News
Nov 19
2014
Cempra to Receive BARDA Funding for 1b and Start-Up of Phase 2/3 Solithromycin Pediatric Studies
Nov 19
2014
$16.0 Million Will be Provided to Cover the Cost of the Study and Other Activities Specified in the Contract
Phase 1b and Phase 2/3 Studies Will Test Intravenous, Oral Capsule and Oral Suspension Formulations of Solithromycin in Pediatric Patients From Newborn to 17 Years of Age
CHAPEL HILL, N.C., Nov. 19, 2014 (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 it has received authorization under its existing contract for the next phase of its contract with the Biomedical Advanced Research and Development Authority (BARDA) that will provide funding of $16.0 million for two clinical studies of solithromycin. Pediatric patients from newborn to age 17 years who are enrolled in the study may receive intravenous, oral suspension or oral capsule formulations of solithromycin, an investigational, fourth generation macrolide antibiotic. In a recently completed Phase 1a study conducted in pediatric patients age 12 to 17 years, solithromycin oral capsules were well tolerated and demonstrated a pharmacokinetic profile similar to that seen in adults.
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Nov 17
2014
Pernix Submits sNDA for TREXIMET® use in Adolescent Patients
Nov 17
2014
MORRISTOWN, NJ, – (BUSINESS WIRE) – November 17, 2014 – Pernix Therapeutics Holdings, Inc. (NASDAQ: PTX) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for TREXIMET (sumatriptan / naproxen sodium) to seek approval for use in adolescent patients, age 12 – 17, for the acute treatment of migraine with or without aura.
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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
Chimerix Announces Completion of Public Offering of Common Stock and Exercise in Full of Option to Purchase Additional Shares of Common Stock
Nov 5
2014
DURHAM, N.C., Nov. 5, 2014 (GLOBE NEWSWIRE) -- Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced the completion of an underwritten public offering of 4,197,500 shares of its common stock, including 547,500 shares sold pursuant to the full exercise of an option previously granted to the underwriters to purchase additional shares of common stock. All of the shares were offered by Chimerix at a price to the public of $29 per share. The gross proceeds to Chimerix from this offering, before deducting underwriting discounts and commissions and other offering expenses payable by Chimerix, were approximately $121.7 million. Chimerix anticipates using the net proceeds from the offering to fund its research and development efforts and for general corporate purposes, including working capital.
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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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Oct 31
2014
Paratek Pharmaceuticals Completes Merger With Transcept Pharmaceuticals
Oct 31
2014
BOSTON, Oct. 30, 2014 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) and Transcept Pharmaceuticals, Inc. (Nasdaq:TSPT) (through October 30) today announced the two companies have completed their merger effective as of October 30, 2014.
Immediately prior to the merger, Paratek received gross proceeds of $93 million in new investment from a combination of certain current and new investors in Paratek, including Abingworth LLP, Aisling Capital, The Baupost Group, HBM Healthcare Investments, Interwest Ventures, Omega Funds, Roumell Asset Management and other highly regarded institutional investors. Together with approximately $14 million in available, pre-merger cash on Transcept's balance sheet, the combined company has approximately $108 million in cash available before the payment of transaction and other fees.
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Oct 27
2014
Syros Pharmaceuticals Closes $53 Million Series B Financing
Oct 27
2014
WATERTOWN, MA, October 27, 2014 – Syros Pharmaceuticals, a therapeutics company focused on discovering and developing novel gene control therapies in cancer and other diseases, announced today that it has closed its Series B round with $53 million in new investment. The proceeds from this financing will be used to advance the company’s portfolio of cancer programs towards the clinic and to expand its gene control product engine into new therapeutic areas.
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Oct 21
2014
Esperion Therapeutics Announces Closing of Follow-On Public Offering and Exercise in Full of Underwriters' Option to Purchase Additional Shares of Common Stock
Oct 21
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 the closing of its follow-on public offering of 4,887,500 shares of common stock, offered at a price to the public of $20.00 per share, which includes the exercise in full by the underwriters of their option to purchase 637,500 additional shares of common stock. This exercise brings the net proceeds in the offering to $91.6 million, after deducting underwriting discounts and commissions and expenses payable by Esperion. Esperion intends to use the net proceeds from the offering, as well as its other existing capital resources, to fund the continued development of ETC-1002 through completion of the anticipated Phase 3 development program, which will include several clinical studies; chemistry, manufacturing and controls (CMC) scale up and supplies development; regulatory compliance and the remainder for working capital and general corporate and administrative expenses.
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