Core Insights - ANI Pharmaceuticals, Inc. announced results from the NEW DAY clinical trial evaluating ILUVIEN for diabetic macular edema (DME) [1][2] - The trial compared the mean number of supplemental aflibercept injections needed in patients treated with ILUVIEN versus those treated with aflibercept [2][3] - The primary endpoint was not met, but secondary endpoints showed a significant reduction in time to first supplemental injection for the ILUVIEN arm [2][4] Study Design and Results - The NEW DAY trial was a multicenter, randomized, active-controlled study involving 306 eyes of treatment-naïve DME patients [8] - Patients were randomized to receive either a single ILUVIEN injection or five monthly aflibercept injections, followed by supplemental injections as needed [2][8] - In the intent-to-treat population, the ILUVIEN arm had a mean of 2.4 supplemental injections compared to 2.5 in the aflibercept arm, which was not statistically significant (p=0.756) [2] - In a post-hoc analysis, the ILUVIEN arm showed a statistically significant reduction in supplemental injections (1.8 vs. 2.5, p=0.029) [3] Secondary Endpoints - The mean time from the last treatment injection to the first supplemental injection was significantly longer in the ILUVIEN arm (185.4 days) compared to the aflibercept arm (132.8 days, p<0.001) [2] - Visual acuity changes showed non-inferiority between the two arms, with a mean change of 1.8 letters in the ILUVIEN arm versus 5.5 letters in the aflibercept arm (p=0.080) [5] - Central subfield thickness changes were also similar, with ILUVIEN showing a mean change of -118.8 µm compared to -113.6 µm for aflibercept (p=0.709) [6] Safety Profile - ILUVIEN was well tolerated, with 41% of patients experiencing treatment-related adverse events, primarily cataracts and increased intraocular pressure [7] - Serious treatment-related adverse events were not reported in either arm [7] - The incidence of intraocular pressure increase was higher in the ILUVIEN arm (16%) compared to the aflibercept arm (3%) [7] Implications for Treatment - The results suggest that ILUVIEN may reduce the treatment burden for patients with DME, potentially supporting its earlier use in clinical practice [4][7] - The study highlights the multifactorial nature of DME and the need for effective treatment options [4]

CHENGDU, China, July 23, 2025 /PRNewswire/ -- BGM Group (the "Company" or "BGM") (NASDAQ: BGM) today announced that it will release its unaudited financial results for the first half 2025 before the U.S. financial markets open on July 24, 2025 Eastern Daylight Time.About BGM BGM Group Ltd. has a strategic focus on the technology fields of AI application, intelligent robots, algorithmic computing power, cloud computing, and biopharmaceuticals.In terms of AI application implementation, the group relies on adv ...

Compounds developed through collaboration with Variational AI show targeted activityVANCOUVER, British Columbia, July 23, 2025 (GLOBE NEWSWIRE) -- Rakovina Therapeutics Inc. (“Rakovina” or the “Company”) (TSX-V: RKV) (FSE: 7JO0), a biopharmaceutical company advancing next-generation cancer therapies through artificial intelligence (AI)-powered drug discovery, today announced meaningful progress in its AI-driven KT-5000AI program, advancing the development of precision ATR (Ataxia Telangiectasia and Rad3-rel ...

Core Insights - Ipsen announced changes to its Executive Committee, effective September 1, 2025, with Mari Scheiffele, Andreas Gerber, and Caroline Sitbon taking on new roles [1][5][7] Group 1: Executive Appointments - Mari Scheiffele will transition from leading commercial operations in the International Region to overseeing all medicines in Oncology and Rare Disease, focusing on product development and pipeline innovation [2][5] - Andreas Gerber joins Ipsen from Johnson & Johnson as Head of International, responsible for operations outside North America, leveraging his experience in Oncology to drive growth in Ipsen's therapeutic areas [3][5] - Caroline Sitbon has been promoted to General Counsel, leading legal and business ethics, and will also serve as the General Secretary of the Board of Directors [4][5] Group 2: Leadership Perspectives - CEO David Loew expressed confidence in the new appointments, highlighting the combination of internal promotions and new leadership as a strength for Ipsen's ongoing transformation [5] - Mari Scheiffele emphasized her commitment to innovation and excellence in her new role [5] - Andreas Gerber expressed enthusiasm for leading the International Region and making a positive impact on patients' lives [5] - Caroline Sitbon conveyed her excitement about ensuring compliance and integrity within the organization [5] Group 3: Company Overview - Ipsen is a global biopharmaceutical company focused on transformative medicines in Oncology, Rare Disease, and Neuroscience, with nearly 100 years of development experience [6][8] - The company operates in over 40 countries and provides medicines to patients in more than 80 countries [8]

Approval based on INAVO120 data showing the Itovebi™ (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone1 Up to 40% of ER-positive breast cancers have a PIK3CA mutation and are associated with poor prognosis; this approval helps address an urgent unmet need2-4Itovebi is the first PI3K-targeted therapy to significantly extend survival, reinforcing the need for biomarker testing at diagnosis5 Basel, 23 July 2025 - Roche (SIX: RO, ROG; OTCQX: R ...

Core Viewpoint - Pharvaris N.V. has announced the pricing of an underwritten offering of 8,250,000 ordinary shares at $20.00 per share and pre-funded warrants to purchase 500,000 ordinary shares at $19.99 each, aiming to raise approximately $175 million before expenses [1]. Group 1: Offering Details - The offering includes 8,250,000 ordinary shares priced at $20.00 each and pre-funded warrants for 500,000 shares at $19.99 each, with the total gross proceeds expected to be around $175 million [1]. - Pharvaris has granted underwriters a 30-day option to purchase an additional 1,312,500 ordinary shares at the public offering price [1]. - The offering is expected to close on or about July 24, 2025, subject to customary closing conditions [1]. Group 2: Company Background - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for treating bradykinin-mediated diseases, including hereditary angioedema (HAE) [5]. - The company aims to provide injectable-like efficacy and placebo-like tolerability with the convenience of oral therapies for preventing and treating angioedema attacks [5]. - Pharvaris is currently conducting pivotal Phase 3 studies for the prevention and on-demand treatment of HAE attacks [5]. Group 3: Underwriters - Morgan Stanley, Leerink Partners, Cantor, Oppenheimer & Co., and Van Lanschot Kempen are acting as joint book-running managers for the offering [2]. - The shares and pre-funded warrants are being offered under an effective shelf registration statement previously filed with the U.S. Securities and Exchange Commission [2].

Core Viewpoint - XORTX Therapeutics Inc. has successfully closed a non-brokered private placement, raising US$925,000 through the issuance of 1,267,123 units at a price of US$0.73 per unit, aimed at funding its gout and kidney disease programs [1][3]. Group 1: Offering Details - Each unit issued consists of one common share and one common share purchase warrant, with the warrant allowing the purchase of an additional common share at US$1.20 for a period of 60 months [2]. - If the closing price of the common shares exceeds US$2.00 for ten consecutive trading days, the warrants will be accelerated and will expire 30 business days after notice [2]. - The offering was approved by the TSX Venture Exchange, and the securities issued will not be subject to a statutory hold period [3]. Group 2: Use of Proceeds - The proceeds from the offering will be utilized for gout programs, general corporate purposes, and working capital [3]. Group 3: Related Party Transactions - The issuance of 8,191 units to an insider constitutes a related party transaction, with exemptions from formal valuation and minority shareholder approval requirements due to the transaction's value being below 25% of the company's market capitalization [5]. Group 4: Company Overview - XORTX Therapeutics is focused on developing therapies for gout and progressive kidney disease, with three advanced products: XRx-026 for gout, XRx-008 for ADPKD, and XRx-101 for acute kidney injury [7]. - The company is also developing XRx-225, a pre-clinical program for Type 2 diabetic nephropathy, targeting purine metabolism to reduce uric acid production [7].

NEW YORK, July 22, 2025 (GLOBE NEWSWIRE) -- Bernstein Liebhard LLP announces that a shareholder has filed a securities class action lawsuit on behalf of investors (the “Class”) who purchased or acquired: (a) Alto Neuroscience, Inc. (“Alto” or the “Company”) (NYSE: ANRO) common stock pursuant and/or traceable to the Offering Documents issued in connection with the Company’s initial public offering conducted on or about February 2, 2024 (the “IPO” or “Offering”); and/or (b) Alto securities between February 2, ...

ABTECT Phase 3 Topline Readout – Analyst and Investor Webcast July 22nd, 2025 Agenda 2 3 This presentation contains information pertaining to Abivax SA ("Abivax," the "Company," "we," "our" or "us"). Joseph B Kirsner Professor In Medicine Chief, Section of Gastroenterology, Hepatology and Nutrition Director, Inflammatory Bowel Disease Center Forward Looking Statements David Rubin, MD David T. Rubin, MD, is a renowned gastroenterologist whose work is focused on new clinical trial designs, novel measures and ...

ROCKVILLE, Md., July 22, 2025 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the Company expects to report financial and business results for the second quarter of 2025 after the market closes on Tuesday, August 5, 2025. Jack Khattar, President and CEO, and Tim Dec, Senior Vice President and CFO, will host a conference call to pre ...