AngioDynamics (ANGO) has entered into a worldwide licensing agreement with privately-held EmboMedics Inc.
AngioDynamics will make an initial $2 million equity investment in EmboMedics through the purchase of preferred stock. The company may make an additional $9 million in equity, as well as milestone driven investments, and can execute an exclusive option to acquire EmboMedics, based on the achievement of certain milestones. This deal is not expected to have a material impact on fiscal year 2015 financial results.
Under the terms of the agreement, AngioDynamics receives an exclusive worldwide license to market and sell, upon regulatory clearances, EmboMedics' microsphere technology.
EmboMedics expects to submit for U.S. FDA 510(k) clearance to market the device as a resorbable microsphere for the embolization of hypervascular tumors by January 2016.
ANGO closed Thursday's trading at $18.25, up 3.63%.
Shares of BioBlast Pharma Ltd. (ORPN) surged more than 19% on Thursday following the receipt of FDA's Fast Track designation for its drug candidate Cabaletta for the treatment of patients with Oculopharyngeal Muscular Dystrophy.
Cabaletta is under a phase 2/3 study, dubbed HOPEMD, in patients with Occulopharyngeal Muscular Dystrophy.
We alerted ORPN to our premium subscribers on March 2, 2015 when it was trading around $6.83 The stock closed Thursday's trading at $7.18, up 19.47% from the previous day's close.
Cardiome Pharma Corp.'s (CRME) (COM.TO) Brinavess, which is approved in Europe to rapidly restore normal heart rhythm in adult patients (aged 18 years or over) who have recently started having atrial fibrillation, has received reimbursement status in Belgium.
Brinavess is expected to be listed for reimbursement in Belgium as of June 1, 2015.
CRME closed Thursday's trading 1.13% higher at $9.38.
DBV Technologies' (DBVT) investigational electrostatic patch for peanut allergy in children, Viaskin Peanut, has received Breakthrough Therapy Designation from the FDA.
The company is actively preparing the launch of its phase III trial of Viaskin Peanut in children suffering from peanut allergy, in close coordination with the FDA. Viaskin Peanut has also received Fast Track designation from the FDA.
DBV Technologies is the first company to announce Breakthrough Therapy Designation from the FDA in food allergy.
The company's American Depositary Shares began trading on the NASDAQ on October 22, 2014, priced at $21.64 each.
DBVT closed Thursday's trading 5.54% higher at $27.44.
Exelixis Inc.'s (EXEL) drug candidate Cabozantinib has received Fast Track designation from the FDA for treatment of patients with advanced renal cell carcinoma who have received one prior therapy.
Cabozantinib is under a phase 3 pivotal trial, dubbed METEOR, in patients with metastatic renal cell carcinoma who have experienced disease progression following treatment with at least one VEGFR tyrosine kinase inhibitor. Exelixis expects to release top-line results from the trial in the second quarter of 2015.
In addition to the metastatic renal cell carcinoma development program, Exelixis is also evaluating Cabozantinib in CELESTIAL, a phase 3 pivotal trial in second-line hepatocellular carcinoma.
EXEL closed Thursday's trading 5.61% higher at $3.01.
The pre-IPO shareholders of Forward Pharma A/S (FWP), who collectively account for over 75% of the company's shares outstanding, have agreed to voluntarily lock-up their shares for an additional 365 days beyond the expiration of the original IPO lock-up period of April 12, 2015. The extended lock-up period now expires on April 12, 2016.
The company's American Depositary Shares began trading on the NASDAQ on October 15, 2014, priced at $21.00 per ADS.
The company's lead drug candidate is FP187, a proprietary formulation of dimethyl fumarate, for the treatment of several inflammatory and neurological indications, including multiple sclerosis. A phase III trial of FP187 for the treatment of multiple sclerosis and/or psoriasis is expected to commence in the next 12 months. A phase 1 fed/fast pharmacokinetic trial, which is a regulatory requirement for controlled release drugs, is expected to be initiated this quarter.
Last November, Forward Pharma sued Biogen Idec in the Regional Court in Dusseldorf, alleging infringement of its German utility model DE 20 2005 022 112 due to Biogen Idec's marketing of Tecfidera in Germany. Tecfidera also contains dimethyl fumarate as the active ingredient for the treatment of multiple sclerosis. An oral proceeding in Germany is scheduled for February 16, 2016.
FWP touched a new high of $30.37 on Thursday before closing the day's trading 4.46% higher at $30.21.
Shares of Medicines Co. (MDCO) were down more than 8% in extended trading on Thursday after the company announced that it expects its net revenue for the first quarter of 2015 to fall well short of analysts' estimates and decline 26% to 29% from the year-ago comparable quarter.
For the first quarter of 2015, the company expects net revenue in the range of $125 million to $130 million compared to $177.2 million in the first quarter of 2014, and well below the consensus estimates of $184.17 million.
The company is slated to release its final results for the first quarter of 2015 on May 5th, 2015.
MDCO closed Thursday's trading at $27.82, down 1.31%. In after-hours, the stock was down 8.34% to $25.50.
Recro Pharma Inc. (REPH) is scheduled to report top-line results from a phase II clinical trial of Dex-IN for the treatment of acute pain on Day 1 following bunionectomy surgery by mid-year 2015.
Bunionectomy surgery generally involves an incision in the top or side of the big toe joint and the removal or realignment of soft tissue and bone.
The trial was originally designed to enroll 200-250 patients. But following encouraging results from the prespecified interim analysis of the trial, the total enrollment for the trial has been adjusted to approximately 170 patients.
REPH closed Thursday's trading at $9.73, up 6.81%.
Rosetta Genomics Ltd. (ROSG) was up over 11% on Thursday as investors cheered the company's decision to acquire CynoGen Inc. (d/b/a PersonalizeDx) from Prelude Corporation, a Fjord Ventures portfolio company.
The acquisition of PersonalizeDx by Rosetta Genomics is expected to close within the next several weeks and is contingent upon the closing of Prelude's purchase of PersonalizeDx from a third party.
On an annualized pro forma basis, including the operations of the PersonalizeDx business, Rosetta Genomics expects 2015 revenues to be in the range of $10 million to $12 million, and expects 2016 revenues to exceed $18 million. Rosetta Genomics also expects to achieve positive EBITDA and positive cash flow from operations prior to the end of 2017.
ROSG closed Thursday's trading 11.86% higher at $3.30.
Shire plc's (SHPG) New Drug Application for Lifitegrast, an investigational treatment for dry eye disease in adults, has been accepted for review by the FDA and granted priorirty review status. The regulatory agency is scheduled to make a decision on Lifitegrast on October 25, 2015.
SHPGY closed Thursday's trading at $254.32, up 2.93%.
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