Shares of Rapport Therapeutics Inc. (NASDAQ:RAPP) were trading up more than 100% at midday on the back of a phase IIa readout showing RAP-219, its TARPγ8-specific AMPAR negative allosteric modulator, exceeded expectations in reducing clinical seizures in patients with drug-resistant focal onset seizures. The study met the primary endpoint, demonstrated a statistically significant reduction in long episodes, an objective electrographic biomarker for clinical seizure reduction, vs. baseline over the eight-week treatment period. With those results in hand, Rapport plans to meet with the U.S. FDA and start prepping for a phase III program expected to start in 2026.

WCLC 2025: In Harmoni trial, ivonescimab fails to reach OS summit

No FDA-approved therapy in EGFR-mutant non-small-cell lung cancer (NSCLC) has shown a statistically significant overall survival (OS) benefit. And ivonescimab (Summit Therapeutics Inc./Akeso Pharmaceuticals Inc.) is apparently not going to be the first. Ivonescimab is a PD-1 and VEGF-targeting bispecific antibody that is approved as a first-line treatment for PD-L1-positive NSCLC in China under the trade name Yīdá Fāng, and is in multiple clinical trials for NSCLC and other solid tumors. Results from the global phase III Harmoni trial presented at the International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer (WCLC) showed a statistically significant increase in progression-free survival, but failed to show a benefit in OS. Furthermore, the drug appeared to work better in Asian than non-Asian populations.

WCLC 2025: Merck-Daiichi’s ADC posts a phase II win in lung cancer

Daiichi Sankyo Co. Ltd. and Merck & Co. Inc.’s antibody-drug conjugate (ADC) ifinatamab deruxtecan produced a confirmed 48.2% objective response rate in a phase II study of previously treated patients with extensive-stage small-cell lung cancer. The treatments received the U.S. FDA’s breakthrough therapy in August for adults with this tough-to-treat cancer. The data were presented at the International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer (WCLC) held in Barcelona. The two companies began the development collaboration in October 2023 as Daiichi offered up the rights to three potentially first-in-class ADC candidates for $22 billion.

Servier in $450M deal for Medicxi-funded phase II fragile X program

Medicxi Ventures’ asset-focused investment model has scored another hit, in a $450 million deal with Servier SA, for KER-0193, an oral small molecule that is ready for phase II development in the treatment of the inherited autism spectrum disorder, fragile X. The French pharma is making an undisclosed up-front payment, to be followed by development and commercial earn-payments of up to the $450 million headline figure, to Kaerus Bioscience Ltd. London-based Kaerus was co-founded and funded by Medicxi to take forward research carried out at the University of Orléans, France, by geneticist Sylvain Briault and Olivier Perche, associate professor of medicine.

NRG raises $67M to test mitochondrial pore inhibitor in ALS

Neurosciences specialist NRG Therapeutics Ltd. is poised to put its new class of small-molecule regulators of the mitochondrial permeability transition pore to the test after closing an oversubscribed £50 million (US$67 million) series B. The company's lead candidate, NRG-5051, has been shown to significantly reduce neuroinflammation in preclinical models of Parkinson's disease and amyotrophic lateral sclerosis (ALS). IND-enabling studies are complete, and the product will enter clinical development in early 2026.

Epigenic Therapeutics raises $60M series B for gene therapies

Epigenic Therapeutics Co. Ltd. closed a $60 million series B round to support clinical development of lead gene therapy candidates EPI-003 for chronic hepatitis B virus and EPI-001 for hypercholesterolemia. The round was led by Lapam Capital with continued participation from existing investors Qiming Venture Partners and Orbimed. Shanghai-based Epigenic is developing next-generation gene modulation therapies using epigenome regulation. The company’s EPIREG technology platform uses artificial intelligence algorithms to develop optimized CRISPR-Cas components.

US FTC to revisit noncompete rule after resounding defeat in court

The U.S. Federal Trade Commission has opened a docket for comment on a request for information regarding noncompete employment contracts, revisiting one of the more controversial subjects in the agency’s recent past. The agency seeks information on abuses of employees in connection with these agreements but may ultimately revert to evaluating these practices on a case-by-case basis rather than by issuing sweeping rules.

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