Nirogacestat

The 2024 ASCO annual meeting presented novel cancer studies, including osimertinib's 84% PFS improvement in EGFR-mutated NSCLC, no CRS in teclistamab pilot, new FDA approvals' uses and adverse effects, MCED tests' potential in health equity challenges, and telehealth's effectiveness in early palliative care for advanced NSCLC.

SpringWorks Therapeutics to participate in a fireside chat at the 7th Annual Evercore ISI HealthCONx Conference on December 3, 2024, at 12:30 p.m. ET in Coral Gables, Florida. Webcast available at https://ir.springworkstx.com.

SpringWorks Therapeutics reports $49.3 million in OGSIVEO® (nirogacestat) net product revenue in Q3, with long-term Phase 3 DeFi trial data showing tumor size reduction and consistent safety. The FDA granted Priority Review for mirdametinib's NDA, and SpringWorks has $498 million in cash to fund operations through anticipated profitability in H1 2026.

SpringWorks Therapeutics reported $49.3M revenue for Q3 2024, driven by OGSIVEO sales, with a net loss of $53.5M. The company launched OGSIVEO in 2023, expanded dosage strengths in 2024, and seeks EMA approval for Europe in 2025. Mirdametinib for NF1-PN is under FDA priority review. SpringWorks plans to invest in R&D and expand OGSIVEO globally, despite facing regulatory, operational, and financial risks.

SpringWorks Therapeutics to present long-term efficacy and safety data of nirogacestat in desmoid tumours at CTOS 2024, showing sustained tumor size reductions, increased response rates, and consistent safety profile.

Long-term nirogacestat treatment in desmoid tumors shows sustained tumor size reductions, increased ORR with new PRs and CRs, improved symptoms, and consistent safety profile over 3 years.

SpringWorks Therapeutics to host Q3 financial results and business updates conference call on Nov 12, 2024, at 8:30 a.m. ET. Webcast and phone participation details available. Replay on the company’s website.

Bispecific antibodies market highlights include >30 development platforms, >USD 8B market size in 2023, and >800 clinical trials. Key approved antibodies like Blincyto and Hemlibra have seen significant sales. The market is driven by innovations in immuno-oncology, with ongoing trials by major pharma companies and research institutions globally.