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

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.)

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

Stocks In Focus

FDA Approves Clinuvel's Drug For Erythropoietic Protoporphyria Patients 

Australian biopharma company Clinuvel Pharmaceuticals Ltd (OTC: 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 (NASDAQ: ACRS) said along with Allergan plc (NYSE: AGN) that it has filed a patent infringement lawsuit against Taro Pharmaceutical Industries Ltd. (NYSE: 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 (NASDAQ: 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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