The Daily Biotech Pulse: Aridis To Study Antibody Cocktail For Coronavirus Variants, Revance & Protalix Data Readouts - iShares Biotechnology ETF (NASDAQ:IBB)

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 Feb. 22)

Acceleron Pharma Inc XLRN
Akari Therapeutics PLC AKTX
Annexon Inc ANNX
Applied Molecular Transport Inc. AMTI
AxoGen, Inc AXGN
Burning Rock Biotech Ltd BNR
Celcuity Inc CELC (announced a $20 million common stock offering)
Celldex Therapeutics, Inc. CLDX
Cerecor Inc CERC
Citius Pharmaceuticals Inc CTXR
DermTech Inc DMTK
Gemini Therapeutics Inc GMTX
Intra-Cellular Therapies Inc ITCI (announced NDA submissions for two indications for Caplyta - as monotherapy and as adjunctive therapy with lithium or valproate for the treatment of depressive episodes associated with bipolar I or II disorder)
iTeos Therapeutics Inc ITOS
Mereo BioPharma Group plc – ADR MREO
Nantkwest Inc NK
Orthofix Medical Inc OFIX
PAVmed Inc PAVM (reacted to its fourth-quarter results)
Pharvaris BV PHVS
Pliant Therapeutics Inc PLRX
RedHill Biopharma Ltd RDHL
Silence Therapeutics ADR Representing 3 Ord Shs SLN
United Therapeutics Corporation UTHR
Vistagen Therapeutics Inc VTGN

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Feb. 22)

bluebird bio Inc BLUE
Pharming Group PHAR
Talis Biomedical Corp TLIS
Vallon Pharmaceuticals Inc VLON

Stocks In Focus

Surface Oncology Exercises Option to License Vaccinex Platform-discovered Anti-CCR8 Antibody

Vaccinex Inc VCNX announced that Surface Oncology Inc SURF will be exercising its option to license the anti-CCR8 antibody discovered via Vaccinex's ActivMAb antibody discovery and novel viral display platform.

The antibody, SRF114, is a fully human IgG1 anti-CCR8 antibody that selectively depletes immuno-suppressive tumor T regulatory cells while sparing peripheral Tregs.

The terms of agreement with Surface Oncology provided that Surface Oncology pay technology access and licensing fees in addition to research funding, and that Vaccinex will qualify for development milestone payments and royalties.

In after-hours trading, Vaccinex shares were down 3.91% to $4.91, while Surface Oncology was up 12.33% to $10.20.

Aridis to Study Inhaled Antibody Cocktail For Neutralizing Emerging Variants of The Novel Coronavirus

Aridis Pharmaceuticals Inc ARDS said it has augmented its inhaled AR-711 monoclonal antibody to COVID-19 with a second mAb, AR-713, that is designed to neutralize newly emerging COVID-19 mutated variants including those from South Africa, Brazil and Japan.

Together, the enhanced dual antibody cocktail will be delivered as an inhaled treatment and is expected to provide broad coverage of all known high-risk strains, the company said. In addition, Aridis announced preclinical development services support from NIAID. The preclinical development services support is also provided by the Coronavirus Immunotherapy Consortium.

Aridis said it is on track to initiate the program's Phase 1/2/3 clinical trial in second half of 2021.

In premarket trading Tuesday, the stock was up 11:45% to $8.08.

Celldex to Expand The Study of CDX-0159 For Additional Dermatologic Indication

Celldex said it will expand clinical development of CDX-0159 into prurigo nodularis, a chronic skin disease characterized by the development of hard, intensely itchy nodules on the skin. CDX-0159 is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity.

Frequency Therapeutics Announces Publication of Positive Phase 1/2 Study Data For Drug to Treat Hearing Loss

Frequency Therapeutics Inc FREQ announced the publication in Otology & Neurotology, results of its FX-322 Phase 1/2 study, showing hearing improvements in adults with acquired sensorineural hearing loss and the first-known linkage of pharmacokinetics and pharmacodynamics for a potential hearing restoration therapy.

Findings from the Phase 1/2 study of FX-322, the company's lead product candidate to treat SNHL, showed statistically significant increases in word recognition and words-in-noise scores, the company added.

In after-hours trading, the stock was up 5.59% to $55.

Revance's DaxibotulinumtoxinA Injection Shows Mixed Results In Mid-stage Study In Upper Limb Spasticity

Revance Therapeutics Inc RVNC announced topline data from its JUNIPER Phase 2 study of DaxibotulinumtoxinA for Injection for the treatment of adults with moderate to severe upper limb spasticity, showing mixed results.

The company said the data validated efficacy and safety, while also achieving key co-primary endpoint on efficacy, with the 500-unit dose showing statistically significant difference from placebo in the Modified Ashworth Score improvement from baseline. On the Physician Global Impression Change assessment, all the three evaluated doses showed numerical improvement compared to placebo but did not reach statistical significance.

Separately, the company reported a sharp increase in its fourth-quarter revenues to $11.1 million, with the increase primarily due to the commercial launch of the RHA Collection of dermal fillers and the HintMD fintech platform. The loss per share widened from 99 cents to $1.24, in line with the consensus.

Protalix Reports Positive Late-stage Data For Drug to Treat Inherited Lysosomal Storage Disease

Protalix Biotherapeutics Inc PLX and Chiesi Global Rare Diseases, announced positive topline results from the BRIGHT Phase 3 clinical trial evaluating pegunigalsidase alfa, 2 mg/kg, administered every four weeks, for the potential treatment of Fabry disease. PRX–102 is Protalix' cell-expressed recombinant, PEGylated, cross-linked α–galactosidase–A product candidate.

The stock was climbing 10.64% to $5.72 in premarket trading Tuesday.

Oncolytics Presents Pre-clinical Data Showing Synergistic Effect of Pelareorep Combination With CART T Cells In Treating Cancer

Oncolytics Biotech, Inc. ONCY announced publication of an e-poster at the CAR-TCR Summit Europe 2021, which showed that loading CAR T cells with pelareorep vastly improved their persistence and efficacy in a murine solid tumor model, in stark contrast to preclinical studies using intratumoral infection with the VSV oncolytic virus that weakened CAR T cells.

The stock was gaining 13.94% to $3.76 in premarket trading Tuesday.

Earnings

ImmuCell Corporation's ICCC product sales rose modestly from $3.63 million in the fourth quarter of 2019 to $3.74 million in the fourth quarter of 2020. The company reversed to a profit of 3 cents from a loss of 4 cents, while analysts, on average, estimated a loss of 4 cents per share.

The company also said it has recently submitted the last of five significant technical sections required to achieve FDA approval to market Re-Tain, its mastitis product under development. A response from the FDA to this chemistry, manufacturing and controls technical section is expected during the third quarter of 2021 after the statutory six-month review period.

The stock declined 12.61% to $10.26 in after-hours trading.

Offerings

PAVmed said it's commencing an underwritten public offering of its common stock. All of the shares to be sold in the offering will be sold by the company, subject to customary closing conditions. PAVmed said it intends to use the net proceeds to repay all of its outstanding debt, including all outstanding convertible notes, with the balance to be used for working capital and general corporate purposes.

The stock slipped 12.43% to $4.86 in after-hours trading.

On The Radar

Earnings

Rubius Therapeutics Inc RUBY (before the market open)
Epizyme Inc EPZM (before the market open)
Clovis Oncology Inc CLVS (before the market open)
Epizyme Inc EPZM (before the market open)
Adamas Pharmaceuticals Inc ADMS (after the close)
Arena Pharmaceuticals, Inc. ARNA (after the close)
AtriCure Inc. ATRC (after the close)
Theravance Biopharma Inc TBPH (after the close)
Masimo Corporation MASI (after the close)
Insulet Corporation PODD (after the close)
Esperion Therapeutics Inc ESPR (after the close)
Myriad Genetics, Inc. MYGN (after the close)
Halozyme Therapeutics, Inc. HALO (after the close)
Inspire Medical Systems Inc INSP (after the close)
Penumbra Inc PEN (after the close)
Xencor Inc XNCR (after the close)
Jazz Pharmaceuticals PLC JAZZ (after the close)
MacroGenics Inc MGNX (after the close)
Medtronic PLCMDT (after the close)

Market News and Data brought to you by Benzinga APIs