Aegerion Pharmaceuticals Inc. (AEGR: Quote) said it continues to be optimistic about the potential for a positive CHMP opinion in the European Union for its homozygous familial hypercholesterolemia drug – JUXTAPID, in the second quarter and approval in mid-2013.
JUXTAPID was approved by FDA for homozygous familial hypercholesterolemia last December.
AEGR touched a new high of $42.99 on Tuesday before closing at $42.04.
Cyclacel Pharmaceuticals Inc. (CYCC: Quote) announced that in a phase II trial, its lead product candidate, Sapacitabine, nearly doubled the expected median survival of older patients with myelodysplastic syndromes who failed front-line therapies like Vidaza and/or Dacogen.
The median survival for patients with intermediate-2 or high-risk myelodysplastic syndromes following treatment failures is 4.3 to 5.6 months. But in the phase II trial, the median overall survival of all the patients who were treated with Sapacitabine, following failure of failed front-line therapies, is approximately 9 months.
CYCC closed Tuesday’s trading at $4.61, down 1.07%. In extended trading the stock was up 0.87% at $4.65.
GTx Inc. (GTXI: Quote) has initiated a proof of concept, phase II, open-label study to evaluate its experimental drug Enobosarm in the treatment of ER positive metastatic breast cancer. The study will randomize 20 postmenopausal women with estrogen receptor (ER) positive metastatic breast cancer who have previously responded to hormone therapy at approximately six clinical sites in the United States.
GTXI closed Tuesday’s trading at $4.62, down 1.28%.
Immunovaccine Inc. (IMV.V: Quote) announced that certain modifications will be made to its stock option plan under which, the number of shares reserved for issuance will increase from 6,250,000 to 6,750,000. These modifications are subject to approval by the TSX Venture Exchange.
IMV.V closed Tuesday’s trading 5.66% higher at C$0.28.
Ligand Pharmaceuticals Inc. (LGND: Quote) said it has acquired financial rights to more than 15 fully-funded development programs from Geneva, Switzerland-based Selexis SA, a privately held global life science company.
The acquisition significantly expands Ligand’s portfolio to more than 85 fully-funded assets, and diversifies its portfolio beyond small molecule therapeutics into biologics, said John Higgins, President and CEO of Ligand.
LGND closed Tuesday’s trading at $27.32, down 0.94%.
Omeros Corp.’s (OMER: Quote) ophthalmology product OMS302 has been granted eligibity for centralized review by the European Medicines Agency. OMS302 is being developed for use during intraocular lens replacement, including cataract surgery and refractive lens exchange.
The EMA’s centralized review allows submission of a single Marketing Authorization Application that, when approved, authorizes the drug to be marketed in all European Union member states and European Free Trade Association countries rather than requiring separate national approvals.
The company intends to submit a New Drug Application for OMS302 to the FDA this quarter and file a Marketing Authorization Application to European regulators in mid-2013.
OMER closed Tuesday’s trading at $4.03, down 2.18%.
Oxygen Biotherapeutics Inc. (OXBT: Quote) is all set to begin enrolling patients in the second cohort of its phase IIb clinical trial to investigate the safety and tolerability of Oxycyte in patients with severe, non-penetrating traumatic brain injury. The second cohort begins officially with the activation of the first of five planned sites in Israel.
OXBT gained 4.13% to close Tuesday’s trading at $0.25.
Shares of Raptor Pharmaceutical Corp. (RPTP: Quote) touched a new 52-week high of $7.67 on Tuesday before closing at $6.90 after the company’s drug PROCYSBI received FDA approval for the treatment of nephropathic cystinosis.
The FDA approval of PROCYSBI triggers the second of two $25 million payments to Raptor under the terms of the HealthCare Royalty Partners $50 million loan agreement.
The drug is expected to be commercially launched in the U.S. by end of Q2 2013.
Roche Group’s (RHHBY) unit Genentech announced Tuesday that its drug ACTEMRA has received FDA approval for the treatment of polyarticular juvenile idiopathic arthritis – for children two years of age and older with active disease. The approval marks the second indication for the drug.
ACTEMRA is already approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying antirheumatic drugs.
Teva Pharmaceutical Industries Ltd.’s (TEVA: Quote) emergency contraceptive Plan B One-Step has been approved by FDA for over-the-counter sale to women 15 years of age and older in the United States.
The approval marks the transition of Plan B One-Step from behind the pharmacy counter to retail outlets with an onsite pharmacy, thereby providing women an extended and improved access to the product.
TEVA closed Tuesday’s trading at $38.29, down 1.16%.
Transition Therapeutics Inc. (TTHI: Quote) (TTH.TO: Quote) touched a new 52-week high of $3.84 on Tuesday before closing at $3.10 after the company announced promising results from a five-week proof of concept clinical study of TT-401 in type 2 diabetic and obese non-diabetic subjects.
According to the study results, TT-401 demonstrated an acceptable safety and tolerability profile at all doses evaluated in diabetic and non-diabetic obese subjects. The company said that the data support a clear development path forward to a larger phase II efficacy study of TT-401.
Shares of Trimel Pharmaceuticals Corp. (TRL.TO: Quote) rose over 30% on Tuesday following the company’s submission of a New Drug Application for CompleoTRT, a bioadhesive intranasal gel testosterone product, indicated for the treatment of testosterone deficiency in men.
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