These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
Pipeline and key clinical candidates for these companies:
Daré Bioscience is advancing products for women’s health, stating that the company’s mission is "to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, fertility, and vaginal and sexual health." Daré’s first FDA-approved product, XACIATO vaginal gel, is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil to treat female sexual arousal disorder utilizing the active ingredient in Viagra; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for hormone therapy following menopause.
Aridis Pharmaceuticals discovers and develops anti-infectives to be used as add-on treatments to standard-of-care antibiotics. The company is advancing multiple clinical stage mAbs targeting bacteria that cause life-threatening infections such as ventilator associated pneumonia and hospital acquired pneumonia, in addition to preclinical stage antiviral mAbs.
Fennec Pharmaceuticals is focused on the development and commercialization of Pedmark to reduce the risk of platinum-induced ototoxicity in pediatric patients. Pedmark received FDA approval in September and has received Orphan Drug Designation in the U.S. Fennec has a license agreement with Oregon Health and Science University for exclusive worldwide license rights to intellectual property directed to sodium thiosulfate and its use for chemoprotection, including the reduction of risk of ototoxicity induced by platinum chemotherapy, in humans.
Altamira Therapeutics is currently active in three areas: the development of RNA therapeutics for extrahepatic therapeutic targets via the OligoPhore/SemaPhore platforms; nasal sprays for protection against airborne allergens and, where approved, viruses or for the treatment of vertigo; and the development of therapeutics for intratympanic treatment of tinnitus or hearing loss.
Precigen says it is "advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases." Precigen says it "operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization."
Recent news on these stocks:
Altamira Therapeutics provided a business update on its strategic repositioning and important business developments. The company remains committed to its primary corporate strategy to focus exclusively on RNA delivery. As previously stated, its discussions with major OTC consumer health companies to partner Bentrio marketing and distribution for North America, Europe and other key markets have moved into a decisive phase. The interim results from the NASAR study in seasonal allergic rhinitis, announced earlier this week, have further bolstered the set of positive safety and efficacy data for Bentrio in allergic rhinitis. And while the COVAMID study may not have reached its primary endpoint and results were not conclusive under the specific test conditions, it is worth noting that treatment with Bentrio showed a trend for faster and more pronounced reduction in nasal viral load and symptoms than untreated controls. Further, the setting of the COVAMID trial is much different from a situation where Bentrio is applied prophylactically, i.e. preventing contact of inhaled airborne viruses with the nasal mucosa. The company has generated positive data from multiple tests with Bentrio on cultured human nasal epithelia cells exposed to various types of viruses, including SARS-CoV2, influenza and human rhinovirus. Preventive application clearly yielded the best outcomes, and Bentrio is best used right before or while being exposed to potentially harmful airborne particles - whether they are allergens such as pollen or house dust mites or viruses. Similarly, the company is striving to sell or partner its other legacy assets - inner ear therapeutics. Unfortunately, the agreed upon sale of these assets to a European family office did not close as the Buyer was not able to secure financing. As the Buyer remains interested in the transaction, discussions continue. Concurrently, Altamira is pursuing a divestiture or partnering transaction for the inner ear assets with other parties. As timelines for the completion of the divestiture / partnering process for the company's legacy assets have shifted, Altamira's Board of Directors has taken measures to enhance its financial flexibility. The company has agreed with FiveT Investment Management to restructure certain terms and conditions of the CHF 5M convertible loan which it had granted to Altamira in February 2022. Under the newly amended terms of the convertible loan agreement, the maturity is extended from February 8, 2023 to March 15, 2023. In addition, if a private or public offering of the company's common shares is implemented before maturity, FiveT will convert a portion of the loan's principal amount and accrued interest into common shares and pre-funded warrants and receive a partial repayment in cash. In this context, the company is calling a special general meeting of its shareholders for February 17, 2023 to propose an increase in the authorized share capital to accommodate its potential future funding needs as well as the possible partial conversion of the FiveT loan.
Daré Bioscience announced the publication of data from a Phase 1 trial evaluating the pharmacokinetics of DARE-HRT1, an investigational intravaginal ring designed to deliver bio-identical 17beta-estradiol and bio-identical progesterone continuously over a 28-day period as part of a hormone therapy regimen, in the journal Menopause, which is the journal of the North American Menopause Society. Daré previously reported positive topline results from this study, as well as from a subsequent Phase 1 / 2 clinical trial of DARE-HRT1. The journal article entitled "Evaluation of 28-Day Estradiol and Progesterone Vaginal Rings in a Phase 1 Clinical Pharmacokinetic Study" is available at the Menopause journal's website in the Latest Articles section. "We are excited to have this peer-reviewed article published in the North American Menopause Society's journal as we believe that the delivery of hormone therapy over 28-days utilizing a novel intravaginal ring which requires no daily action on the part of the patient, or the provider, supports DARE-HRT1's potential to be a first-in-category, convenient non-oral and non-daily option for women suffering from menopausal symptoms," said Sabrina Martucci Johnson, CEO of Daré Bioscience.
H.C. Wainwright analyst Vernon Bernardino lowered the firm's price target on Aridis Pharmaceuticals to $10 from $19 and keeps a Buy rating on the shares. The analyst factored in the removal of near-term revenues from AR-301 use in COVID-19 patients with acute respiratory distress syndrome. However, the firm believes the data suggest that AR-301 has the potential to be a valuable addition to treatment options for ventilator-associated pneumonia caused by S. aureus, and could be used to treat specific patient populations.
Aridis Pharmaceuticals announced top-line results from the AR-301-002 Phase 3 study, which evaluated the superiority of adjunctive use of the investigational monoclonal antibody candidate AR-301 with standard of care, SOC, antibiotics versus SOC antibiotics alone, for the treatment of VAP caused by Gram-positive bacteria Staphylococcus aureus or S. aureus. AR-301-002, the first of two planned Phase 3 studies, enrolled 174 mechanically ventilated intensive care unit ICU patients who were likely to have pneumonia caused by S. aureus, with 120 of those patients ultimately meeting the criteria of S. aureus as the predominant cause of pneumonia being evaluated for efficacy. The COVID-19 pandemic and the subsequent conflict in Eastern Europe limited patient enrollment from the original target sample size of 240. "Despite the limitations of sample size and lack of statistical significance in the primary endpoint, we are pleased to see the clinical benefit trends across the study population." said Hasan Jafri, MD, Aridis' Chief Medical Officer. "In particular, this study highlights the efficacy limitations of standard of care antibiotics and therefore the unmet medical needs in high-risk, vulnerable patient populations such as older adults and those infected with antibiotic resistant MRSA; populations where AR-301 has the potential to fulfill an unmet need," said Dr. Jafri.
Fennec Pharmaceuticals announced that the National Comprehensive Cancer Network has updated its clinical practice guidelines for Adolescent and Young Adult Oncology to include PEDMARK to help reduce the risk of ototoxicity associated with cisplatin use in pediatric patients with localized, non-metastatic solid tumors.
Cantor Fitzgerald analyst Charles Duncan reiterated an Overweight rating on Fennec with a $12 price target after the company announced that the National Comprehensive Cancer Network updated its clinical practice guidelines for adolescent and young adult oncology to include Pedmark to help reduce the risk of hearing loss. The news is "incremental" but a "potentially useful enhancement" to awareness for Pedmark's clinical data-driven profile, the analyst tells investors in a research note. The firm sees the inclusion of Pedmark as an "encouraging predictor of increased uptake" following its approval in September of 2022.
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.