News

Jul 15 2019

AVROBIO Announces 87% Substrate Reduction in First Kidney Biopsy and Additional Positive Data from Clinical Trials of AVR-RD-01 Investigational Gene Therapy in Fabry Disease

Jul 15 2019

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Jul. 15, 2019– AVROBIO, Inc. (NASDAQ: AVRO) (the “Company”) today announced the first kidney biopsy result and additional positive data from two ongoing clinical trials of its AVR‑RD‑01 investigational gene therapy in Fabry disease. To date, eight patients have been dosed in the trials – three patients in the Phase 2 FAB-201 trial and five patients in the Phase 1 FACTs trial.

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Jul 11 2019

Sunesis Announces Pricing of $25 Million Offering of Securities

Jul 11 2019

SOUTH SAN FRANCISCO, Calif., July 10, 2019 (GLOBE NEWSWIRE) — Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) today announced the pricing of underwritten public offerings of (i) 33,333,667 shares of its common stock and (ii) 8,333 shares of its non-voting Series F Convertible Preferred Stock (“Series F Stock”).  The public offering price of each share of common stock is $0.60 and the public offering price of each share of Series F Stock, convertible into 1,000 shares of common stock, is $600.

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Jul 10 2019

TransEnterix, Inc. Announces Sale of AutoLap Assets

Jul 10 2019

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–Jul. 10, 2019– TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced the sale of certain AutoLap® image-based laparoscope positioning system (AutoLap) assets to Great Belief International Limited (GBIL), for total proceeds of $47.0 million. The total proceeds to be paid to the Company for the AutoLap product and intellectual property assets is $17 million, payable in the amount of $5 million by July 31, 2019 and $12 million by November 30, 2019. In addition, GBIL is making an equity investment of $30.0 million in TransEnterix common stock at $2.00 per share, payable on or before September 30, 2019.

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Jun 26 2019

BridgeBio Pharma Announces Pricing Of Its Initial Public Offering

Jun 26 2019

PALO ALTO, Calif.– June 26, 2019 – BridgeBio Pharma, Inc. (“BridgeBio”) today announced the pricing of its initial public offering of 20,500,000 shares of its common stock at a price to the public of $17.00 per share, above the range of $14.00 to $16.00. In addition, BridgeBio has granted the underwriters a 30-day option to purchase up to 3,075,000 additional shares of its common stock. The shares are expected to begin trading on the Nasdaq Global Select Market on June 27, 2019, under the ticker symbol “BBIO” and the offering is expected to close on July 1, 2019, subject to customary closing conditions.

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Jun 19 2019

Atreca Announces Pricing of Initial Public Offering

Jun 19 2019

REDWOOD CITY, Calif., June 19, 2019 (GLOBE NEWSWIRE) — Atreca, Inc. (Nasdaq: BCEL), a biopharmaceutical company utilizing its differentiated platform to discover and develop novel antibody-based immunotherapeutics to treat a range of solid tumor types, today announced the pricing of its initial public offering of 7,350,000 shares of common stock at a price to the public of $17.00 per share.

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Jun 17 2019

Aclaris Therapeutics Announces Positive 6-Month Results from a Phase 2 Open-Label Clinical Trial of ATI-502 Topical in Patients with Androgenetic Alopecia (Male/Female Pattern-Baldness)

Jun 17 2019

WAYNE, Pa., June 17, 2019 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on immuno-inflammatory and dermatological diseases, today announced positive results from a Phase 2 open-label clinical trial of ATI-502 (AGA-201), an investigational topical Janus Kinase (JAK) 1/3 inhibitor, in patients with androgenetic alopecia (AGA), a condition commonly known as male/female-pattern baldness.

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Jun 3 2019

Pivotal Phase 3 ARTEMIS Trial Data Demonstrates Consistent Safety and Efficacy of AR101 in Children and Adolescents with Peanut Allergy

Jun 3 2019

LISBON, Portugal–(BUSINESS WIRE)–Jun. 2, 2019– Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today presented topline results from the pivotal European Phase 3 ARTEMIS clinical trial, which it previously announced had met its primary endpoint, demonstrating the efficacy and safety of AR101 in peanut-allergic children and adolescents after six months of dose escalation and a three-month therapeutic dosing phase. The findings from the ARTEMIS trial reinforce the consistent clinical profile of AR101, demonstrating that patients tolerated 1,000 mg of peanut protein after only nine months of treatment, which was the primary endpoint of the study. The ARTEMIS study builds on the results of the landmark PALISADE trial, which met its primary endpoint of patients tolerating 600 mg of peanut protein at 12 months. AR101 is an investigational biologic drug for use in oral immunotherapy as a treatment to reduce the frequency and severity of allergic reactions following exposure to peanuts. These data were presented here today in an oral session at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2019 in Lisbon.

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May 28 2019

TransEnterix Announces Japanese Regulatory Approval of the Senhance Surgical System

May 28 2019

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–May 28, 2019– TransEnterix, Inc. (NYSE American: TRXC), a medical device company that is digitizing the interface between surgeons and patients to improve minimally invasive surgery, today announced that it has received Japanese regulatory approval for the Senhance™ Surgical System. “Regulatory approval in Japan is a pivotal milestone for our company, as Japan is second only to the U.S. as the world’s largest surgical robotics market,” said Todd M. Pope, president and chief executive officer of TransEnterix. “Japan’s high penetration of laparoscopic surgery coupled with their rapid adoption of robotics and the intense focus on procedure cost creates a considerable market opportunity for Senhance.”

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May 10 2019

FDA Approves Prior Approval Supplement For Bivigam®

May 10 2019

RAMSEY, N.J. and BOCA RATON, Fla., May 10, 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 specialty 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 the Company’s Prior Approval Supplement (“PAS”) for BIVIGAM® (immune globulin intravenous (human), 10% liquid). The FDA’s approval of the PAS for BIVIGAM® approves the use of the Company’s optimized intravenous immune globulin (“IVIG”) manufacturing process and enables ADMA to commence the marketing of BIVIGAM® in the U.S. to patients with Primary Humoral Immunodeficiency (“PI”).

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May 8 2019

Biohaven Announces Expanded Safety And Preliminary Preventive Efficacy Data From Ongoing Long-Term Safety Study, And Presents Case Reports Of Using Rimegepant To Successfully Treat Breakthrough Migraine Attacks In Patients Taking Preventive CGRP-Targeting Monoclonal Antibodies

May 8 2019

NEW HAVEN, Conn., May 7, 2019 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced additional safety and preliminary efficacy results from its ongoing long-term, open-label safety study of its oral calcitonin gene-related peptide (CGRP) receptor antagonist, rimegepant. Based upon this interim analysis of Study BHV3000-201 (NCT03266588 or “Study 201”), database cutoff of February 20, 2019, rimegepant was well tolerated with long-term dosing up to one year in patients with migraine.

Biohaven, for the first time, also reported the safety and preliminary efficacy data from the scheduled dosing cohort. In this cohort of patients with a history of 4 to 14 moderate to severe migraine attacks per month, patients were treated with rimegepant 75 mg every other day for up to 12 consecutive weeks. During the on-treatment period, no rimegepant-treated patients (N=281) experienced ALT or AST levels >3x the ULN. There were also no rimegepant-treated patients who experienced alkaline phosphatase or bilirubin >2x the ULN. With regard to efficacy, 48.4% of subjects in the scheduled dosing cohort experienced a ≥50% reduction in the frequency of monthly migraine days with moderate-to-severe pain intensity during the third month of treatment. The company also presented the first clinical reports suggesting that oral rimegepant has the potential to be safe and consistently effective for the treatment of breakthrough migraine attacks in patients taking injectable CGRP-targeting monoclonal antibody (mAb) preventive therapy.

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