These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:
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- BioCardia (BCDA), 2,211% surge in interest
- Geron Corp (GERN), 420% surge in interest
- Replimune Group (REPL), 21% surge in interest
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.
Geron is a late-stage biopharmaceutical company pursuing therapies with the potential to extend and enrich the lives of patients living with hematologic malignancies. Its investigational first-in-class telomerase inhibitor, imetelstat, “harnesses Nobel Prize winning science in a treatment that may alter the underlying course of these diseases,” the company says.
Replimune Group is focused on the development of novel tumor-directed oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a HSV-1 backbone with payloads added to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform’s dual local and systemic mechanism of action is “expected to be synergistic with most established and experimental cancer treatment modalities, and, with an attractive safety profile the RPx platform has the versatility to be developed alone or combined with a variety of other treatment options,” the company stated.
Recent news on these stocks:
June 7
BioCardia announced that the United States Patent Office has granted Patent No: 11,986,611 titled “Radial and Transendocardial Delivery Catheter,” with a patent term that will expire in 2036. The present invention relates to medical methods and systems suitable for substance delivery to the heart via a radial artery and for the intracardiac delivery of cellular aggregates and other agglomerated materials. Radial artery delivery is a means by which cardiac catheters are advanced through a blood vessel in a patient’s wrist to treat the heart. This approach has significant advantages for patients, enabling them to leave the hospital soon after the procedure with a band aid on their wrist and their arm in a simple sling, allowing them to immediately return to their active lives. In addition, a radial approach permits hospitals and other care centers to greatly reduce costs by eliminating the need for an overnight stay by the patient. For these reasons, trans-radial access is becoming the default approach in many cardiac centers worldwide. Enabling radial access has “enormous potential advantages for biotherapeutic delivery to the heart,” the company stated.
Geron announced that the FDA has approved Rytelo for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents.
Stifel said the “real upside surprise” of Geron’s FDA approval of Rytelo is the lack of a boxed warning for hematological toxicity, which had been viewed by most investors as the more-likely labeling outcome. The firm believes the label should positively impact investor sentiment as it pertains to both Geron’s strategic interest and commercial launch into a disease setting of significant unmet medical need. Consensus estimates still seem to significantly underappreciate Rytelo’s “launch kinetics,” the analyst told investors in a research note. Stifel kept a Buy rating on the shares.
June 6
Replimune Group announced the topline results from the primary analysis of the IGNYTE clinical trial of RP1 plus nivolumab in anti-PD1 failed melanoma. The results by independent central review show one-third of patients receiving RP1 plus nivolumab responded to treatment, improving upon the investigator-assessed data presented at ASCO 2024, with all responses lasting greater than 6 months from baseline. The topline results show the overall response rate was 33.6% by modified RECIST 1.1 criteria, the primary endpoint as defined in the protocol, and 32.9% by RECIST 1.1 criteria, an additional analysis requested by the FDA. Responses from baseline were highly durable, with all responses lasting more than 6 months and median duration of response exceeding 35 months. The Company plans to submit the full primary analysis data from the anti-PD1 failed melanoma cohort including key secondary endpoint data and subgroups for presentation at an upcoming medical congress. RP1 combined with nivolumab continues to be well-tolerated, with mainly Grade 1-2 constitutional-type side effects, observed.
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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.
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Read More on BCDA:
- BioCardia Announces United States Patent Issuance on Intramyocardial Delivery of Cell Aggregates to the Heart Including Minimally Invasive Radial Artery Approach
- BioCardia announces U.S. patent issuance on delivery of cell aggregates
- BioCardia trading halted, news pending
- BioCardia Announces Reverse Stock Split
- BioCardia announces reverse stock split