The Daily Biotech Pulse: Sanofi Expedites COVID-19 Vaccine Timeline, Apyx Cleared For Market Expansion, Miragen's Positive Readout

The following is a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs June 22)

• ADC Therapeutics SA ADCT
• Adverum Biotechnologies Inc ADVM
• Aeglea Bio Therapeutics Inc AGLE
• Affimed NV AFMD - announced presentation at the AACR Virtual Meeting II, data on the Bristol-Myers Squibb Co BMY unit Genentech's RO7297089 and AFM24 developed from Affimed's ROCK platform
• Alnylam Pharmaceuticals, Inc. ALNY
• Amicus Therapeutics, Inc. FOLD
• Ascendis Pharma A/S ASND (presented at the AACR Virtual Meeting II with pre-clinical data for oncology product candidate)
• Atossa Therapeutics Inc ATOS
• Burning Rock Biotech Ltd BNR (announced full exercise of over-allotment option in IPO)
• Cytokinetics, Inc. CYTK
• Dyadic International, Inc. DYAI
• Evoke Pharma Inc EVOK (announced FDA approval for inhaled formulation of its gastroparesis drug)
• Five Prime Therapeutics Inc FPRX (moved higher on an analyst upgrade)
• GENMAB A/S/S ADR GMAB
• GenMark Diagnostics, Inc GNMK
• Halozyme Therapeutics, Inc. HALO - announced eligibility to receive $10-million milestone payment from Johnson & Johnson's JNJ Janssen unit for the first EU commercial sales of the subcutaneous formulation of Darzalex, which uses Halozyme's ENHANZE technology
• Hologic, Inc. HOLX
• Horizon Therapeutics PLC HZNP
• Immunomedics, Inc. IMMU
• Immunovant Inc IMVT
• Incyte Corporation INCY
• Inspire Medical Systems Inc INSP
• Kiniksa Pharmaceuticals Ltd KNSA
• Legend Biotech Corp LEGN (went public June 5)
• MannKind Corporation MNKD
• Meridian Bioscience, Inc. VIVO
• Momenta Pharmaceuticals, Inc. MNTA
• Nantkwest Inc NK
• Neoleukin Therapeutics Inc NLTX (presented at the AACR Virtual Meeting II, preclinical data on its lead immunotherapy candidate NL-201 and applications of its de novo protein design platform)
• Neurocrine Biosciences, Inc. NBIX
• Novavax, Inc. NVAX
• Novo Nordisk A/S NVO
• Passage Bio Inc PASG
• Pliant Therapeutics Inc PLRX
• ResMed Inc. RMD
• Sarepta Therapeutics Inc SRPT (announced a collaboration with Codiak BioSciences to develop engineered exosome therapeutics to deliver gene therapy, gene editing and RNA technologies for neuromuscular diseases)
• Satsuma Pharmaceuticals Inc (NASDAQ: STSA
• Seattle Genetics, Inc. SGEN
• Spero Therapeutics Inc SPRO
• Trevena Inc TRVN
• Trillium Therapeutics Inc TRIL
• Vaxcyte Inc PCVX
• Y-mAbs Therapeutics, Inc YMAB
• Zai Lab Ltd ZLAB

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 22)

• Evofem Biosciences Inc EVFM
• Genetron Holdings Ltd – ADR GTH (went public Friday)
• Lyra Therapeutics Inc LYRA

Stocks In Focus

Apxy Medical Cleared To Sell Helium Plasma Technology To 5 More Countries

Apyx Medical Corp APYX said it has obtained regulatory approval to market and sell its Helium Plasma Technology products in five new countries:  Australia, Brazil, Israel, Taiwan and Thailand. The company said it has contracted with distributors to market and sell its products in each country.

Helium Plasma Technology is sold as Renuvion in the cosmetic surgery market and J-Plasma in the hospital surgical market.

The company said it shipped an initial consignment to Brazil in late June and expects to ship initial commercial orders to each of the other new countries over the second half of 2020.

The stock was up 27.2% at $6.08 premarket Tuesday.

Applied Genetic Shares Gain On Positive Analyst Action

Applied Genetic Technologies Corp AGTC shares moved in reaction to the initiation of its shares with an Outperform rating by Cantor Fitzgerald analyst Kristen Kluska.

The stock was up 5.35% at $6.70 premarket.

Miragen Reports Positive Preclinical Data For Idiopathic Pulmonary Fibrosis Drug

Miragen Therapeutics Inc MGEN announced preclinical safety and efficacy data for MRG-229, which is being evaluated for idiopathic pulmonary fibrosis. It demonstrated mechanistic biomarker regulation and antifibrotic activity in vitro using human model systems.

Subcutaneous administration induced the reversal of pathologic fibrotic gene expression and resulted in a significant reduction of fibrosis, the company said. It also noted that high doses of the product candidate showed no clinically significant toxicity.

Miragen shares were up 9.86% at $1.56 premarket. 

See also: The Week Ahead In Biotech: Karyopharm, Zogenix, Heron, Chiasma On The Radar Ahead Of FDA Decisions

Rewalk Announces Publication Of Positive Results From ReStore Exo-Suit Study  

Rewalk Robotics Ltd RWLK announced publication in the Journal of NeuroEngineering and Rehabilitation the results from a multicenter clinical study of the ReStore Exo-Suit for rehabilitation of individuals with lower limb disability due to stroke, which established device safety, the primary outcome for the study.

Investigation of several exploratory outcome measures, including a pre- and post-assessment of walking speeds, showed that 64% of participants increased their unassisted walking speed by a clinically meaningful margin.

In premarket trading, the stock rallied 15.13% to $1.75.

Teligent Regains Compliance With Nasdaq Listing Standards

Teligent Inc (NEW JERSEY) TLGT said it received a notice from the Nasdaq June 18 indicating that it has regained compliance with the NASDAQ Listing Rule pertaining to maintenance of a minimum bid price of $1 per share. The decision by the exchange follows the closing bid price of the company's shares being at $1 per share or greater for the prior 10 consecutive business days.

The stock rose 5.92% to $3.04 in after-hours trading.

Hepion Reports Positive Animal Testing Data For NASH Drug

Hepion Pharmaceuticals Inc HEPA announced results from a study of its lead drug candidate CRV431, demonstrating antifibrotic activity in an experimental model of renal fibrosis.

The study conducted by SMC Laboratories in Japan evaluated CRV431 in the Unilateral Ureteral Obstruction mouse model.

"To date, every one of our preclinical studies has consistently demonstrated CRV431's antifibrotic activity," the company said.

Hepion said it is advancing what it believes to be a direct-acting antifibrotic molecule in the clinic for the treatment of NASH.

The stock was up 32.4% premarket at $3.31 . 

LeMaitre Buys Artegraf For Up To $90M

LeMaitre Vascular Inc LMAT said it has acquired the business and assets of Artegraft, Inc. for $90 million, including $72.5 million in cash paid at closing, as well as potential earnout payments of $17.5 million payable based upon future sales of the acquired business.

Artegraft processes and sells biologic vascular grafts that are derived from bovine carotid arteries and are implanted primarily in hemodialysis access patients.

Myovant's NDA For Relugolix In Prostate Cancer Accepted For Review

Sumitovant Biopharma said the FDA has accepted for review Myovant Sciences Ltd's MYOV NDA for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer.

The stock was up 9.99% premarket at $19.15. 

Sanofi Expedites COVID-19 Vaccine Timeline, Inks Expanded Collaboration With Translate Bio To Develop mRNA Vaccines

Sanofi SA SNY and Translate Bio Inc TBIO announced an expansion to their existing 2018 collaboration and license agreement to develop mRNA vaccines for infectious diseases, including COVID-19.

The agreement provides for Translate Bio receiving a total upfront payment of $425 million and potential future milestones and other payments up to $1.9 billion as well as tiered royalty payments based upon worldwide sales of the developed vaccines, while Sanofi will receive exclusive worldwide rights for infectious disease vaccines.

The companies said they are in the process of shortlisting COVID-19 vaccine candidates, with a goal to initiate a first-in-human clinical trial in the fourth quarter of 2020.

Meanwhile, Sanofi said at its Virtual R&D event it expects to get regulatory nod for its COVID-19 vaccine it is co-developing with GlaxoSmithKline plc GSK by the first half of 2021, earlier than the initial timeline of second-half of 2021.

In premarket trading Tuesday, Translate Bio shares were up 61.95% at $26.30.

Karuna To Initiate Phase 3 Trial Of Schizophrenia Drug By End Of Year 

Karuna Therapeutics Inc KRTX said an end-of-Phase-2 meeting with the FDA supported the progression of KarXT, its investigational asset for the treatment of acute psychosis in patients with schizophrenia, into Phase 3 development.

The company said it remains on track to initiate the Phase 3 program by the end of 2020.

Seelos Announces Positive Safety Results From Phase 1 Study of Major Depressive Disorder Drug

Seelos Therapeutics Inc SEEL announced final safety data from its Phase I pharmacokinetics/pharmacodynamics study of Intranasal Racemic Ketamine (SLS-002), which showed it was well-tolerated across all doses, with resolution of expected group mean dissociative side-effects that occurred in the higher dose groups within an hour.

The company also announced planned design of a double blind, placebo-controlled proof-of-concept study for acute suicidal ideation and behavior in patients with major depressive disorder, which is to begin in the fall of 2020.

Offerings

Castle Biosciences Inc CSTL said it has commenced a proposed underwritten public offering of 1.5 million shares of its common stock.

The stock slipped 4.49% to $40 in after-hours trading.

On The Radar

Earnings

• Affimed (before the market open)

Related Link: Evoke Gets FDA Nod For Gimoti, A Nasally-Administered Gastroparesis Drug