Company Overview - Lisata Therapeutics is a clinical stage pharmaceutical company focused on developing innovative therapies for cancer and other serious diseases[8] - The company's mission is to rapidly develop and commercialize innovative treatments that improve outcomes for patients with cancer or other serious diseases[10] - Lisata has a proprietary field-leading technology with global IP protection extending beyond 2040[12] - The company projects multiple product and business milestones over the next 12 months[12] - Lisata has existing partnerships that validate its platform technology, with potential for many others[12] - The company's cash runway extends into 1Q 2027 with no debt[12] Certepetide Development and Clinical Trials - Certepetide is designed to optimize solid tumor treatment by converting tumor stroma, reducing immunosuppression, and inhibiting metastasis[23, 24] - In mPDAC, two Phase 1b/2a trials showed that Certepetide plus SoC chemotherapy improved overall survival[73] - In the ASCEND Phase 2b study, Cohort A showed a median overall survival of 12.68 months with Certepetide + SoC compared to 9.23 months with Standard of Care[87] - In the ASCEND Phase 2b study, Cohort B showed a median PFS of 7.46 months with Certepetide + SoC compared to 5.29 months with Standard of Care, nearing statistical significance (HR 0.61, p=0.09)[91, 92] - The iLSTA Phase 1b/2a trial in locally advanced PDAC with chemo & IO showed an Overall Response Rate of 69% in Cohort 3[110] Financial Position - As of June 30, 2025, Lisata had $22 million in cash and investments[140]

Core Insights - Celcuity Inc. is a biotechnology company focused on developing innovative therapies for cancer treatment, particularly its drug gedatolisib targeting hormone-positive breast cancer [1] - The company has received a positive price target of $95 from Needham, indicating a potential increase of approximately 31.69% from its current price of $72.14, driven by strong phase 3 data for gedatolisib [2] - Celcuity's market valuation has surged to $2 billion, with a stock price increase of 40.05%, reflecting strong investor interest and market volatility [3] Financial Position - The company has a robust financial position supported by recent fundraising efforts and loan facilities, ensuring a cash runway extending into 2027, which is crucial for filing a New Drug Application (NDA) for gedatolisib [4] - Celcuity's market capitalization is approximately $3.09 billion, with a trading volume of 5,875,995 shares, positioning it well in the biotech sector [5] Market Performance - The stock price has fluctuated between $71.57 and $83, with a 52-week high of $83 and a low of $7.58, indicating strong investor interest and market volatility [3] - The successful results from the VIKTORIA-1 trial have been a key driver of investor confidence in the company's future prospects [2][6]

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Core Insights - Taiho Oncology Inc. and Cullinan Therapeutics Inc. presented new data from the CNS involvement cohort of the REZILIENT2 study for zipalertinib in advanced or metastatic NSCLC with specific EGFR mutations, to be showcased at ESMO Congress 2025 [1] Summary of Preliminary Efficacy - The ongoing Phase 2b REZILIENT2 trial includes a CNS involvement cohort where 32 patients received zipalertinib 100 mg orally twice daily, with a median of 2 prior lines of therapy [3] - Among the enrolled patients, 21 had ex20ins mutations and 13 had other uncommon mutations [3] - In the evaluable population (n=16), the intracranial objective response rate was 31.3%, with one complete response, and the intracranial disease control rate was 68.8% [4] - The median intracranial duration of response was 8.1 months [4] - The preliminary systemic objective response rate was 27.6% with a median duration of response of 7.6 months [5] - Intracranial antitumor activity was comparable to overall systemic anticancer activity [5] Summary of Preliminary Safety and Tolerability - Zipalertinib was well tolerated at the administered dose, with no new safety signals reported [6] - Treatment-related adverse events of grade 3 or higher occurred in 25% of patients, including anemia and interstitial lung disease, with one death attributed to interstitial lung disease [6] - Following the data release, CGEM stock increased by 4.96% to $7.77 [6]

Core Insights - Nurix Therapeutics is focused on developing innovative therapies for cancer treatment, particularly its oral BTK degrader, bexobrutideg, targeting chronic lymphocytic leukemia (CLL) [1][5] - The company plans to initiate a pivotal phase 2 study in late 2025, indicating a strong commitment to advancing its clinical programs [1][5] Financial Summary - Stifel Nicolaus has set a price target of $33 for NRIX, suggesting a potential upside of approximately 238% from its current price of $9.76 [2][5] - The stock has experienced a decrease of 10.13%, reflecting market volatility, while the company's market capitalization stands at $750.3 million [2] Clinical Data - Nurix's phase 1a data for bexobrutideg shows an impressive 80.9% overall response rate (ORR), supporting the potential for Accelerated Approval [3][5] - The company aims to expand its efforts with a phase 3 trial and explore combination therapies for CLL, targeting a multibillion-dollar market [3][5] Stock Performance - The stock has fluctuated between $9.50 and $10.56 today, with a 52-week high of $29.56 and a low of $8.18, indicating active investor interest [4] - Trading volume stands at 1,996,408 shares, suggesting significant market activity [4]

Core Insights - Aethlon Medical, Inc. has provided updates on its ongoing oncology clinical trial in Australia, focusing on the Hemopurifier's effects on cancer patients not responding to anti-PD-1 therapy [3][4][11] Clinical Trial Observations - The initial cohort of three patients showed promising changes in extracellular vesicles (EVs), microRNAs, and lymphocyte counts after a single treatment with the Hemopurifier [4][5] - Changes in EV and microRNA levels typically returned to baseline within 1 to 3 weeks post-treatment [6] - Two of the three participants exhibited decreases in large EVs, which are implicated in cancer metastasis and immune response inhibition [10] Hemopurifier Mechanism - The Hemopurifier is designed to remove enveloped viruses and tumor-derived EVs from circulation, potentially aiding in cancer treatment by targeting mannose-rich surfaces on EVs and viral proteins [9][11] - The device has received U.S. Food and Drug Administration Breakthrough Device Designation for treating advanced or metastatic cancer and life-threatening viruses [11] Patient Response and Data Limitations - Increases in total T cell numbers and specific T cell subsets were noted in participants following treatment, although the data is limited due to the small sample size [10] - The study's preliminary nature means that no definitive conclusions can be drawn regarding the clinical efficacy of the Hemopurifier [8][10]

Core Insights - Aethlon Medical, Inc. is conducting an ongoing oncology clinical trial in Australia to evaluate the safety, feasibility, and dose-finding of its Hemopurifier device in cancer patients unresponsive to anti-PD-1 therapy [1][2] Summary by Categories Clinical Trial Observations - Preliminary results from the first patient cohort indicate encouraging changes in extracellular vesicles (EVs), microRNAs, and lymphocyte counts after a single Hemopurifier treatment [2][3] - In the initial three patients, two showed decreases in large EVs, which are implicated in cancer metastasis and immune evasion [7] - All three participants exhibited decreases in large EVs carrying PD-L1, which is associated with resistance to anti-PD-1 therapies [7] - Seven out of ten microRNAs examined showed decreases in two of the three participants following treatment, indicating potential effects on cancer growth and metastasis [7] - Improvements in laboratory ratios related to immunotherapy responses were observed in at least two participants after treatment [7] Device Information - The Aethlon Hemopurifier® is designed to remove enveloped viruses and tumor-derived EVs from circulation, potentially aiding in cancer treatment [9] - The device operates extracorporeally and utilizes a combination of plasma separation, size exclusion, and affinity binding [9] - It holds a U.S. Food and Drug Breakthrough Device Designation for treating advanced or metastatic cancer and life-threatening viruses [10] Limitations and Future Directions - The small sample size limits the ability to draw definitive conclusions about the efficacy and dose response of the Hemopurifier [3][8] - Further data from subsequent cohorts will be necessary to determine the reproducibility of the observed changes and the potential for dose-dependent effects [3] - The current observations are part of an early feasibility study and should not be interpreted as evidence of clinical benefit or safety beyond the study parameters [8]

Core Insights - Rigel Pharmaceuticals (RIGL) is advancing its hematology and oncology pipeline, with Tavalisse being the primary revenue driver [1][2] Product Performance - Tavalisse, an oral spleen tyrosine kinase inhibitor, generated sales of $68.5 million in the first half of 2025, reflecting a 44% year-over-year increase [2][10] - Rezlidhia, the second FDA-approved product, reported sales of $13.1 million in the same period, up 31% year over year [3][10] - Gavreto was added to Rigel's portfolio in 2024, contributing incremental sales starting June 2024, which positively impacted the company's revenue in the first half of 2025 [5][10] Future Outlook - Rigel expects steady sales growth as it expands its commercial presence and enhances marketing efforts, projecting total revenues of $270-$280 million for 2025, up from a previous estimate of $200-$210 million [6] Pipeline Development - Rigel is conducting a phase Ib study for R289, a dual IRAK1 and IRAK4 inhibitor, in patients with lower-risk myelodysplastic syndrome (MDS), with plans to initiate the dose expansion phase in the second half of 2025 [8] - The company is also exploring Rezlidhia's application in other cancers with IDH1 mutations, which could serve as a significant growth catalyst [9] Competitive Landscape - The recent FDA approval of Sanofi's Wayrilz (rilzabrutinib) for chronic ITP poses a competitive threat to Tavalisse, despite differing mechanisms of action [11] - Other companies are also developing treatments that may compete with Rigel's marketed products, including Eli Lilly's Retevmo (selpercatinib) for cancer indications [12] Stock Performance and Valuation - Rigel's shares have increased by 70.2% year to date, outperforming the industry and the S&P 500 [13] - The company is trading at a price-to-sales (P/S) ratio of 1.94, below the industry average of 2.47 and its five-year mean of 2.21 [14] Earnings Estimates - The Zacks Consensus Estimate for 2025 earnings per share (EPS) has risen from $2.68 to $5.10 over the past 60 days, with 2026 EPS estimates increasing from $1.61 to $3.07 [17]

Genmab to Buy Cancer-Treatment Developer Merus For $8 Bln in Cash https://t.co/SOvnBOpIrE ...