The Daily Biotech Pulse: Vertex Bets Big On Gene-Editing Therapies, Sanofi Poaches Novartis For CEO Role, Relief In Europe for Endologix

Shanthi Rexaline

Fri, Jun 7, 2019, 5:24 AM

Acorda Therapeutics Inc (NASDAQ: ACOR)
Aduro BioTech Inc (NASDAQ: ADRO)
Akebia Therapeutics Inc (NASDAQ: AKBA)
Aptinyx Inc (NASDAQ: APTX)
Axovant Gene Therapies Ltd (NASDAQ: 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 (NASDAQ: BLCM)
Caladrius Biosciences Inc (NASDAQ: CLBS)
Cellectis SA (NASDAQ: CLLS)
Collegium Pharmaceutical Inc (NASDAQ: COLL)
Dynavax Technologies Corporation (NASDAQ: DVAX)
Evolent Health Inc (NYSE: EVH)
Fennec Pharmaceuticals Inc (NASDAQ: FENC)
Harvard Bioscience, Inc. (NASDAQ: HBIO)
Hemispherx BioPharma, Inc (NYSE: HEB)
IMMURON LTD/S ADR (NASDAQ: IMRN)
IMMUTEP LTD/S ADR (NASDAQ: IMMP)
Invivo Therapeutics Holdings Corp (NASDAQ: NVIV)
MOTIF BIO PLC/S ADR (NASDAQ: MTFB)
Navidea Biopharmaceuticals Inc (NYSE: NAVB)
Neuronetics Inc (NASDAQ: STIM)
Puma Biotechnology Inc (NASDAQ: PBYI)
Seres Therapeutics Inc (NASDAQ: MCRB)
Sierra Oncology Inc (NASDAQ: SRRA)
Solid Biosciences Inc (NASDAQ: SLDB)
Synthetic Biologics Inc (NYSE: SYN)
Theravance Biopharma Inc (NASDAQ: TBPH)
United Therapeutics Corporation (NASDAQ: UTHR)
Xeris Pharmaceuticals Inc (NASDAQ: XERS)
Zafgen Inc (NASDAQ: ZFGN)

Stock In Focus CE Mark Reinstated For Endologix's Nellix Stent Graft

Endologix, Inc. (NASDAQ: 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 (NASDAQ: VRTX) and Crispr Therapeutics AG (NASDAQ: 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 (NYSE: 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 (NASDAQ: SNY)

Clovis Names Ginger Graham Chair Of The Board

Clovis Oncology Inc (NASDAQ: 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.

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The Daily Biotech Pulse: Vertex Bets Big On Gene-Editing Therapies, Sanofi Poaches Novartis For CEO Role, Relief In Europe for Endologix

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