The Daily Biotech Pulse: J&J Pauses Coronavirus Vaccine Studies, Voyager's Huntington's Disease Study Placed On Hold, Altimmune Vaccine Data

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 Oct. 12)

  • 10X Genomics Inc TXG
  • Acceleron Pharma Inc XLRN
  • Adaptive Biotechnologies Corp ADPT
  • Applied Molecular Transport Inc. AMTI
  • Arena Pharmaceuticals, Inc. ARNA
  • argenx SE – ADR ARGX
  • Beigene Ltd BGNE
  • Bio-Rad Laboratories, Inc. Class A Common Stock BIO
  • Blueprint Medicines Corp BPMC
  • Calliditas Therapeutics Adr Rep 2 Ord Shs CALT
  • Cardiff Oncology Inc CRDF
  • CareDx Inc CDNA
  • Castle Biosciences Inc CSTL
  • Denali Therapeutics Inc DNLI
  • Fate Therapeutics Inc FATE
  • Immunovant Inc IMVT
  • Insmed Incorporated INSM
  • Intellia Therapeutics Inc NTLA
  • Jazz Pharmaceuticals PLC JAZZ
  • Kronos Bio Inc KRON (went public Friday)
  • Kura Oncology Inc KURA
  • Kymera Therapeutics Inc KYMR
  • Lantern Pharma Inc. LTRN
  • Natera Inc NTRA
  • Nevro Corp NVRO
  • Novocure Ltd NVCR
  • Orphazyme A S ADR ORPH
  • Repligen Corporation RGEN
  • Rocket Pharmaceuticals Inc RCKT
  • Pacific Biosciences of California Inc PACB
  • SpringWorks Therapeutics Inc SWTX
  • Stoke Therapeutics Inc STOK
  • Surface Oncology Inc SURF -moved on reports of the company exploring a potential sale and Bristol-Myers Squibb Co BMY expressing interest 
  • Tcr2 Therapeutics Inc TCRR
  • TG Therapeutics Inc common stock TGTX
  • Turning Point Therapeutics Inc TPTX
  • Twist Bioscience Corp TWST
  • Veracyte Inc VCYT
  • Vericel Corp VCEL
  • Zai Lab Ltd – ADR ZLAB
  • West Pharmaceutical Services Inc. WST
  • Zoetis Inc ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Oct. 12)

  • Akouos Inc AKUS
  • Alector Inc ALEC
  • Avenue Therapeutics Inc ATXI (announced the receipt of a complete response letter for its opioid pain medication)
  • Aziyo Biologics Inc AZYO (went public Thursday)
  • Intercept Pharmaceuticals Inc ICPT
  • Psychemedics Corp. PMD

Stocks In Focus

Altimmune Reports Positive Preclinical Data For Intranasal COVID-19 Vaccine

Altimmune Inc ALT and the University of Alabama at Birmingham pre-published positive preclinical data for their single-dose, intranasal COVID-19 vaccine candidate, AdCOVID. The data shows strong activation of all three arms of the adaptive immune system following a single intranasal dose of AdCOVID.

The data, from two strains of mice, shows that AdCOVID stimulated strong immune responses including serum neutralizing immunity, T-cell immunity and mucosal immunity, Altimmune said.

The company said it anticipates filing an investigational new drug application with the FDA and commencing a Phase 1 safety and immunogenicity trial of AdCOVID in the fourth quarter of 2020.

Altimmune shares were trading 11.03% higher at $13.99 premarket Tuesday.

Voyager's Huntington's Disease Gene Therapy Study Placed On Clinical Hold

Voyager Therapeutics Inc VYGR said its investigational new drug application for VY-HTT01 has been placed on clinical hold pending the resolution of certain chemistry, manufacturing and controls matters.

VY-HTT01 is a gene silencing therapy that is being evaluated in Huntington's disease. The company submitted the IND in September.

The stock was down 11.06% to $10.69 in after-hours trading.

J&J Pauses Coronavirus Vaccine Studies Due To Unexplained Illness

Johnson & Johnson JNJ, which is among the frontrunners in the race to develop a vaccine against SARS-CoV-2, said late Monday it has temporarily paused further dosing in all COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant.

Following the company's guidelines, the participant's illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board as well as its internal clinical and safety physicians.

Separately, the pharma giant reported above-consensus third-quarter results and raised its full-year guidance.

The stock was down 1.28% to $149.90 premarket Tuesday.

Related Link: The Week Ahead In Biotech: J&J Earnings Kickstarts Pharma Earnings, More IPOs In The Pipeline

Roche To Launch High-Volume Antigen Test For Diagnosing Novel Coronavirus Infection

Roche Holdings AG Basel ADR Common Stock RHHBY sad it intends to launch a high-volume SARS-CoV-2 antigen test - Elecsys SARS-CoV-2 Antigen test - as an aid in the diagnosis of SARS-CoV-2 infection. The company expects to make available the test for markets accepting the CE Mark at the end of 2020.

Roche also said it intends to file for emergency use authorization from the FDA.

Sanofi, Regeneron's Dupixent Aces Late-Stage Pivotal Study In Childhood Ashtma

Sanofi SA SNY and Regeneron Pharmaceuticals Inc REGN said a pivotal Phase 3 trial of Dupixent met its primary and all key secondary endpoints in children ages 6-11 with uncontrolled moderate-to-severe asthma.


In a broad type 2 inflammatory asthma patient population, defined as having elevated eosinophils or elevated fractional exhaled nitric oxide, Dupixent plus the standard of care significantly reduced asthma attacks and improved lung function as early as two weeks after the first dose versus the standard of care alone, the companies said.

Safety results from the clinical trial were generally consistent with the known safety profile of Dupixent in patients ages 12 and older with moderate-to-severe asthma.

The companies said they plan to submit regulatory filings in the U.S. and Europe in the first half of 2021.

Breakthrough Therapy Designation For Inventiva's NASH Drug 

Inventiva ADR Representing Ord Shs IVA said the FDA has granted breakthrough therapy designation to lanifibranor, its lead drug candidate, for the treatment of non-alcoholic steatohepatitis.

Lanifibranor is believed to be the first drug candidate to be granted this status for the treatment of NASH since January 2015, Inventiva said.

The company also said the designation further supports its decision to initiate a Phase 3 pivotal trial in the first half of 2021.

The stock was up 7.4% at $14.66 premarket Tuesday.

Axovant's Gene Therapy Gets Rare Pediatric Disease Designation 

Axovant Gene Therapies Ltd AXGT said it has received rare pediatric disease designation from the FDA for AXO-AAV-GM2, a one-time gene therapy delivered directly to the central nervous system that is in development for GM2 gangliosidosis, also known as Tay-Sachs and Sandhoff disease.

The stock was up 3.8% to $3.82 in premarket trading Tuesday.

Sorrento In-Licenses Stem Cell Therapy Candidate For COVID-19 Treatment

Sorrento Therapeutics Inc SRNE said it has entered into an exclusive license agreement with Personalized Stem Cells, Inc. to acquire global rights to its adipose-derived mesenchymal stem cells for patients suffering from acute respiratory distress syndrome-associated with COVID-19.

Personalized Stem Cell's therapy has been cleared for a Phase 1 clinical trial by the FDA.

Sorrento said it will assume responsibility for executing the Phase 1 trial, which targets enrolling about 20 hospitalized COVID-19 patients in California. Pending the results of the Phase 1 trial, Sorrento said it expects to expand into Phase 2 trials in multiple relevant geographies.

Sorrento shares were up 2.28% to $11.67 premarket.

On The Radar


Johnson & Johnson (Q3 sales at $21.1 billion, up 1.7% year-over-year, and adjusted EPS rose 3.8% to $2.20, vs. consensus estimate of $1.98 per share on revenues of $20.2 billion; raised FY20 guidance above consensus)

Enzo Biochem, Inc. ENZ (Tuesday, after the close)

Related Link: Attention Biotech Investors: Mark Your Calendar For October PDUFA Dates

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