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 on June 6)
- BIOFRONTERA AG/ADR BFRA
- BIO-TECHNE Corp TECH(announced a deal to buy University of Minnesota startup B-MoGen technology)
- Blueprint Medicines Corp BPMC
- Zynex Inc. ZYXI
Down In The Dumps
(Biotech stocks hitting 52-week lows on June 6)
- Acorda Therapeutics Inc ACOR
- Aduro BioTech Inc ADRO
- Akebia Therapeutics Inc AKBA
- Aptinyx Inc APTX
- Axovant Gene Therapies Ltd AXGT(reported six-month follow-up data from the first dose cohort in the Phase 2 trial of AXO-Lenti-PD for the treatment of Parkinson's disease and also issued pipeline update)
- Bellicum Pharmaceuticals BLCM
- Caladrius Biosciences Inc CLBS
- Cellectis SA CLLS
- Collegium Pharmaceutical Inc COLL
- Dynavax Technologies Corporation DVAX
- Evolent Health Inc EVH
- Fennec Pharmaceuticals Inc FENC
- Harvard Bioscience, Inc. HBIO
- Hemispherx BioPharma, Inc HEB
- IMMURON LTD/S ADR IMRN
- IMMUTEP LTD/S ADR IMMP
- Invivo Therapeutics Holdings Corp NVIV
- MOTIF BIO PLC/S ADR MTFB
- Navidea Biopharmaceuticals Inc NAVB
- Neuronetics Inc STIM
- Puma Biotechnology Inc PBYI
- Seres Therapeutics Inc MCRB
- Sierra Oncology Inc SRRA
- Solid Biosciences Inc SLDB
- Synthetic Biologics Inc SYN
- Theravance Biopharma Inc TBPH
- United Therapeutics Corporation UTHR
- Xeris Pharmaceuticals Inc XERS
- Zafgen Inc ZFGN
Stock In Focus
CE Mark Reinstated For Endologix's Nellix Stent Graft
Endologix, Inc. ELGX said the EC Certificate of Conformity, or CE Mark for the Nellix EndoVascular Aneurysm Sealing System has been reinstated by the GMED, the EU Notified Body for Nellix System. The reinstatement was done following an assessment of clinical evidence.
The CE mark was suspended by the GMED in late-January following a voluntary recall and Field Safety Notification issued by Endologix on Jan. 4.
The stock rose 8.38 percent to $7.50 in after-hours trading.
Vertex Inks licensing Agreement With Crispr For Gene-editing Therapies, To Buy Exonics
Vertex Pharmaceuticals Incorporated VRTX and Crispr Therapeutics AG CRSP announced an expansion in their collaboration agreement, and an exclusive licensing agreement to discover and develop gene-editing therapies for the treatment of Duchenne Muscular Dystrophy, or DMD, and Dystrophy Type 1, or DM1.
Vertex has agreed to pay Crispr $175 million upfront, with the latter eligible to receive up to $1 billion, inclusive of the upfront and potential future milestone payments.
Vertex also announced an agreement to buy privately-held Exonics, which focuses on creating transformative gene editing therapies to repair mutations that cause DMD and other severe neuromuscular diseases. The deal provides for Exonics shareholders receiving about $1 billion, including $245 million upfront and potential future payments.
Crispr shares were up 9.23 percent to $40.69 in pre-market trading.
Sanofi Poaches Novartis Pharma Head For CEO Role
Novartis AG NVS announced the appointment of Marie-France Tschudin, currently serving as President, Advanced Accelerator Applications – a Novartis company, as President of Novartis Pharma. Tschudin will directly report to CEO Vas Narasimhan. Paul Hudson, who formerly served as President of the Pharma unit, is taking up the CEO position at Sanofi SA SNY
Clovis Names Ginger Graham Chair Of The Board
Clovis Oncology Inc CLVS announced the appointment of Ginger Graham as Chair of the board following the retirement of James Barrett. Graham has been a member of the board for six years, the company said.
The stock gained 5.73 percent to $15.50 in after-hours trading.
Xeris' PDUFA Date For Gvoke By 3 Months
Xeris said the FDA has extended the review period for its NDA for Gvoke – ready-to-use glucagon injection – by three months, with the new PDUFA date now set for Sep. 10. The decision was taken as the FDA deemed that the company's recent submission in response to an information request by the FDA as constituting a major amendment to the NDA, necessiating additional time for a full review of the submission.
The stock fell 5.12 percent to $7.59 in after-hours trading.
On The Radar
Spring Bank Pharmaceuticals Inc SBPH will present full data for Inarigivir 400mg in healthy volunteers at the HBV Cure Meeting
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