News

Jul 24 2019

Aeglea BioTherapeutics Receives FDA Breakthrough Therapy Designation for Pegzilarginase for Treatment of Arginase 1 Deficiency

Jul 24 2019

AUSTIN, Texas, July 24, 2019 (GLOBE NEWSWIRE) — Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE), a clinical-stage biotechnology company that engineers next-generation human enzymes to provide solutions for diseases with unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to the Company’s lead investigational therapy, pegzilarginase, for the treatment of Arginase 1 Deficiency (ARG1-D), a rare progressive disease presenting in early childhood that results in severe complications and early mortality.

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Jul 20 2019

Marker Therapeutics Reports Interim Results of its MultiTAA T Cell Therapy in Patients with Pancreatic Adenocarcinoma at AACR

Jul 20 2019

San Francisco, CA—July 20, 2019—Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced interim data from an ongoing investigator-sponsored clinical trial led by Baylor College of Medicine, evaluating the Company’s MultiTAA T cell therapy in patients with pancreatic adenocarcinoma. The data were reviewed today in an oral presentation during a plenary session, as well as a poster presentation, at the American Association for Cancer Research’s (AACR) Immune Cell Therapies for Cancer: Successes and Challenges of CAR T Cells and Other Forms of Adoptive Therapy conference held in San Francisco, California from July 19-22, 2019.

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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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