Select News

Aug 9 2017

Aclaris Announces Appointment of Andrew Schiff to Board of Directors

Aug 9 2017

MALVERN, Pa., Aug. 09, 2017 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led, biopharmaceutical company focused on identifying, developing and commercializing innovative and differentiated therapies to address significant unmet needs in medical and aesthetic dermatology, today announced the appointment of Andrew Schiff, Managing Partner of Aisling Capital, to its board of directors, effective August 9, 2017.

READ MORE

Aug 8 2017

Esperion Announces Positive Top-Line Results From Phase 2 Study of Bempedoic Acid / Ezetimibe Combination Plus Atorvastatin

Aug 8 2017

ANN ARBOR, Mich., Aug. 08, 2017 (GLOBE NEWSWIRE) — Esperion Therapeutics, Inc. (NASDAQ:ESPR), the Lipid Management Company focused on developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced positive top-line results from the Phase 2 clinical study (1002-038), also known as the triplet oral therapy study, evaluating the LDL-C lowering efficacy and safety of the bempedoic acid / ezetimibe combination (bempedoic acid 180 mg, ezetimibe 10 mg) plus atorvastatin 20 mg, versus placebo, in patients with hypercholesterolemia. The six-week study met its primary endpoint of greater LDL-C lowering from baseline of 64 percent (p<0.001) in the bempedoic acid / ezetimibe combination plus atorvastatin group, as compared to placebo. Ninety five percent of patients receiving treatment achieved greater than or equal to 50 percent LDL-C lowering reduction and 90 percent achieved LDL-C levels of less than 70 mg/dL.

READ MORE

Aug 8 2017

Aclaris Therapeutics Acquires Confluence Life Sciences, Inc.

Aug 8 2017

MALVERN, Pa., Aug. 08, 2017 (GLOBE NEWSWIRE) — Aclaris Therapeutics, Inc. (“Aclaris”) (NASDAQ:ACRS), a dermatologist-led, biopharmaceutical company focused on identifying, developing and commercializing innovative and differentiated therapies to address significant unmet needs in medical and aesthetic dermatology, today announced that it has acquired Confluence Life Sciences, Inc.(“Confluence”), a privately held biotechnology company focused on the discovery and development of kinase inhibitors to treat inflammatory and immunological disorders and cancer.  At the closing, Aclaris paid approximately $10 million in cash and issued approximately 350,000 shares of its common stock, with a value of approximately $10 million on the closing date, to the former equityholders of Confluence.

READ MORE

Jul 31 2017

Loxo Oncology Announces Acquisition of Highly Selective, Reversible BTK Inhibitor Program

Jul 31 2017

STAMFORD, Conn., July 31, 2017 (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 that the company has entered into a definitive agreement to purchase the Bruton’s tyrosine kinase (BTK) inhibitor program from Redx Pharma Plc. The lead candidate from this program is expected to enter clinical development in 2018.

READ MORE

Jul 26 2017

Sientra Completes Acquisition of Miramar Labs®

Jul 26 2017

SANTA BARBARA, Calif., July 26, 2017 (GLOBE NEWSWIRE) — Sientra, Inc. (NASDAQ:SIEN), a medical aesthetics company, announced today that it has completed the previously announced acquisition of Miramar Labs, Inc., for an aggregate transaction value of $20 million in upfront cash, plus contractual rights for potential contingent payments of up to $14 million in cash upon the achievement of certain milestones. The acquisition of Miramar significantly broadens Sientra’s aesthetics portfolio, adding the miraDry system, the only FDA cleared device to reduce underarm sweat, odor and permanently reduce hair of all colors. The miraDry non-invasive procedure is safe and highly efficacious with a proven commercial and clinical track record.

READ MORE

Jul 18 2017

T2 Biosystems Receives CE Mark for T2Bacteria™ Panel Enabling Commercialization in Europe

Jul 18 2017

LEXINGTON, Mass., July 18, 2017 (GLOBE NEWSWIRE) — T2 Biosystems, Inc. (NASDAQ:TTOO), an emerging leader in the development of innovative diagnostic products to improve patient health, announced today that it has received a CE Mark for its T2Bacteria Panel, allowing for the sale and distribution of the product within the European Union and those countries accepting the CE Mark. The T2Bacteria Panel runs on the Company’s proprietary T2Dx® Instrument and provides highly accurate species-specific test results of targeted bacterial infections direct from whole blood in as fast as about 3.5 hours, and without the need for a time-consuming blood culture. The T2Bacteria Panel is currently available in the United States for Research Use Only (RUO) and the Company is in the final stages of completing the FDA pivotal trial, after which a 510(k) application will be submitted to the FDA. Patient enrollment in the trial is currently 92% complete and the company is very pleased with the product performance demonstrated to date, which for the prospective arm of the study is showing an average sensitivity of 96% and average specificity of 98%.

READ MORE

Jul 18 2017

Menlo Therapeutics Raises $50M

Jul 18 2017

MENLO PARK, Calif.July 18, 2017 /PRNewswire/ — Menlo Therapeutics Inc. announced today that the company has raised $50M to advance development of serlopitant, a novel NK-1 receptor antagonist, as a once-daily oral treatment for pruritus (itch) associated with atopic dermatitis, psoriasis and prurigo nodularis and for treatment of refractory chronic cough.  venBio led the financing and was joined by Novo Holdings A/S, Rock Springs Capital, Aisling Capital, and Bay City Capital as new Menlo Therapeutics investors in this Series C financing. All of Menlo Therapeutics’ Series A and B investors also participated in the financing, including Vivo Capital, Presidio Partners, Remeditex, and F-Prime Capital.

READ MORE

Jul 17 2017

Paratek Announces Phase 3 Study of Oral-Only Dosing of Omadacycline Met All Primary and Secondary FDA and EMA Efficacy Endpoints in Acute Bacterial Skin Infections

Jul 17 2017

BOSTON, July 17, 2017 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today positive top-line results from a pivotal Phase 3 clinical study comparing its once-daily, oral investigational antibiotic, omadacycline, to twice-daily oral linezolid in the treatment of acute bacterial skin and skin structure infections (ABSSSI). The study met all of its primary and secondary endpoints required to support approval for this indication by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This represents the third positive Phase 3 registration study of omadacycline.

READ MORE

Jul 7 2017

Entellus Medical Announces Definitive Agreement to Acquire Spirox

Jul 7 2017

PLYMOUTH, Minn., July 07, 2017 (GLOBE NEWSWIRE) — Entellus Medical, Inc. (NASDAQ:ENTL), a medical technology company focused on delivering minimally invasive ENT procedures, today announced that it has entered into a definitive agreement to acquire Spirox, Inc., a privately-held ENT medical technology company that develops, manufactures and markets the LATERA™ Absorbable Nasal Implant, a minimally invasive option for ENTs and facial plastic surgeons to treat nasal airway obstruction. The company also announced preliminary second quarter 2017 revenue results and updated full year 2017 revenue guidance. Under the terms of the agreement, Entellus has agreed to acquire Spirox for $25 million in cash and 3.4 million shares of Entellus common stock, plus additional contingent payments over four years based on revenue growth.

READ MORE

Jun 27 2017

Esperion Announces FDA Confirmation of Regulatory Pathway to Approval for the Combination of Bempedoic Acid and Ezetimibe

Jun 27 2017

ANN ARBOR, Mich., June 26, 2017 (GLOBE NEWSWIRE) — Esperion Therapeutics, Inc. (NASDAQ:ESPR), the Lipid Management Company focused on developing and commercializing convenient, complementary, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C), today announced the U.S. Food and Drug Administration (FDA) recently confirmed the regulatory pathway to approval for the once-daily, oral combination pill of bempedoic acid 180 mg and ezetimibe 10 mg. Based on feedback received from the FDA, Esperion plans to initiate a single global pivotal Phase 3 bridging study (1002FDC-053) for the bempedoic acid / ezetimibe combination pill that will be conducted concurrently with the ongoing global pivotal Phase 3 program for bempedoic acid. The Phase 3 bridging study will support approval for an LDL-C lowering indication in both the U.S. and Europe. The randomized, double-blind, placebo-controlled study is expected to enroll up to 350 patients with hypercholesterolemia and with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH), including high cardiovascular risk primary prevention patients, whose LDL-C is not adequately controlled. The goal of this study is to evaluate the efficacy and safety of the bempedoic acid / ezetimibe combination, a convenient, cost-effective, once-daily, oral pill. Additional design details for this study will be provided upon initiation by the fourth quarter of 2017, with top-line results expected by the end of 2018.

READ MORE