Tag: biopharmaceutical

  • Synaptogenix, Inc. (SNPX) Stock Skyrockets as Latest Potential Target of Reddit-Driven Meme Stock Phenomenon

    Synaptogenix, Inc.(SNPX) stock prices skyrocketed by a massive 20.80% shortly after market trading commenced on June 17th, 2021, bringing the price per share up to USD$10.75 early on in the trading day.

    Meme Stock Phenomenon

    SNPX could be the latest in a series of stocks that have been picked up by Reddit-driven retail investors tat are responsible for the recent resurgence of the meme stock phenomenon. Underdogs with high short interests find themselves fortuitously bolstered as the community of investors continues to target companies without a logical basis for their support. In the absence of recent news or any fundamental developments, companies sometimes on the brisk of collapse find themselves renewed by the sweeping meme stock craze.

    Securities Purchase Agreement

    The up-and-coming biopharmaceutical company recently announced the successful execution of a securities purchase agreement, wherein SNPX hopes to generate gross proceeds in the amount of USD$12.5 million. The private placement financing of common stock and warrants will comprise holistic units, which will be sold off in the placement that will be primarily led by existing institutional shareholders.

    Allocation of Funds

    Capital generated from the net proceeds of the private placement are forecasted to be allocated towards the supporting of the ongoing development of Brystatin-1. The treatment is currently in Phase 2b of a NIH-sponsored Alzheimer’s disease trial, with further research and development being carried out to facilitate new indications.

    Unit Composition

    Each unit being sold in the offering consists of a single share of SNPX’s common stock combined with one warrant, with a combined purchase price of USD$7.547 per unit. The warrants have an exercise date of five years from when they are issued, and are priced at USD$8.51 per share of common stock. The placement was scheduled to close the same day, on June 16th 2021.

    Future Outlook for SNPX

    Armed with a solid liquidity position from their recent offering, SNPX is undoubtedly delighted with the skyrocketing of their equity value despite a stark absence of media coverage of significant motivators of that stock movement. The company is keen to continue its trajectory of success to usher in more organic growth. 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.

  • Viking therapeutics, Inc. (VKTX) Stock Trending Higher Following Successful Phase 1 VK0214 Clinical Trial Results

    Viking therapeutics, Inc. (VKTX) Stock Trending Higher Following Successful Phase 1 VK0214 Clinical Trial Results

    Viking Therapeutics, Inc. (VKTX) stock prices were up by a marginal 0.83% as of the market closing on June 16th, 2021, bringing the price per share up to USD$6.08 at the end of the trading day. Subsequent premarket fluctuations saw the stock rise by a more significant 5.10%, bringing it up to USD$6.39.

    VK0214 Clinical Trial

    The company announced on June 17th, 2021 the results from its Phase 1 clinical trial of VK0214, the unique, orally available small molecule thyroid receptor beta agonist. Having been both single ascending dose and multiple ascending doses, the trial was designed for the development of the treatment for X-linked adrenoleukodystrophy (X-ALD). As per the results of the study, VK0214 demonstrated promising safety and tolerability, as well as a predictable pharmacokinetic (PK) profile. The initiation of Phase 1b of the study of VK0214 in X-ALD patients is set to commence in the upcoming weeks.

    Details of the Study

    The Phase 1 trial was a double-blind, placebo-controlled study of randomized healthy volunteers, with a primary objective of evaluating the safety and tolerability of VK0214 administered orally over the course of 14 days. The evaluation of the pharmacokinetics of the treatment following single and multiple doses was the secondary objective of the study.

    Layout of the Study

    The first portion of the study was designed to evaluate single doses of the treatment, with the second portion seeing the administering of VK0214 once daily to the study subjects for a period of 14 days. Both parts of the study reported subsequent cohorts having received higher doses of the treatment successfully.

    Results of the Trial

    The safety profile of VK0214 was consolidated, with a demonstrated tolerability at all the doses that were evaluated in the study. There were no serious adverse events reported; and no study-related trends were observed for changes in vital signs, gastrointestinal effects, cardiovascular measures, or physical examinations. The treatment demonstrated exposures that were dose-dependent, with no evidence of accumulation subsequent to multiple doses. The half-life of the treatment was also found to be consistent with expected dosing regimens of once a day.

    Peripheral Findings

    Potential pharmacodynamic effects following exposure to the treatment were determined by laboratory assessments that included a lipid panel. The findings indicated exposure to VK0214 resulted in a reduction in LDL-C triglycerides and apolipoprotein B after 14 days of treatment at all dosage levels. While the study wasn’t powered for it, it did achieve statistical significant in many of the observed lipid reductions.

    Future Outlook for VKTX

    Armed with the promising development of its flagship treatment, VKTX is poised to continue its trajectory of success. The company is keen to push for the commercialization and proliferation of VK0214. 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.

  • Opthea Ltd. (OPT) Stock Skyrockets Seemingly Out of Nowhere; Could It Be the New Meme Stock?

    Opthea Ltd. (OPT) Stock Skyrockets Seemingly Out of Nowhere; Could It Be the New Meme Stock?

    Opthea Ltd. (OPT) stock prices were up by a massive 33.06% shortly after market trading commenced on June 16th, 2021, bringing the price per share up to USD$11.44 early on in the trading day.

    Contextualizing the Surge in Stock Price

    This massive overnight surge comes despite there being an absence of news coverage on any recent developments that would explain the fortuitous change in equity value. While meme stocks have been all the rage in the stock markets as of late, it seems unlikely that the movement in the price of company shares is due to the meme stock phenomenon. More likely is the case that the company has seen fundamental or market developments that have not yet reached the media.

    iPSP Waiver

    The end of March 2021 saw the company announce the receipt of an initial Pediatric Study Plan (iPSP) waiver from the U.S. Food and Drug Administration for OPT-302. The company’s leading product candidate is currently in Phase 3 clinical development for the treatment of neovascular (wet) age-related macular degeneration.

    Marketing Application for OPT-302

    With the intention of submitting a marketing application of the new treatment, the regulatory review process dictates that OPT provide the FDA with a proposed strategy for the investigation the new treatment in the pediatric population. Notably, the FDA has previously agreed to waive the iPSP requirement.

    Receipt of iPSP Waiver

    The company received such an official, agreed waiver from the FDA for OPT-302 across all subsets of the pediatric population. This includes the full pediatric age group under the age of 17 years. The waiver is for the treatment of wet AMD in conjunction with intravitreal anti-VEGF-A therapy. Due to the receipt of this iPSP waiver, OPT will not have to conduct further studies in the pediatric population.

    OPT-302 Trial

    The agreed iPSP will serve as a crucially significant regulatory milestone in the US, the completion of which will facilitate the submission of a marketing application for OPT-302 to the FDA. The company is committed to continuing the process to fulfill the regulatory requirements stemming from their focus on the pivotal Phase 3 clinical trial. These trials in adult patients are designed to support potential marketing approval of OPT-302 as a viable and effective treatment of wet AMD.

    Future Outlook for OPT

    Armed with the fortuitous surge in value of their equity, OPT is poised to capitalize on the opportunities presented to it. The company is keen to continue its trajectory of success and usher in more organic growth over the long-term. Current and potential investors are hopeful that the management will leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Orphazyme A/S (ORPH) Stock Skyrockets as Newest Target of Meme Stock Phenomenon

    Orphazyme A/S (ORPH) Stock Skyrockets as Newest Target of Meme Stock Phenomenon

    Orphazyme A/S (ORPH) stock prices skyrocketed by a monumental 71.24% shortly after market trading commenced on June 16th, 2021, bringing the price per share up to USD$17.21 early on in the trading day.

    Meme Stock Phenomenon

    The meme stock phenomenon continues to dominate the stock exchange, with a slew of stocks being targeted for a coordinated pump by the Reddit-driven retail investors. Underdogs with a high short interests find themselves fortuitously bolstered as the community of investors continues to target companies without a logical basis for their support. In the absence of recent news or any fundamental developments, companies sometimes on the brisk of collapse find themselves renewed by the sweeping meme stock craze.

    About ORPH

    OPRH is a late-stage biopharmaceutical company that specializes in the pioneering of a heat-shock protein response, which it uses to treat neurodegenerative orphan diseases. As such, OPRH aims to develop and commercialize novel therapeutics based on the amplification of heat-shock proteins. The company’s leading drug candidate is arimoclomol.

    Arimoclomol Development

    Arimoclomol is currently in clinical development targeted at four orphan diseases: Niemann-Pick disease Type C (NPC), Amyotrophic Lateral Sclerosis (ALS), Inclusion Body Myositis (IBM) and Gaucher disease. The company is based out of Denmark, with shares of its common stock listed on the Nasdaq as an American Depositary Receipt. With some operations based on the U.S, most of the company’s operations are focused in Europe.

    Future Outlook for ORPH

    Armed with the fortuitous surge in the value of their equity, ORPH is poised to capitalize on the opportunities presented to it. The company is keen to continue its trajectory of success and usher in more organic growth over the long-term. Current and potential investors are hopeful that the management will leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Aptinyx Inc. (APTX) Stock Surges Inexplicably Amid Continuing Meme Stock Phenomenon Throughout Stock Market

    Aptinyx Inc. (APTX) Stock Surges Inexplicably Amid Continuing Meme Stock Phenomenon Throughout Stock Market

    Aptinyx Inc. (APTX) stock prices were up by a massive 28.7134% shortly after market trading commenced on June 11th, 2021, bringing the price per share up to USD$4.1317 early on in the trading day.

    Fortuitous Gains

    This surge in the value of the company’s equity comes despite a lack of significant news or recent developments that would help explain the overnight skyrocketing of the stock. With the meme stock phenomenon that rule the stock market this past week, it is possible the movement stems from a coordinated effort by retail investors to execute a short squeeze.

    Solid Liquidity Position

    In their financial reports for the first quarter of the fiscal year 2021, APTX reported a comfortable liquidity position with USD$146.8 million in cash and cash equivalents as of March 31st, 2021. This is an increase from the USD$141 million reported as of December 31st, 2020. With its current liquidity position, APTX anticipates its operations being funded through to 2023.

    Collaboration Revenue

    Revenue for the first quarter of the fiscal year 2021 came in at USD1 million, an improvement on the USD$0.8 million reported for the same time period of the prior fiscal year. The company’s revenue was generated from its research collaboration agreement with Allergan, a subsidiary of AbbVie. The funding of the company’s operations does not rely on the generation of these revenues.

    R&D Expenses

    Research and development costs were reported at USD$10.3 million for the first quarter of the fiscal year 2021, down from the USD$11.1 million reported for the same time period of the prior fiscal year. The year-over-year decrease is largely attributable to the completion of the exploratory Phase 2 study of NYX-783 in PTSD, having occurred in October 2020. Also contributing to the difference was the temporary suspension of enrollment in the exploratory Phase 2 study of NYX-458 in cognitive impairment, which went on to recommence in March 2021. The decrease was partially offset by the increasing of costs associated with the recommencement of the company’s two Phase 2b studies of NYX-2925 in chronic pain.

    Future Outlook for APTX

    Armed with a solid liquidity position that will see the company through the next several quarters, APTX is poised to push for the commercialization of its pipeline candidates. The company is keen to continue its trajectory of success and capitalize on the recent gains in equity value to ensure further organic growth. 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.