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Day One Reports Fourth Quarter and Full Year 2025 Financial Results and Reaffirms 2026 Outlook and Revenue Guidance
Globenewswire· 2026-02-24 21:00
OJEMDA™ 2025 momentum reflected by Q4 and full year net product revenues of $52.8 million and $155.4 million, respectively 2026 U.S. net product revenue projected at $225 - $250 million Expanded pipeline with January 2026 acquisition of Mersana Therapeutics; Emi-Le in Phase 1 trial for adenoid cystic carcinoma (ACC) Day One to host conference call and webcast today, February 24, 4:30 p.m. ET BRISBANE, Calif., Feb. 24, 2026 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or th ...
Investor Slashes $70 Million From Zymeworks as Stock Jumps 60% in a Year
The Motley Fool· 2026-02-22 17:53
Company Overview - Zymeworks is a clinical-stage biotechnology company focused on developing innovative cancer therapies, particularly through bispecific antibodies and antibody-drug conjugates [6] - The company has a robust pipeline and strategic partnerships with major pharmaceutical firms, providing a competitive edge in targeted oncology therapeutics [6] - As of February 17, 2026, Zymeworks has a market capitalization of $1.74 billion and reported revenue of $134.48 million with a net income of -$63.43 million [4] Recent Developments - Redmile Group significantly reduced its stake in Zymeworks by 3,214,096 shares, valued at approximately $70.10 million, as disclosed in a February 17, 2026, SEC filing [2] - The quarter-end value of Redmile's position in Zymeworks decreased by $50.35 million due to share sales and stock price movements [2] - Following the sale, Zymeworks now accounts for 0.95% of Redmile's reportable 13F assets under management (AUM) [7] Performance Metrics - Zymeworks shares were priced at $23.07 as of February 17, 2026, reflecting a 60% increase over the past year, significantly outperforming the S&P 500's 13% gain during the same period [7] - The company is eligible for up to $440 million in regulatory milestone payments tied to approvals in major markets [9] - Zymeworks ended 2025 with approximately $270.6 million in cash and marketable securities, alongside a $125 million share repurchase authorization [9] Strategic Insights - The reduction in Redmile's position is interpreted as capital recycling rather than a loss of confidence, as Zymeworks is in a transition phase balancing royalty aggregation, internal R&D, and capital returns [10] - The company continues to focus on addressing unmet medical needs in cancer treatment through licensing agreements, research collaborations, and milestone payments from strategic partners [8]
Enliven Therapeutics Chief Scientific Officer Sells ELVN 20K Shares Worth Over $500k
The Motley Fool· 2026-02-01 05:58
Core Insights - The Chief Scientific Officer of Enliven Therapeutics sold 20,000 shares amid a significant stock price increase of 71% in January 2026 [1][5] - The transaction was valued at approximately $535,100, with the shares sold being part of a pre-arranged trading plan [2][7] Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing targeted therapies for cancer, particularly leveraging small molecule drug design [4] - The company has a market capitalization of $1.57 billion and employs 65 people [3] Financial Performance - Enliven Therapeutics reported a net income loss of $97.21 million over the trailing twelve months [3] - The stock price increased by 26.75% over the past year as of January 20, 2026 [3] Recent Developments - The company announced positive initial data from early trials of ELVN-001, a leukemia treatment, contributing to the stock's performance [5] - Enliven aims to advance to phase three of clinical trials for ELVN-001 and is preparing to work with the FDA [6] Investor Considerations - The recent stock performance is closely tied to the progress of the leukemia treatment project, suggesting that investors should monitor FDA approval developments [8]
Immunome to Announce Topline Results from Phase 3 RINGSIDE Trial of Varegacestat in Patients with Desmoid Tumors
Businesswire· 2025-12-14 21:00
Core Insights - Immunome, Inc. is set to host a conference call and webcast on December 15, 2025, to disclose topline results from the Phase 3 RINGSIDE trial of varegacestat, a gamma secretase inhibitor for desmoid tumors [1][2] Company Overview - Immunome is a clinical-stage targeted oncology company focused on developing first-in-class and best-in-class targeted cancer therapies [3] - The company has a portfolio that includes varegacestat, a late-clinical stage gamma secretase inhibitor, IM-1021, a clinical-stage ROR1 antibody-drug conjugate (ADC), and IM-3050, a FAP-targeted radiotherapy that has received IND clearance [3] - Immunome is also advancing a range of early-stage ADCs targeting undisclosed solid tumor indications [3]
NextCure to Present at the Piper Sandler 37th Annual Healthcare Conference
Globenewswire· 2025-11-20 13:00
Core Insights - NextCure, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer treatment, particularly for patients who do not respond to existing therapies [3] Company Participation - NextCure will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference in New York City on December 3 at 11:00 am ET [1] Webcast Information - A live audio webcast of the event will be available on the company's website, with a replay accessible for 30 days post-event [2] Company Overview - NextCure specializes in targeted therapies, including antibody-drug conjugates, aimed at treating cancer patients with disease progression on current therapies [3]
Nuvalent, Inc. (NASDAQ: NUVL) Targets Advanced Cancer with Promising Drug Trials
Financial Modeling Prep· 2025-11-18 00:10
Company Overview - Nuvalent, Inc. is a biopharmaceutical company focused on developing targeted therapies for cancer treatment, particularly its drug neladalkib for advanced ALK-positive non-small cell lung cancer (NSCLC) [1] - The company faces competition from other biotech firms working on similar cancer therapies [1] Recent Developments - On November 17, 2025, Leerink Partners set a price target of $149 for NUVL, indicating a potential upside of 34.77% from its current price of $110.56 [2][5] - The optimistic outlook is supported by promising topline results from the ALKOVE-1 Phase 1/2 trial, which showed a 31% response rate among 253 patients with advanced ALK-positive NSCLC [2][5] Clinical Trial Insights - The trial results are significant as they involve patients previously treated with tyrosine kinase inhibitors (TKIs) and chemotherapy [3] - The recommended Phase 2 dose of neladalkib is 150 mg once daily, determined during the Phase 1 dose-escalation stage, indicating potential for further clinical development in this heavily pretreated patient population [3] Stock Performance - NUVL's stock price is currently $110.11, reflecting a 14.10% increase or $13.61, with fluctuations between $93.30 and $112.52 today [4] - The company's market capitalization is approximately $8 billion, with a trading volume of 1,681,393 shares on the NASDAQ exchange [4][5]
Day One Reports Third Quarter 2025 Financial Results and Corporate Progress
Globenewswire· 2025-11-04 21:00
Core Business Performance - Day One Biopharmaceuticals reported a net product revenue of $38.5 million for OJEMDA in Q3 2025, marking a 15% increase from Q2 2025 and an 89% increase year-to-date compared to FY 2024 [7][13] - The total U.S. OJEMDA net product revenue for 2025 year-to-date reached $102.6 million [7] - Quarterly prescriptions (TRx) for OJEMDA grew to 1,256 in Q3 2025, representing an 18% increase compared to Q2 2025 [7] - New patient starts increased by 19% in Q3 2025, driven by data from the FIREFLY-1 clinical trial [7] Financial Highlights - The company raised its full-year 2025 net product revenue guidance for OJEMDA to between $145 million and $150 million, reflecting strong underlying demand [7] - Research and development expenses for Q3 2025 were $31.4 million, a decrease from $33.6 million in Q3 2024 [13] - Selling, general and administrative expenses were $28.1 million in Q3 2025, slightly down from $29.0 million in Q3 2024 [13] - The net loss for Q3 2025 was $19.7 million, compared to a net income of $37.0 million in Q3 2024 [13] Cash Position - As of September 30, 2025, the company had $451.6 million in cash, cash equivalents, and short-term investments [7][24] Corporate Developments - Heather Adkins Huet, PhD, joined Day One as Chief Scientific Officer in September 2025, bringing over two decades of experience in oncology therapeutics [5] - The company is progressing with the pivotal Phase 3 FIREFLY-2 clinical trial for first-line pediatric low-grade glioma (pLGG), with enrollment completion expected in the first half of 2026 [7] Upcoming Events - Three-year data from the FIREFLY-1 trial will be presented at the Society for Neuro-Oncology on November 23, 2025 [7]
Immunome to Present at 2nd Annual Guggenheim Healthcare Innovation Conference
Businesswire· 2025-10-31 15:51
Core Insights - Immunome, Inc. is set to present at the 2nd Annual Guggenheim Healthcare Innovation Conference on November 11, 2025, at 8:30 a.m. ET [1] - The company focuses on developing first-in-class and best-in-class targeted cancer therapies, with a strong emphasis on innovative therapeutics [3] Company Overview - Immunome is a clinical-stage targeted oncology company dedicated to improving outcomes for cancer patients through advanced therapies [3] - The company has a diverse pipeline, including varegacestat in Phase 3 for desmoid tumors, IM-1021 in Phase 1 targeting ROR1, and IM-3050, a FAP-targeted radioligand that has received IND clearance [3] - Additional preclinical ADCs in the pipeline include IM-1617, IM-1335, and IM-1340, targeting undisclosed markers in various solid tumors [3] Recent Developments - Immunome recently presented preclinical data indicating that its proprietary ADC payload HC74 can overcome multiple mechanisms of ADC resistance, enhancing the efficacy of its therapies [5] - The company has granted inducement awards of stock options to new employees, totaling 69,000 shares on October 1, 2025, and 117,000 shares on September 2, 2025, under Nasdaq Listing Rule 5635(c)(4) [6][7]
Celcuity Inc. (NASDAQ:CELC) Upgraded to "Buy" by Needham with a New Price Target
Financial Modeling Prep· 2025-10-20 21:06
Core Viewpoint - Needham upgraded Celcuity Inc. to a "Buy" rating with a new price target of $95, reflecting confidence in the company's recent clinical trial results for its cancer treatment therapy [1][6]. Group 1: Clinical Trial Results - Celcuity's Phase 3 VIKTORIA-1 clinical trial for gedatolisib demonstrated significant improvement in median progression-free survival for patients with advanced breast cancer [2][6]. - The gedatolisib triplet regimen reduced the risk of disease progression or death by 76% compared to fulvestrant, while the doublet regimen showed a 67% reduction in risk [3][6]. Group 2: Adverse Events and Management Plans - Adverse events were minimal, with hyperglycemia reported in 9.2% of patients on the triplet regimen and 11.5% on the doublet, and treatment discontinuation due to adverse events was low at 2.3% for the triplet and 3.1% for the doublet [4]. - Celcuity's management plans to discuss the trial findings further in a webcast and conference call [4]. Group 3: Stock Performance - Currently, CELC is trading at $72.33, reflecting a 39.20% increase over the past year, with a market capitalization of approximately $3.07 billion [5][6]. - The stock has fluctuated between $71.50 and $83 today, with a 52-week high of $83 and a low of $7.57 [5].
Calidi Biotherapeutics to Present at the second annual Oncology Venture, Innovation, and Partnering Summit in Boston
Globenewswire· 2025-09-29 12:00
Core Insights - Calidi Biotherapeutics, Inc. is participating in the second annual Oncology Venture, Innovation, and Partnering Summit on September 29-30, 2025, in Boston, MA [1] - CEO Eric Poma will discuss the intersection of science and capital in cancer treatment development during a fireside chat on September 30, 2025 [2] - The company's proprietary RedTail platform is designed to deliver genetic medicines to metastatic sites while protecting the virus from immune clearance [4] Company Overview - Calidi Biotherapeutics is a clinical-stage immuno-oncology company focused on targeted therapies for delivering genetic medicines to distal disease sites [4] - The RedTail platform features an engineered enveloped oncolytic virus aimed at systemic delivery and targeting metastatic sites [4] - The lead candidate from the RedTail platform is currently in IND-enabling studies, targeting non-small cell lung cancer, ovarian cancer, and other high unmet medical need tumor types [5]