THE WOODLANDS, Texas, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that Company management will participate in a fireside chat at Citi's Biopharma Back to School Conference on Wednesday, September 3 at 1:45 p.m. ET and at the H.C. Wainwright 27th Annual Global Investment Conference on Monday, September 8 at 3:00 p.m. ET. The live events and replays of the presentations can be accessed via the Events page of the Company’s website at https://investors.lexpharm ...

BRANFORD, Conn., Aug. 27, 2025 /PRNewswire/ -- Azitra, Inc. ("Azitra") (NYSE American: AZTR), a clinical stage biopharmaceutical company focused on developing innovative therapies for precision dermatology, today announced the dosing of the first patient in its Phase 1/2 clinical trial of ATR04-484, a topically applied live biotherapeutic product candidate designed to treat EGFR inhibitor ("EGFRi")-associated rash. Azitra has received Fast Track designation from the FDA for EGFRi associated rash, which impa ...

Core Insights - Cellectar Biosciences, Inc. announced the acceptance of an abstract for oral presentation at the AACR Special Conference on Pediatric Cancer, focusing on interim data from the CLOVER-2 Phase 1b study of iopofosine I 131 in pediatric high-grade glioma patients [1][2] Group 1: Presentation Details - The oral presentation titled "Precision Radiotherapy for Incurable Brain Tumors: Phase 1b Dose & Regimen Optimization Study of Iopofosine I 131 in Inoperable Relapsed or Refractory Pediatric High-Grade Glioma, Interim Data Assessment" is scheduled for September 26, 2025, at 2:50 pm Eastern time [3] - Jarrod Longcor, the chief operating officer of Cellectar, will present the findings during the plenary session [3] Group 2: Background on Pediatric High-Grade Gliomas - Pediatric high-grade gliomas are aggressive tumors affecting the brain and central nervous system, with poor median progression-free survival (PFS) of approximately 2.25 months and overall survival (OS) of about 5.6 months for relapsed cases [4] Group 3: CLOVER-2 Trial Overview - The ongoing Phase 1b trial of iopofosine I 131 includes children, adolescents, and young adults with relapsed or refractory pediatric high-grade gliomas across multiple sites in the U.S. and Canada [5] - The study evaluates the safety and tolerability of two dosing cohorts, with one cohort receiving 20 mCi/m² and the other 10 mCi/m², both separated by 14 days [5] - The trial aims to determine therapeutic activity defined by PFS and OS, as well as antitumor activity through tumor volume reduction [5] Group 4: Company Overview - Cellectar Biosciences is a late-stage clinical biopharmaceutical company focused on developing proprietary drugs for cancer treatment, utilizing its Phospholipid Drug Conjugate™ (PDC) delivery platform [6] - The company's product pipeline includes iopofosine I 131, CLR 121225, and CLR 121125, targeting various solid tumors with significant unmet needs [7][8] - Iopofosine I 131 has received multiple designations from the FDA, including six Orphan Drug and four Rare Pediatric Drug designations [9]

Core Viewpoint - NRx Pharmaceuticals has announced an expanded access policy for NRX-100, a preservative-free ketamine, following its Fast Track designation by the FDA for treating suicidal ideation in patients with depression, including bipolar depression [1][6]. Group 1: Expanded Access Policy - NRX-100 is now available for expanded access to eligible patients, addressing an unmet need in treating suicidal depression [2][6]. - Physicians can request NRX-100 for patients who are not responsive to or cannot tolerate approved treatment options [3][7]. - The company emphasizes the urgent need for NRX-100 for patients with suicidal depression [3]. Group 2: FDA Designation and Clinical Development - The FDA granted Fast Track designation for NRX-100 based on preliminary data indicating its potential to meet an unmet medical need [2][6]. - NRX Pharmaceuticals is also developing NRX-101, which has received Breakthrough Therapy Designation for treating suicidal bipolar depression [5]. Group 3: Patient Statistics and Clinical Trials - Approximately 13 million adults in the U.S. seriously consider suicide each year, with a suicide occurring every 11 minutes [6]. - NRX has filed an Abbreviated New Drug Application (ANDA) and initiated a New Drug Application for NRX-100, based on results from well-controlled clinical trials [8].

Company Overview - Opus Genetics, Inc. is a clinical-stage biopharmaceutical company focused on developing gene therapies for inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders [3] - The company's pipeline includes AAV-based gene therapies targeting conditions such as Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa [3] - Lead gene therapy candidates include OPGx-LCA5, currently in a Phase 1/2 trial for LCA5-related mutations, and OPGx-BEST1 for BEST1-related retinal degeneration [3] - Additionally, the company is advancing Phentolamine Ophthalmic Solution 0.75%, which is approved for one indication and is being studied in two Phase 3 programs for presbyopia and low light vision disturbances [3] Upcoming Presentations - Opus Genetics will present its IRD gene therapy programs at several scientific conferences in September 2025 [1] - Presentation at the Ophthalmology Futures Forum will focus on "Gene & Cell Therapies for Rare & Common Retinal Diseases: Hype Vs Progress" on September 3, 2025 [2] - At the RD 2025 International Symposium, the company will share one-year results from a Phase I/II study of OPGx-LCA5 for inherited retinal degeneration due to biallelic mutations in the LCA5 gene [2] - The LSX World Congress will feature a presentation titled "The Equation for Maturation: Biotech Requirements to Achieve Scale" [2] Key Personnel - Sally Tucker, Ph.D., Senior Vice President Clinical Development, will present at the Ophthalmology Futures Forum and participate in a panel discussion in Paris, France on September 3, 2025 [4] - Ash Jayagopal, Ph.D., Chief Scientific & Development Officer, will present in Prague, Czech Republic on September 15, 2025 [4] - Ben Yerxa, Ph.D., President, will also participate in a panel discussion in Boston, MA on September 17, 2025 [4]

REDWOOD CITY, Calif., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that it will participate in the following investor conferences in September: Cantor Global Healthcare ConferencePresentation Date: Wednesday, September 3, 2025 at 1:00 PM ETPresentation Format: Fireside ChatWebcast: Here Wells Fargo Healthcare ConferencePresentation Date: Thursday, September ...

WAYNE, Pa., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that the Company will participate in two upcoming healthcare conferences in September. On Wednesday September 3, 2025, at 1:00 PM EDT, Aclaris’ Chief Executive Officer Dr. Neal Walker and other members of Aclaris’ senior leadership team will participate in a fireside chat during the ...

FDA Establishes April 23, 2026 as PDUFA Target Date for Review of Submission Seeking Approval for GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) Comprehensive Data Package Supported by Positive Results from Phase 3 STRIVE-ON Safety Trial of GTx-104 PRINCETON, N.J., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulatio ...

BRISBANE, Calif., Aug. 27, 2025 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today announced that Douglas Love, Esq., president & chief executive officer, will participate in fireside chats during the following September investor conferences: Wells Fargo Healthcare Conference on Wednesday, Septemb ...

BXCL501 achieved SERENITY At-Home’s primary endpoint of being well tolerated in the at-home treatment of agitation episodes in patients with bipolar disorders or schizophrenia No discontinuations for tolerability in the BXCL501 arm While not the primary objective of the SERENITY At-Home trial, the preliminary results demonstrate continued effects and consistent benefit with repeat dosing across the course of the trial Following previously disclosed positive FDA feedback, BioXcel plans to submit a sNDA in Q1 ...