Tag: biologics

MALVERN, Pa., June 16, 2025 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) amendment to initiate a Phase 2/3 pivotal confirmatory trial of OCU410ST, a modifier gene therapy candidate being developed for all Stargardt disease (ABCA4-associated retinopathies). The FDA previously granted Rare Pediatric Disease Designation (RPDD) and Orphan Drug Designation for OCU410ST for the treatment of ABCA4-associated retinopathies including Stargardt disease, retinitis pigmentosa 19, and cone-rod dystrophy 3.

HAMPTON, N.J., June 14, 2025 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced data demonstrating that barzolvolimab profoundly improves angioedema at 52 weeks in the Company’s Phase 2 clinical trial in chronic spontaneous urticaria (CSU). Angioedema, characterized by swelling of the deeper dermal layers of the skin and mucous membranes, is a painful, debilitating symptom of CSU that has significant impact on quality of life. It commonly affects the face (lips and eyelids), hands, feet, and genitalia but can also involve the tongue, uvula, soft palate, and pharynx¹.

LEXINGTON, Mass., June 13, 2025 (GLOBE NEWSWIRE) -- Rapid Micro Biosystems, Inc. (Nasdaq: RPID) (the “Company”), an innovative life sciences technology company providing mission critical automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products, today announced the grants on June 2, 2025, of (i) 160,000 restricted stock units (“RSUs”) of the Company’s Class A common stock (“Common Stock”) and (ii) non-qualified stock options to purchase an aggregate of 250,000 shares of Common Stock (the “Options”) as a material inducement to employment to a new employee. All such equity awards were made under the Company’s Inducement Plan, as amended (the “Inducement Plan”) and were approved by a majority of the independent directors of the Board of Directors or a duly authorized committee thereof in accordance with Nasdaq Listing Rule 5635(c)(4). The equity awards are subject to the terms and conditions of the Inducement Plan, and the terms and conditions of the applicable stock option and RSU award agreements covering the grants.