Biotech Alert: Searches spiking for these stocks today

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

• IGM Biosciences (IGMS), 454% surge in interest
• Cassava Sciences (SAVA), 299% surge in interest
• BioNTech (BNTX), 53% surge in interest
• BioXcel Therapeutics (BTAI), 51% surge in interest
• Protagonist Therapeutics (PTGX), 46% surge in interest

Pipeline and key clinical candidates for these companies:

IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with cancer, autoimmune and inflammatory diseases and infectious diseases. IGM’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. IGM also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against oncology and immunology and inflammation targets.

Cassava Sciences is a clinical-stage biotechnology company that says its mission is to detect and treat neurodegenerative diseases, such as Alzheimer’s disease. “Its novel science is based on stabilizing—but not removing—a critical protein in the brain. The company’s product candidates have not been approved by any regulatory authority, and their safety, efficacy or other desirable attributes have not been established,” Cassava has stated.

BioNTech is “pioneering novel therapies for cancer and other serious diseases.” BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab (GMAB), Sanofi (SNY), Genentech, a member of the Roche Group (RHHBY), Regeneron (REGN), Genevant, Fosun Pharma, and Pfizer (PFE).

BioXcel Therapeutics is utilizing artificial intelligence approaches to develop medicines in neuroscience and immuno-oncology. The company’s drug re-innovation approach “leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indices,” BioXcel states. The company’s commercial product, IGALMI, developed as BXCL501, is a proprietary, sublingual film formulation of dexmedetomidine approved for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

Protagonist Therapeutics is a biopharmaceutical company with peptide-based new chemical entities rusfertide and JNJ-2113 in advanced stages of clinical development, both derived from the company’s proprietary technology platform. Rusfertide, a mimetic of the natural hormone hepcidin, is the company’s lead drug candidate currently in a global Phase 3 stage of development. The REVIVE study is now complete, with an open-label extension underway. The global Phase 3 VERIFY study of rusfertide in polycythemia vera is ongoing. Protagonist retains all worldwide development and commercialization rights to rusfertide.

Recent news on these stocks:

July 5

Cassava Sciences announced top-line clinical results from its Cognition Maintenance Study. The CMS is a small proof-of-concept study designed to demonstrate the effects of drug versus placebo in a randomized withdrawal trial design. The study enrolled 157 patients with mild-to-moderate Alzheimer’s disease, a more advanced and difficult-to-treat stage of disease. In this double-blind, placebo-controlled, randomized study, all patients first received open-label simufilam 100 mg for 12 months; patients were then randomized to receive either simufilam 100 mg or placebo for 6 months. 16 U.S. clinical sites participated. The CMS had one pre-specified cognitive endpoint: mean change in ADAS-Cog11 scores over 6 months, drug versus placebo. Simufilam treatment for 6 months slowed cognitive decline by 38% compared to placebo in mild-to-moderate Alzheimer’s disease. The placebo arm declined 1.5 points on ADAS-Cog, and this arm declined at all measured timepoints. The simufilam arm declined 0.9 points on ADAS-Cog, a 38% difference in favor of drug at month 6. Upon randomization into the CMS, mean baseline MMSE scores were 18.6 and 18.1 for the simufilam and placebo arms, respectively. Mean baseline ADAS-Cog scores were 19.3 and 21.9 for the simufilam and placebo arms, respectively. Simufilam treatment for 6 months slowed cognitive decline greater than 200% compared to placebo in mild Alzheimer’s disease. CMS patients with mild Alzheimer’s on placebo declined 0.6 points on ADAS-Cog over 6 months as a group. CMS patients with mild Alzheimer’s on simufilam improved 0.6 points over 6 months as a group, a 205% difference in favor of drug. Upon randomization into the CMS, mean baseline MMSE scores for mild patients were MMSE 24.0 and MMSE 24.1 for the simufilam and placebo arms, respectively. Mean baseline ADAS-Cog scores for mild patients were 11.0 and 11.2 for the simufilam and placebo arms, respectively. After taking open-label simufilam for 12 months, 76 patients with mild Alzheimer’s disease enrolled in the CMS and were randomized to receive either simufilam or placebo for 6 months. Mild patients randomized to simufilam in the CMS showed no material decline in ADAS-Cog scores over 18 months as a group, indicating stable cognition. Mild patients randomized to placebo in the CMS declined by 0.8 points in ADAS-Cog as a group. Simufilam 100 mg twice daily was safe and well tolerated in this study. There were no drug-related serious adverse events. No treatment-emergent adverse events occurred in 5% or more of study participants in the CMS. The CMS was a randomized withdrawal study. Patients who completed 12 months of open-label simufilam treatment were all invited to participate in the CMS. It is not known how long a washout period may be needed to remove lingering drug effects, if any, from prior treatment with open-label simufilam for 12 months. In this small study of oral simufilam in patients with mild-to-moderate Alzheimer’s disease, the pre-specified cognitive endpoint showed a 38% decline in ADAS-Cog over six months in favor of simufilam, with good drug safety. Effects were pronounced in mild patients. Mean baseline MMSE and ADAS-Cog scores were approximately balanced given the small size of each arm.

July 4

Protagonist Therapeutics announced topline results from the Phase 2b FRONTIER 1 clinical trial evaluating the oral interleukin-23 receptor antagonist JNJ-2113 in adult patients with moderate-to-severe plaque psoriasis. The trial achieved all primary and secondary efficacy endpoints. JNJ-2113 is being developed by Johnson & Johnson’s (JNJ) Janssen Biotech under Protagonist’s license and collaboration agreement with Janssen. A greater proportion of patients who received JNJ-2113 achieved PASI 75 as well as PASI 90 and PASI 100 compared to placebo, at week 16, the company said in a statement. Trial results for JNJ-2113 demonstrated a profile that supports its advancement into Phase 3 clinical development for moderate-to-severe plaque psoriasis in adult patients, it added.

July 3

H.C. Wainwright lowered the firm’s price target on BioXcel Therapeutics to $60 from $66 and kept a Buy rating on the shares. The Phase 3 TRANQUILITY II trial met its primary efficacy endpoint but reporting issues raise questions regarding data integrity, the analyst tells investors in a research note. The analyst does not consider this a data integrity problem and notes the serious adverse event did not involve the study drug, the investigator in question was not involved in rating patients’ responses, and the data from the site in question would not have altered the outcome of the TRANQUILITY II study. However, the issue may impact the timeline to approval, says H.C. The firm now expects potential label extension for BXCL501 into the Alzheimer’s disease-associated agitation indication in 2025, while its probability of approval has been downwardly revised to 70% from 80%.

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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 20-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.