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.