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May 1 2016

Cempra Completes NDA Submissions for Solithromycin in the Treatment of Community-Acquired Bacterial Pneumonia

May 1 2016

Solithromycin is designated by FDA as a Qualified Infectious Disease Product

FDA has granted Priority Review and Fast Track designation for solithromycin IV and capsules for the treatment of CABP

Two NDAs submitted, one for intravenous and one for oral capsules

CHAPEL HILL, N.C., May 01, 2016 (GLOBE NEWSWIRE) — Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced the completion of its rolling submission of the New Drug Applications (NDA) for solithromycin to the U.S. Food and Drug Administration (FDA) for the treatment of community-acquired bacterial pneumonia (CABP). Based on the Qualified Infectious Disease Product (QIDP) designation by the FDA of solithromycin, Cempra has Priority Review and has been granted Fast Track for both the oral capsule and intravenous formulations for the treatment of CABP, which could result in an FDA decision on solithromycin’s NDA within eight months, or by the end of 2016, based on the Prescription Drug User Fee Act (PDUFA) performance goals.

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Apr 28 2016

ADMA Biologics Announces Pricing of Public Offering of Common Stock

Apr 28 2016

RAMSEY, N.J., April 28, 2016 (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 treatment and prevention of certain infectious diseases, announced today the pricing of its previously announced underwritten public offering of 1,892,308 shares of common stock at a public offering price of $6.50 per share, resulting in gross proceeds of approximately $12.3 million. Members of management and the Board of Directors participated in excess of ten percent in the offering.

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Apr 18 2016

New Alliance Strengthens Alcon’s Focus on Developing Accommodating Intraocular Lenses

Apr 18 2016

Fort Worth, Texas, April 18, 2016 – Alcon, the global leader in eye care and a division of Novartis, announced today that it has entered into a strategic alliance with PowerVision, Inc., a privately-held, US-based medical device company focused on developing fluid-based lens implants.

PowerVision, Inc. has developed an accommodating IOL (AIOL) which has demonstrated in pilot studies the ability to change focus via a fluid-driven shape-changing technology. The AIOL is intended for cataract patients who also have presbyopia. The technology utilizes the eye’s natural accommodating muscles to transport fluid in the intraocular lens which is implanted in the eye’s capsular bag.

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Mar 30 2016

Zavante Therapeutics Closes $45 Million Series A Financing In Support Of U.S. Development For A First-In-Class Injectable Antibiotic

Mar 30 2016

SAN DIEGO, March 30, 2016 /PRNewswire/ — Zavante Therapeutics, Inc., a privately held, late clinical-stage biopharmaceutical company, today announced that it has closed a $45 million Series A financing, consisting of $35 million from new investors and $10 million from the conversion of outstanding convertible notes. Proceeds from the financing will be used for the development of the Company’s lead product candidate, ZTI-01 (fosfomycin for injection), an injectable antibiotic with a differentiated mechanism of action designed for use in the hospital setting. In the second quarter of 2016, Zavante plans to initiate the ZEUS Study, a single pivotal clinical trial for ZTI-01, a first-in-class broad spectrum IV antibiotic under development to treat multidrug resistant (MDR) pathogens.

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Mar 15 2016

Spirox, Inc. Announces Closing of $45MM Series C Financing

Mar 15 2016

MENLO PARK, Calif.–(BUSINESS WIRE)–Spirox Inc., a privately held medical device company, announced today the closing of a $45 million Series C round of financing led by KKR, a leading global investment firm. In leading the round, KKR joins a strong syndicate of existing investors in the company. Also participating in the financing is new investor HealthQuest Capital along with major existing shareholders Aisling Capital, Aperture Venture Partners and Venrock. Spirox, which is developing a novel, minimally invasive system to be used by Ear, Nose and Throat (ENT) physicians and plastic surgeons to treat patients with nasal obstruction, looks forward to partnering with KKR to help scale the business and better serve the greater ENT community.

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Mar 7 2016

Cempra Authorized to Receive Funds From BARDA for a Phase 2/3 Clinical Trial of Solithromycin in Pediatric Patients

Mar 7 2016

Phase 2/3 Pivotal Trial Will Test Intravenous, Oral Capsule and Oral Suspension Formulations of Solithromycin in Pediatric Patients From Age 2 Months to 17 Years

Cempra to Receive $25.5 Million in Funding for the Next Phase of Its Existing Agreement With BARDA

CHAPEL HILL, N.C. , March 07, 2016 (GLOBE NEWSWIRE) — Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced it has received authorization under its existing contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, to receive funding of $25.5 million through mid-2018 for a Phase 2/3 clinical study of solithromycin. Cempra is responsible for an additional designated portion of the cost of the planned Phase 2/3 study. Pediatric patients from age 2 months to 17 years with community-acquired bacterial pneumonia (CABP) who are enrolled in the study may receive intravenous, oral suspension or oral capsule formulations of solithromycin, an investigational, fourth generation macrolide antibiotic, or a comparator treatment. The planned enrollment of 400 patients for the Phase 2/3 study is expected to begin during the first half of 2016, with full enrollment expected during the first half of 2018.

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Mar 6 2016

Aimmune Therapeutics Announces Phase 2 Follow-On Study of AR101 for the Treatment of Peanut Allergy Demonstrated Increased Desensitization and Improved Tolerability with Low-Dose Maintenance

Mar 6 2016

— All Patients Who Completed 12 Weeks of Low-Dose Maintenance Therapy in the ARC002 Trial Were Desensitized to Levels of Peanut Protein Far Exceeding Those of Typical Accidental Exposures —

— Dr. J. Andrew Bird Presented Data Confirming Safety and Demonstrating Efficacy of AR101 for the Treatment of Peanut Allergy at the 2016 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Los Angeles —

LOS ANGELES–(BUSINESS WIRE)–Mar. 6, 2016– Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing CODIT™(characterized oral desensitization immunotherapy) treatments for life-threatening food allergies, today announced data from the open-label ARC002 Phase 2 trial of its lead product candidate, AR101 for the treatment of peanut allergy. All patients who completed 12 weeks of low-dose maintenance therapy were desensitized to levels of peanut protein beyond the 250-300 mg typically found in one peanut kernel.

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Feb 29 2016

ZELTIQ Announces Fourth Quarter and Full Year 2015 Financial Results

Feb 29 2016

Full Year 2015 Revenue of $255.4 Million, up 46% Year-Over-Year; Announces New CoolAdvantage(TM) Family of Applicators With 35 Minute Treatment Times

PLEASANTON, CA — (Marketwired) — 02/29/16 —

  • Fourth quarter revenue of $78.2 million, up 54% year-over-year; Full year revenue of $255.4 million, up 46% year-over-year
  • Fourth quarter net income of $40.6 million, or $0.99 per diluted share; Full year net income of $41.8 million, or $1.02 per diluted share
  • Fourth quarter Adjusted EBITDA margin of 7.0%; Full year Adjusted EBITDA margin of 7.6%
  • 387 systems shipped, compared to 354 systems in fourth quarter 2014, bringing total system installed base to 4,634 systems
  • 273,112 revenue cycles shipped, up 57% from fourth quarter 2014
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Feb 29 2016

Dermira Completes Patient Enrollment for DRM04 Phase 3 Pivotal Trials in Primary Axillary Hyperhidrosis

Feb 29 2016

Topline Results for Phase 3 ATMOS-1 and ATMOS-2 Clinical Trials Expected in 2Q 2016

MENLO PARK, Calif., Feb. 29, 2016 (GLOBE NEWSWIRE) — Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to identifying, developing and commercializing innovative, differentiated therapies to improve the lives of patients with dermatologic diseases, today announced the completion of patient enrollment in its Phase 3 ATMOS-1 and ATMOS-2 clinical trials for DRM04 in primary axillary hyperhidrosis (excessive underarm sweating). Based on enrollment completing ahead of schedule, Dermira now expects to announce topline efficacy and safety data for both of these trials during the second quarter of 2016, compared with previous guidance of mid-2016.

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Feb 24 2016

ADMA Biologics Recognized as One of New Jersey’s “Best Places to Work 2016”

Feb 24 2016

RAMSEY, N.J., Feb. 24, 2016 (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 treatment and prevention of certain infectious diseases, announced today that the Company has been recognized as one of New Jersey’s “100 Best Places to Work 2016” by the Best Companies Group, a company dedicated to identifying and recognizing places of employment that are leading the way in defining the employee experience, and NJBIZ, a leading New Jersey-focused weekly business news publication.

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