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Novartis ($NVS) announced that its Tafinlar (dabrafenib) and Mekinist (trametinib) for the treatment of patients with BRAF V600-positive advanced/metastatic non-small lung cancer  has been approved by the European Commission. The approval came after the drug combo was given positive opinion by the Committee for Medicinal Products for Human Use in February. The combination had achieved positive results during a Phase 2 study for the safety and efficacy of the drug combo.
Novartis stock is expected to receive some support from the news as its price has gained only nearly 2 percent this year so far. The new approval for the drug will aid the process of marketing the treatment in the European Union market, which is considered lucrative.

Cellect Biotechnology ($APOP) stock shot up in the pre-market session as the company that it has received a formal notice from the European Patent Office of Intention to Grant a patent to the company. The patent covers the engineering of regulatory immune cells with enhanced apoptotic activity to be used for immunomodulation in treating or preventing immune-related disorders. Cellect was awarded this patent in the US earlier this year.
Cellect stock gained over 15 percent in the pre-market session, taking its year to date gain to over 178 percent. The company said that this patent will serve as a base for the future commercialization of its global business. 

 

Serepta Therapeutics ($SRPT) finalized the sale of its Rare Pediatric Disease Priority Review Voucher for $125 million. The voucher is being sold to a subsidiary of Gilead Sciences. Serepta received the voucher along with the FDA approval of EXONDYS 51. The voucher allows for accelerated review of a future marketing application.

Emergent BioSolutions ($EBS) has modified its contract with the U.S. Government's Biomedical Advanced Research and Development Authority (BARDA).The modification will allow  future filling and deliveries of its botulism antitoxin, BAT [Botulism Antitoxin Heptavalentt (A,B,C,D,E,F,G)-(Equine)] to the Strategic National Stockpile. The value of the modification is expected to be nearly $53 million over a period of five years.

Roche ($RHHBY) announced positive results from its Phase 3 clinical trial, ALUR. The trial tests Alecensa  in patients with ALK-positive advanced/metastatic non-small cell lung cancer  who had progressed following treatment with chemo and crizotinib. The results showed that  patients treated with Alecensa experienced significantly improved progression-free survival. The drug is conditionally approved in Europe for this population of patients since February.

Kite Pharma ($KITE) announced that it has completed the rolling submission of its Biologics License Application, seeking approval of lead CAR-T candidate axicabtagene ciloleucel  for treating  relapsed/refractory aggressive non-Hodgkin lymphoma. The company may start it market launch this year, if the treatment is approved. Kite is also expected to file a marketing application in Europe this year.

 

Jaguar Animal Health ($JAGX) reported that it has inked a new definitive merger agreement with Napo Pharmaceuticals. Under the terms of the agreement, Jaguar stockholders and option and warrant holders will retain nearly 25% of Jaguar shares while Napo creditors, RSU, option and warrant holder will hold remaining 75%. Jaguar will do business as Jaguar Health after the merger. The deal is expected to close next quarter.

Amedisys ($AMED) announced that it has entered into a deal with East Tennessee Personal Care Service. Under the terms of the deal, Amedisys will acquire East Tennessee for an undisclosed sum. The deal will be closed by May. East Tennessee personal care services to 600 clients and generates close to $5 million in annualized revenues.

 

Aptevo Therapeutics Inc. ($APVO) announced that for the year ended December 31, 2016 Aptevo’s product sales revenue increased by $8.3 million, or 30%, to $36.3 million from $27.9 million for the year ended December 31, 2015. The company’s net loss for the year ended December 31, 2016, including the impairment, was $112.4 million or ($5.55) per share. It closed the year with cash, cash equivalents, restricted cash and short term investments totaling approximately $54.9 million.

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
Janney Montgomery Scott
Downgrades
Acorda Therapeutics (ACOR)
Buy -> Neutral

High
JMP Securities
Downgrades
Forward Pharma A/S (FWP)
Outperform -> Market Perform

Low
Jefferies Group LLC
Downgrades
Forward Pharma A/S (FWP)
Buy -> Hold

Low
Jefferies Group LLC
Reiterates
Icon Plc (ICLR)
Neutral -> Hold

Low
Wedbush
Reiterates
Kite Pharma (KITE)
Neutral
$60.00
High
Morgan Stanley
Initiates
Loxo Oncology (LOXO)
Overweight
$59.00
Low
Benchmark
Raises Target
InVitae Corp (NVTA)
Buy
$11.00 -> $16.00
Low
Wedbush
Reiterates
Omeros (OMER)
Outperform
$47.00
Low
Barclays PLC
Downgrades
Rewalk Robotics Ltd (RWLK)
Equal Weight -> Underweight
$2.50 -> $1.50
Low
HC Wainwright
Reiterates
Steadymed Ltd (STDY)
Buy
$10.00 -> $15.00
Low

Gainers (% price change) Last Trade Change Mkt Cap
Sangamo Therapeutics Inc SGMO 5.20 +0.50 (10.64%) 368.55M
Endocyte, Inc. ECYT 2.57 +0.15 (6.20%) 109.15M
PDL BioPharma Inc PDLI 2.27 +0.11 (5.09%) 375.82M
NewLink Genetics Corp NLNK 24.10 +0.98 (4.24%) 743.68M
BioTime, Inc. BTX 3.45 +0.14 (4.23%) 383.60M
Losers (% price change)
Acorda Therapeutics Inc ACOR 21.00 -5.75 (-21.50%) 967.33M
Insys Therapeutics Inc INSY 10.51 -0.48 (-4.37%) 750.89M
Ironwood Pharmaceuticals IRWD 17.06 -0.71 (-4.00%) 2.52B
Corcept Therapeutics Inc. CORT 10.96 -0.42 (-3.69%) 1.25B
II-VI, Inc. IIVI 36.05 -1.30 (-3.48%) 2.25B
Most Actives (dollar volume)
Biogen Inc BIIB 273.42 +4.36 (1.62%) 59.05B
Johnson & Johnson JNJ 124.55 -0.11 (-0.09%) 336.94B
Bristol-Myers Squibb Co BMY 54.38 -0.98 (-1.77%) 88.65B
Pfizer Inc. PFE 34.21 -0.14 (-0.41%) 203.72B
Gilead Sciences, Inc. GILD 67.92 +0.39 (0.58%) 89.14B