Catalyst Pharmaceuticals Announces Ruling on Lawsuit against the FDA and Intent to Appeal

CORAL GABLES, Fla., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. (Catalyst) (Nasdaq: CPRX), today reported that the federal judge handling Catalyst's case against the FDA has adopted the previously reported Report and Recommendation of the Magistrate Judge, granted summary judgment in favor of the FDA and Jacobus, and dismissed Catalyst's case. Catalyst is currently reviewing the District Judge's decision, which it believes to be erroneous, and intends to appeal the result to the Eleventh Circuit Court of Appeals.

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Catalyst Pharmaceuticals Announces Ruling on Lawsuit against the FDA and Intent to Appeal

Arcutis Biotherapeutics Announces Proposed Public Offering and Concurrent Private Placement of Common Stock

WESTLAKE VILLAGE, Calif., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology, today announced the commencement of an underwritten public offering of 4,000,000 shares of its common stock. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to 600,000 additional shares of its common stock.

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Arcutis Biotherapeutics Announces Proposed Public Offering and Concurrent Private Placement of Common Stock

ILiAD Biotechnologies Reports Positive Topline Results from Phase 2b Trial for Pertussis Vaccine Candidate BPZE1

-- Phase 2b study in healthy volunteers met primary endpoints of overall safety and induction of mucosal immunity ---- BPZE1 prevented colonization from re-vaccination/challenge in 90% of subjects with no vaccine related serious adverse events --WESTON, Fla., Sept. 29, 2020 (GLOBE NEWSWIRE) -- ILiAD Biotechnologies, LLC (ILiAD) today presented positive topline Phase 2b trial results of its lead pertussis vaccine candidate BPZE1 at the virtual World Vaccine Congress. BPZE1, a live attenuated pertussis vaccine, met both primary endpoints of overall safety and induction of mucosal immunity.“With limited duration of immunity and the inability to significantly stop transmission, acellular vaccines have been associated with the resurgence of whooping cough,” said Cheryl Keech, M.D., Ph.D., chief medical officer and executive vice president of clinical research at ILiAD. “We need a vaccine that can effectively stop the spread of pertussis. In this study, BPZE1 demonstrated reduced nasal colonization and induction of durable mucosal immunity — two key factors necessary for the prevention of transmission and reduction of epidemic pertussis cycles.”

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ILiAD Biotechnologies Reports Positive Topline Results from Phase 2b Trial for Pertussis Vaccine Candidate BPZE1

Larimar Therapeutics Announces Formation of Scientific Advisory Board

BALA CYNWYD, Pa., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Nasdaq:LRMR), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced the formation of its Scientific Advisory Board (SAB). Larimar’s SAB is comprised of distinguished research scientists, professors and industry experts recognized as key opinion leaders in the fields of rare disease, pediatrics and mitochondrial disease.

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Larimar Therapeutics Announces Formation of Scientific Advisory Board

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