Arcturus Therapeutics Holdings IncARCT
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Arcturus will present ARCT-810 Phase 2 OTC deficiency data and its mRNA liver therapeutics platform, a pipeline/R&D development.
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Biotech & Genomic Medicine▲ · 1 stocks
Arcturus Therapeutics Holdings IncAging Population▲ · 1 stocks
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BioNTech Lung Cancer Data Shows Gotistobart Nearly Doubled Survival
BioNTech reported detailed Phase 3 data showing its investigational lung cancer therapy gotistobart nearly doubled median overall survival compared with standard chemotherapy. The shares traded around US$96.69, with a 30 day share price return of 3.87% and a 90 day share price return of 4.85%, while the 1 year total shareholder return declined 2.59% and the 5 year total shareholder return fell 71.40%. BioNTech now trades at roughly a 22% discount to analyst targets, with the most followed fair value view at $120.62 against the last close of $96.69. The company's pipeline includes multiple late stage Phase II and III trials for BNT327 and mRNA cancer immunotherapies in lung and breast cancers, supported by the planned CureVac acquisition. Risks to the bullish case include late stage oncology trial failures and prolonged COVID-19 vaccine demand weakness and related litigation.
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Moderna's mRNA Cancer Therapy Scores First Positive Phase III Readout
Moderna and Merck reported positive results from the late-stage INTerpath-001 study of intismeran autogene (V940/mRNA-4157) in combination with Keytruda in patients with high-risk Stage IIB-IV melanoma whose tumors had been removed through surgery. The study met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival, with the companies stating the improvements were statistically significant and clinically meaningful, though no numerical data were disclosed. INTerpath-001 marks the first positive phase III readout for an individualized neoantigen therapy and an mRNA-based cancer therapy, and five-year follow-up from the phase IIb KEYNOTE-942 study showed the combination reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 59% versus Keytruda alone. Moderna and Merck are evaluating intismeran across nine phase II and phase III studies spanning multiple tumor types, including non-small cell lung cancer, bladder cancer and renal cell carcinoma, while Moderna's broader pipeline includes separate mRNA-based cancer antigen therapies, a T-cell engager and a cell-therapy enhancer. Moderna shares have skyrocketed nearly 400% year to date, outperforming the industry's 7% growth, and the stock trades at 23.44 times forward 12-month sales versus the industry average of 1.90 times.
2impact 4
BioNTech's gotistobart nearly doubles lung cancer survival in Phase 3 trial
BioNTech SE reported that its investigational lung-cancer drug gotistobart produced a clinically meaningful overall-survival benefit in the Phase 3 PRESERVE-003 trial in patients with metastatic squamous non-small cell lung cancer whose disease had progressed after prior immunotherapy and chemotherapy. Reuters said gotistobart nearly doubled survival compared with standard-of-care chemotherapy, strengthening the case for the drug as a potential chemotherapy-free treatment in a population with significant unmet need. The result builds on earlier Stage 1 data, where gotistobart reduced the risk of death by 54% versus docetaxel, with a hazard ratio of 0.46; median overall survival was not yet reached for gotistobart versus 9.95 months for docetaxel, while the 12-month progression-free survival rate was 25.2% versus 0%. BioNTech is now awaiting the pivotal Stage 2 readout, which remains the critical test for registration and broader investor confidence, and the company says it has 14 ongoing pivotal trials and more than 10 novel combination programs, with its lung-cancer strategy spanning more than 16 ongoing clinical trials and five Phase 3 programs. BioNTech had €16.6 billion in cash, cash equivalents, and securities at June 30, 2026, despite spending €1.0 billion on adjusted R&D during the first half, while first-half 2026 revenue fell to €223.7 million from €443.6 million a year earlier and the company expects 2026 revenue of only €1.6 billion to €1.9 billion.