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The Daily Biotech Pulse: Canadian Approval For Amarin's Vascepa, Innate Pharma's Blood Cancer Drug Accepted For Review In Europe

The Daily Biotech Pulse: Canadian Approval For Amarin's Vascepa, Innate Pharma's Blood Cancer Drug Accepted For Review In Europe

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

Scaling The Peaks

(Biotech stocks that hit 52-week highs on Dec. 31.)

  • Aptose Biosciences Inc (NASDAQ: APTO)
  • Ascendis Pharma A/S (NASDAQ: ASND)
  • Avenue Therapeutics Inc (NASDAQ: ATXI)
  • Biondvax Pharmaceuticals Ltd – ADR (NASDAQ: BVXV)
  • BioXcel Therapeutics Inc (NASDAQ: BTAI)
  • ChemoCentryx Inc (NASDAQ: CCXI)
  • Cidara Therapeutics Inc (NASDAQ: CDTX)
  • DURECT Corporation (NASDAQ: DRRX)
  • Esperion Therapeutics Inc (NASDAQ: ESPR)
  • Fortress Biotech (NASDAQ: FBIO)
  • The Medicines Company (NASDAQ: MDCO)
  • Mirati Therapeutics Inc (NASDAQ: MRTX)
  • Nevro Corp (NYSE: NVRO)
  • Oncolytics Biotech, Inc. (NASDAQ: ONCY)
  • Otonomy Inc (NASDAQ: OTIC)
  • Satsuma Pharmaceuticals Inc (NASDAQ: STSA)
  • Soligenix, Inc. (NASDAQ: SNGX)
  • Syneos Health Inc (NASDAQ: SYNH)
  • Urovant Sciences Ltd (NASDAQ: UROV) (announced NDA submission for Vibegron to treat overreactive bladder)
  • Veru Inc (NASDAQ: VERU)
  • Virtra Inc (NASDAQ: VTSI)

Down In The Dumps

(Biotech stocks that hit 52-week lows on Dec. 31.)

  • Akorn, Inc. (NASDAQ: AKRX)
  • Endologix, Inc. (NASDAQ: ELGX)
  • Kaleido Biosciences Inc (NASDAQ: KLDO)
  • Stealth BioTherapeutics Corp (NASDAQ: MITO)
  • Xeris Pharmaceuticals Inc (NASDAQ: XERS)

Stocks In Focus

Amarin Secures Canadian Label Expansion For Vascepa 

Amarin Corporation plc (NASDAQ: AMRN) said Health Canada has approved its Vascepa to reduce the risk of cardiovascular events in statin-treated patients with elevated triglycerides who are at high risk of cardiovascular events due to established cardiovascular disease or diabetes and at least one other cardiovascular risk factor.

In December, the company secured FDA approval for the fish oil pill for the same indication.

The approval was granted to HLS Therapeutics, Amarin's commercial licensee for Vascepa in Canada.

Amarin shares were trading 2.15% higher at $21.90 in Thursday's premarket session. 

Innate Pharma's Blood Cancer Drug Accepted For Review In Europe

INNATE PHARMA S/S ADR (NASDAQ: IPHA) announced the European Medicines Agency has accepted for review its Marketing Authorization Application for Lumoxiti, which is indicated for adult patients with relapsed or refractory hairy cell leukemia who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog.

The FDA approved the drug in September 2018.

Innate Pharma shares were rallying by 24.22% to $8 in Thursday's premarket session. 

Aridis Appoints Insider Nazak As CFO

Aridis Pharmaceuticals Inc (NASDAQ: ARDS) announced the appointment of Michael Nazak as its CFO, effective Jan. 1. Nazak was serving as vice president of finance and replaces Fred Kurland, who elected to retire as CFO.

Medigus, Intellisense To Merge

Medical device company Medigus Ltd. ADR (NASDAQ: MDGS) said it has completed its securities exchange agreement with Intellisense Solutions Inc. (OTC: INLL), pursuant to which the former has transferred 100% of its ownership to ScoutCam Inc., a subsidiary of Intellisense.

Following the transaction and subject to certain pending regulatory and governmental approvals, Intellisense will change its name to ScoutCam and symbol to "SCTC" and will remain quoted on the OTC.

In pre-market trading Thursday, Medigus shares were advancing 10.34% to $1.92.

Aerie's Regulatory Application For Eye Pressure Treatment Accepted For Review In Europe

Aerie Pharmaceuticals Inc (NASDAQ: AERI) said the EMA has accepted for review its MAA for Roclanda 0.02%/0.005%.

Roclanda is marketed as Rocklatan in the U.S. for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. An opinion from the EMA's Committee for Medicinal Products for Human Use is expected in late 2020, the company said.

Related Links:

Week Ahead In Biotech: PDUFA Date Ahead For Astra Zeneca, Merck's Lynparza, Pending Clinical Readouts In Focus

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