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AVEO To Slash Jobs, PSTI, RIGL Hit Hard, STEM, NVIV, RGDX Fatten Purse


In an effort to extend its cash runway for at least two years, AVEO Oncology (AVEO) on Tuesday announced a strategic restructuring that will reportedly include slashing 62% of its workforce. More details about the restructuring will be revealed during a conference call that will be hosted at 8:30 a.m. ET on Wednesday, June 5.

Last month, an FDA panel voted 13 to 1 against approving AVEO's Tivozanib for advanced renal cell carcinoma. AVEO's partner Astellas has also decided not to proceed with a European filing for Tivozanib or financially support future clinical trials in renal cell carcinoma.

AVEO closed Tuesday's trading at $2.49, down 2.35%. In after-hours, the stock gained 1.61% to $2.53.

Bristol-Myers Squibb Co.'s (BMY) and AstraZeneca's (AZN) Biologics License Application for Metreleptin, an investigational agent for treatment of metabolic disorders associated with rare forms of lipodystrophy has been accepted and granted a Priority Review designation by the FDA.

The BLA for Metreleptin was submitted on a rolling basis - with the submission initiated in December 2010 and completed in April 2012.

InVivo Therapeutics Holdings Corp. (NVIV), which trades on the over the counter Bulletin Board, touched a new 52-week high of $4 after the company announced it has raised $16.1 million from warrant call and exercises paving way for up-listing to a National Securities Exchange.

As of June 3, 2013, the company had cash on hand of $23.6 million and total stockholders' equity of $23.7 million, which exceeds the minimum stockholder's equity requirements for national securities exchanges.

La Jolla Pharmaceutical Co. (LJPC) has submitted its investigational new drug application for LJPC-501 to the FDA. LJPC-501 is an investigational drug for the treatment of patients with Type 1 and Type 2 hepatorenal syndrome, or HRS. HRS is a life-threatening form of progressive renal failure in patients with liver cirrhosis or fulminant liver failure.

If the LJPC-501 IND is accepted by the FDA, the company expects to initiate a Phase 1 trial later this year.

LJPC closed Tuesday's trading at $0.08, down 3.61%.

The Medicines Company (MDCO) has agreed to purchase all of the outstanding capital stock of ProFibrix B.V. subject to satisfactory review of the pending phase 3 clinical trial results of ProFibrix's lead biologic Fibrocaps.

Fibrocaps is a dry powder topical formulation of fibrinogen and thrombin being developed to stop bleeding during surgery, and its phase III results are expected in the third quarter of 2013.

As per the terms of the agreement, The Medicines Company will pay ProFibrix a $10 million upfront option payment. If the Medicines Company is satisfied with the phase III trial results and determines to proceed, it will purchase all of the outstanding capital stock of ProFibrix at closing. Otherwise, The Medicines Company may terminate the transaction with no further obligation to the ProFibrix shareholders.

MDCO closed Tuesday's trading at $32.99, down 1.49%.

Pluristem Therapeutics Inc.'s (PSTI) United States phase II study using PLX-PAD cells in patients suffering from Intermittent Claudication has been placed on clinical hold by the FDA due to a serious allergic reaction in a case which required hospitalization.

PSTI dropped more than 14% on Tuesday to close at $2.86. In extended trading the stock gained 3.85% to $2.97.

Rosetta Genomics Ltd. (ROSG) rose more than 8% on Tuesday after the company announced its plans to expand its U.S. commercial footprint from five sales territories currently to 12 territories beginning in July 2013.

Response Genetics Inc. (RGDX) has earned its second milestone payment of $500,000 relating to the development of BRAF-Inhibitor Tafinlar, under a non-exclusive license agreement with GlaxoSmithKline that was signed in 2010.

Response Genetics earned its first milestone payment of $500,000 in July of 2012 for submission of the first Premarket Approval under the contract. On May 29, 2013, GSK announced the FDA's approval of the PMA, thereby triggering the second milestone payment.

RGDX closed Tuesday's trading 1.34% higher at $1.51.

Rigel Pharmaceuticals Inc. (RIGL) took a hit on Tuesday after AstraZeneca, its partner for rheumatoid arthritis drug candidate Fostamatinib, decided to return the rights to the compound to Rigel. AstraZeneca will also not proceed with regulatory filings for Fostamatinib.

Fostamatinib has been evaluated in a phase III program which includes 3 studies namely, OSKIRA-1, OSKIRA-2 and OSKIRA-3.

AstraZeneca was granted rights to develop and commercialize Fostamatinib in February 2010 under a worldwide license agreement with Rigel.

RIGL closed Tuesday's trading at $3.71, down 18.10%.

StemCells Inc. (STEM) announced Tuesday that it has secured $30 million financing commitment from Lincoln Park Capital Fund, LLC, an institutional investor based in Chicago, Illinois.

Accordingly, Lincoln Park will immediately purchase $3.0 million in shares of StemCells common stock at a purchase price of $1.823 per share, which was the average of the prior ten trading days' volume weighted average price.

Furthermore, for a period of three years, the company has the right, at its sole discretion, to sell additional amounts up to $27.0 million of common stock to Lincoln Park subject to certain limitations.

STEM closed Tuesday's trading 4.49% higher at $1.86.

Sunshine Biopharma Inc. (SBFM) announced Tuesday that it has completed a new IND-Enabling study in which Adva-27a, its flagship oncology drug candidate for breast cancer was found to be effective at killing Pancreatic Cancer Cells in vitro.

Apart from Pancreatic Cancer Cells, Adva-27a is also said to be capable of effectively killing other aggressive or multidrug resistant cancer cells including Breast Cancer cells (MCF-7/MDR), Small-Cell Lung Cancer cells (H69AR), and Uterine Sarcoma cells (MES-SA/Dx5), according to the company.
SBFM gained 4.55% on Tuesday to close at $0.23.

St. Jude Medical Inc. (STJ) has initiated the first US clinical study of EnligHTN Multi-Electrode Renal Denervation System to treat patients with drug-resistant high blood pressure.

The study, dubbed EnligHTN IV, will enroll approximately 590 patients between the ages of 18 and 80 with an office systolic blood pressure of 160 mmHg or greater, who are taking three or more antihypertensive medications including a diuretic. Study patients will be enrolled at up to 80 sites in the U.S. and Canada, according to the company.

STJ closed Tuesday's trading at $42.52, down 1.91%. In after-hours, the stock gained 0.10% to $42.56.

Zalicus Inc. (ZLCS) will be advancing its investigational pain drug - Z944, into phase Ib study in the third quarter of 2013.

ZLCS closed Tuesday's trading at $0.61, up 1.67%.

by RTTNews Staff Writer

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