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:
BioCardia is a developer of cell and cell-derived therapies for cardiovascular and pulmonary disease. The company has two biotherapeutic platforms, CardiAMP autologous bone marrow-derived mononuclear cell therapy for cardiovascular indications and the NK1R+ allogeneic bone marrow-derived mesenchymal stem cell therapies for cardiovascular and pulmonary diseases.
Heron Therapeutics is a commercial-stage biotechnology company that says its "advanced science, patented technologies, and innovative approach to drug discovery and development have allowed it to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients."
CorMedix is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The company is focused on developing its lead product DefenCath, a novel, non-antibiotic antimicrobial solution designed to prevent costly and life-threatening bloodstream infections associated with the use of central venous catheters in patients undergoing chronic hemodialysis.
Arcturus Therapeutics is a late-stage clinical mRNA medicines and vaccines company whose pipeline of RNA therapeutic and vaccine candidates includes mRNA vaccine programs for COVID-19 and Influenza, and other programs to potentially treat ornithine transcarbamylase, or OTC, deficiency, and cystic fibrosis, or CF. The company's partnered programs include glycogen storage disease type III and hepatitis B virus.
Gamida Cell is at work on an immunotherapy pipeline of potentially curative cell therapy candidates for patients with solid tumor and blood cancers and other serious blood diseases. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of bone marrow transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies.
Eyenovia is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia, and myopia progression.
MorphoSys is focused on discovering, developing, and delivering innovative cancer medicines. Tafasitamab is a humanized Fc-modified CD19 targeting immunotherapy. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor (XNCR).
Harpoon Therapeutics is developing a novel class of T cell engagers that harness the power of the body's immune system to treat patients suffering from cancer and other diseases. "Using its proprietary Tri-specific T cell Activating Construct, or TriTAC, platform, Harpoon is developing a pipeline of novel TriTACs initially focused on the treatment of solid tumors and hematologic malignancies. Harpoon has also developed a proprietary ProTriTAC platform, which applies a prodrug concept to its TriTAC platform to create a therapeutic T cell engager that remains inactive until it reaches the tumor. Harpoon's third proprietary technology platform, extended release TriTAC-XR, is designed to mitigate cytokine release syndrome," the company states.
Aytu BioPharma is a pharmaceutical company commercializing a portfolio of commercial prescription therapeutics and consumer health products. The company's prescription products include Adzenys XR-ODT extended-release orally disintegrating tablets and Cotempla XR-ODT extended-release orally disintegrating tablets for the treatment of attention deficit hyperactivity disorder, Karbinal ER, an extended-release antihistamine suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor and Tri-Vi-Flor, two complementary fluoride-based prescription vitamin product lines available in various formulations for infants and children with fluoride deficiency. Aytu's consumer health segment markets a range of over-the-counter medicines and consumer health products addressing a range of common conditions including diabetes, allergy, hair regrowth, and gastrointestinal conditions.
Recent news on these stocks:
November 15
Needham lowered the firm's price target on Heron Therapeutics to $4 from $5 but kept a Buy rating on the shares. The company's Q3 financials are unlikely to excite anyone given another slow quarter of growth for Zynrelef and Aponvie, but the management provided detailed Q4 and 2024 guidance parameters that highlight Heron's progress in restructuring and cost reduction, and more importantly mapping out a path to operating cash flow breakeven with positive EBITDA by the end 2024, the analyst told investors in a research note.
RBC Capital raised the firm's price target on CorMedix to $10 from $6 and kept an Outperform rating on the shares. The company reported Q3 "with optimism" heading into its key DefenCath PDUFA in catheter-related blood stream infections prevention in hemodialysis, the analyst tells investors in a research note. All signals appeared positive on the prospects of an approval outcome, which is now seen as increasingly likely this time around, the firm added.
Citi raised the firm's price target on Arcturus Therapeutics to $40 from $35 and kept a Buy rating on the shares. The analyst said that Arcturus provided a meaningful six-month update from the Japan Phase 3 trial for ARCT-154 at the International mRNA Health Conference on November 1, further supporting a "very favorable" durability profile relative to Comirnaty. The firm believes the approval decision for ARCT-154 anticipated in December will be an important catalyst for Arcturus. An approval would create a streamlined regulatory pathway for these future variant-specific vaccines in Japan, in addition to providing platform validation, the analyst told investors in a research note.
Piper Sandler lowered the firm's price target on Gamida Cell to $2 from $5 and kept an Overweight rating on the shares. The firm noted that Gamida Cell recorded revenues of $673,000 having delivered two Omisirge units in Q3, and guided to ship 4-6 units this year. Piper now forecasts Omisirge revenues of $1.0M in Q4 totaling $1.68M this year, growing to $13.5M in 2024. Gamida Cell is exploring strategic alternatives to fund full launch of Omisirge, Piper added.
MorphoSys reported Q3 EUR (3.50) vs. EUR (3.60) last year, and reported Q3 revenue EUR 63.8M vs. EUR 95.8M last year. "With pelabresib, MorphoSys has the potential to meaningfully improve upon current first-line treatments for patients with myelofibrosis. We look forward to showcasing the topline results of our pivotal MANIFEST-2 study by the end of November and, shortly thereafter, in our detailed oral presentation at ASH 2023," said Jean-Paul Kress, CEO of MorphoSys. "Sales of Monjuvi remain on track for its approved indication, allowing us to narrow our full-year 2023 guidance target. Our mid- to late-stage pipeline offers promising value-creating opportunities, with two additional pivotal studies expected to read out over the next two years."
November 14
BioCardia announced the FDA approval of its Phase III clinical trial of its CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure. BioCardia announces that the Food and Drug Administration, FDA, has approved its proposed CardiAMP Heart Failure II study protocol. The currently ongoing CardiAMP Heart Failure trial has completed enrollment and it is anticipated that the final data analyses will be reported in Q4 2024. In an interim analysis of available data to date for study patients followed up through two years, those having N-terminal pro B-type natriuretic peptide levels consistent as demarcating heart failure at screening-baseline showed meaningful clinical improvements over controls, including a 59% relative risk reduction in heart death and a 54% relative risk reduction of Major Adverse Cardiovascular or Cerebrovascular events. Further, all clinical outcome measures evaluated at follow-up for this interim subset favored cell therapy over guideline directed medical therapy, including having improved quality-of-life as measured using the Minnesota Living with Heart Failure Questionnaire, reduced NT-proBNP levels, greater walk distance as measured using the 6-minute walk distance test, and improved cardiac measures such as left ventricular ejection fraction and left ventricular end systolic and end diastolic volumes. Statistical significance was noted for both the reduced heart death equivalents measure and the improved quality of life measure. The FDA has approved the proposed CardiAMP Heart Failure II study which includes an eligibility requirement that patients demonstrate a pre-specified NT-proBNP level at baseline. The proposed primary efficacy endpoint is also modified from that in the currently ongoing study. The CardiAMP Heart Failure II endpoint is a similar hierarchical composite assessment but consists of all-cause death, the cardiac death equivalents of heart transplant and left ventricular assist device implantation, heart failure hospitalizations, worsening heart failure events treated as an outpatient, and change in quality-of-life, with a follow-up duration ranging from a minimum of 12 to a maximum of 24 months.
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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.
BioCardia
+
Heron Therapeutics
+0.0882 (+9.62%)
CorMedix
+0.195 (+5.14%)
Arcturus Therapeutics
+1.175 (+5.30%)
Gamida Cell
+
Eyenovia
+0.015 (+1.17%)
MorphoSys
-0.225 (-3.63%)
Harpoon Therapeutics
+1.16 (+12.29%)
Aytu BioPharma
+ (+0.00%)