News

Management to Host Webcast and Conference Call Today at 1:30 p.m. PT / 4:30 p.m. ET MENLO PARK, Calif., June 01, 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 3 ATMOS-1 and ATMOS-2 pivotal trials for DRM04, a topical anticholinergic product candidate in development for patients with primary axillary hyperhidrosis (excessive underarm sweating). Both clinical trials evaluated the safety and efficacy of DRM04 compared to vehicle.

Company On Track to Initiate Study in Mid-2016 in Genomically Defined Subsets of Patients with Acute Myeloid Leukemia and Myelodysplastic Syndrome CAMBRIDGE, Mass.--(BUSINESS WIRE)--Syros Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) accepted the Company’s Investigational New Drug (IND) application to advance its lead drug candidate, SY-1425, a potent and selective retinoic acid receptor alpha (RARα) agonist, into a Phase 2 clinical trial in genomically defined subsets of patients with relapsed or refractory acute myeloid leukemia (AML) and relapsed high-risk myelodysplastic syndrome (MDS) identified through its platform. Syros is on track to initiate the Phase 2 clinical trial in mid-2016.

SAN DIEGO--(BUSINESS WIRE)--May 31, 2016-- Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today announced that the U.S. Food and Drug Administration (FDA) has designated the company’s novel antifungal product candidate, CD101 topical, as a Qualified Infectious Disease Product (QIDP), with Fast Track status for its development program. The designation is for the development of CD101 for the treatment of vulvovaginal candidiasis (VVC) and for the prevention of recurrent VVC (RVVC).

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.

TransEnterix Appoints Theodore Pappas, MD Senior Surgical Officer New Senior Surgical Officer to enhance company's clinical and development efforts in minimally invasive surgical robotics RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, announced today that it has appointed Theodore N. Pappas, MD as the company's Senior Surgical Officer. In this role, Dr. Pappas will work closely with management on clinical and regulatory strategy as well as guide continued development efforts to maximize surgical value.

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.

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.

- Maintains strong financial position with $314.5 million in capital at quarter end - - Company to hold conference call at 8:30am ET today - DURHAM, N.C., May 09, 2016 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing novel antivirals to address unmet medical needs, today reported top-line results from an interim analysis of the AdVise trial of brincidofovir for serious adenovirus (AdV) infection and other corporate updates including financial results for the first quarter ended March 31, 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.

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.