Key Developments: Anthera Pharmaceuticals Inc (ANTH.W)
0.59USD
30 May 2013
$0.04 (+6.90%)
$0.55
$0.59
$0.59
$0.59
200
6
$3.08
$0.51
Latest Key Developments (Source: Significant Developments)
Anthera Pharmaceuticals Inc Initiates CHABLIS-SC1 Phase 3 Clinical Study In Lupus With Blisibimod
Anthera Pharmaceuticals Inc announced it has initiated the CHABLIS-SC1 Phase 3 study of blisibimod, a inhibitor of B-Cell Activating Factor for the treatment of systemic lupus erythematosus. Lupus is a chronic autoimmune disease, which often leads to severe skin rash, fatigue, joint pain and organ complications. The Phase 3 CHABLIS-SC1 study is a multicenter, placebo-controlled, randomized, double-blind study designed to evaluate the efficacy, safety, tolerability and immunogenicity of blisibimod in patients with clinically active SLE who have not achieved optimal resolution of their disease with corticosteroid use. The study will enroll patients from Latin America, Asia Pacific and Commonwealth of Independent States who will be randomized to receive blisibimod or placebo for 52 weeks after which they will have the option to receive blisibimod therapy in an open-label, long-term, follow-up safety study. The study will enroll approximately 400 patients and the primary endpoint will be a Systemic Lupus Erythematosus Response Index-8. An SRI-8 responder is defined as a patient who has achieved a reduction in SELENA-SLEDAI equal to or greater than 8 points, and no new BILAG A or two B organ domain scores, and no increase in Physician's Global Assessment of greater than 0.3 on a three point scale. As part of the CHABLIS-SC1 clinical study an independent statistician will conduct interim analyses to validate key study assumptions. Full Article
Faruqi & Faruqi, LLP Is Investigating Anthera Pharmaceuticals Inc On Behalf Of Shareholders
Faruqi & Faruqi, LLP, a national law firm concentrating on investor rights, consumer rights and the enforcement of federal antitrust laws, is investigating potential claims against the board of directors of Anthera Pharmaceuticals Incorporated concerning possible breaches of fiduciary duty and other violations of law related to the Company's compensation packages for executive officers. The investigation focuses on the approval and awarding of certain stock options to executives that may have violated the Company's compensation plans. Full Article
Anthera Pharmaceuticals Inc Announces Pricing Of Public Offering Of Common Stock
Anthera Pharmaceuticals Inc announced the pricing of an underwritten public offering of 60,606,061 shares of common stock, offered at a price of $0.66 per share. The Company estimates that the gross proceeds from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Anthera, will be $40.0 million. The offering is expected to close on or about January 30, 2013. In addition, Anthera has granted the underwriters a 30-day option to purchase up to an additional 9,090,909 shares of common stock. The Company intends to use the net proceeds from the offering for general corporate purposes. Jefferies & Company, Inc. is acting as sole book-running manager in the offering and Leerink Swann LLC is acting as co-manager. Trout Capital LLC has acted as an advisor to the Company. Full Article
Anthera Pharmaceuticals Inc Announces Proposed Public Offering Of Common Stock
Anthera Pharmaceuticals Inc announced that it intends to offer and sell shares of its common stock in an underwritten public offering. The Company expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. The Company intends to use the net proceeds from the offering for general corporate purposes. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Jefferies & Company, Inc. is acting as sole book-running manager in the offering and Leerink Swann LLC is acting as co-manager. Full Article
The Law Firm of Levi & Korsinsky, LLP Launches Investigation Into Possible Breaches Of Fiduciary Duty By Board Of Directors Of Anthera Pharmaceuticals Inc. In Connection With Executive Compensation
Levi & Korsinsky, LLP announced that it is investigating Anthera Pharmaceuticals, Inc., and its Board of Directors, in connection with the compensation provided to certain of its executive officers. Full Article
Anthera Pharmaceuticals Inc Provides Clinical Progress Update
Anthera Pharmaceuticals Inc announced the new data from the PEARL-SC clinical study indicate strong trends towards increased time to first lupus flare (1.8-fold) and time to first severe lupus flare (1.6-fold) compared to placebo as defined by the SLE Flare Index. This index is used to document an increase in disease activity in one or more organ systems that results in new or the worsening of clinical signs and symptoms (and/or laboratory measurements). Additionally, there is usually a change in treatment, which includes increasing the dose of ongoing medications or the addition of new therapies. New analyses from the PEARL-SC clinical study also demonstrated an improvement in proteinuria over 24 weeks with 200 mg weekly blisibimod. These decreases in proteinuria resulted in the near normalization of the protein:creatinine ratio compared to baseline in patients who received blisibimod versus no improvement in the placebo group. The Company has completed discussions with the U.S. Food and Drug Administration (FDA) which will allow for the submission of Phase 3 protocols and the initiation of registration studies. FDA has confirmed the primary endpoint of SRI-8 evaluated at week 52 is acceptable for use in phase 3 clinical studies. Full Article
Anthera Pharmaceuticals Inc Announces Pricing Of Public Offering Of Common Stock
Anthera Pharmaceuticals Inc announced the pricing of an underwritten public offering of 33 million shares of its common stock, offered at a price of $1.00 per share. The Company estimates that the gross proceeds from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company, will be $33 million. The offering is expected to close on or about July 24, 2012, subject to customary closing conditions. In addition, Anthera has granted the underwriters a 30-day option to purchase up to an additional 4.95 million shares of common stock to cover over-allotments, if any. The Company intends to use the net proceeds from the offering for general corporate purposes. Piper Jaffray & Co. and Leerink Swann LLC are acting as joint book-running managers in the offering. Canaccord Genuity is acting as lead manager in the offering. Summer Street Research Partners is acting as co-manager in the offering. Full Article
Anthera Pharmaceuticals Inc Announces Proposed Public Offering of Common Stock
Anthera Pharmaceuticals Inc announced that it intends to offer and sell shares of its common stock in an underwritten public offering. The Company expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering to cover over-allotments, if any. The Company intends to use the net proceeds from the offering for general corporate purposes. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. Piper Jaffray & Co. and Leerink Swann LLC are acting as joint book-running managers in the offering. Full Article
Anthera Pharmaceuticals Inc Announces Additional Data From Recently Completed PEARL-SC Study Of Blisibimod In Proposed Phase 3 Population
Anthera Pharmaceuticals Inc announced the final set of clinical data from the Phase 2b PEARL-SC study in patients with systemic lupus erythematosus. Final data from the PEARL-SC clinical study with 200mg weekly blisibimod suggest sustained and greater treatment effects versus placebo utilizing 6, 7, and 8-point improvements in the SELENA-SLEDAI disease-scoring index. In the predefined population of patients with severe disease who were also taking corticosteroids, the SRI-8 treatment benefit in the 200mg weekly blisibimod cohort was seen as early as week eight and achieved statistical significance starting at week 16 (35.4% blisibimod response versus 17.0% placebo response, p=0.04) through the 24 week endpoint (41.7% blisibimod response versus 10.4% placebo response, p<0.001). Additional data regarding time to first severe flare, total flares, proteinuria, and patients achieving a reduction of steroid dose below 7.5mg per day were also positive. Amongst subjects treated with 200mg of blisibimod weekly, the mean time to first severe flare was 1.6-fold longer than subjects treated with placebo (348 days versus to 223 days). The reduction in proteinuria at week 24 was significantly greater amongst subjects treated with blisibimod compared to placebo (35.0% versus 5.1%, p=0.045). Full Article
Anthera Pharmaceuticals Inc To Cut Almost Half Of Its Workforce-Reuters
Reuters reported that Anthera Pharmaceuticals Inc will cut 45% of its workforce, after it stopped a late-stage trial of its experimental lead drug to treat a heart disease. The Company had 38 employees as of December 31, 2011. On March 9, Anthera, which develops drugs to treat cardiovascular and autoimmune disorders, stopped the study Of its drug, varespladib methyl, due to lack of efficacy. Full Article
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