Core Insights - GRI Bio, Inc. announced positive data from its Phase 2a clinical study of GRI-0621 for Idiopathic Pulmonary Fibrosis (IPF), indicating potential disease-modifying effects and therapeutic differentiation [1][10] Gene Expression and Mechanism - RNA-sequencing data showed significant improvement in genes related to lung injury, myofibroblast activation, and fibrosis progression in GRI-0621 treated subjects compared to placebo, validating previous biomarker findings [2][4] - The treatment demonstrated modulation of differentially expressed genes (DEGs) linked to key disease drivers, supporting a mechanism of fibrosis resolution and tissue repair rather than mere symptomatic management [3][4] Lung Regeneration Evidence - GRI-0621 treatment was associated with repair of the alveolar basement membrane and transition of AT2 to AT1 epithelial cells, indicating true lung regeneration rather than just slowing disease progression [5][6] - Earlier data indicated changes in type IV collagen serum biomarkers, suggesting an alveolar repair mechanism, which is now supported by new gene expression findings [6] Consistency Across Data - The new results reinforce previously announced topline data, showing that GRI-0621 treatment led to decreased neutrophil activity, reduced synthesis of fibrillar collagens, and lower levels of pro-fibrotic cytokines [8][9] - The treatment was well-tolerated, differentiating it from existing options that primarily slow disease decline while having significant side effects [7][10] Clinical Study Outcomes - The Phase 2a study met its primary endpoint with favorable safety and tolerability, and multiple secondary endpoints indicative of disease-modifying activity were achieved [12] - Improvements were noted in forced vital capacity (FVC), with twice as many GRI-0621-treated subjects experiencing no decline in FVC at 12 weeks compared to standard care [12]

WALTHAM, Mass., Jan. 28, 2026 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that the first patient has been dosed in ACCEL (ten-03-301), a Phase 3 clinical trial designed to assess the safety and efficacy of IBSRELA® (tenapanor) for the treatment of chronic idiopathic constipation (CIC) in adults. ACCEL is a multicenter, ...

Mainz, Germany, January 28, 2026 (GLOBE NEWSWIRE) – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) announced today that the Supervisory Board has appointed Kylie Jimenez to the Management Board as Chief People Officer (“CPO”) effective March 1, 2026. The appointment is in line with BioNTech’s strategy to become a multi-product oncology company by 2030 and underscores the importance of its global, highly skilled workforce in achieving this objective. In the newly created Management Board role, Kylie ...

-- Veteran Executive Brings More Than 25 Years of Clinical Development and Industry Expertise -- BRISBANE, Calif., Jan. 28, 2026 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced the appointment of Samit Hirawat, M.D., to its Board of Directors. This appointment increases the size of the company’s Board of Directors to 10 members. “Samit is an accomplished and ...

PETACH TIKVA, Israel, Jan. 28, 2026 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) ("PolyPid" or the "Company"), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it will report its fourth quarter 2025 financial results and operational highlights before the open of the U.S. financial markets on Wednesday, February 11, 2026. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results and provide an update on business operations. T ...

Company intends to file an IND in Q4 2026 for its first RedTail lead candidate, CLD-401, a systemically delivered and targeted genetic medicine engineered to deliver high concentrations of IL-15 superagonist to the tumor microenvironment in patients with metastatic disease.Calidi expects to present proof of concept data demonstrating the versatility of the RedTail platform and expanding its oncology platform with new payloads including the simultaneous delivery of tumor-localized BiTEs alongside T-cell ampl ...

Core Insights - OKYO Pharma Limited has successfully held a Type C meeting with the FDA regarding the Phase 2b/3 clinical trial of urcosimod for treating neuropathic corneal pain (NCP) [1][2] - The FDA's alignment on the clinical development program for urcosimod is seen as a significant step forward in addressing the unmet medical need for patients suffering from NCP [2][6] - Urcosimod has received the first IND to treat NCP and has been granted fast track designation by the FDA, with a 120-patient Phase 2b/3 study expected to begin in the first half of the year [2][7] Company Overview - OKYO Pharma is a clinical-stage biopharmaceutical company focused on developing therapies for neuropathic corneal pain and inflammatory eye diseases, with its shares traded on the Nasdaq Capital Market [7] - The company has recently completed a successful Phase 2 trial of urcosimod in NCP patients and is preparing for further clinical studies [7] Neuropathic Corneal Pain (NCP) - NCP is a chronic condition characterized by severe eye pain and sensitivity, often resulting from damage to corneal sensory nerves, with no FDA-approved therapies currently available [3] - Patients with NCP often rely on off-label treatments with limited success [3] Urcosimod Details - Urcosimod is a lipid-conjugated chemerin peptide agonist that has demonstrated anti-inflammatory and pain-reducing effects in preclinical models [4] - Positive data from a Phase 2 trial indicated significant pain reduction in NCP patients, supporting its potential as a treatment option [4] FDA Meeting Highlights - The FDA confirmed that the proposed primary endpoint of Visual Analogue Scale (VAS) pain reduction at Week 12 is clinically meaningful, with a ≥2-point improvement indicating a significant treatment effect [6] - The FDA provided guidance on statistical analysis and endorsed the study design, sample size, and powering assumptions, which de-risks the pathway to a pivotal trial [6]

Company Overview - Travere Therapeutics, Inc. is a biopharmaceutical company focused on developing therapies for individuals with rare kidney and metabolic diseases in the United States [2]. Investigation Details - Robbins Geller Rudman & Dowd LLP is investigating potential violations of U.S. federal securities laws related to Travere, specifically whether the company and certain executives made materially false and/or misleading statements or omitted material information regarding Travere's business and operations [1][2]. Law Firm Background - Robbins Geller is recognized as one of the leading law firms in securities fraud and shareholder litigation, having secured over $2.5 billion for investors in securities-related class action cases in 2024, which is more than the next five law firms combined [3]. - The firm has been ranked 1 in the ISS Securities Class Action Services rankings for four out of the last five years for achieving the most monetary relief for investors [3]. - Robbins Geller has a significant history of obtaining large securities class action recoveries, including the largest ever recovery of $7.2 billion in the Enron Corp. securities litigation [3].

Safety concern warrants reevaluation of study design, including enrollment criteria About CalciMedica CalciMedica is a clinical-stage biopharmaceutical company developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for inflammatory and immunologic diseases. CalciMedica's proprietary technology targets the inhibition of CRAC channels to modulate the immune response and protect against tissue cell injury, with the potential to provide therapeutic benefits in in serious and life ...

Interim results from Phase 2b clinical trial of RAD 101 showed 92% of evaluable participants met the primary endpoint of MRI concordance in imaging study of patients with brain metastases Interim data from additional Cohorts of the Phase 1 clinical trial of RAD 202 and RAD 204 in advanced solid tumors are expected in mid-2026 Cash and cash equivalents of approximately $34.52 million provide runway into 2027 to advance pipeline of high value radiotherapeutic programs through key clinical and regulatory mile ...