The Daily Biotech Pulse: Proteostasis Delays Data, Akron Gets New CEO, Pfizer Halts Vaccine Trial

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

Scaling The Peak

(Biotech stocks hitting 52-week highs on Dec. 20)

XBiotech Inc XBIT

Down In The Dumps

(Biotech stocks hitting 52-week lows on Dec. 20)

Abeona Therapeutics Inc ABEO
Accelerate Diagnostics Inc AXDX
Achieve Life Sciences Inc (NASDAQ: ACHV
Achillion Pharmaceuticals, Inc. ACHN
Acorda Therapeutics Inc ACOR
Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP
ADMA Biologics Inc (NASDAQ: ADMA
Aerie Pharmaceuticals Inc (NASDAQ: AERI
Agios Pharmaceuticals Inc (NASDAQ: AGIO
Akebia Therapeutics Inc AKBA
Akers Biosciences Inc AKER
Altimmune Inc (NASDAQ: ALT
Amicus Therapeutics, Inc. FOLD
AnaptysBio Inc ANAB
Anavex Life Sciences Corp AVXL
ANI Pharmaceuticals Inc Common Stock ANIP
Applied Genetic Technologies Corp AGTC
Apricus Biosciences Inc (NASDAQ: APRI
Aptevo Therapeutics Inc APVO
Aptinyx Inc (NASDAQ: APTX
Arbutus Biopharma Corp (NASDAQ: ABUS
Arca Biopharma Inc (NASDAQ: ABIO
Assembly Biosciences Inc ASMB
Atossa Genetics Inc ATOS
Audentes Therapeutics Inc BOLD
Avrobio Inc AVRO
AxoGen, Inc Common Stock AXGN
AzurRx BioPharma Inc AZRX
Bioblast Pharma Ltd ORPN
Bio-Rad Laboratories, Inc. Class A Common Stock BIO
Biomerica, Inc. BMRA
Bio-Path Holdings Inc BPTH
BioXcel Therapeutics Inc BTAI
bluebird bio Inc BLUE
Blueprint Medicines Corp BPMC
Calithera Biosciences Inc CALA
Catalyst Biosciences Inc CBIO
Catalyst Pharmaceuticals Inc CPRX
Celgene Corporation CELG
Cellectar Biosciences Inc CLRB
Cellectis SA CLLS
CELYAD SA/ADR CYAD
Checkpoint Therapeutics Inc CKPT
Chembio Diagnostics Inc CEMI
Chimerix Inc CMRX
Cidara Therapeutics Inc CDTX
• Clearside Biomedical Inc CLSD
CTI BioPharma Corp CTIC
Cyclacel Pharmaceuticals Inc CYCC
CymaBay Therapeutics Inc CBAY
DBV TECHNOLOGIE/S ADR DBVT
DiaMedica Therapeutics Inc DMAC
Dova Pharmaceuticals Inc DOVA
DURECT Corporation DRRX
Dynavax Technologies Corporation DVAX
Eagle Pharmaceuticals Inc EGRX
Edap Tms SA EDAP
Edge Therapeutics Inc EDGE
Editas Medicine Inc EDIT
Entera Bio Ltd ENTX
Enzo Biochem, Inc. ENZ
Epizyme Inc EPZM
Erytech Pharma SA ERYP
ESSA Pharma Inc EPIX
Evogene Ltd EVGN
Flexion Therapeutics Inc FLXN
Fortress Biotech FBIO
G1 Therapeutics Inc GTHX
Genetic Technologies Limited GENE
Genocea Biosciences Inc GNCA
Genprex Inc GNPX
Geron Corporation GERN
GW Pharmaceuticals PLC- ADR GWPH
Immune Design Corp IMDZ
ImmunoGen, Inc. IMGN
Infinity Pharmaceuticals Inc. INFI
Integra Lifesciences Holdings Corp IART
Intra-Cellular Therapies Inc ITCI
Jounce Therapeutics Inc JNCE
Kala Pharmaceuticals Inc KALA
KITOV PHARMA LT/S ADR KTOV
La Jolla Pharmaceutical Company LJPC
LeMaitre Vascular Inc LMAT
Melinta Therapeutics Inc MLNT
Mersana Therapeutics Inc MRSN
Midatech Pharma PLC-ADR MTP
Miragen Therapeutics Inc MGEN
Moderna Inc MRNA
Molecular Templates Inc MTEM
Mylan NV MYL
Nektar Therapeutics NKTR
NewLink Genetics Corp NLNK
Ocean Bio-Chem, Inc. OBCI
OHR Pharmaceutical Inc OHRP
Oncolytics Biotech, Inc. ONCY
Onconova Therapeutics Inc ONTX
Ophthotech Corp OPHT
Oramed Pharmaceuticals, Inc. ORMP
OptiNose Inc OPTN
OraSure Technologies, Inc. OSUR
Orchard Therapeutics PLC – ADR (NASDAQ: ORTX
Orthofix Medical Inc OFIX
Otonomy Inc OTIC
Ovid Therapeutics Inc OVID
Paratek Pharmaceuticals Inc PRTK
Pieris Pharmaceuticals Inc PIRS
PLx Pharma Inc PLXP
Portola Pharmaceuticals Inc PTLA
Prana Biotechnology Limited PRAN
Prothena Corporation PLC PRTA
Provention Bio Inc PRVB
REALM THERAPEUT/S ADR RLM
Reshape Lifesciences Inc RSLS
Revance Therapeutics Inc RVNC
Rigel Pharmaceuticals, Inc. RIGL
SAGE Therapeutics Inc SAGE
Selecta Biosciences Inc SELB
Seres Therapeutics Inc MCRB
Sierra Oncology Inc SRRA
Sonoma Pharmaceuticals Inc SNOA
Sorrento Therapeutics Inc SRNE
Spectrum Pharmaceuticals, Inc. SPPI
Stellar Biotechnologies Inc SBOT
Stemline Therapeutics Inc STML
Sunesis Pharmaceuticals, Inc. SNSS
Supernus Pharmaceuticals Inc SUPN
Synlogic Inc SYBX
TG Therapeutics Inc TGTX
The Medicines Company MDCO
Titan Medical Inc. TMDI
Tocagen Inc TOCA
Tonix Pharmaceuticals Holding Corp TNXP
Vaccinex Inc VCNX
Vascular Biogenics Ltd VBLT
Verrica Pharmaceuticals Inc VRCA
Viveve Medical Inc VIVE
Zosano Pharma Corp ZSAN
Zynerba Pharmaceuticals Inc ZYNE

Stocks In Focus

GenMark Gets Marketing Clearance For Blood-Stream Infection Detection Panel

GenMark Diagnostics, Inc GNMK announced FDA 510(k) market clearance for its ePlex Blood Culture Identification Gram-Positive, or BCID-GP, panel. This panel along with ePlex Blood Culture Identification Gram-Negative, or BCID-GN and Fungal Pathogen, or BCID-FP, is used to diagnose and manage blood stream infections that can lead to sepsis.

The stock advanced 8.14 percent to $4.25 in after-hours trading.

Akorn Names Pharma Veteran Boothe as CEO

Akorn, Inc. AKRX announced the appointment of pharma industry veteran Douglas Boothe as its president and CEO, effective Jan. 1, 2019.

The stock advanced 4.97 percent to $3.80 in after-hours trading.

JNJ's Janssen Unit Announces Regulatory Filing For Expanded Use of Inflammation Drug

Johnson & Johnson JNJ's Janssen unit said it has submitted a sBLA for Stelara for treating adults with moderately to severely active ulcerative colitis. Stelara has earlier been approved for treating moderate to severe plaque psoriasis, active psoriatic arthritis and moderate to severe Crohn's disease.

Proteostasis To Delay Reporting Data From Cystic Fibrosis Study Until Q1

Proteostasis Therapeutics Inc PTI said it would now report complete efficacy and safety data from the Phase 1 study of its proprietary combination therapy triplet, namely PTI-808, PTI-801 and PTI-428, and the from the high-dose doublet study in subjects with cystic fibrosis in the first quarter of 2019. This is a deviation from the company's plan of reporting preliminary results from the triplet study by dose cohort, as each cohort was completed, beginning with a low-dose cohort.

The stock slumped 21.90 percent to $3.21 in after-hours trading.

Biopharmx Gets Grace Period For Regaining Compliance

Biopharmx Corp BPMX, which is found violating NYSE American continued listing standards with respect to stockholder's equity, said the NYSE Regulation has received its compliance plan and granted a plan period through Sep. 24, 2019.

The penny stock rose 4.65 percent to 10.58 cents in after-hours trading.

Pfizer Discontinues Mid-stage Trial of Anti-bacterial Vaccine

Pfizer Inc. PFE announced discontinuation of its Phase 2b trial dubbed STRIVE that is evaluating its investigational Staphylococcus aureus multi-antigen vaccine due to determination by an independent Data Monitoring Committee that the study reached futility, ie there is a low statistical probability for the study to meet the pre-defined primary efficacy objective in adults undergoing elective spinal fusion surgery after completing a planned Phase 3 expansion of the study.

However, the committee found the investigational vaccine to be safe and well tolerated. Pfizer said it is evaluating the next steps for the potential development of a Staphylococcus Aureus vaccine.

The stock slipped 0.43 percent to $41.77 in after-hours trading.

Regulatory Review Period For Merck's Lung Cancer Drug Extended By 3 Months

Merck & Co., Inc. MRK said the FDA has extended the PDUFA action date for the sBLA for its Keytruda, being evaluated as monotherapy for first-line treatment of locally advanced, or metastatic non-small cell lung cancer, whose tumors express PD-L1 without EGFR or ALK genomic tumor aberrations.

The extension comes due to the additional time FDA will need to review the additional data and analyses the company submitted to the agency, which constitutes a major amendment.

The new PDUFA date is April 11, 2019.

Apellis' C3 Glomerulopathy Therapy Granted Orphan Drug Designation

Apellis Pharmaceuticals Inc APLS said its C3 component inhibitor APL-2 has been granted orphan drug designation for treating C3 glomerulopathy. The designation is granted to novel drugs that are tested for rare diseases affecting fewer than 200,000 people in the US., and accords privileges such as development and commercial incentives, including seven years of market exclusivity in the U.S., consultation by FDA on clinical study design, potential for expediting drug development and certain fee exemptions and reductions.

Merus

Merus NV MRUS said it has reached a settlement of all pending patent litigation and administrative proceedings with Regeneron Pharmaceuticals Inc REGN regarding certain antibody generation platforms of each company.

The agreement provides for signing of a global patent cross-license and a $15 million investment in Merus by Regeneron through purchase of 600,000 Merus shares at $25 per share.

Arca Biopharma Submits Amended Special Protocol Assessment for Heart Drug

Arca Biopharma Inc ABIO said it has submitted an amendment to the Special Protocol Assessment request to the FDA, with the amendment addressing FDA feedback and guidance on the target population for its planned Phase 3 trial.

"The SPA request is part of the Company's ongoing interaction with the FDA focused on the planned Phase 3 clinical development program of Gencaro (bucindolol hydrochloride) as a genetically-targeted treatment for atrial fibrillation in patients with heart failure," the company said.

The stock jumped 11.47 percent to 37.9 cents in after-hours trading.

PLx Pharma to Raise $15M Through Convertible Preferred Stock Offering

PLx Pharma announced an agreement with Park West Asset Management, under which the latter would purchase 15,000 shares of newly issued Series A convertible preferred stock, grossing proceeds of $15 million for the former.

PLx said it will use the proceeds to advance Vazalore to market readiness among other things.

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