Core Insights - Atossa Therapeutics has reported promising results from the Phase 2 Endocrine Optimization Pilot sub-study, demonstrating the bioactivity of low-dose (Z)-endoxifen in treating stage II/III ER+/HER2- breast cancer [1][4] Group 1: Study Results - No participants achieved a pathologic complete response (pCR), with residual cancer burden (RCB) classes indicating moderate to extensive disease [3] - The study showed a median Ki-67 suppression from 10.5% at baseline to 5% by Week 3, with 65% of patients achieving Ki-67 ≤ 10% [6] - Median functional tumor volume decreased by 77.7% from baseline to surgery, with the longest tumor diameter reduced by 36.8% [6] Group 2: Drug Profile - (Z)-endoxifen is a potent Selective Estrogen Receptor Modulator (SERM) that can inhibit and potentially degrade estrogen receptors, showing activity in resistant tumors [5] - The drug targets PKCβ1, an oncogenic signaling protein, at clinically achievable blood levels, and offers comparable or superior bone protection compared to tamoxifen [5] Group 3: Future Directions - Atossa is enrolling participants in an additional I-SPY2 cohort testing (Z)-endoxifen at a 40 mg daily dose, with top-line data expected in 2026 [4] - The company is focused on developing (Z)-endoxifen for metastatic breast cancer, supported by a growing intellectual property portfolio [8]

Presented new amezalpat mechanism-of-action data reinforcing its potential as a novel cancer treatment at the 2025 AACR Annual MeetingGranted Orphan Drug designation by FDA for TPST-1495 for the treatment of familial adenomatous polyposis (FAP)Received FDA “Study May Proceed” letter for Phase 2 trial of TPST-1495 for the treatment of FAPGranted both Orphan Drug & Fast Track designations by FDA for Amezalpat (TPST-1120) for the treatment of patients with hepatocellular carcinoma (HCC) BRISBANE, Calif., May 1 ...

Core Insights - Roche, in collaboration with the Breast International Group (BIG) and other partners, announced significant overall survival results from the phase III APHINITY study for HER2-positive early-stage breast cancer, showing a 17% reduction in the risk of death after ten years for patients treated with a Perjeta-based regimen compared to those receiving Herceptin and chemotherapy [1][2][6]. Study Results - The APHINITY study demonstrated that 91.6% of patients treated with the Perjeta-based regimen were alive at ten years, compared to 89.8% for the control group, with a hazard ratio of 0.83 [6]. - A 21% reduction in the risk of death was observed in the subgroup of patients with lymph node-positive disease, with a hazard ratio of 0.79 [6][5]. - The previously reported invasive disease-free survival benefit was maintained, reinforcing earlier analyses [6][5]. Treatment Implications - The results validate the Perjeta-based regimen as a standard-of-care treatment for high-risk HER2-positive breast cancer patients, particularly those with lymph node-positive disease [2][4]. - Roche's commitment to improving outcomes for HER2-positive breast cancer patients is evident through the development of targeted therapies like Herceptin and Perjeta, which have transformed survival rates [11][10]. Future Presentations - Full results from the APHINITY study will be presented as a late-breaking abstract at the 2025 European Society for Medical Oncology Breast Cancer Congress [3].

Core Insights - Roche, in collaboration with Breast International Group (BIG) and other partners, announced significant overall survival results from the phase III APHINITY study for HER2-positive early-stage breast cancer, showing a 17% reduction in the risk of death after ten years for patients treated with a Perjeta-based regimen compared to standard treatment [1][5][6] Group 1: Study Results - The APHINITY study demonstrated that after ten years, 91.6% of patients treated with the Perjeta-based regimen were alive, compared to 89.8% of those receiving standard treatment, with a hazard ratio of 0.83 [6] - A 21% reduction in the risk of death was observed in the subgroup of patients with lymph node-positive disease, with a hazard ratio of 0.79 [6] - The previously reported invasive disease-free survival benefit was maintained, reinforcing earlier analyses [6] Group 2: Treatment Implications - The results validate the Perjeta-based regimen as a standard-of-care treatment for early-stage HER2-positive breast cancer, particularly for high-risk patients [1][3] - Roche's commitment to improving outcomes for HER2-positive breast cancer patients is evident through the development of targeted therapies like Herceptin and Perjeta, which have transformed survival rates [8][9] Group 3: Future Directions - Full results from the APHINITY study will be presented at the 2025 European Society for Medical Oncology Breast Cancer Congress, indicating ongoing research and collaboration in the field [2][5] - The collaborative efforts in the APHINITY study have led to pivotal trials that continue to enhance understanding and treatment of HER2-positive breast cancer [3][4]

- Stenoparib continues to demonstrate clinical benefit in heavily pre-treated ovarian cancer, with two patients remaining on treatment for more than 19 months- Initiated utilization of share repurchase program- Cash and restricted cash balance of approximately $27 million at end of Q1 2025, reinforcing financial stability TARPON SPRINGS, Fla., May 9, 2025 -- Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing sten ...

Nuvation Bio (NUVB) Q1 2025 Earnings Call May 07, 2025 04:30 PM ET Company Participants Robert DeVita - Executive Director, Corporate Development & IRDavid Hung - Founder, President & CEOColleen Sjogren - Chief Commercial OfficerPhilippe Sauvage - CFOMichael Yee - Managing Director Conference Call Participants Gregory Renza - Director & Senior Analyst of Biotechnology Equity ResearchKaveri Pohlman - Managing Director, Senior Equity Research AnalystSoumit Roy - Biotech Research AnalystYaron Werber - Managing ...

Analyst's Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. I have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech compani ...

Upcoming Events OJEMDA™ (tovorafenib) prescriptions grew 16% in Q1 2025 compared to Q4 2024 Achieved Q1 2025 OJEMDA™ (tovorafenib) net product revenue of $30.5 million Ended the first quarter with $473.0 million in cash, cash equivalents and short-term investments Company to host conference call and webcast today, May 6, 4:30 p.m. ET BRISBANE, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) ("Day One" or the "Company"), a biopharmaceutical company dedicated to develo ...

- Favorable clinical data in PD-(L)1 resistant patients - - Dose expansion enrollment complete with full data expected by year-end 2025 - - Cash runway into the second quarter of 2026 - BOSTON, May 06, 2025 (GLOBE NEWSWIRE) -- Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, today reported financial results for the first quarter 2025, and provided corporate updates. “This was a br ...

Group 1 - Cardiff Oncology (NASDAQ: CRDF) is emerging as a notable player in the colorectal cancer (CRC) biotech sector, with promising results from their randomized phase 2 trial [1] - The company has demonstrated significant potential in addressing CRC, which is a critical area in oncology [1] Group 2 - The article emphasizes the importance of understanding the science behind biotech investments to make informed decisions [1]