The Daily Biotech Pulse: Coronavirus Vaccine Updates From J&J & MediciNova, Australian Regulatory Nod For GW Pharma

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 Sept. 22)

• Arena Pharmaceuticals, Inc. ARNA (H.C. Wainwright maintained a Buy rating on shares)
• Blueprint Medicines Corp BPMC (announced positive top-line results from a early- and mid-stage study of avapritinib in patients with advanced systemic mastocytosis)
• Cassava Sciences Inc SAVA(moved up on insider buying)
• Castle Biosciences Inc CSTL
• Evogene Ltd EVGN
• Guardant Health Inc GH
• InVitae Corp NVTA
• Pacific Biosciences of California Inc PACB
• SpringWorks Therapeutics Inc SWTX
• TFF Pharmaceuticals Inc TFFP
• Vaxcyte Inc PCVX

Down In The Dumps

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

• Amarin Corporation plc AMRN
• Corbus Pharmaceuticals Holdings Inc CRBP
• DBV Technologies ADR Representing 0.5 Ord Shs DBVT
• Genetron Holdings Ltd – ADR GTH
• Genfit SA GNFT
• Harmony Biosciences Holdings Inc HRMY
• Intercept Pharmaceuticals Inc ICPT
• Metacrine Inc MTCR(IPOed Wednesday)
• PainReform Ltd PRFX
• Pandion Therapeutics Inc PAND
• Renalytix AI PLC RNLX
• Satsuma Pharmaceuticals Inc STSA
• SILENCE THERAPE/S ADR SLN
• Vaccinex Inc VCNX (announced a negative clinical readout)

Stocks In Focus

Eisai Announces Positive EMA Committee Recommendation For Label Expansion For Seizure Drug

Eisai Co., Ltd ESALY said it has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use on the license extension application submitted regarding the use of its Fycompa in the treatment of pediatric patients.

The CHMP's positive opinion is to extend the use of Fycompa as an adjunctive therapy for partial-onset seizures, with or without secondary generalization, by expanding the approved age range from 12 years and above to 4 years and above, and for primary generalized tonic-clonic seizures from 12 years and above to 7 years and above.

Separately, Eisai announced new investigational data from two trials under the LEAP clinical program evaluating its Lenvima, plus Merck & Co., Inc's. MRK Keytruda, showing an objective response rate of 21.4% in patients with unresectable or advanced melanoma who had previously progressed on an anti-PD-1/PD-L1 therapy. The results are being presented in a proffered paper at the ESMO Congress 2020.

Athersys' COVID-19 Treatment Gets RMAT Designation

Athersys Inc ATHX said its MultiStem cell therapy was granted regenerative medicine advanced therapy, or RMAT, designation from the FDA for the ARDS program. The RMAT designation facilitates scheduling a Type B meeting with the FDA to discuss multidisciplinary strategic development plans, including expediting manufacturing development for commercialization to support priority review and/or accelerated approval.

In pre-market trading Wednesday, the shares were up 11.68% to $2.20.

Genmab Begins Arbitration Regarding Daratumumab Licensing Agreement with J&J's Janssen Unit

Genmab 10 Sponsored ADR Ord Shs GMAB said it has commenced binding arbitration of two matters arising under its license agreement with Johnson & Johnson's JNJ Janssen unit relating to daratumumab.

The arbitration is to decide whether Genmab is required to share in Janssen's royalty payments to Halozyme Therapeutics, Inc. HALO for the latter's enzyme technology used in the subcutaneous formulation of daratumumab, and also to settle whether Janssen's obligation to pay royalties on sales of licensed product extends, in each applicable country, until the expiration or invalidation of the last-to-expire relevant Genmab-owned patent or the last-to-expire relevant Janssen-owned patent.

Genmab shares were shedding 13.46% to $33.06.

J&J Commences Late-stage Study of Coronavirus Vaccine

J&J announced the launch of its large-scale, pivotal, multi-country Phase 3 trial for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen unit. The initiation of the trial follows positive interim results from the Phase 1/2a clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development.

Based on these results and following discussions with the FDA, the company plans to enroll up to 60,000 volunteers across three continents to study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.

J&J shares were rising 2.73% to $148.14.

MediciNova's Intranasal COVID-19 Vaccine Candidate Produces Positive Results In Animal Studies

MediciNova, Inc. MNOV said its intranasal SARS-CoV-2 vaccine prototype for COVID-19, using BC-PIV technology, successfully induced systemic serum IgG and mucosal IgA neutralizing antibodies against the S1 antigen (Ag) of SARS-CoV-2 in mice.

MediciNova shares were surging up 21.66% to $6.44.

GW Pharma Epidiolex Gets Regulatory Nod In Australia

GW Pharmaceuticals PLC- ADR GWPH said the Australian Therapeutic Goods Administration has approved Epidyolex for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age and older.

This represents the CBD drug's third global regulatory approval, following FDA approval in 2018 and European Commission approval in 2019.

Centogene Expands COVID Testing Facility to Dusseldorf Airport

Centogene NV CNTG announced today the opening of its new COVID-19 testing facility at Düsseldorf Airport.

"With our new COVID-19 testing facility at Düsseldorf Airport, we build on our experience from Frankfurt and Hamburg Airport, where we have successfully carried out hundreds of thousands of tests since June," Centogene said.

AC Immune's Out-licensed Alzheimer's Drug Flunks Mid-stage Trial

AC Immune SA ACIU said Roche Holding AG's (RHHBY) Genentech unit informed top line results from a Phase 2 trial of the anti-Tau antibody, semorinemab, in early Alzheimer's disease, showing the investigational asset did not meet its primary efficacy endpoint as well as two secondary endpoints.

Offerings

Zogenix, Inc. ZGNX announced its intention to offer, subject to market and other conditions, $200 million in aggregate principal amount of convertible senior notes due 2027 in a private offering to qualified institutional buyers.

The stock slid 5.89% to $21.25 in after-hours trading.

Wave Life Sciences Ltd WVE said it has priced its underwritten public offering of 8.33 million of its ordinary shares at $12 per share. All of the shares in the offering are to be sold by Wave Life Sciences.

The stock plunged 23.55% to $12.21 in after-hours trading.

NanoVibronix Inc NAOV announced an upsized bought out deal, offering 1.795 million shares of its common stock at $1 per share. The offering is expected to close Sept. 25.

On The Radar

Clinical Readouts

GlycoMimetics Inc GLYC will present at the 2020 American Academy of Neurology, or AAN, Science Highlights, a poster on data from a post hoc analysis of the Phase 3 RESET trial that evaluated rivipansel as a treatment option for acute vaso-occlusion in sick cell disease patients requiring hospitalization for treatment.

Axsome Therapeutics Inc AXSM will present at the AAN meeting already-released Phase 3 data for AXS-07 in migraine.

Earnings

Centogene (before the market open)