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Celldex Therapeutics Initiates Phase 1b Study of CDX-0159 in Chronic Spontaneous Urticaria

HAMPTON, N.J., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) announced today that enrollment has opened and the first patient has been dosed in its randomized, double-blind Phase 1b study of CDX-0159 in patients with chronic spontaneous urticaria (CSU). CDX-0159 is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells. As previously presented, CDX-0159 demonstrated a favorable safety profile as well as profound and durable reductions of plasma tryptase, indicative of systemic mast cell ablation in a Phase 1a single dose, healthy volunteer study.

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Celldex Therapeutics Initiates Phase 1b Study of CDX-0159 in Chronic Spontaneous Urticaria

Outlook Therapeutics Announces Initiation of Supplemental Open-Label Safety Study for ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

MONMOUTH JUNCTION, N.J., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a?late clinical-stage?biopharmaceutical company?working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg?for use in retinal?indications, today announced the initiation and enrollment of the first patients in its planned supplemental open-label safety study evaluating ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (AMD) (NORSE THREE).

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Outlook Therapeutics Announces Initiation of Supplemental Open-Label Safety Study for ONS-5010 / LYTENAVA™ (bevacizumab-vikg)

BioCorRx Partners with Truusight Health to Integrate Recovery Program Into Self-Funded Health Plans

ANAHEIM, CA, Oct. 13, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire -- BioCorRx Inc. (OTCQB: BICX) (“BioCorRx®”) (“Company”), a developer and provider of advanced solutions in the treatment of substance use disorders (SUD), today announced their partnership with Truusight Health, a healthcare solutions and care navigation and management company, to bring the Company’s Recovery Program to self-funded health plans.

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BioCorRx Partners with Truusight Health to Integrate Recovery Program Into Self-Funded Health Plans

Motus GI Hosting Key Opinion Leader Call on Improving Endoscopy Outcomes with the Pure-Vu® System

FORT LAUDERDALE, Fla., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Motus GI Holdings, Inc., (NASDAQ: MOTS) ("Motus GI" or the "Company"), a medical technology company providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions, announced today that it will host a key opinion leader (KOL) call on improving inpatient endoscopy outcomes with the Pure-Vu® system on Friday, October 16, 2020.

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Motus GI Hosting Key Opinion Leader Call on Improving Endoscopy Outcomes with the Pure-Vu® System

Syneos Health Wins Society for Clinical Research Sites Eagle Award for Fourth Consecutive Year

MORRISVILLE, N.C., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Syneos Health® (Nasdaq:SYNH), the only fully integrated biopharmaceutical solutions organization, today announced that it was awarded the Society for Clinical Research Sites (SCRS) Eagle Award, sweeping the CRO category for the fourth consecutive year. Presented at SCRS’s Global Site Solutions Summit, the award recognizes the CRO that best exemplifies a site-focused approach to clinical trial management, demonstrating outstanding leadership, professionalism, integrity, passion and dedication to advancing the clinical research profession through strong site partnerships.

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Syneos Health Wins Society for Clinical Research Sites Eagle Award for Fourth Consecutive Year

Auris Medical Announces Initiation of Part B of TRAVERS Phase 2 Study with AM-125 in Vertigo

Hamilton, Bermuda, October 13, 2020 – Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today announced that the first patient has been randomized in Part B of its “TRAVERS” Phase 2 trial of AM-125 (intranasal betahistine) in acute vertigo. This follows the positive read-out from the interim analysis on Part A of the study in early September 2020, the completion of enrollment into the oral treatment group, and the receipt of regulatory clearance for Part B in the first three of the participating study countries.

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Auris Medical Announces Initiation of Part B of TRAVERS Phase 2 Study with AM-125 in Vertigo

AnaptysBio Reports Positive Topline Data from GALLOP Phase 2 Clinical Trial of Imsidolimab in Moderate-to-Severe Generalized Pustular Psoriasis (GPP)

SAN DIEGO, Oct. 13, 2020 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today announced positive topline data from an interim analysis of its Phase 2 clinical trial of imsidolimab for the treatment of moderate-to-severe generalized pustular psoriasis (GPP), also known as the GALLOP trial. GPP is a chronic, life-threatening, rare inflammatory disease with no approved therapies.

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AnaptysBio Reports Positive Topline Data from GALLOP Phase 2 Clinical Trial of Imsidolimab in Moderate-to-Severe Generalized Pustular Psoriasis (GPP)

Indus Holdings, Inc. Pre-Announces Record Q3 2020 Revenues in Excess of $14 Million, ~15% EBITDA Margins, and Positive Operating Income

SALINAS, Calif., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Indus Holdings, Inc. ("Indus” or the “Company”) (CSE:INDS; OTCQX: INDXF), a leading, vertically-integrated, California-focused cannabis company, announced preliminary unaudited revenue and adjusted EBITDA for the third quarter ended September 30, 2020. All figures stated are in US Dollars. Based on a preliminary review, the Company currently anticipates:

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Indus Holdings, Inc. Pre-Announces Record Q3 2020 Revenues in Excess of $14 Million, ~15% EBITDA Margins, and Positive Operating Income