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Clearside Biomedical Announces Plan to Explore Strategic Alternatives to Advance its Proprietary Suprachoroidal Space (SCS®) Delivery Platform and Promising Ophthalmology Pipeline
Globenewswire· 2025-07-17 11:05
Core Insights - Clearside Biomedical, Inc. is exploring a range of strategic alternatives to enhance its SCS platform and drug development pipeline, aiming to maximize stockholder value [1][2][3] - The company has retained Piper Sandler to assist in the strategic evaluation process, considering options such as asset sales, licensing, collaborations, and mergers [1][2] - Clearside's SCS Microinjector is a validated delivery platform for therapies targeting serious retinal diseases, with five commercial and late-stage development collaborations [1][4][10] Company Highlights - The SCS Microinjector enables a non-surgical, repeatable procedure for targeted delivery of therapies to the macula, retina, and choroid, potentially preserving and improving vision in patients with sight-threatening eye diseases [4][10] - Clearside's lead program, CLS-AX, is in development for the treatment of wet age-related macular degeneration (AMD) and has shown positive Phase 2b clinical data [2][8][10] - The company has successfully navigated the FDA regulatory pathway for its first product, XIPERE, which is approved for suprachoroidal use [8][10] Internal Pipeline - CLS-AX is a proprietary axitinib injectable suspension being developed for wet AMD, with a Phase 3 program planned to maximize its commercial potential [8][10] - The company is also evaluating small molecules for treating geographic atrophy (GA) and diabetic macular edema (DME), addressing high unmet medical needs in retinal diseases [8][10] External Collaborations - Clearside has established partnerships with various companies utilizing its SCS injection platform for other ophthalmic therapeutic innovations, including gene therapies and anti-tumor agents [10][13]
NLS Pharmaceutics Highlights Continued Progress in iTOL-102 Diabetes Program as BIRD Foundation Approves Additional Milestone Payment to Kadimastem and iTolerance for Continued Co-Development of Type 1 Diabetes Cell Therapy
Prnewswire· 2025-07-17 11:00
This news follows the February 2025 announcement by NLS and Kadimastem regarding the successful completion of a Type B Pre-IND meeting with the U.S. Food and Drug Administration (the "FDA"). The FDA provided constructive guidance on the clinical development pathway, enabling the companies to advance toward initiating First-in-Human clinical trials of iTOL-102. The BIRD Foundation's approval of a fifth disbursement of funds is based on the program's recent scientific and regulatory progress. The milestone pa ...
Immuron - FY25 global sales exceed projection, up 49% on prior year
Globenewswire· 2025-07-17 10:00
Sales Highlights (unaudited): Global Annual sales AUD$7.3 million up 49% on prior yearJune 2025 Quarter AUD$2.0 million up 55% on prior year Australia Annual sales AUD$5.2 million up 40% on prior yearJune 2025 Quarter AUD$1.5 million up 58% on prior year North America Annual sales AUD$2.0 million up 76% on prior yearJune 2025 Quarter AUD$0.5 million up 49% on prior year MELBOURNE, Australia, July 17, 2025 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integra ...
Ascentage Pharma Announces Closing of Placement Shares in Top-Up Placement
Globenewswire· 2025-07-17 08:30
Core Viewpoint - Ascentage Pharma Group International has successfully completed an offshore placement of 22 million ordinary shares, raising approximately HKD1,492 million (around US$190.1 million) to support its commercialization and global clinical development efforts in the biopharmaceutical sector [1][2]. Group 1: Offshore Placement Details - The offshore placement involved the sale of 22 million ordinary shares at a price of HKD68.60 per share, with the shares representing approximately 6.29% of the company's issued share capital prior to the placement [1]. - The net proceeds from the placement will be utilized for commercialization efforts, global clinical development of core pipeline candidates, and strengthening global operations [2]. Group 2: Regulatory and Transactional Aspects - The offshore placement was conducted outside of the United States and was not offered to the public, complying with Regulation S under the Securities Act of 1933 [3]. - The Replacement Shares will be issued in a transaction not involving a public offering, and the securities have not been registered under the Securities Act [3]. Group 3: Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancers, with a rich pipeline of innovative drug candidates targeting key proteins in the apoptotic pathway and next-generation kinase inhibitors [5]. - The lead asset, olverembatinib, is a third-generation BCR-ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia (CML) and is currently undergoing global registrational Phase III trials [6]. - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for the treatment of relapsed and/or refractory chronic lymphocytic leukemia (CLL) and is involved in multiple global registrational Phase III trials [7].
Ascentage Pharma Announces Closing of Placement Shares in Top-Up Placement
GlobeNewswire News Room· 2025-07-17 08:30
Core Viewpoint - Ascentage Pharma Group International has successfully completed an offshore placement, raising approximately HKD1,492 million (around US$190.1 million) to support its commercialization efforts and global clinical development [1][2]. Group 1: Offshore Placement Details - The company closed an offshore placement involving the sale of 22 million ordinary shares at HKD68.60 per share, with the shares representing about 6.29% of the company's issued share capital prior to the placement [1]. - The vendor, an affiliate of the CEO, will subscribe for the same number of new shares at the same price, resulting in net proceeds for the company [1]. - The issuance of the new shares is expected to occur by July 28, 2025 [1]. Group 2: Use of Proceeds - The net proceeds from the offshore placement will be utilized for commercialization efforts, enhancing patient access, advancing global clinical development of core pipeline candidates, and strengthening global operations through infrastructure and working capital [2]. Group 3: Company Overview - Ascentage Pharma is a global biopharmaceutical company focused on addressing unmet medical needs in cancer treatment, with a robust pipeline of innovative drug candidates [5]. - The lead asset, olverembatinib, is a third-generation BCR-ABL1 inhibitor approved in China for specific types of chronic myeloid leukemia (CML) [6]. - The second lead asset, lisaftoclax, is a novel Bcl-2 inhibitor recently approved for treating relapsed and/or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) [7].
Press Release: Sanofi announces extension of Blueprint tender offer
Globenewswire· 2025-07-17 05:00
Core Points - Sanofi has extended its tender offer to acquire all outstanding shares of Blueprint Medicines Corporation at a price of $129.00 per share in cash, plus contingent rights for additional payments of up to $6.00 per share based on specified milestones [1][2] - The expiration date for the tender offer has been moved to 17:00 EDST on July 17, 2025, from the previous date of July 16, 2025 [2] - As of July 16, 2025, approximately 29,742,419 shares, or 45.85% of Blueprint's total outstanding shares, have been validly tendered, with an additional 23,400,152 shares tendered by notice of guaranteed delivery, representing 36.08% of the outstanding shares [3] Offer Details - The tender offer is subject to conditions outlined in the offer to purchase, including the requirement for a majority of Blueprint's outstanding shares to be tendered [5] - The offer is being managed by Rothko Merger Sub, Inc., a wholly owned subsidiary of Sanofi, and Innisfree M&A Incorporated is acting as the information agent for the offer [4][6] Company Background - Sanofi is a research and development-driven biopharmaceutical company focused on improving lives through innovative medicines and vaccines, leveraging its understanding of the immune system [7]
Nature Medicine Published Phase 1 Results of Innovent Biologics' Anti-CLDN18.2 ADC (IBI343) in Patients with Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Prnewswire· 2025-07-17 00:00
CLDN 18.2 is a tight junction protein expressed in differentiated epithelial cells on the gastric mucosa under normal physiological conditions. Previous studies have revealed that Claudin18.2 is highly expressed in multiple types of cancer, including gastric cancer (60-80%), pancreatic cancer (50%), esophageal carcinoma (30-50%), and lung cancer (40-60%). Targeting CLDN18.2 with monoclonal antibodies (mAbs) and ADCs represents a promising new approach for treating gastric cancer. This published study is a g ...
Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Hims & Hers and Sarepta and Encourages Investors to Contact the Firm
GlobeNewswire News Room· 2025-07-16 23:53
Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In Hims & Hers (HIMS) or Sarepta (SRPT) To Contact Him Directly To Discuss Their Options If you purchased or acquired securities in any of the above companies during their class period and would like to discuss your legal rights, call Bragar Eagel & Squire partner Brandon Walker or Marion Passmore directly at (212) 355-4648 NEW YORK, July 16, 2025 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a national ...
Avicanna Announces Closing of Non-Brokered Private Placement
GlobeNewswire News Room· 2025-07-16 21:30
NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES. ANY FAILURE TO COMPLY WITH THIS RESTRICTION MAY CONSTITUTE A VIOLATION OF UNITED STATES SECURITIES LAWS TORONTO, July 16, 2025 (GLOBE NEWSWIRE) -- Avicanna Inc. (“Avicanna” or “Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products is pleased to announce that it has closed a non-brok ...
Avicanna Announces Closing of Non-Brokered Private Placement
Globenewswire· 2025-07-16 21:30
NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES. ANY FAILURE TO COMPLY WITH THIS RESTRICTION MAY CONSTITUTE A VIOLATION OF UNITED STATES SECURITIES LAWS TORONTO, July 16, 2025 (GLOBE NEWSWIRE) -- Avicanna Inc. (“Avicanna” or “Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a biopharmaceutical company focused on the development, manufacturing, and commercialization of plant-derived cannabinoid-based products is pleased to announce that it has closed a non-brok ...