BELTSVILLE, Md., Nov. 20, 2025 (GLOBE NEWSWIRE) -- NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, today announced that it will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference in New York City on Wednesday, December 3rd, at 11:00 am ET. A live audio webcast will be available through the Investors section of the company’s website at www.nex ...

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]

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]

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]

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].

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]

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 H.C. Wainwright 27th Annual Global Investment Conference in New York City on September 8 at 4:00 pm 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, and aims to advance treatments by leveraging its expertise in biological pathways and biomarkers [3].