STOCKS TELEGRAPH

Tag: Biotechnology

  • Relmada Therapeutics Inc. (RLMD) Stock Continues Downward Trend Despite Promising Top-line Data from REL-1017 Study

    Relmada Therapeutics Inc. (RLMD) stock prices were down 3.26% some time after market trading commenced on July 27th, 2021, bringing the price per share down to USD$24.30 early on in the trading day.

    Positive REL-1017 Topline Data

    July 27th 2021 announced the top-line results of the human abuse potential study with REL-1017, the company’s lead candidate. The novel NMDA receptor channel blocker is in Phase 3 development for the treatment of the major depressive disorder (MDD). Top-line results indicated all three doses of REL-1017 tested in recreational opioid users demonstrated a highly statistically significant difference from the control group. The 25mg, 75mg, and 150mg therapeutic, supratherapeutic, and maximum tolerated doses were compared to the active control drug, oxycodone 40 mg.

    RLMD Stock’s Study Endpoints

    The primary endpoint of the study was a measure of ‘likability’ with the subjects rating the maximum effect for Drug Liking “at the moment” using a 1=100 bipolar rating scale. The visual analog scale (VAS) has 100 as the highest likeability, 50 as the neutral, and the 0 as the highest dislike. The data clearly shows a very meaningful difference between the REL-1017 treatment and oxycodone at all three tested doses.

    Safety of REL-1017

    The results consolidate previous findings about the lack of opioid effects of REL-1017. RLMD stock is keen to continue the clinical development of REL-1017 as a novel, safe, and rapidly effective treatment for MDD. The findings have been consistent with RLMD stock’s development programs and confirms what has already been established by an extensive body of literature that indicates the lack of abuse potential of REL-1017. The results strongly support the ongoing REL-1017 late-stage development program.

    Consolidated Scope for RLMD Stock

    The results are in line with HAP results that have been seen for other drugs that affect the CNS and have been scheduled at Classes IV or V, or remain unscheduled, during the assessment and review period. RLMD stock is keen to address the large unmet need for patients suffering from depression in the absence of safe and rapidly effective treatments.

    Future Outlook for RLMD

    Armed with the promising topline results from its study of REL-1017, RLMD is poised to capitalize on the enormous marketspace it finds needing to be addressed. Current and potential investors are hopeful that management will be able to leverage the resources at their diposal to facilitate significant and sustained increases in shareholder value.

  • Lexaria Bioscience Corp. (LEXX) Stock Showing Increased Volatility Ahead of Success of Antiviral Drug Studies

    Lexaria Bioscience Corp. (LEXX) stock prices soared by 28.07% at the end of the trading day on July 21st, 2021, bringing the price per share up to USD$8.44 at the end of the trading day. Subsequent premarket fluctuations have seen the stock fall by 11.14%, bringing it down to USD$7.50.

    DehydraTECH Evaluation

    The company reported having successfully met its objectives for its 2021 antiviral drug examination program designed to evaluate DehydraTECH. The technology exhibited evidence of superior oral absorption of its processed compounds of leading classes of antiviral drugs for Covid-19, HIV/AIDS, and other infection diseases. DehydraTECH was also evaluated in regard to its processing of those compounds managing to preserve expected viral inhibitory performance, guided by efficacy testing in infected mammalian cells. The treatment was also proven to not adversely affect the drug molecules chemically, thereby creating new molecular entities that would prove to be difficult in guiding through the regulatory approval process.

    Continued Development

    To this end, LEXX is allocating resources towards a comprehensive multi-pronged program. It is designed to demonstrate essential proof-of-concept safety, efficacy, and formulation/scalability feasibility data to potential pharmaceutical industry partners. This is in line with the company’s strategy to create additional value-adding opportunities for further collaborative product development.

    Expanding Market Footprint

    The company is keen to leverage its DehydraTECH technology to pursue strategic collaboration opportunities with established industry partners who may be incorporating the technology with antiviral drugs. The company is striving to prove DehydraTECHworks to enhance oral delivery characteristics of relevant drugs, with its scope extending to other related treatments as well. Cumulatively, the company hopes to help develop treatments to fight a myriad of virus triggered diseases, including, but not limited to, shingles, influenza, viral forms of gastroenteritis, hepatitis, meningitis, and pneumonia.

    Scope of DehydraTECH

    Despite the efficacy and accessibility of vaccines to prevent many viral infections, thousands of people die annually from viral infections while being unvaccinated. Current estimations peg more than 99% of the 200,000 US death since January 1st, 2021 as a result of the Covid-19 pandemic being in people who were unvaccinated. This demonstrates the vital and expansive existing need for successful treatment options for those who are unvaccinated.

    Future Outlook for LEXX

    Armed with the continued proliferation of its flagship DehydraTECH technology, LEXX is poised to capitalize on the opportunities arising from its expanding network of strategic partners. Current and potential investors are hopeful that management will continue to leverage the resources at its disposal to facilitate significant and sustained increases in shareholder value.

  • Trinity Biotech PLC (TRIB) Stock Surges Higher Following Announcement of Proliferation of Covid-19 Testing Space

    Trinity Biotech PLC (TRIB) Stock Surges Higher Following Announcement of Proliferation of Covid-19 Testing Space

    Trinity Biotech PLC (TRIB) stock prices were up 11.70% shortly after market trading commenced on July 16th, 2021, bringing the price per share up to USD$2.229 early on in the trading day.

    Rapid Antigen Test

    The company reported being at an advanced stage in the development of an antigen test for the coronavirus that has been devastating the globe. The company leverages its core lateral flow technology to develop the test, which can be utilized without any specialized equipment, providing a result in 12 minutes. Accessibility is further enhanced with its easy-to-use anterior nasal swab sample.

    Scope of Antigen Test

    With the onset of the global coronavirus having signaled an unfathomable long-term toll on economies across the world, the world’s ongoing efforts to mitigate and eventually nullify its effects persist. As public health efforts continue with full force, antigen tests have played a critical role in the overall diagnostic response. As the world hurtles towards universal immunization, the company expects antigen tests to be a part of the core response to the pandemic, in combination with Covid-19 vaccinations.

    Rapid Antibody Test

    June 2021 saw the company submit a EUA application to the FDA for the UniGold Covid-19 rapid antibody test, which detects IgG antibodies against the coronavirus. The antibody test demonstrated a 100% sensitivity and a specificity of 95% over the course of the validation studies. The test was measured against a comparator PCR method which facilitated the confirmation of prior infection.

    EUA Application

    July 2021 saw the FDA inform TRIB that its application for the Emergency Use Authorization of the serological test would not currently be prioritized, on account of the sheer volume of EUA requests currently being processed by the government agency. In order to facilitate the timely commercialization and proliferation of its treatment, the company is exploring additional prospective pathways that would see it gain regulatory approval, thus allowing sales of the test in the U.S. Hitherto, any such potential options have required too significant and additional investment for them to be viable.

    Future Outlook for TRIB

    With the world’s continued efforts towards the aim of making the coronavirus a thing of the past, TRIB is poised to capitalize on the access it has gained to a burgeoning market. The company is keen to leverage its resources in order to drive increased market penetration. Current and potential investors are hopeful for the stock price to recover and increase over the long term.

  • Vyant Bio, Inc. (VYNT) Stock Undergoes Minor Volatility Ahead of Granting of US Patent for iPSCs

    Vyant Bio, Inc. (VYNT) stock prices were down by 5.22% at the end of the trading day on July 14th, 2021, bringing the price per share down to USD$3.27 at the end of the trading day. Subsequent premarket fluctuations have seen the stock recover by 5.81%, bringing it up to USD$3.46.

    StemoniX Granted US Patent

    July 13th, 2021 saw the company announce that StemoniX, its wholly-owned subsidiary, was issued a US Patent by the United States Patent and Trademark Office (USPTO). The patent is titled “High Throughput Optical Assay of Human Mixed Cell Population Spheroids” and covers a novel approach to the application of human-induced Pluripotent Stem Cells (iPSCs) as an effective tool in the illumination of the biology of complex human cell types, such as those of the central nervous system (CNS).

    Nature of iPSC Platform

    Human iPSC-based, high-throughput platforms that currently exist have lacked reliability and functional consistency. The patent also covers the use of 3D co-cultures of cortical neurons and astrocytes that display spontaneous, rhythmic, and highly synchronized neural activity. This activity can visualized as calcium oscillations on standard, high-throughput fluorescent readers as a platform for CNS-based discovery effects.

    Details of iPSC

    Spontaneous activity and spheroid structure proved to be highly consistent from well-to-well, which is a feature that is lacking in traditional 2D cultures. The technology facilitates a cost-effective method to perform high-throughput drug screening (HTS) in regard to 3D human tissue relevant models that have a higher degree of biological accuracy. This patent marks the third patent granted to StemoniX, with additional applications currently pending across globe.

    Competitive Advantage

    Existing conventional high-throughput drug screening typically makes use of recombinant cell lines that overexpress a drug target of interest. The technology is aimed to deliver the development of relevant cellular disease models that will be used in high-throughput screening. Human iPSCs have been proven to have significant advantages over recombinant cell lines or primary rodent cells that will be used in drug screening. Given that the cells are derived from human donors, human genetic diseases can be modelled more accurately, particularly when used in tandem with modern genome editing techniques.

    Future Outlook for VYNT

    Armed with the promising potential of the patent granted to StemoniX, VYNT is poised to capitalize on the expanded scope of opportunities presented to it. Keen to pioneer their segment of the healthcare system, the company is pushing for the continued development of their innovative technology. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to usher in significant and sustained increases in shareholder value.

  • Qualigen Therapeutics, Inc. (QLGN) Stock on the Rise Following IND Submission for Novel Covid-19 Treatment, QN-165

    Qualigen Therapeutics, Inc. (QLGN) stock prices were up 1.6854% as of the market opening on July 14th, 2021, with premarket trading having seen the stock rise sharply. As of writing, the price per share of QLGN stock was USD$1.81.

    IND Submission

    July 14th, 2021 saw the biotechnology company announce the submission of an Investigational New Drug Application to the U.S Food and Drug Administration with an initial target indication for the treatment of hospitalized Covid-19 patients with the company’s QN-165. The DNA aptamer is a broad-based antiviral drug candidate that has shown antiviral activity in various in vitro assays against a plethora of viruses.

    Milestone for QLGN

    The significant milestone is the first IND application submitted by the company for its most advanced therapeutics program. The IND application submission for Phase 1b/2a clinical trials for QN-165 represents another step in the company’s evolution from a globally patented and commercially successful diagnostics company to a clinical-stage therapeutics company with multiple programs.

    QN-165

    QN-165 is a unique drug candidate that presents an entirely novel approach to combating viruses, which the company thinks it will be able to work against all virus strains and variants. The treatment is a piece of synthetic DNA that does not target the coronavirus directly, as existing treatments do. Rather, it targets and binds to the nucleolin protein and has the capacity to enter cells that overexpress nucleolin. Nucleolin is exploited by viruses such as Covid-19 to gain access to a cell, manipulating it for its own viral replication purposes.

    Scope of QN-165

    By tying up nucleolin, QN-165 is anticipated to block the mechanism entirely, thus preventing the virus replication process. Because of this, even the mutation of the virus is not expected to result in a loss of efficacy of the treatment, on account of nucleolin being targeted instead of the virus itself. This is what the company believes will make the treatment effective against a plethora of viral mutations, including all strains and variants of the novel coronavirus.

    Future Outlook for QLGN

    With the world hurtling towards global immunizations, the onslaught of variants and strains that pop up across the globe are becoming an increasingly significant concern. Treatments such as QN-165 are set to address those concerns, thereby signaling the massive potential for commercialization and proliferation of the expansive market. Investors are hopeful that management will leverage its resources to deliver the treatment as quickly as possible, thus ensuring maximum increases in shareholder value.

  • INmune Bio, Inc. (INMB) Stock on the Rise Following First Patient Treatment in INKmune Phase 1 Clinical Trial

    INmune Bio, Inc. (INMB) stock prices were up by 12.67% as of the market closing on July 13th, 2021, bringing the price per share up to USD$26.68. Subsequent premarket fluctuations saw the stock rise by 7.01%, bringing it up to USD$28.55.

    INKmune

    July 12th, 2021 saw the company announce the use of INKmune, its Natural Killer (NK) cell priming platform, had been used to treat the first patient in Phase 1 clinical trial. The treatment is being explored as a viable option for patients with high-risk myelodysplastic syndrome. MDS is a hematopoietic stem cell disorder that is indicated by functionally defective NK cells, with the level of dysfunction being predictive of overall survival. Roughly 33% of MDS cases develop into acute myelogenous leukemia (AML). With no known cure for MDS, existing therapies like chemotherapy and bone marrow/stem cell transplantation have varying degrees of success.

    Research Conducted

    With levels of NK function in MDS patients being predictive of overall survival, 15 years of lab research into potential patient treatment has raised hopes. The enhancement of low-level NK activity in patients with poor prognosis to the level of those with better overall survival, thereby altering the course of the disease, could be highly commercially promising.

    Scope of Research

    Lab work has shown INKmune binding to multiple NK receptors and initiates the activation of more than 3000 genes associated with function, trafficking, proliferation, and overall survival. With not a single cytokine available that has such a myriad of physiological effects, INKmune is being referred to as a psuedokine.

    Expanded Opportunities

    The treatment of the first patient in the trial serves as a major milestone, with the company being the first to study the INKmune platform in a formal clinical setting. With it being widely known that dysfunctional NK cells in cancer patients are not effective at eradicating residual disease after chemotherapy, leading to relapse and poor outcomes. The company has shown that with the delivery of tumor-specific activating signals to NK cells with INKmune, autologous tumor killing can be initiated.

    Future Outlook for INMB

    Armed with the significant milestone of having treated the first patient in the study, INMB is poised to capitalize on the opportunities afforded to it as a result. The company is keen to push for the accelerated development and eventual commercialization and proliferation of the treatment. Current and potential investors are hopefully that management will continue to leverage the resources at its disposal to facilitate significant and sustained increases in shareholder value.

  • Origin Agritech Ltd. (SEED) Stock Surges Following Expansion of GMO Trait Portfolio

    Origin Agritech Ltd. (SEED) Stock Surges Following Expansion of GMO Trait Portfolio

    Origin Agritech Ltd. (SEED) stock prices were up by 29.22% some time after market trading commenced on July 12th, 2021, bringing the price per share up to USD$11.63 early on in the trading day.

    Exclusive Rights Agreement

    July 12th, 2021 saw the company announce that it had entered into an exclusive rights agreement with the Biology Research Institute of the Chinese Academy of Agricultural Sciences, in regard to its proprietary drought resistant GMO trait. The agreement will see the company gain exclusive global rights to the GMO trait for the entire duration of the patent. The Chinese Ministry of Agriculture and Rural Affairs approved the drought tolerance corn for production trials, representing the fourth stage in a five stage process to receive a bio-safety certificate.

    Drought Resistant Traits

    With the company already having successfully converted its elite corn hybrids into drought resistant  traits, which express excellent performance under water stress conditions throughout the growing period. Multi year experiments have indicated drought tolerance corn yield that is 9.2 to 16.2% higher than non-GMO corn under water stress conditions. In the case of irrigation, the GMO enhanced corn increases water use efficiency by 33-47%.

    Approval for Hybrid Corn Breeds

    July 8th, 2021 had seen the company announce its approval from the Ministry of Agriculture and Rural Affairs for four of its new hybrid corn breeds. This move has seen the company expand its product pipeline and increase its competitiveness in the Chinese corn seed market. The company also has GMO enhanced versions of the newly approved hybrids that are currently in the approval pipeline.

    Scope of Approval

    The Ministry of Agriculture and Rural Affairs recently increased the national standards required for the approval of corn and rice varieties, thus further promoting further innovation in germplasm development. Being on of the few participating companies in the Green Pass program, the company is in a unique position to streamline the approval process, resulting in the submission of more hybrids for approval per year. This will, in turn, strengthen the company’s ability to add multiple new hybrids to market annually, which will include many GMO enhanced hybrids.

    Future Outlook for SEED

    Armed with the recent development of its product pipeline, SEED is poised to push for the accelerated commercialization and effective proliferation of its corn hybrids in the Chinese market space. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Advaxis, Inc. (ADXS) Stock Skyrockets Ahead of Definitive Merger Agreement with Biosight Ltd

    Advaxis, Inc. (ADXS) Stock Skyrockets Ahead of Definitive Merger Agreement with Biosight Ltd

    Advaxis, Inc. (ADXS) stock prices skyrocketed by a massive 41.25% shortly after market trading commenced on July 6th, 2021, bringing it up to USD$0.667 early on in the trading day.

    Merger with Biosight

    July 6th, 2021 saw the company announce its definitive merger agreement with Biosight Ltd, which will see shareholders of Biosight become majority holders of the combined company upon the closing of the transaction. The resulting entity will be a public company, with a focus on the clinical advancement and commercialization of Biosight’s lead product, BST-236. As of closing, the combined company forecasts a solid liquidity position with roughly USD$50 million in cash, cash equivalents, and marketable securities. The closing of the transaction is expected for the second half of 2021, with the combined company being renamed Biosight Therapeutics, to be traded on the Nasdaq Capital Market under the BSTX ticker symbol.

    Aspacytarabine

    The company anticipates topline results from its ongoing Phase 2 trial of aspacytarabine within 12-18 months. Enrollment has been completed for the trial of first-line therapy in AML patients who cannot undergo traditional chemotherapy. Recent data indicated complete remission rates of 39% across all evaluable patients, with 63% of cases with negative minimal residual disease and median overall survival of 10 months.

    R&D Costs

    Research and development costs for the second quarter of fiscal 2021 were reported at USD$4.34 million, up from the USD$3.92 million for the prior year quarter. The year-over-year difference was largely attributable to the winding down of some legacy studies. Further compounding the difference were losses on disposal of research-related property and equipment in connection with the termination of the office lease at ADXS’s former location.

    Solid Liquidity Position

    ADXS reported USD$48.1 million in cash and cash equivalents as of April 30th 2021, with the company confident that it is enough to fund its obligations as they arise. The solid liquidity position will see the ordinary course of the business through to the third fiscal quarter of 2023.

    Future Outlook for ADXS

    Armed with a solid liquidity position and a lucrative merger, ADXS is poised to capitalize on the opportunities afforded to it. The company is keen to facilitate the commercialization and proliferation of BST-236 in order to usher in further growth.

  • Larimar Therapeutics, Inc. (LRMR) Stock on the Rise as Resolution of FDA Clinical Hold Continues to Develop

    Larimar Therapeutics, Inc. (LRMR) stock prices were up by a marginal 1.54% as of the market closing on July 2nd, 2021, bringing the price per share up to USD$9.89 at the end of the trading day. After hours trading saw the stock surge by 10.21%, bringing it up to USD$10.90.

    Clinical Hold for CTI-1601

    May 25th 2021 saw the company announce that the U.S. Food and Drug Administration had placed a clinical hold on LRMR’s ongoing CTI-1601 clinical program. As a result, the company did not complete its previously announced private placement financing. The clinical trial is for the treatment of patients with FA who are unable to produce enough human frataxin, with CTI-1601 serving is a recombinant fusion protein that is delivered to patients’ mitochondria.

    Contextualizing the Hold

    The clinical hold came after the company’s reporting to the FDA in regard to mortalities occurring at the highest dose levels in an ongoing 180-day non-human primate toxicology study. The study was designed to support extended CTI-1601 treatment in patients. The FDA implemented the hold in light of needing a full study report from the company’s NHP study, with a restriction on the initiation of additional clinical trials until the report has been submitted and approved by the FDA.

    Effects of FDA Decision

    The disappointing formal clinical hold notification does not, however, change the company’s previously stated strategy for the clinical development of CTI-1601. LRMR plans to complete its NHP toxicology study, assess the data, and discuss the data with the FDA in order to obtain prior consent for the commencement of their Jive and pediatric MAD trial. Patient safety continues to be a top priority, with the company confident that despite the hiccup, the path forward is still in place.

    Deferral of Trials

    With the added regulatory requirements associated with the formal clinical hold, the company is entertaining the possibility of deferring the initiation of its clinical trials. The trials are being considered to be pushed up to 2022. Despite the termination of the planned private placement financing, the company reported a solid cash position as of March 31st, 2021. Having reported USD$81.4 million in cash and cash equivalents, the company anticipates being able to fund its operations through to the first half of 2022.

    Future Outlook for LRMR

    Confident in the timely resolution of the speedbumps in the road towards the commercialization of its treatment candidates, LRMR is poised to continue its trajectory of success. The company is keen to address the FDA’s requirement so it can continue pushing for the development of its various clinical trials.

  • Brickell Biotech, Inc. (BBI) Stock Rallies Ahead of Sofpironium Bromide Clinical Trial Milestones

    Brickell Biotech, Inc. (BBI) Stock Rallies Ahead of Sofpironium Bromide Clinical Trial Milestones

    Brickell Biotech, Inc. (BBI) stock prices were down by a marginal 0.52% as of the market closing on June 29th, 2021, bringing the price per share down to USD$0.93 at the end of the trading day. Subsequent pre-market fluctuations saw the stock rally by 5.91%, bringing it up to USD$0.98.

    Sofpironium Bromide Gel, 15%, Study

    The company’s U.S Phase 3 clinical program is comprised of two pivotal studies designed to evaluate sofpironium bromide gel, 15%. Cardigan I and Cardigan II each have approximately 350 subjects enrolled, each of which is above the age of 8 and has primary axillary hyperhidrosis. The efficacy and safety of topically applied sofpironium bromide gel will be evaluated in the multicenter, randomized, double-blinded, vehicle-controlled studies, with safety and tolerability assessments being performed throughout the studies.

    Details of the Study

    The regimen consists of subjects applying the treatment or a placebo to their underarms once daily before sleeping at night for a period of six consecutive weeks, with a 2-week post-treatment follow up. The co-primary efficacy endpoints of both studies include the demographic of patients that exhibited at least a 2-point improvement on the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale, which is a proprietary and validated patient-reported outcome measure. The studies will also evaluate changes in gravimetric sweat production (GSP) from baseline to the end of treatment.

    Scope of Clinical Study

    Topline results from each of the Cardigan clinical studies is expected for the fourth quarter of 2021. The success of these results will form the basis of a potential NDA in the U.S for sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis.

    Phase 1 PPH Clinical Study

    June 24th, 2021 had seen the company announce that its development partner, Kaken Pharmaceutical, had initiated a Phase 1 clinical study to assess the pharmacokinetics of sofpironium bromide gel. The Study would assess the efficacy and safety of the treatment in patients with primary palmoplantar hyperhidrosis in Japan. PPH is a medical disorder that is very common, resulting in excessive sweating from the palms and soles. Primary palmar hidrosis is estimated to affect 5.33% of the Japanese population, while primary plantar hyperhidrosis is thought to affect 2.79% of the population. With no existing approved topical prescription treatments available for PPH in Japan, the study’s scope is potentially massive.

    Future Outlook for BBI

    Armed with a solid liquidity position, BBI is poised to capitalize on the strides made in its clinical studies, with the company pushing for the commercialization and proliferation of sofpirinium bromide gel, 15%. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.