News

Oct 8 2014

Chimerix's Brincidofovir Shows Potential Survival Benefit in Adenovirus Infection

Oct 8 2014
- Preliminary Data From Ongoing AdVise Trial to be Presented as Late Breaker at IDWeek 2014 - DURHAM, N.C., Oct. 8, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, announced today preliminary data for its investigational antiviral brincidofovir (BCV, CMX001) showing improved survival for patients with adenovirus in the open-label pilot portion of the Phase 3 AdVise Trial. These data will be presented at the annual meeting of the Infectious Diseases Society of America (IDSA), IDWeek, on Saturday, October 11 at 10:50 a.m. EDT in Philadelphia, PA.
READ MORE about Chimerix's Brincidofovir Shows Potential Survival Benefit in Adenovirus Infection

Oct 6 2014

Actavis to Acquire Durata Therapeutics, Inc.

Oct 6 2014
DUBLIN, Ireland and CHICAGO, Oct. 6, 2014 /PRNewswire/ -- Actavis plc (NYSE: ACT), a leading global specialty pharmaceutical company, and Durata Therapeutics, Inc. (NASDAQ: DRTX), an innovative pharmaceutical company focused on the development and commercialization of novel therapeutics for patients with infectious diseases and acute illnesses, today announced that they have entered into a definitive merger agreement under which a subsidiary of Actavis will commence a tender offer to acquire all of the outstanding shares of Durata common stock for $23.00 per share in cash, or approximately $675 million in the aggregate, and contingent value rights (CVRs) entitling the holder to receive additional cash payments of up to $5.00 per share if certain regulatory or commercial milestones related to Durata's lead product DALVANCETM are achieved.  Actavis expects the acquisition to be accretive by the end of the first year.
READ MORE about Actavis to Acquire Durata Therapeutics, Inc.

Oct 2 2014

Dermira Prices Initial Public Offering

Oct 2 2014
REDWOOD CITY, Calif., October 2, 2014 – Dermira, Inc. (NASDAQ: DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated medical dermatology products to dermatologists and their patients, today announced the pricing of its initial public offering of 7,812,500 shares of common stock at a price to the public of $16.00 per share. The shares are expected to begin trading on The NASDAQ Global Select Market on October 3, 2014 under the symbol DERM. In addition, Dermira has granted the underwriters a 30 day option to purchase up to an additional 1,171,875 shares of common stock to cover over-allotments, if any. Concurrently with the offering, Dermira is also selling through a private placement 468,750 shares of its common stock to UCB S.A., an existing stockholder, at the initial public offering price.
READ MORE about Dermira Prices Initial Public Offering

Oct 1 2014

Esperion Therapeutics Announces Positive Top-Line Phase 2b Results for ETC-1002, An Investigational Therapy for Patients with Hypercholesterolemia

Oct 1 2014
ANN ARBOR, Mich.--(BUSINESS WIRE)-- 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 hypercholesterolemia and other cardiometabolic risk markers, today announced positive top-line results from ETC-1002-008, a Phase 2b study evaluating the efficacy and safety of ETC-1002 monotherapy compared with ezetimibe monotherapy in patients with hypercholesterolemia, with or without statin intolerance.
READ MORE about Esperion Therapeutics Announces Positive Top-Line Phase 2b Results for ETC-1002, An Investigational Therapy for Patients with Hypercholesterolemia

Sep 30 2014

TransEnterix, Inc. Secures up to $25 Million in Growth Capital from Oxford Finance and Silicon Valley Bank

Sep 30 2014
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery, today announced that it has expanded its existing agreement with Oxford Finance LLC and Silicon Valley Bank to provide for up to $25.0 million in growth capital.
READ MORE about TransEnterix, Inc. Secures up to $25 Million in Growth Capital from Oxford Finance and Silicon Valley Bank

Sep 29 2014

Daiichi Sankyo to Acquire Ambit Biosciences

Sep 29 2014
TOKYO and SAN DIEGO, Sept. 29, 2014 /PRNewswire/ -- Daiichi Sankyo Company, Ltd. (hereinafter Daiichi Sankyo) (TSE: 4568) and Ambit Biosciences (NASDAQ: AMBI), jointly announced today that they have entered into a definitive merger agreement under which Daiichi Sankyo will acquire all of the outstanding common stock of Ambit Biosciences for $15 per share in cash through a tender offer followed by a merger with a subsidiary of Daiichi Sankyo, or approximately $315 million on a fully diluted basis.  In addition to the upfront cash payment, each Ambit Biosciences stockholder will receive one Contingent Value Right (CVR), entitling the holder to receive an additional cash payment of up to $4.50 for each share they own if certain commercialization related milestones are achieved. The total transaction is valued at up to $410 million on a fully diluted basis.
READ MORE about Daiichi Sankyo to Acquire Ambit Biosciences

Sep 29 2014

Agile Announces Dosing of First Patients in Twirla(R) Phase 3 SECURE Study

Sep 29 2014
PRINCETON, N.J., Sept. 29, 2014 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc., (Nasdaq:AGRX) a women's health specialty pharmaceutical company focused on the development and commercialization of new prescription contraceptive products, today announced that the first patients have been dosed in its SECURE study. The SECURE study is a single-arm, open-label, multicenter Phase 3 trial that will assess the efficacy, safety and tolerability of Agile's investigational once-weekly transdermal contraceptive patch, Twirla® (AG200-15).
READ MORE about Agile Announces Dosing of First Patients in Twirla(R) Phase 3 SECURE Study

Sep 25 2014

Cempra Completes Enrollment of Solitaire-Oral Phase 3 Trial

Sep 25 2014
Top-Line Data Expected in First Quarter of 2015 CHAPEL HILL, N.C., Sept. 25, 2014 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP) today announced the completion of enrollment of the global Solitaire-Oral Phase 3 clinical trial of oral solithromycin in adult patients with moderate to moderately severe community-acquired bacterial pneumonia (CABP). Top-line efficacy and safety data are expected to be announced during the first quarter of 2015.
READ MORE about Cempra Completes Enrollment of Solitaire-Oral Phase 3 Trial

Sep 22 2014

T2 Biosystems Receives FDA Authorization to Market T2Candida and T2Dx for the Detection of Sepsis-Causing Pathogens

Sep 22 2014
– Novel test to identify Candida, one of the most lethal forms of common bloodstream infections that cause sepsis, faster than current methods – hours instead of days – – More than 10 million people tested for Candida every year – LEXINGTON, Mass., Sept. 22, 2014 (GLOBE NEWSWIRE) -- T2 Biosystems (Nasdaq:TTOO), a company developing innovative diagnostic products to improve patient health, today announced that it has received market authorization from the U.S. Food and Drug Administration (FDA) for its first two products, the T2Candida® Panel and the T2Dx® Instrument for the direct detection of Candida species in human whole blood specimens from patients with symptoms of, or medical conditions predisposing the patient to, invasive fungal infections. T2Candida and T2Dx, for the first time, provide sensitive detection of specific sepsis-causing pathogens directly from a whole blood specimen in approximately four hours. All other currently FDA-cleared detection systems require cultured blood samples for species-specific identification and take two to five days or more to provide results.
READ MORE about T2 Biosystems Receives FDA Authorization to Market T2Candida and T2Dx for the Detection of Sepsis-Causing Pathogens

Sep 22 2014

ntersect ENT Announces Positive Data From Clinical Trial of New In-Office Implant for Recurrent Chronic Sinusitis

Sep 22 2014
MENLO PARK, Calif. and Orlando, Fla.--Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced initial results from RESOLVE, a clinical study of the company's investigational steroid eluting implant designed to treat patients with recurrent sinus obstruction in the office setting. Results were presented at the annual American Rhinologic Society meeting in Orlando, Fla., and were recognized by the society with the Cottle Award for Best Clinical Science Research, Intersect ENT's third Cottle Award for the clinical evidence supporting its products.
READ MORE about ntersect ENT Announces Positive Data From Clinical Trial of New In-Office Implant for Recurrent Chronic Sinusitis