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 (NASDAQ:TXG)
- Acceleron Pharma Inc (NASDAQ:XLRN)
- Adaptive Biotechnologies Corp (NASDAQ:ADPT)
- Applied Molecular Transport Inc. (NASDAQ:AMTI)
- Arena Pharmaceuticals, Inc. (NASDAQ:ARNA)
- argenx SE – ADR (NASDAQ:ARGX)
- Beigene Ltd (NASDAQ:BGNE)
- Bio-Rad Laboratories, Inc. Class A Common Stock (NYSE:BIO)
- Blueprint Medicines Corp (NASDAQ:BPMC)
- Calliditas Therapeutics Adr Rep 2 Ord Shs (NASDAQ:CALT)
- Cardiff Oncology Inc (NASDAQ:CRDF)
- CareDx Inc (NASDAQ:CDNA)
- Castle Biosciences Inc (NASDAQ:CSTL)
- Denali Therapeutics Inc (NASDAQ:DNLI)
- Fate Therapeutics Inc (NASDAQ:FATE)
- Immunovant Inc (NASDAQ:IMVT)
- Insmed Incorporated (NASDAQ:INSM)
- Intellia Therapeutics Inc (NASDAQ:NTLA)
- Jazz Pharmaceuticals PLC (NASDAQ:JAZZ)
- Kronos Bio Inc (NASDAQ:KRON) (went public Friday)
- Kura Oncology Inc (NASDAQ:KURA)
- Kymera Therapeutics Inc (NASDAQ:KYMR)
- Lantern Pharma Inc. (NASDAQ:LTRN)
- Natera Inc (NASDAQ:NTRA)
- Nevro Corp (NYSE:NVRO)
- Novocure Ltd (NASDAQ:NVCR)
- Orphazyme A S ADR (NASDAQ:ORPH)
- Repligen Corporation (NASDAQ:RGEN)
- Rocket Pharmaceuticals Inc (NASDAQ:RCKT)
- Pacific Biosciences of California Inc (NASDAQ:PACB)
- SpringWorks Therapeutics Inc (NASDAQ:SWTX)
- Stoke Therapeutics Inc (NASDAQ:STOK)
- Surface Oncology Inc (NASDAQ:SURF) -moved on reports of the company exploring a potential sale and Bristol-Myers Squibb Co (NYSE:BMY) expressing interest
- Tcr2 Therapeutics Inc (NASDAQ:TCRR)
- TG Therapeutics Inc common stock (NASDAQ:TGTX)
- Turning Point Therapeutics Inc (NASDAQ:TPTX)
- Twist Bioscience Corp (NASDAQ:TWST)
- Veracyte Inc (NASDAQ:VCYT)
- Vericel Corp (NASDAQ:VCEL)
- Zai Lab Ltd – ADR (NASDAQ:ZLAB)
- West Pharmaceutical Services Inc. (NYSE:WST)
- Zoetis Inc (NYSE:ZTS)
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Oct. 12)
- Akouos Inc (NASDAQ:AKUS)
- Alector Inc (NASDAQ:ALEC)
- Avenue Therapeutics Inc (NASDAQ:ATXI) (announced the receipt of a complete response letter for its opioid pain medication)
- Aziyo Biologics Inc (NASDAQ:AZYO) (went public Thursday)
- Intercept Pharmaceuticals Inc (NASDAQ:ICPT)
- Psychemedics Corp. (NASDAQ:PMD)
Stocks In Focus
Altimmune Reports Positive Preclinical Data For Intranasal COVID-19 Vaccine
Altimmune Inc (NASDAQ: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 (NASDAQ: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 (NYSE: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.
Roche To Launch High-Volume Antigen Test For Diagnosing Novel Coronavirus Infection
Roche Holdings AG Basel ADR Common Stock (OTC: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 (NASDAQ:SNY) and Regeneron Pharmaceuticals Inc (NASDAQ: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 (NASDAQ: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 (NASDAQ: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 (NASDAQ: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. (NYSE:ENZ) (Tuesday, after the close)