biobucks. Clinical data will tell us whether this was an impulse buy or a savvy bet to shape the future of ADCs.