Nuvation Bio, Inc. is a biopharmaceutical company tackling some of the unmet needs in oncology by developing differentiated and novel therapeutic candidates. Its proprietary portfolio includes six novel and mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. The company was founded by David Hung on March 20, 2018 and is headquartered in New York, NY.
相关临床试验
22
8 进行中
药物批准
1
批准总数
监管机构
1
监管机构数
成立时间
N/A
进行中（未招募）
5
22.7%
已完成
4
18.2%
尚未招募
3
13.6%
招募中
4
18.2%
终止
3
13.6%
Unknown
1
4.5%
撤回
2
9.1%
- The FDA approved a supplemental New Drug Application updating the taletrectinib label with a median duration of response of 49.7 months in TKI-naive advanced ROS1-positive NSCLC. - The update reflects a median follow-up of 51 months in the Phase 2 TRUST-I study and adds 14 months of data from the pivotal TRUST-I and TRUST-II trials. - TRUST-I reported an objective response rate of 90.3% and median progression-free survival of 49.6 months, with no changes to the label's safety sections. - Taletrectinib, an oral CNS-active selective ROS1 inhibitor, retains its June 2025 full approval for locally advanced or metastatic ROS1-positive NSCLC across lines of therapy.
- The FDA approved a supplemental New Drug Application for taletrectinib (IBTROZI), updating the label with a median duration of response of 49.7 months in TKI-naive ROS1-positive NSCLC. - Updated data from the phase 2 TRUST-I and TRUST-II trials reflect a median follow-up of 51 months in TRUST-I plus 14 additional months of follow-up. - The approval arrived four months ahead of the January 4, 2027 PDUFA date, with no changes to safety labeling and no new safety signals identified. - Nuvation Bio reported median progression-free survival of 49.6 months and a 3-year overall survival rate of 65.3% in the TKI-naive population.
- Nuvation Bio presented new subgroup analyses from the pivotal TRUST-I and TRUST-II studies at the IASLC 2026 World Conference on Lung Cancer in Seoul. - In TKI-naive patients, objective response rates were 90.0% with prior chemotherapy versus 89.8% without, with median durations of response of 48.3 and 54.3 months. - Efficacy was also consistent by ROS1 fusion partner, with ORRs of 89.5% for CD74 fusions and 88.9% for non-CD74 fusions in TKI-naive patients. - Long-term follow-up showed no new safety signals, with mostly low-grade AST/ALT increases, diarrhea, nausea and vomiting as the most common adverse events.
- Nuvation Bio's Ibtrozi, a ROS1 TKI for NSCLC, demonstrated a 90% response rate and 50-month duration of response, which CEO David Hung calls the highest combined rate ever seen for any drug in any cancer. - The company's brain tumor drug safusidenib showed a 44% response rate in low-grade glioma and striking complete responses in high-grade glioma, including a glioblastoma patient tumor-free for over three years. - Nuvation Bio is well capitalized with over $535 million in cash and used a royalty financing strategy, selling 5% of Ibtrozi U.S. sales for $150 million to fund development. - A novel drug-drug conjugate (DDC) platform is in development, designed to overcome limitations of antibody-drug conjugates by using two conjugated small molecules for improved tumor targeting.
- Director Robert Mashal purchased 25,000 shares of Nuvation Bio on June 9, 2026, at $4.73 per share, signaling confidence as the stock has nearly doubled over the past year. - The insider buy comes as taletrectinib, Nuvation's ROS1-positive lung cancer treatment, is already approved in the U.S., Japan, and China, with the UK's MHRA recently validating Eisai's application. - Nuvation Bio's pipeline includes CDK inhibitors, BET inhibitors, Wee1 kinase inhibitors, adenosine receptor antagonists, and a proprietary drug-drug conjugate platform targeting oncology indications. - A separate insider sale by Chief People Officer Stacy Markel was executed under a pre-established Rule 10b5-1 trading plan adopted in December 2025, her first reported sale in over six years.
- Nuvation Bio reported 432 new patients started on IBTROZI (taletrectinib) since its June 2025 launch, with treatment adoption rates approximately six times greater than prior ROS1 tyrosine kinase inhibitor launches. - The company generated $24.7 million in preliminary net product revenue from IBTROZI since launch, including $15.7 million in the fourth quarter of 2025. - IBTROZI has become the preferred treatment for advanced ROS1-positive non-small cell lung cancer across treatment lines, demonstrating an impressive duration of response of over four years. - The company entered an exclusive licensing agreement with Eisai Co., Ltd. to develop and commercialize taletrectinib in multiple international markets including Europe, Canada, and several Asian countries.
- Nuvation Bio and Eisai announced an exclusive licensing agreement granting Eisai development and commercialization rights for taletrectinib in Europe and multiple other territories outside the U.S., China, and Japan. - The deal includes €50 million upfront payment and up to €145 million in milestone payments, plus double-digit tiered royalties up to the high-teens from future sales in licensed territories. - Taletrectinib is a next-generation ROS1 inhibitor already approved in the U.S., China, and Japan for advanced ROS1-positive non-small cell lung cancer, with a Marketing Authorization Application expected in Europe in the first half of 2026. - The partnership leverages Eisai's global infrastructure to accelerate patient access to this treatment for ROS1+ NSCLC, a rare form affecting approximately 2% of NSCLC patients worldwide.
- Innovent Biologics announced that seven innovative drugs, including a new indication for TYVYT and first-time inclusions of SYCUME and five targeted therapies, have been added to China's 2025 National Reimbursement Drug List. - The included therapies address critical unmet needs across oncology, thyroid eye disease, and hematological malignancies, with coverage spanning lung, liver, gastric, esophageal, and gynecological cancers. - SYCUME represents China's first approved IGF-1R antibody drug for thyroid eye disease, offering a groundbreaking non-invasive therapy after 70 years of limited treatment options. - The NRDL inclusion, effective January 1, 2026, will significantly enhance patient accessibility and affordability for these innovative treatments across China.
- Nuvation Bio has enrolled the first patient in part 2 of the G203 study, a global randomized trial evaluating safusidenib versus placebo for maintenance treatment of high-grade IDH1-mutant astrocytoma. - The FDA has agreed to upgrade G203 to a Phase 3 registration-enabling trial with approximately 300 patients, using progression-free survival as the primary endpoint that could support full approval. - No targeted therapies are currently FDA-approved for high-grade IDH1-mutant gliomas, representing a significant unmet medical need for patients who face inevitable disease recurrence. - Safusidenib demonstrated promising activity in Phase 1 studies with higher response rates than other IDH inhibitors in recurrent or progressive high-grade IDH1-mutant gliomas.
- Nuvation Bio Inc. stock surged 14.9% driven by promising clinical trial results and positive analyst sentiment from major investment firms. - Wedbush raised its price target to $6 while RBC increased its target to $7, reflecting growing confidence in the company's diverse oncology pipeline. - The company's strategic focus includes next-generation treatments such as a ROS1 inhibitor and brain-penetrant IDH1 inhibitor for cancer therapy. - Despite current profitability challenges with significant net losses, strong liquidity position and increased investor conference participation signal potential growth trajectory.
