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Veru’s Novel COVID-19 Drug Candidate Reduces Deaths by 55% in Hospitalized Patients in Interim Analysis of Phase 3 Study; Independent Data Monitoring Committee Halts Study Early for Overwhelming Efficacy

04/20/2022

— Independent Data Monitoring Committee Unanimously Recommends that Phase 3 Clinical Trial for Sabizabulin for Treatment of Hospitalized COVID-19 Patients at High Risk for ARDS Be Stopped Early Due to Overwhelming Evidence of Efficacy — — Sabizabulin Treatment Showed Statistically Significant and Clinically Meaningful 55% Reduction in Deaths Compared to Placebo in Moderate-Severe Hospitalized Patients…

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Context Therapeutics® Announces Positive Data from ONA-XR in Early Breast Cancer at 2021 San Antonio Breast Cancer Symposium

12/16/2021

Data demonstrated ONA-XR decreased proliferation in tumors with high PR+ at baseline in early breast cancer Two additional metastatic breast cancer clinical trials in progress also presented Excerpt from the Press Release: PHILADELPHIA, Dec. 09, 2021 (GLOBE NEWSWIRE) — Context Therapeutics Inc. (Nasdaq: CNTX), a women’s oncology company developing small molecule and immunotherapy treatments for…

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Spero Therapeutics Announces Positive Topline Results from Phase 1 Bronchoalveolar Lavage Clinical Trial of SPR206, A Novel Intravenous Next Generation Polymyxin Antibiotic for the Treatment of Multi-drug Resistant Gram-Negative Infections in the Hospital Setting

02/22/2022

SPR206 shown to be well-tolerated; achieved lung exposures consistent with predicted therapeutic levels, when administered three times daily at 100 mg Results support further development of SPR206 in the setting of hospital-acquired pneumonia and ventilator-associated pneumonia Excerpt from the Press Release: CAMBRIDGE, Mass., Feb. 16, 2022 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. (Nasdaq: SPRO), today announced…

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Meissa Announces Preclinical Data on Intranasal COVID-19 Vaccine Showing Protection from SARS-CoV-2 Challenge after a Single Dose

07/30/2021

Excerpt from the Press Release: REDWOOD CITY, Calif.–(BUSINESS WIRE)–Meissa Vaccines (“Meissa”), a biotechnology company developing vaccines to prevent serious viral respiratory infections, announced today the release of preclinical data in nonhuman primates (NHPs) of the company’s intranasal recombinant live attenuated COVID-19 vaccine (MV-014-212). The data demonstrate that a single adjuvant-free dose of MV-014-212 provided equivalent protection against SARS-CoV-2…

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Editas Medicine Presents Preclinical Data on EDIT-103 for Rhodopsin-associated Autosomal Dominant Retinitis Pigmentosa at the Association for Research in Vison and Ophthalmology Conference

05/12/2022

Studies in non-human primates demonstrated nearly 100% gene editing knockout of endogenous RHO gene and more than 30% replacement protein levels Treated eyes showed morphological and functional photoreceptor preservation  EDIT-103 advancing towards IND-enabling studies Excerpt from the Press Release: CAMBRIDGE, Mass., May 04, 2022 (GLOBE NEWSWIRE) — Editas Medicine, Inc. (Nasdaq: EDIT), a leading genome…

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Tempest Presents Data Supporting the Dual Mechanism of TPST-1495 as an Optimal Approach for Targeting the Prostaglandin Pathway in Cancer

11/18/2021

Excerpt from the Press Release: Data Reported at the 2021 Society for Immunotherapy of Cancer Annual Meeting SOUTH SAN FRANCISCO, Calif., Nov. 12, 2021 (GLOBE NEWSWIRE) — Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing potentially first-in-class therapeutics that combine both targeted and immune-mediated mechanisms, today reported in vitro and in vivo preclinical…

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Talaris Therapeutics Presents Data on COVID-19 Outcomes Among Kidney Transplant Patients Treated with FCR001

04/12/2022

Low rate of COVID-19 infection observed in vaccinated, durably chimeric patients off immunosuppression No evidence of acute kidney injury or impaired renal function in FCR001-treated patients with COVID-19 infection No patients lost chimerism as a result of COVID-19 vaccination or infection Excerpt from the Press Release: BOSTON and LOUISVILLE, Ky., April 06, 2022 (GLOBE NEWSWIRE) — Talaris Therapeutics,…

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NANOBIOTIX Announces First Patient Enrolled in NANORAY-312 Global Phase III Registrational Study of NBTXR3 in Head and Neck Cancer

01/11/2022

First patient randomized in pivotal phase III study evaluating radiotherapy-activated NBTXR3 with or without cetuximab in high-risk elderly patients with locally advanced head and neck squamous cell carcinoma The randomized study is designed to demonstrate treatment outcome superiority of radiotherapy-activated NBTXR3 versus the standard of care for global registration The US Food and Drug Administration…

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Phio Pharmaceuticals Announces Preclinical Data Demonstrating PH-762 Enhances Persistence of T cells for Tumor Cell Killing as Presented by Helmholtz Munich at the 9th Immunotherapy of Cancer Conference

10/04/2022

Excerpt from the Press Release: MARLBOROUGH, Mass., Sept. 22, 2022 /PRNewswire/ — Phio Pharmaceuticals Corp. ( Nasdaq: PHIO), a clinical stage biotechnology company developing the next generation of therapeutics based on its proprietary self-delivering RNAi (INTASYL™) therapeutic platform, today announced that its research partner, Helmholtz Munich, presented preclinical data showing that Phio’s lead clinical product PH-762, an…

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Rhythm Pharmaceuticals Presents New Data on Experience of People Living with Rare Genetic Diseases of Obesity and Provides Updates on Uncovering Rare Obesity® Genetic Testing Program

10/19/2021

— New data in patients with POMC or LEPR deficiency obesity show setmelanotide led to clinically meaningful improvements in health related quality of life measures and hunger —  — Updated results from Uncovering Rare Obesity® testing program suggest up to 64.5 percent of individuals with early-onset, severe obesity may carry variants linked to rare genetic diseases of…

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