Select News

Aug 10 2015

Scott Braunstein Joins Aisling Capital as Operating Partner

Aug 10 2015

NEW YORK, Aug. 10, 2015 /PRNewswire/ — Aisling Capital, a leading investment firm that invests in companies developing and commercializing important and innovative healthcare products, services and technologies, announced that Scott Braunstein, MD has joined the firm as an Operating Partner. Dr. Braunstein will assist in evaluating potential future investments for the firm, as well as working broadly with Aisling portfolio companies.

“Scott has over 25 years of experience in the healthcare industry in a variety of clinical, business, strategy, product and technology leadership roles. We are delighted to welcome him to Aisling Capital,” said Drew Schiff, MD, Managing Partner at Aisling Capital. “In his new role, Scott will contribute his unique insights and perspectives to our late-stage private equity investment strategies.”

Dr. Braunstein serves as Senior Vice President, Strategy and Corporate Development at Pacira Pharmaceuticals. He spent 12 years as a Healthcare Analyst and Portfolio Manager at J.P. Morgan Asset Management, where he invested in and conducted diligence on a wide variety of pharmaceutical products and product candidates. He reviewed pharmaceutical company strategies, business models and management teams, and provided stock recommendations for the J.P. Morgan Asset Equity Group.

“I am very excited to join Aisling Capital and its talented team,” said Dr. Braunstein. “I am looking forward to working across the firm’s impressive portfolio of healthcare companies to help them better meet their business objectives, as well as identifying new investment opportunities.”

Dr. Braunstein serves as a director of Esperion Therapeutics (Nasdaq: ESPR), STAT Medical and the Cornell Alumni Association for the College of Agriculture and Life Sciences. Dr. Braunstein received his M.D. from the Albert Einstein College of Medicine and completed his residency in internal medicine at Cornell University-New York Hospital. He received his B.S. from Cornell University.

READ MORE

Aug 5 2015

Aimmune Therapeutics Announces Pricing of Initial Public Offering

Aug 5 2015

BRISBANE, Calif.–(BUSINESS WIRE)–Aug. 5, 2015– Aimmune Therapeutics, Inc. today announced the pricing of its initial public offering of 10,000,000 shares of its common stock at a public offering price of $16.00 per share, before underwriting discounts and commissions. In addition, Aimmune has granted the underwriters a 30-day option to purchase up to an additional 1,499,999 shares of common stock at the same price. Aimmune’s common stock is expected to begin trading on The NASDAQ Global Select Market on August 6, 2015 under the symbol AIMT.

READ MORE

Aug 3 2015

Dermira Doses First Patients in DRM04 Phase 3 Program in Axillary Hyperhidrosis

Aug 3 2015

Two Identical Studies to Enroll a Combined Total of 660 Patients

Topline Phase 3 Data Expected in the Second Half of 2016

Represents Dermira’s Second Product Candidate in Phase 3 Development

Dermira Updates 2015 Financial Guidance

MENLO PARK, Calif., Aug. 3, 2015 (GLOBE NEWSWIRE) — Dermira, Inc. (NASDAQ:DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today announced the initial dosing of the first patients in a Phase 3 program for DRM04 in patients with axillary hyperhidrosis (excessive underarm sweating). The DRM04 Phase 3 program consists of two identical, randomized, double-blind, vehicle-controlled studies, ATMOS-1 and ATMOS-2, each enrolling approximately 330 patients. The program is designed to assess the safety and efficacy of DRM04 compared to vehicle to support a potential New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA).

READ MORE

Aug 3 2015

Cidara Therapeutics Initiates Phase 1 Study of Lead Antifungal Product Candidate CD101 IV

Aug 3 2015

SAN DIEGO–(BUSINESS WIRE)–Aug. 3, 2015– Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today announced the initiation of a Phase 1, randomized, double-blind, dose-escalation study to determine the safety, tolerability, and pharmacokinetics of CD101 IV in healthy subjects.

READ MORE

Aug 3 2015

Chimerix Completes Targeted Enrollment for Brincidofovir Phase 3 AdVise Trial for Adenovirus Infection

Aug 3 2015

DURHAM, N.C., Aug. 3, 2015 (GLOBE NEWSWIRE) — Chimerix, Inc. (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced completion of enrollment of the targeted 200 patients in the Phase 3 AdVise trial evaluating brincidofovir for the treatment of adenovirus infection in immunocompromised patients.

READ MORE

Jul 31 2015

ADMA Biologics Announces Submission of RI-002 Biologics License Application (BLA) to FDA

Jul 31 2015

RAMSEY, N.J., July 31, 2015 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures and intends to commercialize specialty plasma-based biologics for the primary immunodeficiency (PI) population and the treatment and prevention of certain infectious diseases, announced that it has submitted its Biologics License Application (BLA) to the United States Food and Drug Administration (FDA), seeking marketing authorization for RI-002.

READ MORE

Jul 30 2015

Synergy Pharmaceuticals Announces Positive Results in the Second Phase 3 Trial of Plecanatide in Patients with Chronic Idiopathic Constipation (CIC)

Jul 30 2015

NEW YORK– Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) today announced positive top-line results from the second of two pivotal phase 3 clinical trials evaluating the efficacy and safety of two different plecanatide treatment doses (3.0 mg and 6.0 mg), taken as a tablet once-a-day, in 1337 adult patients with chronic idiopathic constipation (CIC).

READ MORE

Jul 28 2015

Esperion Therapeutics Announces Positive Top-Line Phase 2 Results for ETC-1002 in Patients With Hypercholesterolemia and Hypertension

Jul 28 2015

ETC-1002-014 Study Meets Primary Endpoint
LDL-Cholesterol Lowering Significantly Greater Than Placebo, With Neutral Effect on Blood Pressure
ETC-1002 Observed to Be Safe and Well-Tolerated
Conference Call and Webcast on Tuesday, July 28, 2015 at 8:00 a.m. Eastern Time

ANN ARBOR, MI — (Marketwired) — 07/28/15 — Esperion Therapeutics, Inc. (NASDAQ: ESPR), an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, low-density lipoprotein cholesterol (LDL-cholesterol) lowering therapies for the treatment of patients with hypercholesterolemia and other cardiometabolic risk markers, today announced positive top-line results from ETC-1002-014, a Phase 2 exploratory study evaluating the safety and efficacy of ETC-1002 (bempedoic acid) in patients with both hypercholesterolemia and hypertension.

READ MORE

Jul 27 2015

Pernix Releases Positive in vitro Abuse Deterrent Data for Third Generation Extended Release Hydrocodone ZX007

Jul 27 2015

MORRISTOWN, N.J., July 27, 2015 (GLOBAL NEWSWIRE) – Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX), a specialty pharmaceutical company, today announced positive results from Category 1 (in vitro) abuse deterrence studies with ZX007, utilizing Altus Formulation’s proprietary INTELLITAB™ abuse deterrent technology platform. ZX007 is an abuse-deterrent, extended-release oral hydrocodone bitartrate formulation product in development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate, The purpose of the studies was to perform a comprehensive battery of laboratory tests to assess the physical and chemical properties of ZX007. These studies were conducted in accordance with the April 2015 Food and Drug Administration (FDA) Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling.

READ MORE

Jul 27 2015

University of Colorado Cancer Center and Loxo Oncology Announce Publication That Provides Clinical Validation For LOXO-101 Against TRK Fusion Cancer

Jul 27 2015

Peer-Reviewed Research Brief Published in Cancer Discovery

First Confirmed Patient Response

AURORA, Colo. and STAMFORD, Conn., July 27, 2015 (GLOBE NEWSWIRE) — The University of Colorado Cancer Center and Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company focused on the discovery, development and commercialization of targeted cancer therapies, today announced the publication of a research brief in the online edition of the journal Cancer Discovery, describing the first patient with a tropomyosin receptor kinase (TRK) fusion cancer enrolled in the Phase 1 dose escalation trial of LOXO-101, the only selective TRK inhibitor in clinical development. Additional contributors to the paper include the Knight Cancer Institute at Oregon Health & Science University and Foundation Medicine, Inc. (Nasdaq:FMI).

READ MORE