PRINCETON, N.J., Sept. 2, 2025 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that Christopher J. Schaber, Ph.D., President and Chief Executive Officer, has been invited to deliver a corporate presentation at the upcoming H.C. Wainwright 27th Annual Global Investment Conference. The conference will be held September ...

Core Viewpoint - CorMedix Inc. has completed the acquisition of Melinta Therapeutics LLC, which is expected to enhance its revenue base and product portfolio, particularly in the hospital space, while providing significant growth opportunities [2][4]. Strategic and Financial Benefits - The acquisition is described as transformational, expanding CorMedix's commercial product portfolio with seven innovative drug products and a pipeline that has near-term revenue growth potential [4][5]. - Pro forma combined revenues for 2025 are now estimated to be between $325 million and $350 million, with synergized adjusted EBITDA projected to be between $165 million and $185 million [5][4]. - Melinta's portfolio generated total revenues of $120 million in 2024 and is expected to deliver between $125 million and $135 million for FY 2025 [5]. - The acquisition is anticipated to be accretive to earnings per share (EPS) with double-digit accretion expected in 2026 [1][5]. Product Portfolio and Growth Potential - The acquisition strengthens CorMedix's portfolio with multiple growth-driving assets, including marketed products such as MINOCIN, REZZAYO™, and VABOMERE, which will enhance revenue and reach in infectious disease [5]. - REZZAYO™ has ongoing Phase III studies that, if successful, could support a supplemental New Drug Application for expanded use, with peak annual sales potential exceeding $200 million [5]. - The combination is expected to achieve annual run-rate synergies of approximately $35 million to $45 million in the near term [5]. Leadership and Organizational Structure - The senior leadership team of the newly merged company will consist of executives from both CorMedix and Melinta, maintaining their current roles unless otherwise specified [4][11]. - The company plans to finalize a permanent commercial organization structure by the end of the year [6]. Acquisition Terms and Financing - CorMedix paid $300 million for the acquisition, consisting of $260 million in cash and $40 million in equity, funded through existing cash and a $150 million convertible debt financing [7]. - An additional regulatory milestone payment of up to $25 million is contingent upon FDA approval for REZZAYO™'s expanded indication [7].

JERUSALEM, Sept. 2, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company focused on developing novel and innovative biological drug candidates for the treatment of inflammation and immunology (I&I) related diseases and on providing CDMO services through its Scinai Bioservices business unit, today announced its financial results for the six months ended June 30, 2025.Six-Month 2025 Financial Summary  Revenues for the six months ended Jun ...

Core Insights - Veeva Systems has seen significant adoption of its Veeva RIM platform, with over 450 companies, including 19 of the top 20 biopharmaceutical firms, utilizing it for regulatory information management [1][6] - The company has formed strategic partnerships with Accumulus Technologies and DNAnexus to enhance connectivity and integration with multiple health authority platforms, aiming to improve efficiency and compliance in regulatory processes [1][4][5] Veeva RIM Adoption and Impact - The adoption of Veeva RIM is helping regulatory teams improve efficiency and reduce cycle times, providing an end-to-end solution that accelerates time to market and enhances collaboration among global stakeholders [2][3] - More than 85 organizations are leveraging Veeva Submissions Publishing to implement continuous publishing, which reduces rework and accelerates submission timelines [3] Strategic Partnerships - The partnership with Accumulus Technologies aims to modernize information sharing with over 70 regulatory agencies worldwide, facilitating seamless regulatory submissions and expediting treatment delivery to patients [4] - Integrating DNAnexus Trusted Regulatory Spaces with Veeva RIM is expected to enhance data sharing capabilities for inter-agency collaboration and expedite regulated product approvals [5] Company Overview - Veeva Systems provides cloud-based software, data, and consulting services tailored for the life sciences industry, serving over 1,500 customers, including major biopharmaceutical companies and emerging biotechs [6]

WATERTOWN, Mass., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company with a therapeutics pipeline consisting of seven programs that target novel mechanisms of action for a broad range of underserved, prevalent diseases, today announced that the Company will participate in three investor conferences in September. 2025 Wells Fargo Healthcare Conference: Members of management will be available for one-on-one meetings on Thursday, September ...

LA JOLLA, Calif., Sept. 2, 2025 /PRNewswire/ -- CalciMedica Inc. ("CalciMedica" or the "Company") (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, today announced that Rachel Leheny, Ph.D., Chief Executive Officer, will present at the H.C. Wainwright 27th Annual Global Investment Conference on Monday, September 8, 2025, at 3:30 p.m. ET.A li ...

Core Viewpoint - Olema Pharmaceuticals has announced a new clinical trial collaboration with Pfizer to evaluate the combination of palazestrant and atirmociclib in treating metastatic breast cancer, aiming to establish palazestrant as a potential backbone endocrine therapy [1][2] Group 1: Clinical Trial Collaboration - The collaboration involves a Phase 1b/2 study to assess the safety and combinability of palazestrant and atirmociclib in patients with ER+/HER2- metastatic breast cancer [1][2] - Pfizer will supply atirmociclib for the study, while Olema will lead the trial [2] - This marks Olema's second clinical trial agreement with Pfizer, following a previous agreement in November 2020 [3] Group 2: Product and Pipeline Information - Olema's lead product candidate, palazestrant (OP-1250), is an orally available complete estrogen receptor antagonist and selective ER degrader, currently in a Phase 3 trial called OPERA-01 [4][5] - Palazestrant has received FDA Fast Track designation for treating ER+/HER2- metastatic breast cancer that has progressed after endocrine therapy [5] - The company is also developing OP-3136, a KAT6 inhibitor, which is in a Phase 1 clinical study [4] Group 3: Future Plans and Expectations - The new study is expected to involve approximately 35 patients, with initiation anticipated in the second half of 2025 [6] - Successful results from this study could inform a pivotal Phase 3 trial for the combination therapy in the frontline metastatic breast cancer setting [6]

SOUTH SAN FRANCISCO, Calif., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with kidney and metabolic diseases, today announced the appointment of Misbah Tahir as chief financial officer (CFO), effective immediately. “We’re thrilled to welcome Misbah as Maze’s Chief Financial Officer at such a pivotal time for the company. We are preparing for several key milestones, including da ...

REHOVOT, Israel, and HOBOKEN, N.J., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a global biopharmaceutical company with a portfolio of marketed products indicated for rare and serious conditions and a leader in the specialty plasma-derived field, today announced that Amir London, Chief Executive Officer, will participate in the 2025 Wells Fargo Healthcare Conference and the H.C. Wainwright 27th Annual Global Investment Conference. Mr. London is scheduled to present at the 2 ...

Core Viewpoint - FibroGen, Inc. has successfully completed the sale of its China subsidiary to AstraZeneca for approximately $220 million, significantly enhancing its financial position and extending its cash runway into 2028 [1][2][7] Financial Impact - The total consideration for the sale includes $85 million in enterprise value and about $135 million in net cash held in China, marking a $60 million increase from initial guidance [1][7] - Following the sale, FibroGen repaid its term loan facility to Morgan Stanley Tactical Value for approximately $81 million, simplifying its capital structure [2][7] Clinical Development Plans - The company is on track to initiate the Phase 2 monotherapy trial of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) in the third quarter of 2025 [2][4][7] - FibroGen intends to submit the Phase 3 protocol for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the fourth quarter of 2025, following a positive meeting with the U.S. FDA [3][4] Product Rights and Development - FibroGen retains rights to roxadustat in the U.S. and all markets not licensed to Astellas, excluding China and South Korea [3] - The company continues to advance the clinical development of FG-3246 and its companion diagnostic FG-3180 [4][5]