The Daily Biotech Pulse: Moderna's Vaccine Authorized In Japan, Neovasc's Adverse Ruling In Germany, Metacrine Rallies On Insider Buying

Here's a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs May 20)

• Alexion Pharmaceuticals, Inc. ALXN
• Anebulo Pharmaceuticals, Inc. ANEB
• Catalyst Pharmaceuticals, Inc. CPRX
• Elanco Animal Health Incorporated ELAN
• ESSA Pharma Inc. EPIX
• I-Mab IMAB (reacted to ASCO abstract)
• Novo Nordisk A/S NVO
• PDS Biotechnology Corporation PDSB (moved on ASCO abstract)
• PRA Health Sciences, Inc. PRAH
• Protagonist Therapeutics, Inc. PTGX
• ShockWave Medical, Inc. SWAV
• Vera Therapeutics, Inc. VERA (IPOed May 14)
• Verastem, Inc. VSTM

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows May 20)

• Atreca, Inc. BCEL
• Black Diamond Therapeutics, Inc. BDTX ( reacted to ASCO abstract)
• Foghorn Therapeutics Inc. FHTX
• Inhibikase Therapeutics, Inc. IKT
• InMed Pharmaceuticals Inc. INM
• Lyra Therapeutics, Inc. LYRA
• Onconova Therapeutics, Inc. ONTX (moved on ASCO abstract)
• Pharming Group N.V. PHAR

Stocks In Focus

Moderna's COVID-19 Vaccine Authorized For Emergency Use In Japan

Moderna, Inc.MRNA said Japan's Ministry of Health, Labour and Welfare granted special approval under article 14-3 of the Pharmaceuticals and Medical Devices Act for emergency use of Moderna's mRNA COVID-19 vaccine in Japan. The company's Japanese partner Takeda Pharmaceutical Company Limited TAK will begin distributing the vaccine immediately.

Inspire's Sleep Therapy Gets Coverage by Anthem

Inspire Medical Systems, Inc. INSP said Anthem, Inc. ANTM will provide coverage for the Company's Inspire therapy, effective May 20.

The stock rose 3.08% to $183 in after-hours trading.

Larimar's CTI-1601 Gets Priority Medicines Designation In Europe

Larimar Therapeutics, Inc. LRMR said the European Medicines Agency has granted Priority Medicines designation to CTI-1601 for the treatment of Friedreich Ataxia. CTI-1601 is a recombinant fusion protein intended to deliver human frataxin into the mitochondria of patients with Friedreich Ataxia, who are unable to produce enough of this essential protein.

Through PRIME, the EMA offers early and proactive support to medicine developers to optimize the generation of robust data on a medicine's benefits and risks and enable accelerated assessment of medicines applications so that these medicines can reach patients earlier.

Related Link: Attention Biotech Investors: Mark Your Calendar For May PDUFA Dates

Neovasc Gets Unfavorable Verdict In a Litigation In Germany Over Tiara Patent

Neovasc Inc NVCN said the Higher Regional Court in Munich, Germany has upheld the first instance judgment of the Regional Court Munich of June 16, 2017, in which the court had found that Edwards Lifesciences Corporation EW had contributed in part to the invention of the Tiara and awarded to Edwards co-entitlement rights to the disputed Tiara European patent application

Neovasc said it is currently reviewing its possibilities for appeal.

The stock fell 2.62% to 83 cents in after-hours trading.

Metacrine Rises On Insider Buying

Metacrine, Inc. MTCR shares firmed up after two separate filings revealed CEO Preston Klassen and chief medical officer Hubert Chen bought shares in the company. Klassen bought 20,547 shares of the company at $3.6352 apiece and Chen acquired 3,289 shares at $3.60.

The stock rallied 10.27% to $4.08 in after-hours trading.