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Nuvalent has initiated a rolling NDA submission to the FDA for zidesamtinib, a ROS1-selective inhibitor, for advanced ROS1-positive NSCLC patients previously treated with TKIs. The submission is supported by pivotal data from the ARROS-1 trial presented at WCLC 2025. Zidesamtinib has been granted RTOR designation, potentially accelerating its review. The drug is designed to overcome resistance mutations and improve treatment of brain metastases. Completion of the rolling submission is expected in Q3 2025. Nuvalent is also in discussion with the FDA regarding potential expansion of indications.

Summit Therapeutics announced positive Phase III HARMONi trial data for ivonescimab plus chemotherapy in EGFR-mutated NSCLC patients who progressed after EGFR-TKI treatment. While the primary analysis showed a positive OS trend (HR=0.79, p=0.057), longer follow-up of Western patients demonstrated improved OS (HR=0.78, p=0.0332). North American patients showed a promising OS HR of 0.70. Ivonescimab’s safety profile was consistent with prior studies. A conference call will be held September 8, 2025, to discuss these findings.

At IFA 2025, GlocalMe unveiled its “3-3-5 Digital Inclusion Framework” to address the global digital divide. This initiative focuses on bridging three gaps between carrier networks, local/international access, and human-pet connectivity. It’s powered by CloudSIM®, AI HyperConn®, and a positioning system, and realized through five product lines including Pet Network (PetPhone), Personal Mobile Network (eSIM Trio), Travel Network (Numen Air, MeowGo G40 Pro, G50 Pro), Life Network (UniCord Pro, RoamPlug), and Home Network (GuardFlex Pro). GlocalMe emphasizes both 5G and 4G coverage, leveraging AI to optimize connectivity performance and cost.

BioMarin announced positive Phase 3 PEGASUS study results for PALYNZIQ® in adolescents (12-17) with PKU, presented at ICIEM 2025. PALYNZIQ demonstrated a 49.7% decrease in mean blood Phe levels compared to diet alone. A significant proportion of PALYNZIQ-treated participants achieved target Phe levels, with a safety profile consistent with adult patients. BioMarin plans to submit these data to global health authorities in the second half of 2025, seeking to expand PALYNZIQ’s indication to include adolescents.

Johnson & Johnson’s Phase 3 MARIPOSA study reveals that first-line RYBREVANT^® plus LAZCLUZE^® significantly reduces EGFR- and MET-driven resistance in EGFR-mutated NSCLC compared to osimertinib. The combination demonstrates a lower incidence of MET amplification and EGFR mutations, potentially transforming disease biology. This chemo-free regimen has shown an overall survival benefit exceeding four years. These findings, presented at WCLC 2025, support the combination’s approval in multiple markets.

Manulife and UpLink announced the winners of the “Innovating for Asia’s Demographic Future Challenge”, the second in a longevity-focused series. Ten ventures addressing financial resilience, healthy aging, and lifelong fulfillment in Asia’s changing demographic landscape were selected from over 85 submissions. Winners gain access to networking, partnerships, and visibility, with three top innovators receiving a share of CAD $200,000. The challenge highlights the urgent need for innovation to support Asia’s aging population, projected to be one in four over 60 by 2050.

Hesai Group (HSAI) announced a global offering of 17 million Class B shares, including a Hong Kong public offering and an international offering, alongside a dual-primary listing on the Hong Kong Stock Exchange (“2525”). The maximum Hong Kong offer price is HK$228.00 per share. Cornerstone investors committed approximately US$148 million, representing about 29.8% of the initial offering. Proceeds will fund R&D, manufacturing, business expansion, and working capital. The dual-listing aims to diversify Hesai’s investor base and mitigate regulatory uncertainties.

Revive Therapeutics (RVVTF) is extending its private placement to raise up to $650,000 by issuing units at $0.021 each. Each unit includes a share and a warrant exercisable at $0.05 for 36 months. Having already raised $60,900 in the first tranche, the remaining $589,000 will be used for working capital and settling trade payables. The securities are subject to a four-month and one-day hold period. While providing needed capital, the offering involves significant dilution potential for shareholders.

THEMAC Resources Group’s (TSXV: MAC) application to transfer Santa Teresa water rights for the Copper Flat Mine was denied by the New Mexico State Engineer. Filed in 2019, the application sought to change the water diversion point and usage. THEMAC is now exploring alternative water management, including dry stack tailings technology. This more sustainable approach could eliminate the need for the contested water rights. The company is currently evaluating the implementation and permitting requirements for this technology.

GSR IV Acquisition Corp. (GSRF) has closed its $230 million IPO, including the full exercise of the over-allotment option. The offering consisted of 23 million units at $10.00 each. Each unit includes one Class A ordinary share and one-seventh of a right, convertible into shares upon a business combination. Units trade on Nasdaq under “GSRFU,” with shares and rights to follow under “GSRF” and “GSRFR.” Polaris Advisory Partners and The Benchmark Company were joint bookrunners; the latter acting as qualified independent underwriter. GSRF is a blank check company seeking a merger target.