– NDA submitted in 1Q 2025 for ziftomenib for the treatment of adult patients with relapsed or refractory AML with an NPM1 mutation – – Data from Phase 1b/2 registration-directed trial of ziftomenib selected for oral presentation at ASCO Annual Meeting – – $45.0 million milestone payment earned for NDA submission under collaboration agreement with Kyowa Kirin – – First patients dosed in Phase 1 trial of ziftomenib plus imatinib in GIST – – $703.2 million in pro forma cash, together with anticipated collabor ...

First real-world dataset with integrated clinical and multiomic insights from 25,000 patients treated with GLP-1 therapiesDataset will advance development of GLP-1 therapies in new indications and accelerate discovery of novel drug targets in patients who are unresponsive to therapiesSAN DIEGO, May 1, 2025 /PRNewswire/ -- Illumina, Inc. (NASDAQ: ILMN), and Ovation.io, Inc., an organization dedicated to building best-in-class multiomics datasets, today announced the development of the largest commercially av ...

WILMINGTON, Del., May 01, 2025 (GLOBE NEWSWIRE) -- Prelude Therapeutics Incorporated (Prelude) (Nasdaq: PRLD), a clinical-stage precision oncology company, announced today that the Company will participate in the Citizens Life Sciences Conference taking place in New York on May 7, 2025. On Wednesday, May 7, 2025, at 11:00 a.m. ET, Kris Vaddi, Ph.D., Chief Executive Officer of Prelude, Jane Huang, M.D., President and Chief Medical Officer, and Peggy Scherle, Ph.D., Chief Scientific Officer will participate i ...

Financial Data and Key Metrics Changes - Net revenue for Q1 2025 was $26.6 million, a decrease from $46.5 million in Q1 2024, primarily due to a temporary payment suspension from TRICARE and slowing order growth [20][21] - Gross profit in Q1 2025 was $18.2 million, representing 69% of revenue, compared to $37.2 million or 80% of revenue in Q1 2024 [20][21] - Net loss for Q1 2025 was $10.4 million, or $0.33 per share, compared to a net income of $10,000 in the previous year [21][22] Business Line Data and Key Metrics Changes - Device revenue was $11.9 million, while supplies revenue was $14.7 million in Q1 2025 [20] - Non-NexWave product order percentage increased to 34% in Q1 2025, up from an average of 30% in the previous year [13] Market Data and Key Metrics Changes - The company is experiencing a temporary payment suspension from TRICARE, which has affected revenue recognition [6][12] - The patient monitoring market is identified as a multibillion-dollar opportunity, with the company planning to enter with a superior product [19] Company Strategy and Development Direction - The company is restructuring to operate without TRICARE business in a worst-case scenario and is focusing on new revenue opportunities [9][10] - The company aims to generate revenue exceeding $800 million annually in the long term [25] - The launch of the Nico pulse oximeter is anticipated to significantly impact the patient monitoring market, with a focus on improving health equity [19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about growth prospects despite current challenges, emphasizing a commitment to high-quality service and technology [24][25] - The company expects to receive a response from TRICARE regarding the payment suspension within 40 days [24] Other Important Information - The company has reduced overall staff by approximately 15%, primarily in the corporate office, which is expected to result in annual savings of about $35 million [13] - The company maintains a strong balance sheet with $40 million in working capital and approximately $24 million in cash [22] Q&A Session Summary Question: Insights into TRICARE conversations and potential domino effects - Management indicated that the claims from TRICARE were vague and emphasized compliance with guidelines, stating there are no current issues with other payers [28][30][31] Question: Clarification on Q1 revenue miss and future guidance - The revenue miss was attributed to multiple factors, and management is waiting for clarity on TRICARE before providing full-year guidance [32][34][35] Question: Confirmation of TRICARE payments in Q1 and Q2 guidance - Management confirmed that Q1 revenue and guidance for Q2 do not include TRICARE payments, and they expect reimbursement for claims once the suspension is lifted [37][38] Question: Plans if TRICARE outcome is negative - The company plans to refocus its sales force to generate revenue from other areas if TRICARE payments are not restored [40][41] Question: Expected revenue from Nico post-approval - Management expects to launch Nico immediately upon FDA clearance, with revenue anticipated in 2026 [42]

Phase 1a dose-escalation study data update: treatment with NXP900 resulted in exposure levels leading to robust pharmacodynamic responses across a range of tolerated doses; NXP900 has an acceptable safety profile, dose limiting toxicity dose level has not been identified in doses up to 250 mg/day Preclinical posters strengthen the NXP900 clinical development strategy as single agent in biomarker-targeted cancers and in combination with market leading therapies to overcome resistance in NSCLC Fort Lee, NJ ...

Core Points - iBio, Inc. has entered into an agreement with existing institutional investors to exercise warrants for 5,626,685 shares at a reduced price of $1.11 per share, generating approximately $6.2 million in gross proceeds [1][2] - In exchange for exercising the existing warrants, investors will receive new warrants to purchase up to 11,253,370 shares at an exercise price of $0.86, expiring in five years [2] - The transaction is expected to close around April 30, 2025, pending customary closing conditions [2][3] Financial Details - The gross proceeds from the warrant exercise will be approximately $6.2 million before deducting advisory fees and other expenses [1] - The new warrants allow for the purchase of shares at a significantly lower price compared to the existing warrants [2] Company Overview - iBio, Inc. is a biotech company focused on developing precision antibody therapies using AI and advanced computational biology for various diseases [6] - The company aims to transform drug discovery and accelerate development timelines to address unmet medical needs [6]

CAMBRIDGE, Mass., April 28, 2025 (GLOBE NEWSWIRE) -- Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading-edge computational and experimental technologies, will report first quarter 2025 financial results and corporate highlights after the U.S. financial markets close on Monday, May 5, 2025. About Relay Therapeutics Relay Therapeutics (Nasdaq: RLAY) is a clinical-stage precision medicine company transforming the dru ...

Tempus AI, Inc. (TEM) is scheduled to report first-quarter fiscal 2025 results on May 6.In the last reported quarter, the company’s adjusted loss of 18 cents was wider than the Zacks Consensus Estimate of a loss of 15 cents per share. Tempus AI, which went public in June 2024,  exceeded estimates in one of the trailing three quarters and missed in two, the average negative earnings surprise being 6.46%. (Find the latest EPS estimates and surprises on Zacks Earnings Calendar).The Zacks Consensus Estimate for ...

Core Insights - Kura Oncology has initiated the KOMET-015 Phase 1 clinical trial to evaluate ziftomenib in combination with imatinib for patients with advanced gastrointestinal stromal tumors (GIST) after imatinib failure [1][3] - The combination of ziftomenib and imatinib has shown robust and durable antitumor activity in both imatinib-sensitive and imatinib-resistant GIST preclinical models [1][2] Company Overview - Kura Oncology is a clinical-stage biopharmaceutical company focused on precision medicines for cancer treatment, with ziftomenib being a key investigational menin inhibitor [8] - The company has received Breakthrough Therapy Designation from the FDA for ziftomenib in treating relapsed/refractory NPM1-mutant acute myeloid leukemia (AML) [7][8] Clinical Trial Details - The KOMET-015 trial is designed to assess the safety, tolerability, and preliminary antitumor activity of ziftomenib combined with imatinib in adults with GIST who have shown disease progression on imatinib [3][4] - The trial will evaluate primary objectives including safety and tolerability, and secondary endpoints such as overall response rate (ORR) and progression-free survival (PFS) [3] Market Context - Approximately 4,000 to 6,000 new cases of GIST are diagnosed annually in the U.S., with limited treatment options available for advanced cases [2][5] - Most patients develop resistance to imatinib within two years, highlighting the need for new therapeutic options [2][6] Preclinical Findings - Preclinical studies indicate that the combination of ziftomenib and imatinib exerts antitumor activity through a synthetic lethal mechanism, targeting vulnerabilities in GIST tumors [2][3] - The combination has the potential to delay or overcome resistance to imatinib in patients [2]

Patent Supporting Gout and Autosomal Dominant Polycystic Kidney Disease Programs CALGARY, Alberta, April 28, 2025 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the "Company") (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late stage clinical pharmaceutical company focused on developing innovative therapies to treat gout and progressive kidney disease , is pleased to announce receipt of notification that the patent "Xanthine Oxidase Inhibitor Formulations" will be granted by the European Patent Of ...