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

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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 (NASDAQ: XBIT)

Down In The Dumps

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

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

Stocks In Focus

GenMark Gets Marketing Clearance For Blood-Stream Infection Detection Panel

GenMark Diagnostics, Inc (NASDAQ: 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. (NASDAQ: 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 (NYSE: 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 (NASDAQ: 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 (NYSE: 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. (NYSE: 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. (NYSE: 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 (NASDAQ: 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 (NASDAQ: MRUS) said it has reached a settlement of all pending patent litigation and administrative proceedings with Regeneron Pharmaceuticals Inc (NASDAQ: 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 (NASDAQ: 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.

Posted-In: Biotech News FDA Trading Ideas Best of Benzinga

 

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