Last updated: August 18, 2026
EyePoint’s Duravyu missed the LUGANO primary endpoint in wet AMD on the full dataset, and only cleared non inferiority after excluding 9 of 211 patients with unexplained vision loss. The same day AstraZeneca stopped its Phase 3 volrustomig lung cancer trial and reported two other Phase 3 lung cancer wins.
This page covers the August 17, 2026 clinical readouts and deals: EyePoint’s LUGANO result and what comes next, AstraZeneca’s eVOLVE-Lung02 discontinuation alongside the SAFFRON and DESTINY-Lung04 wins, the Slate Medicines and Fulcrum Therapeutics reverse merger, Eli Lilly’s ion channel deal with OmniAb, and the smaller items from the day, with tables, timelines, and sources.
What happened in EyePoint’s LUGANO Phase 3 trial of Duravyu?
EyePoint Pharmaceuticals said Duravyu (vorolanib intravitreal insert, 2.7 mg every six months) did not achieve the primary endpoint of average change in best corrected visual acuity at weeks 52 and 56 versus on label 2 mg aflibercept in the full LUGANO dataset. Shares fell about 70 percent in premarket trading, per RTTNews.
The company’s release, dated August 17, 2026, describes what it calls a 4 percent asymmetric cohort of 9 of 211 patients who experienced vision loss of 15 or more letters that EyePoint says was unrelated to wet age related macular degeneration. When those patients are excluded in an ad hoc analysis, Duravyu was non inferior to aflibercept with a nominal p value of 0.0096. The prespecified secondary endpoints went EyePoint’s way: a 42 percent reduction in treatment burden versus aflibercept (p less than 0.0001), about two fewer injections on average, 76 percent of Duravyu patients supplement free through week 32 and 54 percent through week 56, and 94 percent receiving zero or one supplemental injection by week 32 and 79 percent by week 56. Central subfield thickness differed by 4 microns at week 56. EyePoint reported no differences in cataract, intraocular pressure elevation, or inflammation between arms and no cases of insert migration, anterior chamber opacities, retinal vasculitis, or severe intraocular inflammation.
| LUGANO measure | Result | Source |
|---|---|---|
| Primary endpoint, full dataset | Not achieved (average BCVA change, weeks 52 and 56, vs 2 mg aflibercept) | EyePoint release, Aug 17, 2026 |
| Ad hoc analysis excluding 9 of 211 patients | Non inferior, nominal p = 0.0096 | EyePoint release |
| Treatment burden | 42 percent reduction vs aflibercept, p less than 0.0001; about two fewer injections | EyePoint release |
| Supplement free rate | 76 percent through week 32; 54 percent through week 56 | EyePoint release |
| Zero or one supplement | 94 percent by week 32; 79 percent by week 56 | EyePoint release |
| Central subfield thickness | 4 micron difference at week 56 | EyePoint release |
| Safety | No differences in cataract, IOP, inflammation; no insert migration, vasculitis, or severe IOI | EyePoint release |
| Share move | About 70 percent decline premarket (prior close $14.75; premarket $4.48) | RTTNews, market report |
What happens next for Duravyu after the LUGANO miss?
The second pivotal wet AMD trial, LUCIA, reads out in the fourth quarter of 2026, and EyePoint still plans a new drug application in the first half of 2027. Two diabetic macular edema Phase 3 trials, COMO and CAPRI, are fully enrolled with topline data expected in the fourth quarter of 2027.
The regulatory question is whether a full dataset miss on one of two pivotal trials, rescued by an ad hoc exclusion, is enough for a non inferiority filing if LUCIA succeeds cleanly. Non inferiority claims are typically judged on the prespecified analysis, and the FDA generally treats post hoc patient exclusions with skepticism, so the label case will rest heavily on LUCIA and on whether the agency accepts EyePoint’s characterization of the nine patients. The secondary endpoints matter commercially because the value proposition of a six month insert is fewer injections, but they do not substitute for the primary. More than 900 patients were randomized across LUGANO and LUCIA combined.
| Duravyu milestone | Timing |
|---|---|
| LUGANO topline (wet AMD, first pivotal) | Reported August 17, 2026 |
| LUCIA topline (wet AMD, second pivotal) | Q4 2026 |
| Potential wet AMD NDA submission | H1 2027 |
| COMO and CAPRI topline (diabetic macular edema) | Q4 2027 |
Why did AstraZeneca stop the eVOLVE-Lung02 trial of volrustomig?
AstraZeneca discontinued the Phase 3 eVOLVE-Lung02 trial after an independent data monitoring committee concluded that volrustomig plus chemotherapy was unlikely to meet either of its dual primary endpoints, progression free survival or overall survival, in the primary analysis population of patients with PD-L1 expression below 1 percent.
The trial enrolled 895 patients across 25 countries and compared volrustomig, a PD-1 and CTLA-4 bispecific antibody, plus chemotherapy against pembrolizumab plus chemotherapy as first line treatment for metastatic non small cell lung cancer with PD-L1 expression below 50 percent. AstraZeneca reported no new safety signals and said the profile was consistent with the individual medicines. Susan Galbraith, executive vice president of oncology hematology research and development, said the company had aimed to improve outcomes for patients whose lung cancers have lower PD-L1 expression and would learn from the trial. Phase 3 trials of volrustomig continue in cervical cancer, head and neck squamous cell carcinoma, and mesothelioma. BioSpace framed the result as an extension of a run of AstraZeneca setbacks that includes the Wainua ATTR-CM failure with Ionis, the Ultomiris thrombotic microangiopathy miss, the sonesitatug vedotin gastric cancer miss, and elecoglipron’s weight loss data.
| eVOLVE-Lung02 detail | Value |
|---|---|
| Drug | Volrustomig (PD-1 and CTLA-4 bispecific) plus chemotherapy |
| Comparator | Pembrolizumab plus chemotherapy |
| Setting | First line metastatic NSCLC, PD-L1 below 50 percent |
| Enrollment | 895 patients, 25 countries |
| Dual primary endpoints | PFS and OS in PD-L1 below 1 percent |
| Outcome | Discontinued; IDMC judged both primary endpoints unlikely to be met |
| Ongoing volrustomig Phase 3 trials | Cervical cancer, head and neck squamous cell carcinoma, mesothelioma |
What did AstraZeneca win in lung cancer the same day?
Two separate Phase 3 lung cancer trials met their primary endpoints on August 17, 2026: HUTCHMED and AstraZeneca’s SAFFRON trial of Orpathys (savolitinib) plus Tagrisso (osimertinib) in MET driven EGFR mutated NSCLC, and Daiichi Sankyo and AstraZeneca’s DESTINY-Lung04 trial of Enhertu (trastuzumab deruxtecan) in first line HER2 mutant NSCLC.
SAFFRON was a randomized, open label, global Phase 3 study of 338 patients with EGFR mutated locally advanced or metastatic NSCLC whose tumors had MET overexpression or amplification after progression on first or second line osimertinib. It compared savolitinib plus osimertinib against platinum based doublet chemotherapy across 230 centers in 29 countries and, per HUTCHMED, showed statistically significant and clinically meaningful improvements in both progression free survival and overall survival. HUTCHMED said about 34 percent of tumors develop high MET overexpression or amplification after progression on a third generation EGFR inhibitor. Data will be presented at a forthcoming medical meeting and shared with global regulators to complement the existing China approval based on the SACHI trial. DESTINY-Lung04 compared Enhertu against platinum and pemetrexed chemotherapy plus pembrolizumab in previously untreated HER2 mutant advanced NSCLC and met its progression free survival primary endpoint; overall survival follow up continues. HER2 mutations occur in roughly 2 to 4 percent of NSCLC. Neither release included effect sizes.
| Trial | Regimen vs comparator | Population | Result |
|---|---|---|---|
| SAFFRON (HUTCHMED and AstraZeneca) | Savolitinib plus osimertinib vs platinum doublet chemotherapy | 338 patients, EGFRm NSCLC with MET overexpression or amplification after osimertinib | PFS and OS met; figures at a future meeting |
| DESTINY-Lung04 (Daiichi Sankyo and AstraZeneca) | Enhertu vs platinum pemetrexed plus pembrolizumab | First line HER2 mutant advanced NSCLC | PFS met; OS ongoing |
| eVOLVE-Lung02 (AstraZeneca) | Volrustomig plus chemo vs pembrolizumab plus chemo | 895 patients, first line NSCLC, PD-L1 below 50 percent | Discontinued |
What are the terms of the Slate Medicines and Fulcrum Therapeutics reverse merger?
Slate Medicines will merge into Fulcrum Therapeutics in an all stock deal alongside a $245 million oversubscribed private placement led by Frazier Life Sciences. Fulcrum holders keep about 5.0 percent of the combined company and receive an estimated $270 million dividend before closing; the company will trade on Nasdaq as SLTE.
Per the joint release, pre merger Slate stockholders including the financing participants will own about 95.0 percent, subject to adjustment for Fulcrum’s net cash at closing, and Fulcrum will contribute about $20.3 million of net cash to the combined company. Investors named in the placement include Forbion, RA Capital Management, Deep Track Capital, Foresite Capital, OrbiMed, RTW Investments, and Mingxin Capital. The lead asset is SLTE-1009, a subcutaneous monoclonal antibody that blocks both PACAP and VIP for migraine prevention, with Phase 1 clearance in Australia and pharmacokinetic and safety data expected in mid 2027. SLTE-2100 is a bispecific antibody against PACAP, VIP, and CGRP with clinical entry expected in the second half of 2027. Cash runway runs into 2029, Gregory Oakes is chief executive, and closing is expected in the fourth quarter of 2026. Slate emerged from stealth in February 2026 with a $130 million Series A, per Fierce Biotech, and Fulcrum began exploring alternatives in June after discontinuing pociredir in sickle cell disease.
| Term | Slate and Fulcrum (Aug 17, 2026) | Fibrx: Skye and Redx (Aug 14, 2026), for comparison |
|---|---|---|
| Structure | All stock reverse merger into Nasdaq listed Fulcrum | Combination of Nasdaq listed Skye and UK based Redx |
| New money | $245 million private placement, led by Frazier | About $125 million: about $68 million PIPE, $36 million Series A, up to $22 million equity line |
| Public shell holders keep | About 5.0 percent, plus an estimated $270 million dividend | About 5.38 percent, no dividend |
| Net cash contributed by shell | About $20.3 million | Not disclosed as a separate figure |
| Lead asset | SLTE-1009, anti PACAP and VIP antibody, migraine prevention, Phase 1 | RXC008, gut restricted pan ROCK inhibitor, fibrostenotic Crohn’s, Phase 2 start H2 2026 |
| Runway | Into 2029 | Through 2029 |
| Expected close | Q4 2026 | Q4 2026 |
Endpoints News reported the same day that 17 reverse mergers have been completed in 2026, the most since 2018, and that bankers expect the pace to continue; that count is Endpoints’ and has not been independently confirmed here.
What did Eli Lilly agree with OmniAb on ion channels?
OmniAb announced a global collaboration and license agreement with Eli Lilly for a new ion channel discovery program: an undisclosed upfront payment, up to $370 million in research, development, and commercial milestones, and tiered royalties on global net sales. The target and modality were not disclosed.
OmniAb, spun out of Ligand Pharmaceuticals in 2022, generates human sequence antibodies from transgenic animals and has positioned ion channels, historically a difficult class for antibodies, as a specialty. Chief executive Matt Foehr said the company’s ion channel technologies are well positioned to drive the discovery program. Prior OmniAb partners include Johnson and Johnson, Boehringer Ingelheim, Merck KGaA, and Teva. For Lilly, this is a small, option like transaction: almost all of the $370 million is contingent, and it sits alongside the $50 million cash purchase of Sangamo’s delivery and zinc finger platforms announced last week.
Why did Johnson and Johnson return prizlon-cel to AbelZeta?
Johnson and Johnson has returned rights to prizloncabtagene autoleucel, a bispecific CAR T therapy for large B cell lymphoma, to AbelZeta Pharma, per BioSpace. The asset was licensed in May 2023 and quietly dropped from J&J’s pipeline presentation in April 2026 before the July return.
BioSpace reports the original deal carried a $245 million upfront for rights outside Greater China, with an option on China added in December 2023, and that Phase 1b data in June 2025 showed high response rates in small cohorts (12 patients in third line with 92 percent overall response and 75 percent complete response). J&J has since struck a $785 million partnership with Sail Biomedicines in cell therapy, per BioSpace. The company has not published a reason for the return.
Why is Celcuity’s Revtorpyk launch waiting on a second factory?
Celcuity’s Revtorpyk (gedatolisib) was approved on July 14, 2026 for HR positive, HER2 negative, PIK3CA wild type advanced breast cancer, and the company’s second quarter release says shipments will begin late in the third quarter. Endpoints News reported on August 17 that the company is awaiting FDA review of a second manufacturing facility, which Endpoints put at two to four months.
Celcuity’s August 13 release does not itself describe a second facility; it states that the launch is on track for late third quarter 2026, that cash and investments were $754.0 million at quarter end, and that the second quarter net loss was $78.9 million with runway into 2029. The facility detail is Endpoints’ reporting. It fits the manufacturing pattern covered here since August 12: the agency’s facility questions are shaping commercial timelines for products whose clinical packages have already cleared.
What else happened in biotech and medtech on August 17, 2026?
Regeneron ended a uveitis trial after a safety event, Vera’s Trutakna kidney function data appeared in the FDA’s summary basis for approval, Johnson and Johnson’s Monarch robot cleared an AI software update, the FDA named Cadence to its TEMPO digital health pilot, and seven drugmakers backed a US trade probe of German drug pricing.
| Item | Detail | Source |
|---|---|---|
| Regeneron REGN7041 | Anti CD3 antibody for non infectious posterior uveitis; Phase 1/2a TITAN terminated after review of a safety event; cause not identified; specifics not disclosed | Fierce Biotech, company statement |
| Ivonescimab in China | Endpoints reports the newest Chinese approval for Summit and Akeso’s PD-1 and VEGF bispecific came with longer follow up showing a smaller PFS benefit (about 28 percent risk reduction) than the earlier interim (about 40 percent); US PDUFA date remains November 14, 2026 | Endpoints News, attributed |
| Vera Trutakna eGFR | FDA summary basis for approval shows eGFR stabilization through 52 weeks in ORIGIN 3, with 60 and 72 week data from fewer patients; agency called it promising but not definitive; analysts compare it favorably with Otsuka’s Voyxact | BioSpace, citing the SBA and Jefferies and Guggenheim notes |
| J&J Monarch Quest 3 | FDA clearance for AI software update to the robotic bronchoscopy platform: automated nodule boundaries, 3D visualization, broader imaging compatibility; fourth major software launch in 18 months | MedTech Dive |
| FDA TEMPO pilot | Cadence (HypertensionOS, AI assisted hypertension medication titration) named second participant after Dexcom; program plans up to 10 manufacturers across four focus areas; Cadence cites a retrospective analysis of more than 23,000 patients showing 7/5 mm Hg reduction at 30 weeks | MedTech Dive |
| Germany drug pricing probe | Seven large drugmakers plus PhRMA and BIO filed comments supporting the USTR Section 301 investigation of Germany’s drug pricing rules | Endpoints News, attributed |
| China investigator initiated trials | Fierce Biotech feature on two previously undisclosed gene therapy deaths in Chinese IITs (a HuidaGene Duchenne CRISPR trial and a base editing trial); Order 818 took effect May 2026 requiring GMP product, large animal toxicology, and five day serious adverse event reporting | Fierce Biotech |
| Merck KGaA | 20 roles cut at EMD Serono’s Billerica, Massachusetts site, effective second half of October; 280 staff remain | Fierce Biotech |
| Evaxion | Discontinued EVX-03 DNA vaccine in NSCLC to fund EVX-05 glioblastoma vaccine with Duke; runway extended to H2 2027 | Fierce Biotech |
How does August 17 change the binary ledger?
The running tally of who holds clinical and regulatory binaries and what they were paid added five entries on August 17: two Phase 3 wins, two discontinuations, one reverse merger, one option style discovery deal, and one asset handed back to its originator.
| Ledger column | Aug 17 entry | What changed hands |
|---|---|---|
| Binary resolved, left tail | EyePoint LUGANO; AstraZeneca eVOLVE-Lung02; Regeneron REGN7041 | EyePoint equity repriced about 70 percent per market reports; AstraZeneca and Regeneron absorbed the losses internally |
| Binary resolved, right tail | SAFFRON; DESTINY-Lung04 | HUTCHMED and Daiichi Sankyo gain filing rights; effect sizes withheld for congresses |
| Creation vehicles | Slate and Fulcrum | $245 million new money; shell holders keep 5.0 percent plus about $270 million dividend |
| Contingent consideration | Lilly and OmniAb | Up to $370 million in milestones plus royalties; upfront undisclosed |
| Binary returned | J&J and AbelZeta prizlon-cel | Rights back to originator after $245 million upfront in 2023, per BioSpace |
| Deferral pending | Capricor deramiocel | August 22 PDUFA still formally in place; no FDA notice of a new goal date as of August 17 |
Frequently asked questions
Did EyePoint’s Duravyu fail its Phase 3 trial?
Duravyu did not achieve the primary endpoint of average BCVA change at weeks 52 and 56 versus aflibercept in the full LUGANO dataset. An ad hoc analysis excluding 9 of 211 patients with vision loss of 15 or more letters that EyePoint attributes to causes other than wet AMD showed non inferiority with a nominal p value of 0.0096.
What is Duravyu?
Duravyu is EyePoint’s intravitreal insert of vorolanib, a tyrosine kinase inhibitor, dosed at 2.7 mg every six months. It is being developed for wet age related macular degeneration and diabetic macular edema as an alternative to frequent anti VEGF injections such as aflibercept.
When will EyePoint report the LUCIA trial?
EyePoint expects LUCIA topline data in the fourth quarter of 2026, with a potential NDA submission in the first half of 2027.
How much did EyePoint stock fall after LUGANO?
RTTNews reported a premarket move from a prior close of $14.75 to $4.48, about 70 percent. That is a market report, not a company figure.
Why did AstraZeneca discontinue the volrustomig lung cancer trial?
An independent data monitoring committee concluded volrustomig plus chemotherapy was unlikely to meet either dual primary endpoint, progression free survival or overall survival, in patients with PD-L1 expression below 1 percent. AstraZeneca reported no new safety signals.
Is volrustomig still in development?
Yes. AstraZeneca continues Phase 3 trials of volrustomig in cervical cancer, head and neck squamous cell carcinoma, and mesothelioma.
What did the SAFFRON trial show?
Savolitinib plus osimertinib improved both progression free survival and overall survival with statistical significance versus platinum doublet chemotherapy in 338 patients with EGFR mutated NSCLC and MET overexpression or amplification after osimertinib, per HUTCHMED. Numbers will be presented at a medical meeting.
What did DESTINY-Lung04 show?
Enhertu met its progression free survival primary endpoint against platinum and pemetrexed chemotherapy plus pembrolizumab in first line HER2 mutant advanced NSCLC. Overall survival follow up is ongoing.
What is Slate Medicines’ lead drug?
SLTE-1009, a subcutaneous monoclonal antibody that blocks both PACAP and VIP for migraine prevention. It has Phase 1 clearance in Australia, with pharmacokinetic and safety data expected in mid 2027.
What do Fulcrum shareholders get in the Slate merger?
About 5.0 percent of the combined company, subject to a net cash adjustment, plus an estimated $270 million dividend paid before closing.
How big is the Slate private placement and who is in it?
$245 million, oversubscribed, led by Frazier Life Sciences with Forbion, RA Capital Management, Deep Track Capital, Foresite Capital, OrbiMed, RTW Investments, and Mingxin Capital.
What are the terms of the Lilly and OmniAb ion channel deal?
An undisclosed upfront, up to $370 million in research, development, and commercial milestones, and tiered royalties on global net sales, for a single ion channel discovery program with an undisclosed target.
Why is Celcuity’s Revtorpyk launch slower than expected?
Celcuity says shipments begin late in the third quarter of 2026. Endpoints News reports the company is awaiting FDA review of a second manufacturing facility, which it put at two to four months.
Has the FDA set a new PDUFA date for Capricor’s deramiocel?
Not as of August 17, 2026. Capricor said on its second quarter call that the FDA indicated it would extend the August 22 date on receipt of a BLA amendment; the FDA has not confirmed that publicly, and no new goal date has been announced.
What is the FDA’s TEMPO pilot?
Technology Enabled Meaningful Patient Outcomes, a program run with CMS that exempts certain digital health devices from premarket authorization while collecting real world Medicare data. Dexcom was the first participant in July 2026; Cadence was named the second on August 17.
Sources
Primary sources
- EyePoint Pharmaceuticals press release, “EyePoint Announces Topline Data from LUGANO, the First of Two Pivotal Phase 3 Clinical Trials for DURAVYU 2.7mg in Wet AMD,” August 17, 2026 (GlobeNewswire).
- AstraZeneca press release, “Update on eVOLVE-Lung02 Phase III trial of volrustomig plus chemotherapy in metastatic non-small cell lung cancer,” August 17, 2026.
- HUTCHMED press release on the SAFFRON global Phase III readout, August 17, 2026 (GlobeNewswire).
- Daiichi Sankyo and AstraZeneca press release on DESTINY-Lung04, August 17, 2026.
- Fulcrum Therapeutics and Slate Medicines joint press release, “Fulcrum Therapeutics and Slate Medicines Announce Merger Agreement to Advance Next-Generation Migraine Therapies,” August 17, 2026 (GlobeNewswire).
- OmniAb press release, “OmniAb Announces Global Collaboration and License Agreement for Ion Channel Program with Eli Lilly & Company,” August 17, 2026.
- Celcuity second quarter 2026 results release, August 13, 2026.
- Summit Therapeutics press release on NMPA approval of ivonescimab plus chemotherapy in squamous NSCLC, August 12, 2026.
Trade press and market reports
- Fierce Biotech, August 17, 2026: AstraZeneca eVOLVE-Lung02; Regeneron REGN7041; Slate and Fulcrum; Lilly and OmniAb; Merck KGaA cuts; Evaxion; China IIT feature.
- Endpoints News, August 17, 2026: reverse merger count; ivonescimab China follow up; Celcuity second facility; Germany Section 301 comments; AstraZeneca lung cancer wins.
- BioSpace, August 17, 2026: AstraZeneca setbacks; J&J and AbelZeta; Vera Trutakna summary basis for approval.
- MedTech Dive, August 17, 2026: J&J Monarch Quest 3 clearance; FDA TEMPO second participant.
- RTTNews, August 17, 2026: EyePoint premarket share move.
Related coverage
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- PTC and Lilly bought Sangamo for parts: what the $163.55M auction says about gene therapy
- Why the FDA rejected ITM’s radiopharma therapy and stalled Scholar Rock’s SMA filing
- Sionna’s cystic fibrosis trial failure and what it means for Vertex
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