Streetbeat News

Regulatory

ARTL

Artelo Biosciences, Inc. (NASDAQ:ARTL) will present preclinical data on ART26.12 and ART12.11, potential treatments for anxiety and depression, at Neuroscience 2023. The company plans to file an IND application with the FDA in the first half of 2024 to develop ART26.12 for the treatment of neuropathic pain. ART26.12 has shown positive effects in animal models of painful neuropathies, including chemotherapy-induced peripheral neuropathy and diabetic neuropathy.

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November 02, 2023 | 12:54 pm

VRTX

Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) will present data on TRIKAFTA®, a treatment for cystic fibrosis, at the 2023 North American Cystic Fibrosis Conference. The data will highlight the long-term clinical benefits and safety profile of TRIKAFTA® among pediatric populations. Interim data from two open-label extension studies will be presented, showing sustained improvements in CFTR function and respiratory symptoms, with no evidence of a decline in lung function over a 3.5-year treatment period.

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November 02, 2023 | 12:53 pm

CSBR

Champions Oncology, Inc. (NASDAQ:CSBR) has announced that its European research operations site in Bresso, Italy, has received ISO-9001:2015 laboratory accreditation from the Bureau Veritas S.p.A. and ATS certification from the Lombardy Region. These certifications validate the quality of clinical testing services that Champions Oncology's European research team can provide and will enable specialty testing of clinical patient sample across all phases for their global biopharma partners in Europe.

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November 02, 2023 | 12:51 pm

JAGX

Jaguar Health, Inc. (NASDAQ:JAGX) has entered into a revenue sharing license and commercialization agreement with Quadri Pharmaceuticals Store LLC. The agreement grants Quadri Pharma exclusive rights to promote, commercialize, and distribute a powder formulation of crofelemer for rare intestinal failure diseases in multiple Middle East countries, following regulatory approval. Quadri Pharma will cover 50% of the development costs for the specified rare disease indications for three years.

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November 02, 2023 | 12:50 pm

SPY

USA Nonfarm Productivity for Q3 has increased by 4.7%, surpassing the estimated 4.1% and the prior 3.6%.

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November 02, 2023 | 12:31 pm

BWAY

BrainsWay Ltd. (NASDAQ & TASE: BWAY) announced that the Clinical TMS Society (CTMSS) has published the first coverage recommendations for smoking addiction treatment using transcranial magnetic stimulation (TMS). BrainsWay's Deep TMS is the only TMS technology to have received FDA clearance for the treatment of smoking addiction. The CTMSS now recommends TMS coverage for individuals with a confirmed diagnosis of Tobacco Use Disorder (TUD) who failed two alternative treatment methods, cannot tolerate drugs, or have other comorbid medical conditions.

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November 02, 2023 | 12:31 pm

TEVA

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced new data supporting the safety, efficacy, and real-world effectiveness of AUSTEDO tablets for treating Huntington's disease (HD) chorea. The data will be presented at the Huntington Study Group® (HSG) Annual Meeting. The results show that 92% of patients achieved optimal dosing by week 12 with the AUSTEDO 4-week patient titration kit. The data also reinforce the efficacy and tolerability of AUSTEDO.

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November 02, 2023 | 12:28 pm

TNXP

Tonix Pharmaceuticals' vaccine candidate, TNX-1800, has been selected by the National Institute of Allergy and Infectious Diseases (NIAID) for inclusion in early phase clinical trials. The trials are part of the Project NextGen initiative, aimed at developing the next generation of vaccines and therapeutics for COVID-19. The Phase 1 clinical trial of TNX-1800 is expected to start in the second half of 2024, with NIAID covering the full cost of the trial. Tonix will supply the vaccine candidate.

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November 02, 2023 | 12:26 pm

RYTM

Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM) has received a reimbursement recommendation from the Canadian Agency for Drugs and Technologies in Health (CADTH) for its drug IMCIVREE (setmelanotide), used for weight management in patients with obesity due to Bardet-Biedl syndrome (BBS). The recommendation is based on the demonstrated clinical benefit in a Phase 3 trial. IMCIVREE is the first and only therapy approved in Canada for this purpose.

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November 02, 2023 | 12:24 pm

CRBP

Corbus Pharmaceuticals Holdings, Inc. (NASDAQ:CRBP) presented results from two pre-clinical studies on its CRB-601 anti-aVb8 integrin monoclonal antibody at the 38th Annual Meeting of the Society for Immunotherapy of Cancer. The studies demonstrated robust pre-clinical anti-tumor activity of CRB-601, alone and in combination with anti-PD-1 therapy. The company plans to submit an Investigational New Drug application for CRB-601 by the end of 2023 and expects to initiate its Phase 1 study by the end of June 2024.

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November 02, 2023 | 12:23 pm