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May 27 2016

Aclaris Therapeutics Announces $20.0 Million Private Placement

May 27 2016

MALVERN, Pa., May 27, 2016 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a clinical-stage specialty pharmaceutical company, announced today that it has entered into a stock purchase agreement with a group of institutional accredited investors for the private placement of 1,081,082 shares of common stock at a purchase price of $18.50 per share, yielding expected gross proceeds of $20.0 million.  The private placement is expected to close on or about June 2, 2016, subject to the satisfaction of customary closing conditions.

The private placement was led by Aisling Capital with participation by additional new and existing investors.

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May 25 2016

Cempra Announces Successful Results in the Phase 2 Community Acquired Bacterial Pneumonia (CABP) Trial Conducted by Japanese Partner, Toyama Chemical (a subsidiary of FUJIFILM Holdings Corporation)

May 25 2016

CHAPEL HILL, N.C., May 25, 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, is jointly developing solithromycin for the Japanese market in partnership with Toyama Chemical, a subsidiary of FUJIFILM Holdings Corporation.  The Japanese market is the second largest antibiotic market in the world with a macrolide market potential of over $450 million.

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May 17 2016

Loxo Oncology Announces the Closing of its Follow-On Offering of Common Stock and Full Exercise of the Underwriters’ Option to Purchase Additional Shares

May 17 2016

STAMFORD, Conn., May 17, 2016 (GLOBE NEWSWIRE) — Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced the closing of its previously announced underwritten public offering of 1,926,250 shares of common stock at a public offering price of $21.50 per share, which included the exercise in full by the underwriters of their option to purchase 251,250 additional shares of common stock. Gross proceeds to Loxo Oncology from this offering were approximately $41.4 million. Loxo Oncology intends to use the net proceeds from this offering for general corporate purposes, which may include funding research and development, increasing its working capital, acquisitions or investments in businesses, products or technologies that are complementary to its own, and capital expenditures.

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May 10 2016

Dermira Announces Positive Topline Phase 2b Clinical Trial Results for DRM01 in Patients with Facial Acne Vulgaris

May 10 2016

MENLO PARK, Calif., May 10, 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 topline results from its Phase 2b dose-ranging study for DRM01 in patients with facial acne vulgaris. DRM01 is a novel, small molecule designed to inhibit sebum production following topical application. The clinical study evaluated the safety and efficacy of DRM01 and demonstrated statistically significant improvements in all primary endpoints compared to vehicle at the highest dose and in most primary endpoints at the two lower doses. DRM01 was well-tolerated with adverse events primarily mild or moderate in severity.

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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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Apr 17 2016

Loxo Oncology TRK Inhibitor LOXO-101 Shows Durable Anti-Tumor Activity Across TRK Fusion Cancers in AACR Phase 1 Update

Apr 17 2016

STAMFORD, Conn., April 17, 2016 (GLOBE NEWSWIRE) — Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced new results from its Phase 1 open-label, dose-escalation trial of LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK). A presentation at the 2016 American Association for Cancer Research (AACR) Annual Meeting in New Orleans on April 17, 2016 provided updated data from the Phase 1 trial, which was last reported at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics inNovember 2015.

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Apr 4 2016

Versartis Presents Confirmatory Year Two Data from Ongoing Somavaratan Extension Study at Late-Breaker Session at ENDO Annual Meeting

Apr 4 2016

MENLO PARK, Calif., April 04, 2016 (GLOBE NEWSWIRE) — Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing somavaratan (VRS-317), a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), announced that Year 2 safety and efficacy data from its ongoing Extension Study of somavaratan in children with GHD were presented yesterday in a late-breaker oral presentation at the Endocrine Society’s 98th Annual Meeting & Expo (ENDO 2016), in Boston, MA. George Bright, MD, Versartis’ Global Pediatric Clinical Development Advisor, presented the results at the late breaker oral session (LB-OR02-2) titled “Somavaratan (VRS-317) Treatment of Children with Growth Hormone Deficiency (GHD): Results at 2 Years” on Sunday, April 3, 2016.

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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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