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Pfizer Inc. ($PFE) announced that the FDA has accepted its new drug applications (NDA) for its diabetes candidate, ertugliflozin as a monotherapy as well as two fixed-dose combination tablets. The company is developing the drug in collaboration with Merck & Co. Inc. The companies had filed three NDAs with the FDA, one as a monotherapy and one each for fixed-dose combinations ertugliflozin/Januvia and ertugliflozin/metformin. 
The final result is expected to be out by the end of this year in December. The European Medicines Agency has already validated the three marketing applications. Pfizer stock has gained over 14 percent in the past 12 months.

Valeant Pharmaceuticals International Inc. ($VRX) announced its new restructuring deal. The company has commenced an offer to purchase cash up to $600 million of aggregate principal amount of the outstanding 6.75% senior notes due 2018. The company is also looking to refinance and amend its existing credit agreement to let it borrow new term B loans under the credit agreement and simultaneously issue secured debt securities. 
The refinancing may extend the maturity date of the revolving facility. Earlier this month, the company had announced the divesture of its skincare products. The company used the net proceeds of the sale to pay down approximately $1.1 billion of its senior secured term loans. The company stock has lost over 80 percent of its value in the past 12 months.

 

BaiGene ($BGNE) announced that It has inked a new definitive agreement with Guangzhou Development District  to establish a state-of-the-art commercial-scale biologics manufacturing facility in Guangzhou, Guangdong Province, China. The collaboration will also provide funding for research and development of biologic drug candidates in China. The total direct investments are expected to be worth nearly $330 million.

Apricus Biosciences Inc. ($APRI) reported that it has completed the sale of its ex-U.S. assets and rights related to Vitaros®, Apricus` on-demand topical cream indicated for the treatment of patients with erectile dysfunction to Ferring International Center S.A. The transfer was made pursuant to a definitive agreement with Ferring, which is an existing commercialization partner for Vitaros in Latin America and certain parts of Europe and Asia. 

Cycalcel Pharmaceuticals Inc. ($CYCC) reported that according to the preclinical data, both its CYC065, a second-generation, clinical stage, CDK2/9 inhibitor, and CCT68127, a pre-clinical stage CDK2/9 inhibitor, demonstrated prominent antitumor activity against lung cancer through anaphase catastrophe, a novel, cancer specific mechanism of action. Combination of CCT68127 with the MEK inhibitor, trametinib, was also proved synergistic.

Amicus Therapeutics Inc. ($FOLD) announced that it has commercially launched its precision medicine Galafold in Italy following the final publication of reimbursement guidelines by the Ministry of Health. The treatment will now be reimbursed in Italy as a therapy for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease and who have an amenable mutation.

 

XTL Biopharmaceuticals Ltd. ($XTLB) reported that it has inked a new definitive agreement with its existing investors for receiving proceeds of $2.8 million in a private placement offering. In pursuance to the agreement, XTL will issue 1.4 million American Depository Shares (ADSs) at a purchase price of $2.00 per ADS, $0.01 below yesterday's closing price.   the investors will receive an unregistered warrant to purchase one ADS for each ADS purchased.

Avadel Pharmaceuticals ($AVDL) announced that its Board of Directors has authorized the repurchase of up to $25 million of the Company’s ordinary shares, represented by American Depository Shares (ADS) which are listed for trading on the NASDAQ Global Market.  The company intends to carry out the transaction through open-market transactions, block transactions on or off the exchange, in privately negotiated transactions, or through other permissible means.

 

XTL Biopharmaceuticals Ltd. ($XTLB) reported that it has inked a new definitive agreement with its existing investors for receiving proceeds of $2.8 million in a private placement offering. In pursuance to the agreement, XTL will issue 1.4 million American Depository Shares (ADSs) at a purchase price of $2.00 per ADS, $0.01 below yesterday's closing price.   the investors will receive an unregistered warrant to purchase one ADS for each ADS purchased.

Avadel Pharmaceuticals ($AVDL) announced that its Board of Directors has authorized the repurchase of up to $25 million of the Company’s ordinary shares, represented by American Depository Shares (ADS) which are listed for trading on the NASDAQ Global Market.  The company intends to carry out the transaction through open-market transactions, block transactions on or off the exchange, in privately negotiated transactions, or through other permissible means.

Brokerage
Action
Company
Rating
Price Target
HC Wainwright
Lowers Target
Rigel Pharmaceuticals (RIGL)
Buy
$6.00 -> $5.00
Stifel Nicolaus
Raises Target
Tetraphase Pharmaceuticals (TTPH)
Hold
$5.00 -> $7.00

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