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Insys Therapeutics ($INSY) reacted positively to the news that the FDA has granted Fast Track designation to the company’s cannabidiol (CBD) oral solution for the treatment of Prader-Willi syndrome, an inherited disorder characterized by weak muscle tone, feeding difficulties, delayed development and poor growth. The Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the marketing application.
The company stock gained over 8 percent in the pre-trading session.

Agios Pharmaceuticals ($AGIO) announced the submission of its New Drug Application for ivosidenib, an investigational oral treatment for patients with relapsed or refractory acute myeloid leukemia and an isocitrate dehydrogenase-1 mutation. The company has requested priority review for the application, which, if granted, could result in a six-month review process. The application is supported by data from the ongoing Phase 1 dose-escalation and expansion study of ivosidenib in patients with advanced hematologic malignancies and an IDH1 mutation.

 
Amgen ($AMGN) announced that consequent to its repatriation of cash, it expects to incur $6 billion to $6.5 billion in taxes over a period of time. The company did not specify how much of its $38.9B in cash and other holdings it plans to move back to the U.S.
AbbVie ($ABBV) received a respite as a US district judge overturned a $150 million verdict against the company. The ruling was the result of lawsuits claiming the company fraudulently misrepresented the risks of its AndroGel testosterone replacement drug.

DelMar Pharmaceuticals ($DMPI) announced receiving Fast Track designation for its VAL-083 for its recurrent glioblastoma treatment VAL 083. Fast Track status provides for more frequent interactions with the FDA review team and a rolling review of the marketing application.

Aptose Biosciences ($APTO) announced that the FDA has given orphan drug designation to CG’806, a highly potent pan-FLT3/pan-BTK inhibitor, for the treatment of patients with acute myeloid leukemia. The Orphan Drug designation grants seven-year period of market exclusivity if approved, among other benefits.

 

Mallinckrodt ($MNK) announced sealing its $1.2 billion deal with Sucampo. The deal valued Sucampo stock at $18 per share. The deal is expected to be accretive for Mallinckrodt.

Alexion Pharmaceuticals ($ALXN) announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Soliris as a treatment for patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin therapy or plasmapheresis.

Brokerage Action Company Name Rating Price
Target Impact on
Share Price Actions
William Blair
Downgrades Agile Therapeutics (AGRX)
Market Perform Low

Needham & Company LLC
Lowers Target Corium International (CORI)
Buy $14.00 Low

Ladenburg Thalmann Financial Services
Downgrades Ignyta (RXDX)
Buy -> Neutral Low

Gainers (% price change)Last TradeChangeMkt CapInfinity PharmaceuticalsINFI2.06+0.20 (10.75%)104.42MArray Biopharma IncARRY12.27+1.07 (9.55%)2.42BBioScrip IncBIOS2.83+0.18 (6.79%)360.87MImmunomedics, Inc.IMMU14.65+0.84 (6.08%)2.23BExelixis, Inc.EXEL29.47+1.66 (5.97%)8.72BLosers (% price change)GTx, Inc.GTXI11.79-0.93 (-7.31%)253.98MPacific Biosciences ofPACB2.67-0.19 (-6.64%)310.39MClearfield IncCLFD12.05-0.65 (-5.12%)166.43MMannKind CorporationMNKD2.41-0.11 (-4.37%)276.85MUtah Medical ProductsUTMD79.55-3.40 (-4.10%)295.85MMost Actives (dollar volume)Akorn, Inc.AKRX32.08+0.04 (0.12%)4.01BChemed CorporationCHE242.41+1.03 (0.43%)3.87BC R Bard IncBCR332.28+0.88 (0.27%)24.22BBristol-Myers Squibb CoBMY60.96-0.54 (-0.88%)99.77BBecton Dickinson and CoBDX217.23-0.55 (-0.25%)49.52B