Key Highlights of SpringWorks Therapeutics - OGSIVEO (nirogacestat) is the first and only FDA-approved therapy for desmoid tumors[15] - GOMEKLI (mirdametinib) is the first and only FDA-approved therapy for both adults and children with NF1-PN[15] - SpringWorks Therapeutics expects profitability in the first half of 2026[10] - SpringWorks Therapeutics had $461.9 million in cash, cash equivalents, and marketable securities[132] OGSIVEO (Nirogacestat) for Desmoid Tumors - OGSIVEO generated $61.5 million in net revenue in Q4 2024 and $172.0 million in FY 2024[15] - Between October 2023 and October 2024, approximately 11,000 patients with desmoid tumor ICD-10 claims were identified[15] - Objective response rate (ORR) increased from 34.3% with up to 1 year of treatment to 45.7% with up to 4 years of treatment[48] GOMEKLI (Mirdametinib) for NF1-PN - GOMEKLI is approved for the treatment of adult and pediatric patients 2 years of age and older with NF1-PN[10] - The U S market includes approximately 30,000 adult and 10,000 pediatric patients with NF1-PN[15] - In clinical trials, GOMEKLI showed a confirmed overall response rate of 41% in adults (n=58) and 52% in pediatrics (n=56)[67]

Plinabulin's Mechanism and Preclinical Evidence - Plinabulin is a unique tubulin binder with a distinct binding site compared to other tubulin-binding agents[16, 21] - Preclinical studies show that Plinabulin, combined with radiation and anti-PD-1, activates dendritic cells (DCs), stimulates T-cell proliferation, and achieves abscopal effects[17, 24] - Plinabulin induces DC maturation, especially when administered after irradiation (IR), and Plinabulin-treated DCs stimulate T cell proliferation, enhanced by combining with IR[25] Clinical Efficacy and Immune Activation - In a Phase 1 study, the Plinabulin triple combination (with radiation and PD-1/PD-L1 inhibitors) led to an 80% disease control rate (DCR) in 10 IO-refractory patients[18, 32] - Durable responses were observed in 2 Hodgkin lymphoma patients who progressed after 12 or 16 prior lines of therapy[33] - Responding patients exhibited early immune activation with DC maturation and proinflammatory monocytes in the peripheral blood across six different cancer types[19, 35] Summary and Future Directions - Plinabulin demonstrates induction of DC maturation and re-sensitization to anti-PD(L)1 in IO-refractory tumors[37] - The impressive overall results, showing a high 80% disease control rate in ICI-refractory and heavily pre-treated patients, warrant further clinical studies of Plinabulin/IO combinations in IO-refractory settings[37, 38]

AstraZeneca (AZN -2.36%) might soon be on the hook for an eventual 11-figure payout, and investors weren't all that comfortable with this. A Bloomberg article published Thursday morning said that the company is pursuing what might end up being an expensive partnership with a biotech.A cautious market traded AstraZeneca stock down by more than 2% following the report, on a day when the S&P 500 index landed firmly in positive territory with a 0.8% gain.That's one big price tagThe article that dinged AstraZene ...

Key Takeaways REGN gained FDA approval for Lynozyfic to treat relapsed or refractory multiple myeloma. Lynozyfic showed a 70% response rate and 45% complete response rate in the LINKER-MM1 trial. The approval makes Lynozyfic the first FDA-cleared BCMAxCD3 bispecific with biweekly or monthly dosing.Regeneron Pharmaceuticals, Inc. (REGN) obtained FDA approval for linvoseltamab-gcpt for the treatment of relapsed or refractory (R/R) multiple myeloma (MM).The regulatory body granted accelerated approval to lin ...

Key Takeaways MRK is focused on Winrevair's growth as Keytruda, its top revenue driver, faces patent expiration in 2028. Winrevair showed significant efficacy in PAH phase III trials, leading to early study stoppages. The FDA granted priority review to MRK's sBLA to update Winrevair's label, with a decision due on Oct. 25.Merck’s (MRK) blockbuster PD-L1 inhibitor, Keytruda, approved for several types of cancer indications, is the company's biggest revenue driver. The drug alone accounts for around 50% of ...

Corporate Presentation August 6, 2024 1 Forward Looking Statements Please visit www.TAVALISSE.com for Full Prescribing Information. Please visit www.REZLIDHIA.com for Full Prescribing Information, including Boxed WARNING. Please visit www.GAVRETO.com for Full Prescribing Information. 2 Growing Our Hematology and Oncology Business Commercial Execution Development & Expansion Development Programs1 In-Licensing and Product Acquisition • Identify new late-stage assets which leverage current capabilities and cap ...

Unleashing the Potential of Immuno-Oncology Therapies June 5, 2025 © 2025 Xilio Therapeutics, Inc. 1 Forward-Looking Statements and Disclaimers This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding plans, timing and expectations related to: development timelines and anticipated milestones for Xilio's programs; the receipt of future contingent payments under Xilio's coll ...

Data show confirmed ORR of 83% (10/12) at doses selected for ongoing expansion study Median follow-up of 9.0 months as of the updated data cutoff Responses observed in patients with low PD-L1 and/or CLDN18.2 expression Company to host investor event on Tuesday, July 8th ROCKVILLE, Md., July 02, 2025 (GLOBE NEWSWIRE) -- I-Mab (NASDAQ: IMAB) (the Company), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced the pres ...

Key Takeaways AbbVie is acquiring Capstan Therapeutics for up to $2.1B to expand its immunology portfolio. The acquisition adds CPTX2309, a phase I in vivo CAR-T therapy for autoimmune diseases, to AbbVie's pipeline. Capstan's CellSeeker tLNP platform enables RNA delivery to engineer specific cell types inside the body.AbbVie (ABBV) announced that it has entered into a definitive agreement to acquire privately held biotech, Capstan Therapeutics, for up to $2.1 billion in cash.The impending acquisition wil ...

These forward-looking statements are made as of the date of this press release and we do not intend, and do not assume any obligation, to update these forward-looking statements, except as required by law. We cannot assure you that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance and accordingly investors are cautione ...