The Daily Biotech Pulse: FDA Approves Clinuvel Drug, Aclaris Files Patent Lawsuit Against Taro, Viela Out-Licenses Autoimmune Disorder Drug

The following is a roundup of top developments in the biotech space over the last 24 hours. 

None of the NYSE or Nasdaq-listed biotech stocks hit 52-week highs on Tuesday.

Down In The Dumps

(Biotech stocks that hit 52-week lows Oct. 8.)

  • ABIOMED, Inc. ABMD
  • Adamas Pharmaceuticals Inc ADMS
  • Adaptimmune Therapeutics PLC – ADR ADAP
  • AEterna Zentaris Inc. AEZS
  • Albireo Pharma Inc ALBO
  • Alpine Immune Sciences Inc ALPN
  • Arbutus Biopharma Corp ABUS
  • Aurinia Pharmaceuticals Inc AUPH
  • BioCryst Pharmaceuticals, Inc. BCRX
  • BIOLASE Inc BIOL
  • BioTelemetry Inc BEAT
  • CELYAD SA/ADR CYAD
  • Cerus Corporation CERS
  • Chimerix Inc CMRX
  • Clovis Oncology Inc CLVS (Goldman reiterated a Sell rating on the stock and cut the price target from $13 to $3.)
  • Corbus Pharmaceuticals Holdings Inc CRBP
  • CymaBay Therapeutics Inc CBAY
  • CytomX Therapeutics Inc CTMX
  • DelMar Pharmaceuticals Inc DMPI
  • DiaMedica Therapeutics Inc DMAC
  • Endologix, Inc. ELGX
  • Erytech Pharma SA ERYP
  • Exagen Inc XGN
  • Fulcrum Therapeutics Inc FULC
  • GENFIT S A/ADR GNFT
  • Gossamer Bio Inc GOSS
  • ImmuCell Corporation ICCC
  • INmune Bio Inc INMB
  • Intellia Therapeutics Inc NTLA
  • Intercept Pharmaceuticals Inc (NASDAQ: ICPT
  • Iterum Therapeutics PLC (NASDAQ: ITRM
  • Kalvista Pharmaceuticals Inc KALV
  • Kiniksa Pharmaceuticals Ltd KNSA
  • Morphic Holding Inc MOR
  • MOTIF BIO PLC/S ADR MTFB
  • Nektar Therapeutics NKTR (reacted to analyst action)
  • Neon Therapeutics Inc NTGN
  • Neuralstem, Inc. CUR
  • Novelion Therapeutics Inc NVLN (announced delisting from Nasdaq)
  • Obseva SA OBSV
  • Histogenics Corp. OCGN
  • Onconova Therapeutics Inc ONTX
  • OncoSec Medical Inc ONCS
  • Plus Therapeutics Inc PSTV
  • Pulmatrix Inc PULM
  • Puma Biotechnology Inc PBYI (reacted to Goldman's rating downgrade to Sell and price target reduction)
  • Qiagen NV QGEN (pre-announced Q3 shortfall and departure of CEO)
  • Rexahn Pharmaceuticals, Inc. REXN
  • Satsuma Pharmaceuticals Inc STSA
  • Savara Inc SVRA
  • Sierra Oncology Inc SRRA
  • Silk Road Medical Inc SILK
  • Sorrento Therapeutics Inc SRNE
  • Tetraphase Pharmaceuticals Inc TTPH
  • TRACON Pharmaceuticals Inc TCON
  • TransMedics Group Inc TMDX
  • Trinity Biotech plc TRIB
  • TrovaGene Inc TROV
  • Urogen Pharma Ltd URGN
  • Viveve Medical Inc VIVE

Stocks In Focus

FDA Approves Clinuvel's Drug For Erythropoietic Protoporphyria Patients 

Australian biopharma company Clinuvel Pharmaceuticals Ltd CLVLY said the FDA has approved Scenesse, or afamelanotide16mg, for increasing pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria, a rate genetic metabolism disorder.

The drug is administered as a 16mg controlled-release injectable implant and is designed to provide protection for up to 60 days.

Aclaris Files Patent Infringement Lawsuit Against Taro 

Aclaris Therapeutics Inc ACRS said along with Allergan plc AGN that it has filed a patent infringement lawsuit against Taro Pharmaceutical Industries Ltd. TARO related to the ANDA the latter has filed with the FDA to market a generic version of 1% RHOFADE cream.

"Aclaris intends to vigorously enforce its intellectual property rights relating to RHOFADE," the company said.

Rhofade is indicated for the treatment of persistent facial erythema associated with rosacea in adults.

Viela Out-Licenses Autoimmune Disorder Drug To Mitsubishi Tanabe

Viela Bio Inc VIE said it has entered a collaboration agreement with Mitsubishi Tanabe Pharma for the development and commercialization of its inebilizumab, a humanized anti-CD19 monoclonal antibody, in nine Asian regions for neuromyelitis optica spectrum disorder as well as other potential future indications.

The agreement provides for Viela receiving an upfront licensing fee of $30 million as well as additional contingent payments based in part on sales revenue.

Related Links:

The Week Ahead In Biotech: Pfenex And Clinuvel On The Radar Ahead of FDA Decisions, 2 IPOs On Deck

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