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Oncology

All articles tagged with #oncology

Genentech bets on Dupac to outpace ADC resistance in $1B deal
business21 hours ago

Genentech bets on Dupac to outpace ADC resistance in $1B deal

Genentech agreed to pay DualityBio $45 million upfront with potential milestones over $1 billion to access the Dupac ADC payload platform, aiming to overcome resistance in patients progressing on current topoisomerase-based ADCs. DualityBio will develop Dupac-based ADCs for Genentech and advance candidates into the clinic, after which Genentech will take over development from Phase 1a, leveraging China’s faster, cost advantages. The deal follows previous DualityBio collaborations with Western pharma and expands its platform beyond topoisomerase payloads.

via Fierce Biotech|
#antibody-drug-conjugates#business#dualitybio
KRAS-targeting pancreatic cancer pill approved, signaling a broader oncology breakthrough
health1 day ago

KRAS-targeting pancreatic cancer pill approved, signaling a broader oncology breakthrough

The FDA approved Revolution Medicines’ Rasonque, a daily KRAS-targeting pill for adults with metastatic pancreatic adenocarcinoma after one prior therapy or when chemotherapy isn’t feasible. In trials, median overall survival more than doubled (13.2 months vs 6.7) and death risk was reduced by about 60%, with no KRAS mutation test required. Priced at $39,800 per 30 days and backed by patient-support and expanded-access programs, the approval is viewed as a major advance and a potential platform for RAS-driven cancers, with off-label use anticipated and ongoing development of related therapies.

via Fortune|
#fda-approval#health#oncology
business3 days ago

Moderna Stock Rally Was Telegraphed by Early Trial Signals

Moderna’s shares jumped after Merck and Moderna announced that their Phase III melanoma trial of intismeran autogene with KEYTRUDA met its endpoints, a readout that was effectively foreshadowed by pre-announced signals: a fully enrolled study, Merck covering about half the trial cost, and prior commentary that implied a big move could come. The stock rose to around $145, within a 52-week range of roughly $22–$174, despite Moderna’s weaker 2025 results and restructuring. The piece highlights how identifying funded, binary events in a pipeline—well before a readout—can inform portfolio strategies, as demonstrated by Moderna’s surge.

via Trefis|
#business#melanoma#merck
Moderna's cancer vaccine breakthrough could reshape its growth trajectory
finance9 days ago

Moderna's cancer vaccine breakthrough could reshape its growth trajectory

Moderna's stock surged about 177% after news that its personalized mRNA cancer vaccine intismeran, in combination with Merck's Keytruda, reduced melanoma recurrence in a Phase 3 trial, signaling a potential shift for the biotech beyond infectious disease. Analysts from Jefferies, Bank of America, Citi, and JPMorgan call the result a watershed for Moderna's oncology outlook, with upside if label expansions and cross-indication uptake materialize, though questions remain about dataset completeness and commercial adoption. Fuller data and presentations are expected at the upcoming ESMO meeting, while the stock cooled slightly in premarket trading after yesterday's rally.

via Yahoo Finance|
#cancer#finance#intismeran
AI trial monitors promise up to 82x ROI in oncology
technology16 days ago

AI trial monitors promise up to 82x ROI in oncology

A Tufts CSDD analysis of Medable's AI clinical monitoring agent finds potential ROI up to 82x and an eNPV as high as $21 million per oncology program, driven by savings from reduced site visits, faster enrollment and earlier database locks. Phase 2 ROI is about 64x, Phase 3 around 82x; direct operating savings are roughly $4.4 million (Phase 2) and $5.6 million (Phase 3). Across portfolios, the impact could reach hundreds of millions for sponsors with multiple indications, with development time shortened by about 18 weeks. Some admin savings weren’t included in the eNPV calculations.

via Fierce Biotech|
#ai#clinical-trials#enpv
AI Slashes Time and Costs in Late-Stage Cancer Trials, Tufts Finds
healthcare16 days ago

AI Slashes Time and Costs in Late-Stage Cancer Trials, Tufts Finds

Tufts’ Center for the Study of Drug Development finds Medable’s AI monitoring agent can speed up late-stage (phase 2/3) cancer drug trials by about 10 weeks and cut direct operating costs by up to $5.6 million, with larger net benefits as the drug targets more cancers (potentially up to $565 million for 50 indications). The technology could become standard in 3–5 years, aiding enrollment, data locking, and earlier safety assessments, while still facing challenges like patient recruitment, consent, drug distribution, and the need for human verification.

via Axios|
#ai#clinical-trials#cost-savings
Daraxonrasib Goes to Patients Early Through Expanded Access Ahead of FDA Decision
health17 days ago

Daraxonrasib Goes to Patients Early Through Expanded Access Ahead of FDA Decision

Following dramatic RASolute 302 results, physicians nationwide are offering the oral RAS inhibitor daraxonrasib to patients under expanded-access programs before FDA approval. The drug nearly doubled median overall survival in previously treated metastatic pancreatic cancer (6.7 to 13.2 months) and Revolution Medicines has filed for FDA approval. More than 2,000 patients are on EAP, with sites across the U.S.; institutions cover IRB and safety monitoring costs. Huntsman Cancer Institute reported about 50 patients through its EAP; setup takes 2–3 weeks and delivery occurs in about 7–10 days after consent. Side effects include skin toxicity, managed with dermatology input and topical/doxycycline. Trials continue in first-line metastatic pancreatic cancer, post-surgery settings, and second-line RAS-mutant NSCLC.

via Medscape|
#daraxonrasib#expanded-access-program#fda-approval
Replimune Wins FDA Nod for Tudriqev After Roller-Coaster Run, Shares Dip
biotech-and-pharma21 days ago

Replimune Wins FDA Nod for Tudriqev After Roller-Coaster Run, Shares Dip

Replimune secures FDA clearance for Tudriqev, used with Opdivo to treat advanced melanoma, on its third submission after two prior denials. The approval, supported by an advisory panel’s positive vote, sets up the company for its first commercial launch, though the stock fell about 6% as investors weighed execution risk and the company’s regulatory history. Initial rollout targets ~200 early-adopter hospital accounts with full launch expected over the next year, and analysts see significant upside if Tudriqev captures a meaningful share of refractory melanoma—potentially $1B+ in annual sales—despite launch challenges and competition from Amgen and Iovance Biotherapeutics.

via Barron's|
#biotech#biotech-and-pharma#fda-approval
Vaping’s hidden cancer risk: oncologists warn of a future lung cancer surge
health27 days ago

Vaping’s hidden cancer risk: oncologists warn of a future lung cancer surge

Oncologists warn that vaping may fuel a future rise in lung cancer because e-cigarette aerosols carry carcinogens and metals that damage lung tissue; with vaping popular among teens, long-term risk is a growing concern. Early warning signs should not be ignored, and stopping vaping plus avoiding secondhand exposure is advised. If cancer is suspected, low-dose CT screening and biopsy guide diagnosis and enable personalised treatments such as surgery, chemotherapy, targeted therapy, immunotherapy and SBRT.

via The Times of India|
#e-cigarettes#health#lung-cancer
Pancreatic cancer braces for post-daraxonrasib era
biotech1 month ago

Pancreatic cancer braces for post-daraxonrasib era

At a European pancreatic cancer conference, experts hailed the anticipated launch of daraxonrasib as a potential milestone that could reshape care, echoing the impact of checkpoint inhibitors. But they warned the new therapy would bring opportunities and challenges—from access and pricing to real-world effectiveness and how it will be integrated into standard treatment and combination strategies as data emerge.

via STAT|
#biotech#clinical-trials#daraxonrasib
GSK pivots to oncology expansion with $10.6B Nuvalent takeover
business2 months ago

GSK pivots to oncology expansion with $10.6B Nuvalent takeover

GSK agreed to acquire Nuvalent for $10.6 billion in cash, paying about $124 per share (roughly a 40% premium) to bolster its oncology pipeline and offset expected HIV revenue declines when its best-selling HIV medicine loses exclusivity in 2028. Nuvalent brings late-stage lung-cancer assets neladalkib and zidesamtinib, plus an early-stage and preclinical portfolio, with potential blockbusters if approved by the FDA. The deal would be GSK’s second-largest ever and signals a shift toward larger biotech deals amid strong M&A activity, with guidance unchanged for 2026 and growth anticipated from 2027.

via CNBC|
#biotech#business#lung-cancer
business2 months ago

JNJ to Acquire Firefly Bio to Expand KRAS-Targeted Degrader Antibody Platform

Johnson & Johnson will acquire Firefly Bio for $1 billion in cash to bolster its oncology pipeline with Firefly's Firelink degrader antibody conjugate (DAC) platform, designed to target KRAS-driven solid tumors by delivering selective protein degraders to cancer cells while sparing healthy tissue, with closing expected later this year pending regulatory approvals.

via Johnson & Johnson|
#business#degrader-antibody-conjugate#firefly-bio