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Coherus BioSciences Inc. ($CHRS) reported that CHS-1420, its proposed biosimilar of adalimumab (Humira®), met the primary endpoint in a clinical pharmacokinetic (PK) bioequivalence study that compared CHS-1420 to Humira in healthy subjects. These endpoints are maximum serum concentration (Cmax), area under the time-concentration curve from first to last time point measured (AUC-0-last), and area under the time-concentration curve from first time point extrapolated to infinity (AUC0-inf).
These results are likely to boost Coherus stock price which has lost nearly 11 percent of its value this year so far. However, its 12 months gain stands at nearly 72 percent.

Vermillion Inc. ($VRML) announced that it has inked a deal with Blue Cross Blue Shield of Michigan. The collaboration has been signed through Vermillion’s ASPiRA LABs and involves its ovarian cancer risk assessment test, OVA1 (MIA). The company stated that OVA1 (MIA) has been included by the ACOG in their guidelines for the Evaluation and Management of Adnexal Masses.
The company stock shot up more than 11 percent in its Thursday trading session and touched its 52 weeks high of $2.85. The stock value is now up over 175 percent this year so far. Its value accretion in the past 12 months stands at over 63 percent.

 

• Juno Therapeutics ($JUNO) announced that it has ended its flagship cancer drug trial. The trial was suspended by the Food and Drug Administration in November last year following the death of patients. The Phase II "Rocket" trial used Juno’s JCAR015 immunotherapy treatment to re-engineer adult patients’ immune systems for fight acute lymphoblastic leukemia. The same trial was also halted in July by the FDA after two patients died from cerebral edema.
• Intercept Pharmaceuticals ($ICPT) announced that its Ocaliva has been recommended by the National Institute for Health and Care Excellence for routine use by the National Health Service (NHS) in England, Wales and Northern Ireland. The treatment is conditionally approved in the European Union for the treatment of primary biliary cholangitis in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.

• Aurinia Pharmaceuticals Inc. ($AUPH) announced top line results from its Phase IIb AURA-LV (AURA) study in lupus nephritis. At 48 weeks, the trial met the complete and partial remission (“CR”/ “PR”) endpoints, demonstrating statistically significantly greater CR and PR in patients in both low dose (23.7mg of voclosporin twice daily (p< .001)) and high dose (39.5mg twice daily (p=.026)) cohorts versus the control group. The company also said that there were no further deaths in patients given its experimental lupus drug in a mid-stage study, allaying safety concerns related to the treatment. Aurinia is looking to start a pivotal study later this year. • Merck & Co. Inc. ($MRK) announced that its Odactra has been approved by the FDA. This is the first allergen extract that is administered sublingually to treat house dust mite-induced nasal inflammation, with or without eye inflammation in people between the ages of 18 and 65.

 
• PTC Therapeutics Inc. ($PTCT) reported that it would stop developing its cystic fibrosis drug after it failed to meet the main goal of a late-stage study. The trial did not meet its primary or secondary endpoints. The company plans to discontinue current clinical development of ataluren in cystic fibrosis, close ongoing extension studies and withdraw its application for marketing authorization in cystic fibrosis in Europe.
• Sanofi ($SNY) entered into a collaboration with MedImmune through its vaccines global business unit Sanofi Pasteur. The agreement pertains to developing and commercializing a monoclonal antibody called MEDI8897 for the prevention of Respiratory Syncytial Virus (RSV) associated illness in newborns and infants. MedImmune is the global biologics research and development arm of AstraZeneca.

Jefferies Group LLC Reiterates
Akorn (AKRX)

Buy
Guggenheim Reiterates ANI Pharmaceuticals (ANIP)
Neutral
HC Wainwright Raises Target Aurinia Pharmaceuticals (AUPH)
Positive $12.00
Piper Jaffray Companies Reiterates Cara Therapeutics (CARA)
Overweight
BMO Capital Markets Reiterates Cooper Companies, Inc. (The) (COO)
Buy
Jefferies Group LLC Raises Target Cooper Companies, Inc. (The) (COO)
$220.00
Guggenheim Reiterates Edge Therapeutics (EDGE)
Buy -> In-Line
Leerink Swann Initiates Edge Therapeutics (EDGE)
Outperform
Mizuho Raises Target Endo International PLC (ENDP)
$17.00
Stifel Nicolaus Downgrades Kite Pharma (KITE)
Buy -> Hold $74.00
Jefferies Group LLC Reiterates Karyopharm Therapeutics (KPTI)
Buy

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