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Dynavax Techologies ($DVAX) stock perked up as the company announced that an FDA advisory panel voted 12-1 in favor of the available data for is hepatitis B vaccine for adults. The advisory panel is of the view that the data supports the safety profile of the experimental drug. The Heplisav B earlier received 13-1 vote from a prior panel showing that the data from Phase 3 clinical trials supported the effectiveness of the vaccine. The company stock reacted positively to the news and showed strong gains.

Gilead Sciences ($GILD) received the approval for its Vosevi for the treatment of adult patients with genotype 1 - 6 chronic hepatitis C virus (HCV) infection. The drug was approved by the FDA in the US in July this year. The European Commission also authorized the extension of suitable patients for Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) to include adolescents aged 12 - 18 years with HCV genotype 1, 3, 4, 5 and 6. Harvoni is the first direct-acting antiviral regimen to receive marketing authorization in the European Union extended for use in the adolescent population.

 

Invacare ($IVC) announced its plan to transfer production of its Invacare Rea annual wheelchairs to Fondettes in France. The company currently produces the wheelchairs at its Dio, Sweden facility, which will now be used for producing beds for the Nordic market.

NewLink Genetics ($NLNK) reported that it plans to restructure its operations in order to focus on the development of its lead drug candidates indoximod and NLG802. The company also plans to cut its headcount by almost 50 percent to 70.

Otsuka Pharmaceutical ($OTSKF) announced receiving the FDA approval for is ABILIFY MAINTENA as the monotherapy maintenance treatment of bipolar I disorder in adults. It is designed to be administered once per month via intramuscular injection.

AbbVie ($ABBV) announced receiving the European Commission approval for MAVIRET for the treatment of adult patients with genotype 1 - 6 hepatitis C virus (HCV) infection. It is the only HCV med approved for use in patients with any stage of CKD.

 

CytRx ($CYTR) announced inking a new global licensing deal with NantCell, a subsidiary of NantWorks. The licensing deal is with regard to the development and commercialization of aldoxorubicin for all indications. CytRx is entitled to receive up to $343 million in milestone and royalty payments.

Haemonetics ($HAE) announced receiving the 510(k) clearance from the FDA for its NexSys PCS plasmapheresis system. The system comes with a bi-directional connectivity with it NexLynk DMS donor management system enabling automated collection procedure programming and end-of-procedure documentation.

Brokerage Action Company Rating Price Target Impact on Share Price
Canaccord Genuity Initiates Aceto Corporation (ACET)
Buy $19.00 Low

BMO Capital Markets Reiterates Amphastar Pharmaceuticals (AMPH)
Hold $16.00 Low

Canaccord Genuity Initiates ANI Pharmaceuticals (ANIP)
Buy $60.00 Low

Cowen and Company Downgrades athenahealth (ATHN)
Outperform -> Market Perform Low

Leerink Swann Initiates AxoGen (AXGN)
Outperform $22.00 Low

Argus Upgrades Celgene Corporation (CELG)
Hold -> Buy Low

Royal Bank Of Canada Upgrades Dynavax Technologies Corporation (DVAX)
Sector Perform -> Outperform $7.00 -> $26.00 High

Gainers (% price change)Last TradeChangeMkt CapLeMaitre Vascular IncLMAT33.94+5.54 (19.51%)638.39MImmunoGen, Inc.IMGN6.96+0.87 (14.29%)621.86MOmnicell, Inc.OMCL48.55+5.77 (13.50%)1.80BNewLink Genetics CorpNLNK7.70+0.70 (10.00%)225.04MAcadia Healthcare Co. IncACHC53.00+3.77 (7.66%)4.65BLosers (% price change)CyberOptics CorporationCYBE17.25-6.40 (-27.06%)119.77MMEDNAX IncMD47.73-8.76 (-15.51%)4.43BNuVasive, Inc.NUVA67.11-9.79 (-12.73%)3.40BQuidel CorporationQDEL32.85-3.19 (-8.85%)1.09BAbaxis IncABAX47.62-4.36 (-8.39%)1.08BMost Actives (dollar volume)Merck & Co., Inc.MRK64.11+0.42 (0.66%)175.35BGilead Sciences, Inc.GILD75.94+0.98 (1.31%)99.23BJohnson & JohnsonJNJ131.85+1.02 (0.78%)355.18BPfizer Inc.PFE33.15+0.15 (0.45%)197.41BCelgene CorporationCELG134.10-0.05 (-0.04%)104.71B