Showing posts with label biotechnology. Show all posts
Showing posts with label biotechnology. Show all posts

Saturday, January 30, 2016

#NEWS: $NEOS $MPO 5 Stocks Under $10 Set to Soar

NEOS - Neos Therapeutics
5 Stocks Under $10 Set to Soar


Another under-$10 stock that's starting to trend within range of triggering a big breakout trade is Neos Therapeutics (NEOS) , which develops, manufactures and commercializes products for the treatment of attention deficit hyperactivity disorder using its drug delivery technologies. This stock has been smacked lower by the sellers over the last six months, with shares dropping sharply lower by 52.7%.

Thursday, January 28, 2016

Why $AMDA is UP 30% #Realtime @ $2.50 ?

SALT LAKE CITY, Jan. 28, 2016 (GLOBE NEWSWIRE) -- Amedica Corporation (AMDA), a company that develops and commercializes silicon nitride ceramics as a biomaterial platform, is pleased to announce all four submissions to the Orthopaedic Research Society (“ORS”) Annual Meeting were accepted for presentation occurring March 5-8, 2016 in Orlando, Florida.  

Why $NEOS is UP 60% #PreMarketGainers @ $15.00 ?

DALLAS and FORT WORTH, Texas, Jan. 27, 2016 (GLOBE NEWSWIRE) -- Neos Therapeutics, Inc. (NEOS), a pharmaceutical company with a late‐stage pipeline of innovative extended-release (XR) product candidates for the treatment of attention-deficit/hyperactivity disorder (ADHD), today announced that the U.S. Food and Drug Administration (FDA) approved Adzenys XR-ODT™ for the treatment of ADHD in patients six years and older. With this approval, Adzenys XR-ODT is the first and only extended-release orally disintegrating tablet (ODT) for the treatment of ADHD.

Wednesday, January 27, 2016

Why $FATE is UP 17% #PreMarketGainers @ $2.90 ?

Fate Therapeutics, Inc. (NASDAQ: FATE) announced today the U.S. Food and Drug Administration (FDA) has cleared the Company's investigational new drug (IND) application for ProTmune, a programmed cellular immunotherapy consisting of donor-sourced mobilized peripheral blood cells which have been functionally modulated using two small molecules. The IND is now active and Fate Therapeutics plans to initiate a multi-center, randomized, controlled Phase 1/2 clinical trial in adult patients with hematologic malignancies undergoing mobilized peripheral blood (mPB) hematopoietic cell transplantation (HCT) in mid-2016.

Tuesday, January 26, 2016

Why $PETX is UP 12% #AfterHoursGainers @ $3.55 ?

LEAWOOD, Kan.Jan. 25, 2016 /PRNewswire/ -- Aratana Therapeutics, Inc. (NASDAQ: PETX), a pet therapeutics company focused on the licensing, development and commercialization of innovative biopharmaceutical products for companion animals, today announced the Company filed an administrative New Animal Drug Application (NADA) with the Food and Drug Administration's Center for Veterinary Medicine (CVM) for Galliprant® for the control of pain and inflammation in dogs with osteoarthritis. The Animal Drug User Fee Act (ADUFA) date for approval is set for March 25. Aratana anticipates commercial availability of Galliprant to veterinarians in fall 2016.

Why $RLYP is UP 10% #AfterHoursGainers @ $21.50 ?

Relypsa, Inc. (NASDAQ: RLYP) announced results from 12 Phase 1 studies in healthy volunteers evaluating potential drug-drug interactions between Veltassa for oral suspension and 12 drugs that had previously demonstrated binding in in vitro tests. When Veltassa was administered at the same time as the drugs being tested, there was no clinically meaningful reduction in absorption for nine of the 12 drugs. Three drugs showed reduced absorption when they were co-administered with Veltassa, however, when dosing of Veltassa and these drugs was separated by three hours, no reduction in absorption was observed.

Monday, January 25, 2016

Why $CASI is UP 32% #Realtime @ $1.10 ?

By: OCTASTAFF

Sparkle Byte Ltd New Position in CASI Pharmaceuticals Inc (NASDAQ:CASI)

Sparkle Byte Ltd has filled a SC 13D form regarding Casi Pharmaceuticals, Inc 1.13 +0.30 36.33%. Filing Link: 000095010316010428Per Sparkle Byte Ltd’s filing, the filler now owns 13.6% of the company, holding 5,693,892 shares.
CASI Pharmaceuticals Inc (NASDAQ:CASI) is a newly disclosed equity position and the filing was required due to activity on January 14, 2016. This most probably shows Sparkle Byte Ltd’s confidence and optimism in the future of the company.

Why Sparkle Byte Ltd Bought Casi Pharmaceuticals, Inc

Item 4. Purpose of Transaction
The Reporting Persons acquired the securities reported herein for investment purposes. The Reporting Persons may, from time to time, make additional purchases of Common Stockeither in the open market or in privately-negotiated transactions, depending upon the Reporting Persons’ evaluation of theIssuer’s business, prospects and financial condition, the market for the Common Stock, other opportunities available to theReporting Persons, general economic conditions, stock market conditions and other factors. Depending upon the factors noted above,the Reporting Persons may also decide to hold or dispose of all or part of their investments in the Common Stock or the Warrantand/or enter into derivative transactions with institutional counterparties with respect to the Issuer’s securities, includingthe Common Stock and debt securities convertible into the Common Stock.
Except as set forth in Item 3 and thisItem 4, the Reporting Persons have no present plans or proposals that relate to or that would result in any of the actions specifiedin clauses (a) through (j) of Item 4 of Schedule 13D of the Securities Exchange Act of 1934, as amended.
A copy of the Securities Purchase Agreementis filed as Exhibit 99.2 hereto, and is incorporated herein by reference.

Company Profile

CASI Pharmaceuticals, Inc. is a biopharmaceutical company. The Company is focused on the acquisition, development and commercialization of therapeutics for cancer and other medical needs. Its product pipeline includes ENMD-2076, ZEVALIN, MARQIBO, CE Melphalan and 2ME2 (2-methoxyestradial). Its lead internal drug candidate is ENMD-2076 is a selective Aurora A and angiogenic kinase inhibitor for the treatment of cancer. ZEVALIN is indicated for patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin’s lymphoma. MARQIBO is indicated for the treatment of Philadelphia chromosome-negative acute lymphoblastic leukemia. Captisol Enabled melphalan is being investigated and is intended to be used as a conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma. 2ME2 (2-methoxyestradiol) is an orally active compound that has anti-proliferative, anti-angiogenic and anti-inflammatory properties under reformulation development.
Form 13D is SEC filing that must be submitted within 10 days, by anyone who acquires beneficial ownership of more than 5% of any publicly traded securities. A filer must promptly update its 13D filing in case of acquisition or disposition of 1% or more of the securities that are the subject of the filing. These filings may be a precursor to hostile takeovers, company breakups, and other “change of control” events.

Sparkle Byte Ltd Just Reported Giant Casi Pharmaceuticals Inc Stake - Octafinance

Sparkle Byte Ltd has filled a SC 13D form regarding Casi Pharmaceuticals, Inc . Filing Link: 000095010316010428. Per Sparkle Byte Ltd's filing, the filler now owns 13.6% of the company, holding 5,693,892 shares. CASI Pharmaceuticals Inc (NASDAQ:CASI) is a newly disclosed equity position and the filing was required due to activity on January 14, 2016.

Why $AFMD is UP 7% #PreMarketGainers @ $3.95 ?

Affimed NV (NASDAQ:AFMD) recently disclosed that it has entered a clinical research partnership with Merck & Co., Inc. (NYSE:MRK) in terms of immune-oncology treatment. As per the agreement, Affimed will conduct a Phase 1b clinical trial with a combination of Keytruda—Merck’s anti-PD-1 therapy—with its own AFM13, for Hodgkin’s Lymphoma patients. These include patients who were not affected by chemotherapy, which includes treatment with antibody-drug-conjugate Adcetris—a renowned drug in the market.
Merck will supply its drug to Affimed for the clinical trial. The trial’s main purpose is to build a proper dosing regimen for the drug combination, and to test its safety and efficacy. The study is expected to commence in the first half of calendar year 2016 (1HCY16).
Previously, Affimed witnessed some management changes. It announced Joerg Windisch’s appointment as the new COO, and that Bernhard Ehmer has been included in the Supervisory Board. Mr. Ehmer has extensive clinical development track record in biopharmaceuticals. The company’s shareholders approved the new appointments at the Extraordinary Shareholder Meeting, held on January 21, 2016 in Amsterdam.

Affimed Teams up with Merck to Combat Hodgkin's Lymphoma

Affimed NV (NASDAQ:AFMD) has announced a new partnership with Merck & Co., Inc. (NYSE:MRK) to conduct trials for a combination of both companies' key candidates for Hodgkin's Lymphoma.
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