These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
- Iveric Bio (ISEE), 156% surge in interest
- Aurinia (AUPH), 154% surge in interest
- Ionis Pharmaceuticals (IONS), 150% surge in interest
- Paratek Pharmaceuticals (PRTK), 125% surge in interest
- Citius Pharmaceuticals (CTXR), 123% surge in interest
Pipeline and key clinical candidates for these companies:
Iveric Bio is focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs. The company says it is "committed to having a positive impact on patients’ lives by delivering high-quality, safe and effective treatments designed to address debilitating retinal diseases including earlier stages of age-related macular degeneration."
Aurinia Pharmaceuticals is focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. In January 2021, the company introduced Lupkynis, which it notes is the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis.
Ionis has been a leader in RNA-targeted therapy, pioneering new markets and changing standards of care with its novel antisense technology. Ionis currently has three marketed medicines and a promising late-stage pipeline highlighted by cardiovascular and neurological franchises.
Paratek Pharmaceuticals is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases or other public health threats for civilian, government and military use. The company’s lead commercial product, Nuzyra, is a once-daily oral and intravenous antibiotic available in the United States for the treatment of adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. Paratek has a collaboration agreement with Zai Lab for the development and commercialization of omadacycline in the greater China region and retains all remaining global rights. Paratek is also conducting a Phase 2b study with Nuzyra in a rare disease, nontuberculous mycobacterial pulmonary disease, caused by Mycobacterium abscessus complex.
Citius is a late-stage biopharmaceutical company focused on developing and commercializing critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies. The company’s pipeline includes two late-stage product candidates, Mino-Lok, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections, which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and I/ONTAK, a novel IL-2R immunotherapy for an initial indication in CTCL, for which a BLA is under review by the FDA. Mino-Lok was granted Fast Track designation by the FDA.
Recent news on these stocks:
April 25
Ionis Pharmaceuticals announced that its partner Biogen (BIIB) has received FDA approval of Qalsody, or tofersen, 100 mg/15mL injection for the treatment of amyotrophic lateral sclerosis, or ALS, in adults who have a mutation in the superoxide dismutase gene. This indication is approved under accelerated approval based on a reduction in plasma neurofilament light chain observed in patients treated with Qalsody. Continued approval for this indication may be contingent upon verification of clinical benefit from ongoing trial(s). The ongoing Phase 3 ATLAS study of tofersen in people with presymptomatic SOD1-ALS will serve as the confirmatory study. Qalsody is the first and only approved treatment to target a genetic cause of ALS and the latest Ionis-discovered medicine to gain market approval.
April 24
MKT Capital, a significant shareholder of Aurinia Pharmaceuticals, which together with its affiliates beneficially owns approximately 4.2% of Aurinia’s outstanding shares, issued a letter to the company’s shareholders announcing its intention to withhold support for three directors at 2023 Annual Meeting. The letter partially reads, "We initially invested in Aurinia in 2019 because we believed the drug LUPKYNIS had the potential to become a great commercial success as an oral treatment option for advanced lupus nephritis. Unfortunately, since the drug’s commercialization three years ago, the Company has been unable to broaden its distribution or grow sales under Chairman Dr. George Milne and Chief Executive Officer Peter Greenleaf’s leadership. As a result, LUPKYNIS is being used for the treatment needs of 1,500 patients three years in, or roughly less than 1% of the total 135,000 patient addressable market in the U.S. alone. As a long-term shareholder of Aurinia, we have spent a considerable amount of time reviewing the Company’s corporate governance, executive compensation practices and capital allocation decisions and have attempted to engage meaningfully with management to better understand its overall strategy. Our diligence over the past several years has led us to the following conclusion: a reconstituted Board of Directors should commence a strategic review process immediately to explore a sale of the entire business, which we believe could attract a well-capitalized strategic acquirer or private equity buyer and yield up to $28 per share, or more than a 192% premium for shareholders. We are deeply troubled by the Board’s decisions, especially as it relates to executive compensation, which we believe illustrate that several incumbent directors are either unable or unwilling to advance shareholders’ best interests or embrace and act on shareholder feedback… we intend to WITHHOLD support for three current directors at the 2023 Annual General Meeting of Shareholders scheduled for May 17, 2023: Chairman Dr. George Milne, CEO Peter Greenleaf and Compensation Committee Chair Joseph Hagan. In our view, these incumbents have perpetuated a culture of failure and self-enrichment at the expense of shareholders and must be held accountable."
Citius Pharmaceuticals has advanced its clinical trial for Mino-Lok, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections. Of the 92 events required to complete the trial, the company estimates that 85 events have been achieved to date. The trial has enrolled 190 patients, of which 16 patients are in active treatment or pending study completion data review, which may result in additional events. The multi-center Mino-Lok Phase 3 trial continues to recruit patients at 35 clinical trial sites in the U.S. and India. The primary endpoint for this study is the time to a catheter failure event between randomization and TOC in the Intent-to-Treat Population. Additional secondary outcome measures include overall success, microbiological eradication, and clinical cure, among others.
April 23
Iveric bio announced new findings from exploratory analyses of data for avacincaptad pegol, or ACP, which were presented today at the 2023 annual meeting of the Association for Research in Vision and Ophthalmology, in New Orleans. A post-hoc analysis from the GATHER1 and GATHER2 pivotal Phase 3 clinical trials showed, for the first time in an interventional study in GA, a relationship between GA growth and worsening vision loss. In this combined analysis, greater vision loss was correlated with increased GA growth. See accompanying graph. As previously announced, the post-hoc analysis of GATHER1 and GATHER2 combined data signaled a 56% risk reduction in the rate of persistent vision loss in GA patients receiving ACP 2 mg compared to sham over the first 12 months of treatment. Persistent vision loss was defined as a loss of greater than or equal to15 letters in Best Corrected Visual Acuity from baseline measured at any two consecutive visits up to month 12. Multiple sensitivity analyses were conducted to evaluate this finding, including 10- and 20-letter loss at two consecutive visits up to month 12, and results were consistent.
Hear more from InvestingChannel by signing up for The Spill.
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.
Published first on TheFly
See the top stocks recommended by analysts >>
Read More on ISEE:
