ONXX receives FDA Approval. SGEN and ASTX granted positive CHMP recommendations. ANTH and SOMX offering details + PSDV SGYP ARRY news
Onyx Pharmaceuticals (Nasdaq: ONXX) today announced that it received accelerated approval from the FDA for Kyprolis (carfilzomib) for Injection, for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent, and have demonstrated disease progression on or within 60 days of completion of the last therapy. Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) is entitled to receive a $600,000 milestone payment from Onyx Pharmaceuticals but is also is required to make a payment of $3.5 million toward the former stockholders of CyDex Pharmaceuticals, which Ligand acquired in 2011.
Seattle Genetics, Inc. (Nasdaq:SGEN) today announced that it has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the conditional marketing authorization of ADCETRIS (brentuximab vedotin) for two indications: (1) the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30. Final approval is expected to be announced in approximately two months.
Astex Pharmaceuticals, Inc. (Nasdaq:ASTX) announced that CHMP granted a positive opinion recommending approval of DACOGEN (decitabine) for Injection in the treatment of adult patients (age 65 years and above) with newly diagnosed de novo or secondary acute myeloid leukemia (AML). Final approval is expected to be announced by the EMA in approximately two months.
Anthera Pharmaceuticals, Inc. (Nasdaq: ANTH) 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, with an option to purchase up to issue an additional 4.95 million shares of common stock to cover over-allotments, if any.
Somaxon Pharmaceuticals, Inc. (Nasdaq:SOMX) said it will issue 9.4 million shares of its common stock and warrants to purchase up to approximately 4.7 million shares of its common stock to institutional investors at a combined public offering price of $0.32 per share and per warrant for aggregate gross proceeds of approximately $3.0 million. The warrants will have an initial exercise price of $0.46 per share, will be exercisable commencing six months and one day from the date of issuance and will expire on the fifth anniversary of the initial exercise date.
pSivida Corp. (NASDAQ: PSDV) said following receiving an Investigational New Drug (IND) approval from the FDA, it is now in a position to initiate a Phase 3 trial to treat posterior uveitis with its injectable sustained-release micro-insert.
Array BioPharma Inc. (NASDAQ: ARRY) announced that an $8.5 million milestone was achieved in its collaboration with Amgen after Amgen reached a pre-defined patient enrollment level in a Phase 2a clinical trial for the worldwide development of the small-molecule glucokinase activator (GKA) program, including AMG 151.
Synergy Pharmaceuticals Inc. (Nasdaq:SGYP) and Callisto Pharmaceuticals, Inc. (OTCBB:CLSP) announced today that they have entered into a definitive merger agreement pursuant to which Callisto will merge into Synergy. Under the terms of the merger agreement, each outstanding share of Callisto common stock will be exchanged for 0.17 shares of Synergy common stock and the 22,295,000 shares of Synergy held by Callisto will be canceled.