News

Apr 22 2019

Poseida Therapeutics Raises $142 Million In Series C Financing

Apr 22 2019

SAN DIEGO, April 22, 2019 — Poseida Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging proprietary non-viral gene engineering technologies to create life-saving therapeutics, today announced closing of a Series C financing round, raising $142 million led by a $75 million equity investment from Novartis Pharma AG, and joined by several new investors including Aisling Capital Management, Pentwater Capital Management, Perceptive Advisors as well as additional undisclosed institutional investors. Current investors Malin Corporation plc., Longitude Capital, Vivo Capital and Boxer Capital, LLC also participated in the financing.

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Apr 12 2019

Ajax Health Raises More Than $85 Million to Advance Medical Device Innovations

Apr 12 2019

MENLO PARK, Calif., April 12, 2019 /PRNewswire/ — Ajax Health II, the latest medical device venture from serial healthcare entrepreneur Duke Rohlen, announced today that it has raised more than $85 million, which will be used to strategically operate and expand innovative medical device companies. HealthQuest Capital led the funding, with participation from Aisling Capital and Polaris Partners.

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Apr 7 2019

Aeglea BioTherapeutics Announces New Positive Phase 1/2 Data for Pegzilarginase in Patients with Arginase 1 Deficiency at 2019 Annual Meeting of the Society for Inherited Metabolic Disorders

Apr 7 2019

AUSTIN, Texas, April 07, 2019 (GLOBE NEWSWIRE) — Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, today presented new positive Phase 1/2 data for pegzilarginase in patients with Arginase 1 Deficiency (ARG1-D) at the 2019 Annual Meeting of the Society for Inherited Metabolic Disorders (SIMD) in Bellevue, Washington. The oral presentation was delivered by Dr. George Diaz, M.D., Ph.D., Division Chief of Medical Genetics in the Department of Genetics and Genomic Sciences at the Icahn School of Medicine at Mt. Sinai, New York, NY, and a Principal Investigator on the pegzilarginase Phase 1/2 trial.

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Apr 1 2019

FDA Approves ASCENIV™, A Novel Intravenous Immune Globulin

Apr 1 2019

RAMSEY, N.J. and BOCA RATON, Fla., April 01, 2019 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, announces that the U.S. Food and Drug Administration (“FDA”) has approved ASCENIV™, Immune Globulin Intravenous, Human – slra 10% Liquid, formerly referred to as RI-002. ASCENIV™ is an Intravenous Immune Globulin (“IVIG”) drug product for the treatment of Primary Humoral Immunodeficiency Disease (“PIDD” or “PI”) in adults and adolescents (12 to 17 years of age). The Company anticipates having the product available for commercial launch during the second half of 2019.

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Mar 25 2019

European Phase 3 Trial of Aimmune Therapeutics’ AR101 Meets Primary Endpoint

Mar 25 2019

BRISBANE, Calif.–(BUSINESS WIRE)–Mar. 25, 2019– Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today announced that its phase 3 European clinical trial of AR101 for the treatment of peanut allergy, known as ARTEMIS (AR101 Trial in Europe Measuring oral Immunotherapy Success), met its primary efficacy endpoint. Topline data show that the proportion of AR101-treated patients who tolerated a 1,000-mg dose of peanut protein (2,043 mg cumulative) in a blinded exit challenge after approximately nine months of AR101 treatment was significantly higher (p<0.00001) than in the placebo group. Specifically, the median tolerated dose of peanut protein for AR101-treated patients improved 100-fold, from 10 mg at baseline to 1,000 mg at exit. The trial also greatly exceeded a 15% lower-bound of the 95% confidence interval (CI) of the difference between treatment arms for all endpoints. In addition, the safety profile and completion rate observed in ARTEMIS are consistent with the results seen in previous AR101 clinical trials. Notably, no cases of anaphylaxis or of eosinophilic esophagitis (EoE) were observed. Aimmune plans to present full results in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress in early June.

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Mar 18 2019

Biohaven Secures Priority Review Voucher (PRV) To Expedite Regulatory Review Of Rimegepant Zydis ODT New Drug Application

Mar 18 2019

NEW HAVEN, Conn., March 18, 2019 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological and neuropsychiatric diseases, including rare disorders, today announced that the company has purchased a U.S. Food and Drug Administration (FDA) priority review voucher (PRV) to use with the NDA submission of rimegepant Zydis®ODT in the second quarter of 2019. The PRV entitles the holder to designate an NDA for priority review and provides for an expedited 6-month review.

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Mar 18 2019

U.S. FDA Accepts BLA Filing of Aimmune Therapeutics’ AR101 for Peanut Allergy

Mar 18 2019

BRISBANE, Calif.–(BUSINESS WIRE)–Mar. 18, 2019– Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today announced that the Biologics License Application (BLA) for AR101 has been accepted for review by the U.S. Food and Drug Administration (FDA).

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Mar 18 2019

Alcon Announces Acquisition of PowerVision, Inc.

Mar 18 2019

Fort Worth, Texas, March 18, 2019 – Alcon, the global leader in eye care and a division of Novartis, announced today that it has acquired PowerVision, Inc., a privately-held, US-based medical device development company focused on creating fluid-based intraocular lens implants. The acquisition furthers Alcon’s commitment to bring this innovative, accommodating lens to cataract patients throughout the world.

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Mar 4 2019

Verona Pharma Reports Positive Interim Data with Ensifentrine Dry Powder Inhaler Formulation in First of Two-Part Phase 2 Clinical Trial in COPD

Mar 4 2019

LONDON, March 04, 2019 (GLOBE NEWSWIRE) — Verona Pharma plc (AIM:VRP) (Nasdaq: VRNA) (“Verona Pharma”), a clinical stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, announces positive interim efficacy and safety data from part one of a two-part Phase 2 clinical trial of a dry powder inhaler (“DPI”) formulation of ensifentrine in patients with moderate-to-severe chronic obstructive pulmonary disease (“COPD”). The positive data support initiation of the second part of the Phase 2 trial to evaluate the ensifentrine DPI formulation in patients with moderate-to-severe COPD over one week of twice-daily treatment.

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Feb 27 2019

Eidos Therapeutics Initiates ATTRibute-CM, A Phase 3 Study Of AG10 In ATTR-CM With Registrational 12-Month Endpoint

Feb 27 2019

SAN FRANCISCO, Feb. 27, 2019 (GLOBE NEWSWIRE) — Eidos Therapeutics, Inc. (Eidos) (Nasdaq:EIDX), today announced the initiation and design of its pivotal global Phase 3 trial (ATTRibute-CM) of AG10 in patients with transthyretin (TTR) amyloid cardiomyopathy (ATTR-CM). The design of the ATTRibute-CM study, which incorporates feedback from FDA, includes two potentially registrational endpoints. In Part A, benefit in change from baseline in 6-minute walk distance (6MWD) will be evaluated at 12 months, potentially accelerating the time to registration. In Part B, reduction in all-cause mortality and frequency of cardiovascular-related hospitalizations will be evaluated at 30 months.

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