Tag: diseases

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

JENA, Germany, July 11, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced that it has received a written notice (the “Notice”), dated July 11, 2025, from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the last thirty (30) consecutive business days, the bid price for the Company’s common shares had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq under Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Rule”).

EMERYVILLE, Calif., July 11, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced that on July 8, 2025, the compensation committee of the Company’s board of directors granted one new non-executive employee 4,600 Restricted Stock Units (RSUs). The RSUs were granted pursuant to the Company’s 2025 Employment Inducement Award Plan, which was approved by the Company’s board of directors in February 2025 under Rule 5635(c)(4) of The Nasdaq Global Market for equity grants to induce new employees to enter into employment with the Company.

Saint Herblain (France), July, 11 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) will lift the temporary restriction on vaccinating people aged 65 years and above after concluding a thorough review of Valneva’s single-dose chikungunya vaccine IXCHIQ^® by EMA’s safety committee (PRAC).

The global adrenal crisis market is witnessing significant growth driven by increasing adrenal insufficiency recognition and rising adrenal crisis incidents. The expanding global prevalence of autoimmune diseases and corticosteroid use for chronic conditions further accelerates market demand. However, challenges such as high treatment costs, limited awareness in low-income regions, and diagnostic complexities may slow adoption in emerging markets. Between 2025-2035, advancements in diagnostic technologies and innovative therapies are expected to bolster market growth, though access issues remain crucial. Key players like Eton Pharmaceuticals, Antares Pharma, and Pfizer are leading with product innovation and strategic partnerships.

– Absence of neurotoxicity of any grade in low-volume disease to-date –

HOUSTON, July 11, 2025 (GLOBE NEWSWIRE) -- FibroBiologics, Inc. (Nasdaq: FBLG) (“FibroBiologics”), a clinical-stage biotechnology company with 275+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, today announced that Founder and Chief Executive Officer, Pete O’Heeron, will present at the Advanced Wound Care Summit USA in Boston, Massachusetts, on July 15, 2025. The presentation will include recent research advances using fibroblast-based technology for indications such as wound healing and psoriasis.

SOUTH SAN FRANCISCO, Calif., July 11, 2025 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”, “Company”), a clinical stage biopharmaceutical company focused on improving patient outcomes through best-in-class therapies for liver and viral diseases, today announced that the Compensation Committee of the Company’s Board of Directors granted non-qualified stock options to purchase an aggregate of 2,100 shares of the Company’s stock (the “Inducement Grant”) to newly hired employees on July 8, 2025 (the “Grant Date”), in connection with the commencement of employment.

BRISBANE, Calif. , July 10, 2025 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA) today announced that on July 6, 2025, the Compensation Committee granted inducement awards consisting of non-qualified stock options to purchase 133,500 shares of Class A common stock and restricted stock units (RSUs) for 73,695 shares of Class A common stock to fifteen (15) new employees under the Inducement Plan. The Compensation Committee approved the awards as an inducement material to the new employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4).