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Karyopharm Therapeutics Inc. ($KPTI) stock jumped as the company announced that the e U.S. Food and Drug Administration (FDA) Division of Hematology Products has lifted the partial clinical hold placed on the clinical trials for selinexor (KPT-330). This latest action will now allow Karyopharm to start patient enrollment and dosing of new patients for the clinical trials of selinexor in hematological malignancies. The company may also resume Investigator Sponsored Trials in hematologic malignancies with selinexor.

The company said that its worked diligently to update and submit the required documents to the FDA, which allowed the hematology divison to expeditiously remove the partial clinical hold. Karyopharm stock has gained over 42 percent in the past 12 months.

Boston Scientific ($BSX) announced that it has inked a new deal with privately held Switzerland-based Symetis SA. Pursuant to the agreement, the company will buy the Swiss firm for $435 million. It is a cash deal. Symetis is engaged in the development of  minimally invasive transcatheter aortic valve implantation devices. The company has now halted its IPO. This was the Swiss company’s second attempt at going public.
Boston Scientific said that Symetis’ Acurate systems would complement its Lotus valve devices. The technology is used in transcatheter aortic valve devices. Boston Scientific recently recalled its Lotus range of heart devices, citing reports of problems with the locking mechanism.

 

Sangamo Therapeutics ($SGMO) reported postive preclinical data related to its zinc finger protein transcription factor (ZFP-TF)-mediated gene regulation technology. The company said that in animal model testing, the drug candidate showed a significant reduction in tau mRNA and tau protein expression, the first evidence of a tau-lowering agent showing efficacy on neuritic dystrophy in an amyloid mouse model of Alzheimer's disease.

Ritter Pharmaceuticals ($RTTR) reported positive results from its Phase 2b/3 clinical trial assessing RP-G28 in people with lactose intolerance. The trial showed a reduction in symptoms across a range of outcome measures, but only after excluding data from one center. The study met  its primary endpoint showed a statistically significantly larger responder group (40%) who received RP-G28 compared to placebo.

Roche ($RHHBY) announced that its OCREVUS (ocrelizumab) has been approved by the FDA for the treatment of relapsing and primary progressive forms of multiple sclerosis. It is a humanized monoclonal antibody that selectively targets CD20-positive B cells, which are believed to play a key role in the degradation of myelin and nerve cells.

Regeneron Pharmaceuticals ($REGN) reported that the FDA has approved Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis. The wholesale acquisition cost in the U.S. will be $37,000 per year. The company’s BLA was accepted by the FDA in late September under Priority Review. Regeneron is collaborating with Sanofi for the development of the drug.

 

Amgen ($AMGN) inked a new deal with Inovalon and Avalere Health unit for providing data to support outcomes-based contracting (OBC), which more payers are demanding as a way to justify drug prices.  The deal will focus specifically on rheumatoid arthritis. The parties to the contract did not reveal the financial terms and conditions of the collaboration.

Jazz Pharmaceuticals ($JAZZ) announced signing an exclusive license deal with Nippon Shinyaku Co., Ltd. for developing and commercializing Defitelio (defibrotide sodium) and Vyxeos (cytarabine and daunorubicin liposome injection) in Japan. The agreement provides for Jazz to receive an upfront payment, milestones and royalties on net sales. Defitelio was approved in the U.S. last year for the treatment of hepatic veno-occlusive disease.

 

Affimed NV ($AFMD) reported that its revenue for the fourth quarter of 2016 was €1.4 million  while revenue for the full year 2016 was €6.3 million . The company suffered net loss of €5.4 million, or €0.16 per common share for the fourth quarter. Its net loss for the full year 2016 was €32.2 million, or €0.97 per common share. Affimed’s Cash and cash equivalents and financial assets totaled €44.9 million as of December 31, 2016 compared to €76.7 million as of December 31, 2015.
 
Aldeyra Therapeutics Inc. ($ALDX) announced that its loss for the financial year stood at approximately $18.7 million compared to a net loss of approximately $12.1 million for the year ended December 31, 2015. Basic and diluted net loss per share was $1.65 for the year ended December 31, 2016 compared to $1.40 per share for the same period in 2015.

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
Aegis
Downgrades
Achaogen (AKAO)
Buy -> Hold

Low
BTIG Research
Reiterates
Kite Pharma (KITE)
Hold

Low
Cantor Fitzgerald
Reiterates
Corbus Pharmaceuticals Holdings (CRBP)
Buy
$17.00
High
Chardan Capital
Lowers Target
Ritter Pharmaceuticals (RTTR)
Buy -> Buy
$4.50 -> $3.50
Low
HC Wainwright
Upgrades
Galectin Therapeutics (GALT)
Neutral -> Buy
$3.50
Low
HC Wainwright
Reiterates
vTv Therapeutics (VTVT)
Buy
$13.00
Low
Jefferies Group LLC
Reiterates
Tivity Health (TVTY)
Buy
$33.00
Low
JPMorgan Chase & Co.
Upgrades
Grifols SA, Barcelona (GRFS)
Neutral -> Overweight

Low
SunTrust Banks
Upgrades
NewLink Genetics Corp (NLNK)
Hold -> Buy
$12.00 -> $30.00
Low

Gainers (% price change)Last TradeChangeMkt CapVertex PharmaceuticalsVRTX108.01+18.34 (20.45%)26.83BSangamo Therapeutics IncSGMO4.65+0.60 (14.81%)317.80MAchillion PharmaceuticalsACHN4.27+0.48 (12.66%)583.80MPacific Biosciences ofPACB5.38+0.53 (10.93%)481.01MCelldex Therapeutics, IncCLDX3.71+0.31 (9.12%)457.12MLosers (% price change)Rockwell Medical IncRMTI6.30-0.33 (-4.98%)340.01MCommunity Health SystemsCYH8.81-0.44 (-4.76%)962.43MClovis Oncology IncCLVS64.39-2.67 (-3.98%)2.82BDepomed IncDEPO13.79-0.44 (-3.09%)817.85MII-VI, Inc.IIVI38.60-1.00 (-2.53%)2.42BMost Actives (dollar volume)Vertex PharmaceuticalsVRTX108.01+18.34 (20.45%)26.83BUnitedHealth Group IncUNH163.44-1.91 (-1.16%)156.17BRegeneron PharmaceuticalsREGN394.14+11.59 (3.03%)41.69BBiogen IncBIIB268.53-5.58 (-2.04%)57.75BAmgen, Inc.AMGN163.06-1.65 (-1.00%)119.94B