Tenax Therapeutics’ TNX-103 misses its primary endpoint in the Phase 3 LEVEL trial in pulmonary hypertension due to heart failure with preserved ejection fraction, AbCellera’s ABCL635 meets both primary efficacy endpoints in a Phase 2 trial in menopausal vasomotor symptoms, ITM’s 177Lu-edotreotide receives a Complete Response Letter from the FDA in gastroenteropancreatic neuroendocrine tumours, Sionna Therapeutics’ SION-719 fails its key activity endpoint in the PreciSION CF Phase 2a trial in cystic fibrosis, and NeOnc Technologies’ NEO100 meets its primary endpoint in a Phase 2a trial in recurrent IDH1-mutant high-grade glioma: the most significant clinical trial results 14 August 2026 has to offer from across the pipeline.
This week delivered an unusually lopsided set of readouts spanning cardiopulmonary medicine, women’s health, radiopharmaceutical oncology, rare respiratory disease and neuro-oncology, with three of the five outcomes falling on the negative side of the ledger. The standout is a late-stage failure in a condition that still has no approved therapy anywhere in the world, a result whose accompanying biomarker findings are striking enough to complicate rather than settle the question of whether the drug works. Around it sat a regulatory rejection that turned entirely on manufacturing rather than medicine, a discontinued proof-of-concept programme in a field where the incumbent already sets a demanding bar, and two positive datasets whose promise rests on short follow-up and a small uncontrolled cohort respectively. Here, Life Science Daily News brings you the most significant clinical trial results 14 August 2026.
Clinical Trial Results 14 August 2026: Tenax’s TNX-103 Misses Primary Endpoint in Phase 3 LEVEL Trial
Tenax Therapeutics announced on 10 August 2026 topline results from LEVEL, its registrational Phase 3 trial of TNX-103 (oral levosimendan) in patients with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF). The trial did not meet its primary endpoint. Least-squares mean change in six-minute walk distance at week 12 was 14.0 metres on TNX-103 against 10.4 metres on placebo, giving a least-squares mean treatment difference of 3.5 metres (p=0.63). The key secondary endpoint, change in Kansas City Cardiomyopathy Questionnaire total symptom score, also failed to separate, with a treatment difference of 0.1 points. LEVEL randomised 241 patients across 41 sites in the United States and Canada, with patients receiving TNX-103 1 mg twice daily, titrated to three times daily from week 5 as tolerated, or placebo.
Prespecified analyses pointed in a different direction from the headline result. Among the 119 patients whose baseline walk distance fell below the trial median of 333 metres, the treatment difference was 26.3 metres (95% CI 6.0 to 46.7, nominal p=0.0112). In patients aged 71 and over it was 27.1 metres. Across the overall population, NT-proBNP fell 49 per cent relative to placebo (nominal p<0.0001) and right ventricular systolic pressure by 3.5 mmHg (nominal p=0.0045). Tenax was explicit that these nominal p-values are not adjusted for multiplicity and do not establish efficacy. TNX-103 was generally well tolerated, with serious adverse events balanced at 10.8 per cent against 10.7 per cent on placebo, although treatment-related adverse events were more than twice as common in the active arm, at 38.3 per cent versus 17.4 per cent. The company intends to request a Type C meeting with the FDA and parallel scientific consultation with the EMA, proposing an enriched population for future registrational work. Full results are due at the European Society of Cardiology Congress in Munich from 28 to 31 August. A second Phase 3 trial of TNX-103 in the same indication, LEVEL-2, is already under way.
AbCellera’s ABCL635 Meets Both Primary Endpoints in Phase 2 Menopause Trial
AbCellera announced on 10 August 2026 positive topline results from the Phase 2 portion of its Phase 1/2 trial of ABCL635, an antibody antagonist of the neurokinin 3 receptor (NK3R) being developed as a non-hormonal, long-acting subcutaneous treatment for moderate to severe vasomotor symptoms due to menopause. The trial randomised 92 postmenopausal women, experiencing a mean of roughly ten moderate or severe hot flushes per day at baseline, one to one to a single 600 mg subcutaneous dose or placebo. Both primary efficacy endpoints were met. Frequency fell by a mean of 8.8 events per day at week 4 against 3.5 on placebo, a placebo-adjusted difference of 5.3 (p<0.001), equivalent to an 83 per cent reduction versus 33 per cent. Severity fell by 1.4 points against 0.3, a placebo-adjusted difference of 1.1 (p<0.001).
Sleep scores and patient global impression of change also improved. The drug was well tolerated across the four-week period, with no serious adverse events, no severe adverse events and no adverse events leading to discontinuation; headache, fatigue and injection site reactions were the most common events occurring more often than on placebo. The interest lies in the format rather than the target, since NK3R blockade is already clinically validated by small-molecule therapies, but an antibody raises the prospect of dosing measured in months rather than days. The caveats are equally plain. This is a 92-patient study with four weeks of follow-up after a single dose, reported as topline only, and durability beyond week 4 is unmeasured. AbCellera describes the candidate as potentially best in class, a claim only a Phase 3 programme against an active comparator could substantiate.
FDA Issues Complete Response Letter for ITM’s 177Lu-edotreotide in Neuroendocrine Tumours
ITM Isotope Technologies Munich announced on 10 August 2026 that it had received a Complete Response Letter from the FDA, dated 7 August, regarding its New Drug Application for 177Lu-edotreotide (ITM-11) in gastroenteropancreatic neuroendocrine tumours (GEP-NETs). The agency stated it was unable to approve the application in its present form, citing chemistry, manufacturing and controls items together with matters relating to a third-party commercial facility. ITM said the FDA identified no concerns regarding the clinical or nonclinical data package or the safety profile of the candidate, and requested no additional studies. The agency had accepted the application in November 2025 and set a Prescription Drug User Fee Act goal date of 28 August 2026. The company is reviewing the feedback and assessing next steps with the relevant external parties.
The distinction matters because the underlying evidence is untouched. The pivotal Phase 3 COMPETE trial met its primary endpoint, with 177Lu-edotreotide demonstrating a clinically and statistically significant improvement in progression-free survival against everolimus in patients with inoperable, progressive Grade 1 or Grade 2 disease. Those results were published in The Lancet on 2 July 2026. Chief Executive Andrew Cavey said the company’s confidence in the therapeutic potential of the candidate had not wavered and that the COMPETE data package stands. A second Phase 3 study, COMPOSE, continues in well-differentiated, aggressive Grade 2 or Grade 3 somatostatin receptor-positive GEP-NETs. The episode is a reminder that radiopharmaceuticals carry a manufacturing burden most drug classes do not, since short-lived isotopes demand production, labelling and distribution networks that must satisfy inspection in their own right. A facility the sponsor does not own can hold up an approval the clinical data would otherwise support. ITM has said it intends to resubmit in order to complete the review of the application, but has not published a timeline.
Sionna’s SION-719 Misses Key Activity Endpoint and Is Dropped as a Cystic Fibrosis Add-On
Sionna Therapeutics announced on 10 August 2026 that its PreciSION CF Phase 2a proof-of-concept trial did not achieve its key activity endpoint. SION-719, a stabiliser of the first nucleotide binding domain of the CFTR protein, produced a mean placebo-adjusted sweat chloride change of minus 1.0 mmol/L (p=0.7) when added to standard of care. The randomised, double-blind, placebo-controlled crossover trial enrolled 15 adults with cystic fibrosis homozygous for F508del on a stable, physician-prescribed dose of Trikafta. The company received the topline data on 7 August, is continuing to analyse the study, and confirmed it will not advance SION-719 as an add-on to standard of care.
SION-719 was generally well tolerated across 14 days of add-on dosing, with most treatment-emergent adverse events mild to moderate, no serious adverse events and no meaningful trends in adverse events related to liver function tests. Sionna also reported potential confounders in the trial, including higher than anticipated variability in individual sweat chloride levels and differences in Trikafta exposure between the SION-719 and placebo periods, and is assessing how far these bear on interpretation. Its separate Phase 1 trial of SION-451 in dual combinations achieved its safety, tolerability and pharmacokinetic objectives and identified twice-daily SION-451 plus once-daily SION-2222 as the preferred pairing, in which one participant discontinued for rash. In the cohorts taking SION-2222 twice daily rather than once, two participants discontinued for elevated liver function tests and flu-like symptoms. The company ended the second quarter with approximately $268.3 million in cash, cash equivalents and marketable securities, and intends to take actions to preserve capital. Sweat chloride is a pharmacodynamic marker of CFTR function rather than a clinical outcome, but a result this close to zero leaves little to build on.
NeOnc’s Intranasal NEO100 Meets Primary Endpoint in Recurrent IDH1-Mutant High-Grade Glioma
NeOnc Technologies announced on 12 August 2026 positive topline results from the Phase 2a portion of NEO100-01, an open-label study of intranasal NEO100, a purified pharmaceutical-grade formulation of perillyl alcohol, in patients with recurrent or progressive Grade III and Grade IV IDH1-mutant glioma. The study met its primary endpoint. Six-month progression-free survival was 48.9 per cent (95% CI 26.3 to 68.1) by RANO 2.0 criteria, against the 20 per cent rate prespecified in the study design as the expectation for standard of care (p=0.0047). Median overall survival was 26.09 months, with 12 deaths among 24 patients, and 86.7 per cent of patients were alive at six months. Objective response rate was 8.3 per cent, or two of 24 patients.
NEO100 is self-administered at home four times daily in 28-day cycles at the recommended Phase 2 dose of 1,152 mg per day, delivered along olfactory and trigeminal pathways in a design intended to reach the brain directly while avoiding systemic cytotoxic exposure. Five of the 24 patients remain on treatment, one progression-free for approximately 19 months and another in an ongoing partial response sustained for 114 days. No major toxicities were reported and adverse events have been predominantly low grade. The population is one that approved and late-stage IDH-targeted agents do not serve, since those have been developed in the front-line setting for lower-grade, non-enhancing tumours. NeOnc set the limitations out in its own release: the study was single-arm and open-label, enrolled 24 patients of a planned 28, was not powered as a confirmatory trial, and its comparison is against a prespecified historical benchmark rather than a randomised control arm. It also disclosed that the primary efficacy analysis reflects RANO 2.0 criteria and Kaplan-Meier estimation, and that results differ under the response criteria and estimation method specified in the study protocol. The company will request a Type B meeting with the FDA to align on a registrational path.
Looking Ahead
This week’s clinical trial results 14 August 2026 tilt heavily towards disappointment, and the honest reading is that the two successes are also the smallest and earliest of the five. The cardiopulmonary failure is the most consequential event of the week, not least because the accompanying biomarker and subgroup findings are strong enough to invite a second attempt in an enriched population, a familiar and often unrewarding path after a missed Phase 3. The neuroendocrine tumour rejection is the least informative about a drug and the most informative about an industry, since nothing in the clinical package was questioned and the obstacle sits inside a facility the sponsor does not control. The cystic fibrosis miss removes a candidate from a field where the incumbent modulator regimen already sets a demanding bar for any add-on. The antibody result in menopause and the glioma data both look promising on their own terms, and both rest on evidence that a larger controlled study will have to confirm. Catch up on our previous clinical trials roundup. Life Science Daily News will continue to bring you accurate, timely coverage of the clinical trial results 14 August 2026 that matter most across the global life sciences pipeline.
