Tag: gene

Bragar Eagel & Squire, P.C. Litigation Partner Brandon Walker Encourages Investors Who Suffered Losses In Hims & Hers (HIMS), Sarepta (SRPT), or PetCo (WOOF) To Contact Him Directly To Discuss Their Options

CAMBRIDGE, Mass., July 11, 2025 (GLOBE NEWSWIRE) -- Fulcrum Therapeutics, Inc.^® (Nasdaq: FULC), a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases, today announced that the company granted non-statutory stock options to a new employee. Fulcrum granted stock options to purchase shares of the company’s common stock pursuant to the company’s 2022 Inducement Stock Incentive Plan, as amended, or the plan, as an inducement material to the new employee entering into employment with Fulcrum in accordance with Nasdaq Listing Rule 5635(c)(4).

Complete Response Letter (CRL) cited specific chemistry, manufacturing and controls (CMC) related observations that are resolvable

SAN CARLOS, Calif., July 10, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced the appointment of Marc. R Theoret, M.D. to assume the newly created position of Senior Vice President, Regulatory Strategy, where he will focus on clinical regulatory strategy for Iovance’s pipeline. Effective immediately, Dr. Theoret will report to Dr. Raj K. Puri, M.D., Ph.D., Chief Regulatory Officer.

Outcome of Regenerative Medicine Advanced Therapy (RMAT) meeting provides clear regulatory pathway to approval in a continuous Phase 1 / 2 / 3 study, avoiding the requirement for an additional registrational study and accelerating time to potential approval

The Viral Vectors and Plasmid DNA Manufacturing Market forecast indicates a surge past $6 billion by 2025, driven by gene therapy advancements. The report highlights market dynamics, growth prospects, and regulatory challenges impacting this sector. Discover innovative opportunities and key players in this evolving landscape.

London – 9 July 2025 - Purespring Therapeutics, a precision nephrology company focused on transforming the treatment of kidney diseases, today announces that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PS-002, enabling the initiation of a Phase I/II clinical trial in patients with primary IgA nephropathy (IgAN).