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Biotech Alert: Searches spiking for these stocks today

Stay ahead of biotech stocks seeing a surge in interest from retail and financial professional investors with this exclusive recap from The Fly

These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:

  • Nabriva Therapeutics (NBRV), 5,664% surge in interest
  • Axsome Therapeutics (AXSM), 1,540% surge in interest
  • Arcus Biosciences (RCUS), 731% surge in interest
  • Sarepta Therapeutics (SRPT), 195% surge in interest

Pipeline and key clinical candidates for these companies:

Nabriva Therapeutics is engaged in the commercialization and development of anti-infective agents to treat serious infections. Nabriva received FDA approval for Xenleta, which it identifies as "the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia," or CABP. Nabriva is also developing Contepo for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections, or cUTI, including acute pyelonephritis. Nabriva entered into an exclusive agreement with subsidiaries of Merck (MRK) to market, sell and distribute Sivextro in the United States and certain of its territories.

Axsome Therapeutics is developing and delivering novel therapies for central nervous system, or CNS, conditions that have limited treatment options. AXS-05 is a novel, oral, patent protected, investigational N-methyl-D-aspartate receptor antagonist with multimodal activity under development for the treatment of Alzheimer’s disease agitation and other central nervous system disorders.

Arcus Biosciences is developing differentiated molecules and combination medicines for people with cancer. The company has expedited the development of six investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, the adenosine axis and most recently, HIF-2alfa.

Sarepta engineers precision genetic medicine for rare diseases. The company holds leadership positions in Duchenne muscular dystrophy, or DMD, and limb-girdle muscular dystrophies, or LGMDs, and currently has more than 40 programs in various stages of development. Sarepta’s pipeline is driven by its multi-platform Precision Genetic Medicine Engine in gene therapy, RNA and gene editing.

Recent news on these stocks:

November 28

Nabriva Therapeutics announced topline results from their Phase 1 clinical trial that assessed the safety and pharmacokinetics of oral and intravenous XENLETA in adult patients with cystic fibrosis. "We are excited to share positive topline results from this important study of XENLETA in patients with CF," said Christine Guico-Pabia, M.D., MBA, MPH, Nabriva’s Chief Medical Officer. "The data indicate that the PK of XENLETA in CF patients is consistent with that observed in previous single-dose healthy volunteer studies evaluating the approved oral and IV dosing for adults with community-acquired bacterial pneumonia . In addition, XENLETA was well-tolerated and the adverse event profile in CF patients was consistent with that described across our clinical program. XENLETA has been demonstrated to be a potent anti-staphylococcal antibiotic in in vitro and clinical studies, including against methicillin-resistant S. aureus. There are limited treatment options for the management of bacterial exacerbations in CF patients caused by S. aureus and the results of this study support the potential utility of XENLETA in this difficult to treat patient population. We would like to thank the study participants, investigators, and the Cystic Fibrosis Foundation for their support of this important study and look forward to sharing the complete results with the medical community in the first half of 2023."

Axsome Therapeutics announced that AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the primary and key secondary endpoints in the ACCORD Phase 3 trial, by substantially and statistically significantly delaying the time to relapse and preventing relapse of agitation in patients with Alzheimer’s disease, as compared to placebo. The ACCORD study was a double-blind, placebo-controlled, multi-center, randomized withdrawal, U.S. trial which treated 178 patients with Alzheimer’s disease agitation. Patients achieving a sustained clinical response after open-label treatment with AXS-05 were randomized in a 1:1 ratio to continue treatment with AXS-05 or to discontinue AXS-05 and switch to placebo. AXS-05 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration for the treatment of Alzheimer’s disease agitation. There are currently no FDA-approved treatments for Alzheimer’s disease agitation.

Gilead (GILD) and Arcus Biosciences announced an update from the fourth interim analysis of the randomized, open-label Phase 2 ARC-7 study in patients with first-line metastatic non-small cell lung cancer, or NSCLC, with PD-L1 tumor proportion score of 50% without epidermal growth factor receptor or anaplastic lymphoma kinase mutations. ARC-7 is evaluating the combinations of anti-TIGIT antibody domvanalimab plus anti-PD-1 antibody zimberelimab and domvanalimab plus zimberelimab and etrumadenant, an A2a/b adenosine receptor antagonist, versus zimberelimab alone, and represents the first randomized Phase 2 study of an Fc-silent anti-TIGIT/anti-PD-1 combination. The protocol-specified fourth interim analysis was conducted when the trial reached full enrollment, with a clinical data cutoff date of August 31. A total of 150 patients have been randomized across the three study arms. For the current interim analysis, efficacy was evaluated in study patients who had at least 13 weeks of potential follow-up and were eligible for at least two imaging scans. Both domvanalimab combinations continued to show clinically meaningful differentiation compared to zimberelimab monotherapy across multiple efficacy measures, including objective response rates, progression-free survival and six-month landmark PFS. Detailed results from this fourth interim analysis and an exploratory analysis on 12 patients who crossed over from zimberelimab monotherapy arm to triplet therapy will be presented on December 20, 2022, at the Monthly Plenary Series, a new virtual forum for presentation and discussion of the latest cancer research.

Sarepta Therapeutics announced that the FDA has accepted the Company’s Biologics License Application seeking accelerated approval of SRP-900 for the treatment of ambulant individuals with Duchenne muscular dystrophy. SRP-9001 has been granted Priority Review by the FDA, with a regulatory action date of May 29, 2023. SRP-9001 is an investigational gene therapy for Duchenne being developed in partnership with Roche. Duchenne is characterized by a mutation in the dystrophin gene that results in the lack of dystrophin, which acts as a shock absorber for muscle at the membrane. SRP-9001 is designed to treat the proximate cause of Duchenne by delivering to muscle a gene that codes for a shortened, functional form of dystrophin.

About “Biotech Alert”

The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel.

This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 15-plus million retail and financial professional investors through InvestingChannel’s online financial news media ecosystem.

This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals.

Keywords: biotech, biotech sector, biotech alert, investingchannel, XBI, SPDR S&P Biotech ETF

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