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Vitae Pharmaceuticals, NASDAQ:VTAE, VTAE

HC Trending Hot Stocks= Bristol-Myers Squibb Co (BMY), Mast Therapeutics Inc (MSTX)

Shares of Bristol-Myers Squibb Co (NYSE:BMY) ended Tuesday session in green amid volatile trading. The shares closed up +0.26 points or 0.47% at $55.74 with 8.62 million shares getting traded. Post opening the session at $55.68, the shares hit an intraday low of $55.50 and an intraday high of $55.89 and the price vacillated in this range throughout the day. The company has a market cap of $93.23 billion and the numbers of outstanding shares have been calculated to be 1.66 billion shares.

On September 27, 2016 Bristol-Myers Squibb Company (BMY) and Nektar Therapeutics (NKTR) announced a new clinical collaboration to evaluate Bristol-Myers Squibb’s Opdivo (nivolumab) with Nektar’s investigational medicine, NKTR-214, as a potential combination treatment regimen in five tumor types and seven potential indications. Opdivo is a PD-1 immune checkpoint inhibitor designed to overcome immune suppression. NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of PD-1 on these immune cells.

“We are excited to explore the potential benefits in multiple types of cancer of the combination of Opdivo with Nektar’s innovative cancer immunotherapy,” said Fouad Namouni, M.D., Head of Oncology, Bristol-Myers Squibb. “We believe that a combination regimen which utilizes two different and complementary mechanisms designed to harness the body’s own immune system to fight cancer has the potential to provide new treatment options for patients.”

The Phase 1/2 clinical trials will evaluate the potential for the combination of Opdivo and NKTR-214 to show improved and sustained efficacy and tolerability above the current standard of care in melanoma, kidney, colorectal, bladder and non-small cell lung cancer patients. An initial dose-escalation trial is underway with Opdivo and NKTR-214.

Bristol-Myers Squibb and Nektar will equally share costs of the combined therapy trials. Nektar will maintain its global commercial rights to NKTR-214.

“We’re very pleased to be collaborating with Bristol-Myers Squibb, a global leader in immuno-oncology, in order to advance quickly the development of NKTR-214 with a PD-1 immune checkpoint inhibitor,” said Howard W. Robin, President and CEO of Nektar Therapeutics. “NKTR-214 is designed to grow tumor infiltrating lymphocytes (TILs) in vivo and replenish the immune system, which is critically important as many patients battling cancer lack sufficient TIL populations to benefit from approved checkpoint inhibitor therapies. The combination of checkpoint inhibition with T cell growth could lead to synergistic effects that may provide a new treatment option for patients.”

Shares of Mast Therapeutics Inc (NYSEMKT:MSTX) ended Tuesday session in red amid volatile trading. The shares closed down -0.009 points or -7.56% at $0.114 with 16.21 million shares getting traded. Post opening the session at $0.12, the shares hit an intraday low of $0.11 and an intraday high of $0.12 and the price vacillated in this range throughout the day. The company has a market cap of $23.05 million and the numbers of outstanding shares have been calculated to be 211.82 million shares.

Mast Therapeutics Inc (MSTX) on Sept. 26, 2016  provided an update related to its business strategy and the clinical development of its product candidates.

  • The Company’s cash, cash equivalents, and investment securities were $30.3 million at August 31, 2016.
  • The Company will focus on clinical development of AIR001 (sodium nitrite solution for intermittent inhalation) for the treatment of heart failure with preserved ejection fraction (HFpEF).  Specifically, during 2016 and 2017, the Company will continue to support three ongoing investigator-sponsored Phase 2 clinical studies of AIR001 being conducted at prestigious research institutions.
  • The Company has begun to wind down its vepoloxamer programs in sickle cell disease and heart failure and expects those activities will be completed in the fourth quarter of 2016.
  • While furthering the development of AIR001 through the ongoing Phase 2 clinical studies, the Company is planning to initiate a process to evaluate partnership opportunities for its assets.
  • As a result of cost savings anticipated by the termination of its vepoloxamer clinical programs and related operations and the prioritization of its AIR001 program, the Company estimates that its operating expenses for 2017 will be in the range of $9 to $10 million, excluding share-based compensation expense.  This anticipated level of spend reflects an approximate 70% reduction from estimated operating expenses for 2016 of approximately $32 to $34 million, excluding share-based compensation expense.
  • The Company will make the $10 million prepayment on its debt facility triggered by the recently announced results of its Phase 3 study of vepoloxamer in early October 2016.  After that prepayment, the principal amount of the Company’s debt will be approximately $3.5 million, which is scheduled to be repaid in equal monthly installments of principal and interest through January 1, 2019.

“Following a critical review of our pipeline and opportunities we have determined that a focus on AIR001 will provide for a strong foundation from which we will seek to return value to our stockholders,” stated Brian M. Culley, the Company’s Chief Executive Officer.  “However, these decisions likely will have a significant impact on our talented team members and I want to personally thank those who may be affected for their hard work, dedication and contributions to the vepoloxamer program.”




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