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Clinical Trial Results

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Eli Lilly and Co. (LLY), and Incyte (INCY) announced Friday positive new data for baricitinib (marketed as OLUMIANT) in adult patients with Alopecia Areata or AA. The trial results support the therapeutic potential of baricitinib. Baricitinib, an oral JAK1/JAK2 inhibitor discovered by Incyte, is developed...

regeneron oct29 Regeneron announced positive results from its late stage COVID-19 outpatient trial, indicating that its antibody cocktail therapy significantly reduced virus levels and need for further medical attention. The trial results showed that investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints.

europeanstock dec30 27oct20 Shares of Scholar Rock (SRRK) soared to a new high in Monday's trading, on the back of positive six-month interim analysis results from the company's phase II trial of SRK-015 in patients with Type 2 and Type 3 Spinal Muscular Atrophy, dubbed TOPAZ.

Swiss drug major Novartis AG (NVS) announced Monday positive Phase II interim analysis results for iptacopan (LNP023), an investigational oral treatment for rare renal disease C3 glomerulopathy or C3G. C3G is an ultra-rare and severe form of primary glomerulonephritis, affecting young patients with...

Gilead Sciences, Inc. (GILD) announced Wednesday that new 48-week data from the BRAAVE 2020 study shows Biktarvy as an effective treatment regimen in Black Americans with HIV. BRAAVE 2020, a Phase 3 clinical trial, is evaluating the safety and efficacy of switching to Biktarvy (bictegravir 50 mg/emtricitabine...

Merck & Co. Inc. (MRK) announced Tuesday positive top line results from two additional Phase 3 adult studies evaluating V114, the company's investigational 15-valent pneumococcal conjugate vaccine. The studies evaluated the safety, tolerability and immunogenicity of the vaccine. The company noted...

CytoDyn Inc. announced recommendations from the Data Safety Monitoring Committee following its review of the interim analysis of the company's Phase 2b/3 registrational trial in patients with severe-to-critical COVID-19. The Committee recommended the trial continue without modification to achieve the...

Dr. Reddy's Laboratories Ltd. (RDY) and Russian Direct Investment Fund (RDIF), Russia's sovereign wealth fund, announced that they have received approval from the Drug Control General of India or DCGI to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India. This will be a...

Medicenna Therapeutics Corp. (MDNA) (MDNA.TO) has been advised to proceed with a hybrid phase III registration trial of MDNA55 in recurrent glioblastoma, following a recent End of phase II meeting with the FDA.

Regeneron Pharmaceuticals Inc. (REGN) and Sanofi (SNY) announced Tuesday that a pivotal Phase 3 trial of Dupixent (dupilumab) met its primary and all key secondary endpoints in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. In the trial, Dupixent added to standard of care...

Rigel Pharmaceuticals Inc. (RIGL) announced enrollment of the first patients in a multicenter, phase 2 trial that will evaluate the safety of fostamatinib for the potential treatment of hospitalized COVID-19 patients. fostamatinib is the company's oral spleen tyrosine kinase inhibitor. The study is...

The German Breast Group (GBG) and Pfizer Inc. (PFE) announced Friday that the collaborative Phase 3 PENELOPE-B trial of IBRANCE (palbociclib) in Early Breast Cancer did not meet the primary endpoint of improved invasive disease-free survival (iDFS) in women with hormone receptor-positive (HR+), human...

Amgen (AMGN), Cytokinetics, Incorporated (CYTK) and Servier announced topline results from GALACTIC-HF, a phase 3 clinical trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction. The company said the results of GALACTIC-HF showed that treatment with omecamtiv mecarbil...

Bristol Myers Squibb's (BMY) phase III study investigating its blockbuster drug Opdivo in combination with chemotherapy as *neoadjuvant treatment of resectable non-small cell lung cancer, dubbed CheckMate 816, has met the primary endpoint of pathologic complete response.

Corbus Pharmaceuticals Holdings, Inc. (CRBP) announced Tuesday that the CF-002 Phase 2b study of lenabasum in patients with cystic fibrosis (CF) did not meet the primary endpoint of a statistically significant reduction in rate of new pulmonary exacerbations (PEx) per subject per 28 weeks. However,...

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