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Feb 26 2015

Intersect ENT Reports Fourth Quarter and Year 2014 Results

Feb 26 2015

MENLO PARK, Calif.–(BUSINESS WIRE)– Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today reported financial results for the fourth quarter and year ended December 31, 2014.

2014 Business Highlights

  • Achieved year over year revenue growth of 115%
  • Realized 2014 gross margin of 74% versus 55% in 2013
  • Completed the RESOLVE study and commenced the RESOLVE II study in December 2014. RESOLVE II is a pivotal Phase III clinical study of the company’s RESOLVE steroid releasing implant designed to treat patients with recurrent sinus obstruction in the office setting
  • Commenced enrollment in September 2014 of the PROGRESS study to assess the safety and efficacy of the PROPEL® mini steroid releasing sinus implant when placed in the frontal sinus opening
  • Completed enrollment in a feasibility study to assess the company’s investigational NOVA steroid releasing sinus implant. This implant is designed primarily as a treatment in the physician’s office for patients suffering from chronic sinusitis who have not yet had sinus surgery
  • Completed an initial public offering in July 2014, raising net proceeds of $55.8 million, after deducting underwriting discounts and commissions and offering expenses
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Feb 23 2015

ADMA Biologics Announces Positive Data on Primary and Secondary Endpoints from its Pivotal Phase III Clinical Trial for RI-002 at the AAAAI Medical Conference

Feb 23 2015

RAMSEY, N.J., Feb. 23, 2015 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, announced positive results on the primary and secondary endpoint evaluations from its pivotal Phase III trial for RI-002 in Primary Immune Deficiency Disease (PIDD) in a poster presentation yesterday at the American Academy of Allergy, Asthma and Immunology Annual Meeting (http://annualmeeting.aaaai.org). In December 2014, the company announced that the trial met its primary endpoint with zero serious bacterial infections (SBI).

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Feb 6 2015

Dermira Announces Positive Phase 2b Results for DRM04 in Patients with Hyperhidrosis

Feb 6 2015

MENLO PARK, Calif., February 5, 2015 – Dermira, Inc. (NASDAQ: DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today announced positive Phase 2b study results for DRM04, its proprietary topical anticholinergic product, in patients with axillary hyperhidrosis, or excessive underarm sweating. Based on the results of this study (DRM04-HH02) and its first Phase 2b study (DRM04-HH01), Dermira plans to initiate a Phase 3 program for DRM04 in axillary hyperhidrosis in the second half of 2015, consistent with previous expectations and subject to an end-of-phase 2 meeting with the U.S. Food and Drug Administration (FDA).

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Feb 2 2015

Esperion Therapeutics Announces Removal of PPAR Partial Clinical Hold for ETC-1002

Feb 2 2015

ANN ARBOR, MI –(Marketwired – February 02, 2015) – 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 cardio-metabolic risk markers, today announced the U.S. Food and Drug Administration (FDA) has removed the peroxisome proliferator-activated receptor (PPAR) partial clinical hold on ETC-1002. The action by the FDA will now allow Esperion to conduct clinical trials exceeding six months in duration.

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Jan 4 2015

Cempra Announces Positive Topline Phase 3 Clinical Results for Oral Solithromycin in the Treatment of Community Acquired Bacterial Pneumonia

Jan 4 2015

CHAPEL HILL, N.C., Jan. 4, 2015 (GLOBE NEWSWIRE) — Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics in the face of rising antibiotic resistant bacterial infections, today announced positive topline results from a global, pivotal Phase 3 clinical trial of solithromycin oral capsules (Solitaire- Oral) in the treatment of patients with community acquired bacterial pneumonia (CABP).

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Dec 3 2014

ADMA Biologics Announces Positive Top-Line Phase III Data for Primary Immune Deficiency Disease (PIDD) Patients

Dec 3 2014

RAMSEY, N.J., Dec. 3, 2014 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, today announced its lead product candidate RI-002 has demonstrated positive Phase III results and successfully achieved its primary endpoint.

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Nov 17 2014

Actavis Successfully Completes Durata Therapeutics, Inc. Tender Offer

Nov 17 2014

DUBLIN, Nov. 17, 2014 /PRNewswire/ — Actavis plc (NYSE: ACT) today announced that it has successfully completed its tender offer to purchase all outstanding shares of 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.  As previously announced, Actavis offered to purchase all outstanding shares of Durata for $23.00 per share in cash, or approximately $675 million in the aggregate, and one contingent value right (CVR) per share, entitling the holder to receive additional cash payments of up to $5.00 per CVR if certain regulatory or commercial milestones related to Durata’s lead product DALVANCETM are achieved.

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Nov 12 2014

ViewRay MRIdian System Receives CE Mark

Nov 12 2014

CLEVELAND, Ohio, November 11, 2014— ViewRay™, a privately held medical device company, announced today that its MRIdian™ \mə-ˈri-dē-ən\ system, the world’s first and only MRI-guided radiation therapy system, has received CE Mark (Conformité Européenne) approval. This milestone allows the company to deliver MRIdian systems throughout Europe and other regions that require the CE Mark.

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Nov 10 2014

Daiichi Sankyo and Ambit Announce Results of Tender Offer

Nov 10 2014

TOKYO, Japan and San Diego, CA (November 10, 2014) – Daiichi Sankyo Company, Limited (hereinafter, Daiichi Sankyo) (TSE: 4568) and Ambit Biosciences Corporation (hereinafter, Ambit Biosciences) (NASDAQ: AMBI) today announced the results of Daiichi Sankyo’s tender offer to purchase all of the outstanding shares of Ambit Biosciences’ common stock for $15.00 per share plus one non-transferable contingent value right per share, which will entitle the holder thereof to a maximum payment of $4.50 upon the achievement of certain commercialization related milestones relating to quizartinib. The tender offer is being effected by Daiichi Sankyo’s subsidiary, Charge Acquisition Corp.

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Nov 5 2014

ADMA Biologics Approved for Trading on NASDAQ

Nov 5 2014

RAMSEY, N.J., Nov. 5, 2014 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (OTCQB:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, today announced that the NASDAQ stock market has approved ADMA’s common stock for listing on the NASDAQ Capital Market and is expected to begin trading on November 10, 2014 under the symbol “ADMA.”

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