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Tag: pharma

  • TRxADE HEALTH, Inc. (MEDS) Stock Dips Significantly Following Disclosure of Q2 2021 Financial Reports

    TRxADE HEALTH, Inc. (MEDS) stock prices were down 4.01% as of the market closing on July 26th, 2021, bringing the price per share down to USD$5.26 at the end of the trading day. Subsequent premarket fluctuations saw the stock plummet by 19.20%, bringing it down to USD$4.25.

    Expanding Consumer Base

    MEDS stock continued to allocate resources toward the expansion of its drug procurement marketplace over the course of Q2 2021. The quarter reported having added roughly 195 new registered members, bumping the total number of registered members up to more than 12,700. The company also signed various enterprise retail partnerships to onboard new customers to its telehealth platform, partnering up with the likes of Brookshire Grocery, Winn-Dixie, and Big Y. MEDS stock’s Bonum Health product is now offered in 500 stores across all 50 states, increasing accessibility to its thousands of customers.

    MEDS Stock’s Partnerships

    MEDS stock also secured a group purchasing agreement with QualityCare Pharmacies, an independent pharmacy prescription drug buying group. QualityCare is the newest part of the company’s rapidly expanding GPO offering, aimed to drive substantial gains in wallet share amongst independent pharmacies on the TRxADE platform. MEDS stock also launched a government-oriented health passport solution with an accompanying mobile app, facilitating the expedition of post-Covid-19 reopening.

    MEDS Stock Revenue Reports

    Revenues for Q2 2021 were up to USD$1.9 million, down from the USD$6.6 million in the same quarter of the prior year. This year-over-year decrease was largely driven by non-recurring sales of personal protective equipment (PPE) in the 2020 quarter, in relation to global efforts to manage the outbreak of the Covid-19 pandemic.

    Additional Financials

    The second quarter of 2021 saw MEDS stock report gross profits in the amount of USD$0.8 million, representing 44.3% of the quarter’s revenues. This is comparable to the USD$2 million reported for the prior-year quarter, representing 30.4% of revenues. The substantial year-over-year increase in gross profit margin was largely driven by fewer lower margin PPE sales in the 2021 quarter. Operating expenses for the second quarter of 2021 came in at USD$3.4 million, up from the USD$2.5 million reported in the prior-year quarter. This increase was largely driven by an inventory investment loss of USD$1.2 million.

    Future Outlook for MEDS

    Armed with its expanding network of strategic collaborations and the success of its most recent financial reports, MEDS stock is poised to continue its trajectory of success. The company is keen to allocate resources so as to usher in further growth, with investors hoping for long-term increases in shareholder value.

  • Agile Therapeutics Inc. (AGRX) Stock Exhibits Minor Volatility Following Promising Q2 2021 Financial Reports

    Agile Therapeutics Inc. (AGRX) stock prices were down 3.45% as of market closing on July 26th, 2021, bringing the price per share down to USD$1.12 at the end of the trading day. Subsequent premarket fluctuations saw the stock rise by 4.46%, bringing it up to USD$1.17.

    AGRX Stock Prescriptions Improved

    The second quarter of 2021 saw AGRX stock report total prescriptions coming in at 5,027, up a massive 171% from the numbers reported for the prior quarter. New prescriptions were up 103% over the quarter, reported at 2,857. These increases were driven by increases in the number of prescribers and growing refill rates. As of June 30th, 2021, the company reported more than 2,087 healthcare providers, while 2,033 prescriptions were dispensed as refills. Up 355% from the prior quarter. AGRX also reported an increase in the total number of prescriptions per prescriber.

    AGRX Stock’s Market Reach

    AGRX stock has continued expanding the market footprint of Twirla, with it being available to Medicaid patients across roughly 75%, either through traditional and/or managed Medicaid. This development sees Twirla cover roughly half of the total Medicaid transdermal TRx market with no restrictions. Based on claims, Twirla reports having access to roughly 55% of the commercial and government CHC market.

    Cost of Product Revenue

    Cost of product revenues for the quarter ended June 30th, 2021 was reported at USD$1.1 million and included direct and indirect expenses. These costs supported AGRX stock’s manufacturing and distribution efforts, including, but not limited to, personnel costs and roughly USD$500,000 of non-cash depreciation expense. These relatively fixed costs are expected to stay roughly the same as sales increase with expected volume increases.

    Additional Financials

    AGRX stock was selling units from validation batches until May 2021, with no associated product cost on account of the cost having been previously expensed already. Roughly 76% of the units sold over the second quarter of 2021 had an associated product cost, as will all future sales of the product. As of June 30th, 2021, the company reported USD$31.1 million in cash, cash equivalents, and marketable securities. This is compared to the USD$54.5 million reported as of December 31st, 2020.

    Future Outlook for AGRX

    With the company’s flagship Twirla gaining traction and snowballing in sales, AGRX stock is poised to capitalize on the increasing momentum. The company is keen to continue its trajectory of success as it effectively allocated its resources to stay lean. Current and potential investors are hopeful that management will be able to leverage the resources at its disposal to facilitate significant and sustained increases in shareholder value.

  • NovaBay Pharmaceuticals, Inc. (NBY) Stock Surges Following Announcement of Partnership with ImprimisRx

    NovaBay Pharmaceuticals, Inc. (NBY) Stock Surges Following Announcement of Partnership with ImprimisRx

    NovaBay Pharmaceuticals, Inc. (NBY) stock prices surged by 13.0835% some time after market trading commenced on July 19th, 2021, bringing the price per share up to USD$0.6517 early on in the trading day.

    Partnership with ImprimisRx

    July 19th, 2021 saw the company announce its partnership with ImprimisRx, leading ophthalmological pharmaceutical businesses in the United States. The partnership will facilitate the proliferation of Avenova, driven by the widespread promotion of prescription treatment. ImpromisRx will provide NBY with national sales, marketing, and distribution support for the FDA-cleared treatment, which comes in 40 ml bottles as a 0.01% hypochlorous acid. The treatment has been clinically proven to be effective in the management of numerous chronic eye conditions as an antimicrobial lid and lash solution.

    About ImprimixRx

    The partnering company has a proven track record of successfully commercializing high-quality products through its extensive consumer base of thousands of ophthalmologists and optometrists. This position itself superbly to partner up with NBY to expand the reach of Avenova. With its cutting-edge model, ImprimisRx has streamlined the ordering and delivery of products by making the pharmaceutical value chain leaner.

    Details of the Agreement

    As per the agreement, the expansion of Avenova within the prescription channel via cost-effective means has been made possible. This will be done by facilitating the engagement of ophthalmologists and optometrists, enhancing the accessibility of Avenova to unprecedented levels. The compelling addition of the treatment to the company’s ophthalmic product portfolio is set to support its long-standing commitment to its loyal customer base.

    Scope of Avenova

    The treatment caters to a massive dry eye market that is rapidly growing, with the current indication of as many as 30 million Americans reporting suffering from chronic eye conditions, such as blepharitis and meibomian gland dysfunction. The unique treatment is the only lid and lash spray that is suitable for everyday use, having been formulated with NovaBay’s patented pure hypochlorous acid. Avenova is typically prescribed before and after cataract and Lasik procedures by ohthalmologists and optometrists, consolidating it as a complementary treatment for many of the partnering company’s existing product line.

    Future Outlook for NBY

    Armed with the expansive scope of its new strategic partnership, NBY is poised to capitalize on the added opportunities in front of it. The company is keen to usher in further growth by allocating resources towards the expansion and consolidation of the market footprint of Avenova. Investors are confident in management’s ability to leverage their resources to drive increases in shareholder value.

  • Endo International PLC (ENDP) Stock Continues Trending Down as Legal Trials Continue

    Endo International PLC (ENDP) stock prices were down 3.06% as of the market closing on July 15th, 2021, bringing the price per share down to USD$3.49 at the end of the trading day. Subsequent premarket fluctuations have seen the stock dip by 4.01%, bringing it down to USD$3.35.

    Health Canada Approval

    June 9th 2021 saw the company announce the approval of Wakix (pitolisant) by Health Canada for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy. The approval of the treatment by Health Canada will facilitate the provision of a much-needed treatment for Canadians that suffer from narcolepsy. The treatment also affords patients the option to manage their EDS or as a treatment for their cataplexy attacks. The company is continuing to offer novel treatment options to help support the unmet needs of the Canadian patient demographic.

    ENDP Partnerships

    The company intends to collaborate with the Canadian Agency for Drugs and Technologies in Health (CADTH), as well as the Institut national d’excellenceensanteen services sociaux (INESSS). This partnership will facilitate the hasty provision of Wakix to its patients. 2018 saw the company’s subsidiary, Endo Ventures Ltd., entered into an agreement with Bioproject SCR. This partnership will see the company register, commercialize and distribute pitolisant on an exclusive basis across Canada. The commercialization of pitolisant in Canada will be conduced by Paladin Labs, an operating company of ENDP.

    Ahead of the Competition

    Wakix is in a class of its own, being the first and only Health Canada approved treatment for EDS and cataplexy symptoms in adult patents with narcolepsy. The first-in-class highly selective histamine 3 receptor antagonist/inverse agonist works through an innovative and unique mechanism of action. It increases the levels of histamine and other wakefulness promoting neurotransmitters in the brain.

    Mechanics of Wakix

    The tablet is to be taken once daily, every morning upon waking up. Wakix is thus far the only treatment for cataplexy that is not a controlled drug, having been approved by Health Canada. The treatment is currently marketed across Europe and the United States, serving as a registered trademark of Bioproject Europe Ltd.

    Future Outlook for ENDP

    Armed with the massively successful scope of the commercialization of Wakix having proliferated the entirety of the North American market, ENDP is poised to capitalize on the expanded opportunities for growth. Current and potential investors are hopeful that management will be able to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Sonoma Pharmaceuticals, Inc. (SNOA) Stock Drops Significantly Despite Promising Financial Reports for Fiscal Q4 2021

    Sonoma Pharmaceuticals, Inc. (SNOA) stock prices were down 18.88% some time after market trading commenced on July 15th, 2021, bringing the price per share down to USD$6.23 early on in the trading day.

    Partnership with EMC Pharma

    March 26th, 2021 saw the company report having entered into a new partnership with EMC Pharma in light of it having gained exclusive rights for the U.S commercialization of prescription dermatology and prescription eye care products. The pharmaceutical company was also granted non-exclusive rights to sell their wound care products into government channels. The initial term of the agreement is subject to minimum purchases and is set for five years, with the option to renew.

    Network of Partnerships

    September 2020 saw the company launch two new products, Nasocyn Nasal Care and Oracyn Oral Care in collaboration with its partner, Te Arai Biofarma Ltd. December 2020 saw the company partner up with Gabriel Science, LLC in order to penetrate the dental markets in the U.S with their HOCI product. January 2021 saw the company receive clearances in Thailand, after which the sales of Dermodacyn disinfectant commenced in Hong Kong and Thailand, through its partner, VetSynova Co. Ltd.

    Total Revenues

    Total Revenues for the quarter ended March 31st, 2021 came in at USD$2.2 million, down by USD$2.1 million as compared to the same time period of the prior year. The 50% reduction was largely driven by the USD$1.6 million decline in the U.S, which, in turn, was motivated by the decline of the company’s dermatology business. The dermatology business has since been partnered with EMC Pharma, LLC. Further compounding the year-over-year difference was USD$800,000 in revenue adjustments in relation to the overestimation of revenue in the prior-year quarter, having been determined using a look-back analysis.

    Invekra Contract

    As a result of the Invekra contract having concluded in October of 2020 resulted in a USD$0.7 million reduction in revenues generated from Latin America sales, further contributing to the yearly difference in total revenue. As per the contract, SNOA the company manufactured at low margins for Invekra. Since the conclusion of the contract, manufacturing has continued at reduced quantities but higher margins.

    Future Outlook for SNOA

    Armed with a network of partnerships secured over the past few quarters, SNOA is poised to capitalize on the chances afforded to it. The company is keen to continue its trajectory of success as it pushes for the consolidation and expansion of its market footprint around the globe. Current and potential investors are hopeful that management will be able to usher in sustained and significant 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.

  • Aerpio Pharmaceuticals, Inc. (ARPO) Stock Surges After Being Massively Upgraded by Analysts

    Aerpio Pharmaceuticals, Inc. (ARPO) Stock Surges After Being Massively Upgraded by Analysts

    Aerpio Pharmaceuticals, Inc. (ARPO) stock prices skyrocketed by 69.0059% some time after market trading commenced on July 8th, 2021, bringing the price per share up to USD$2.89 earlier in the trading day.

    Upgrading of ARPO Stock

    Analyst Robert Burns of H.C Wainwright upgraded ARPO from a Neutral rating to a Buy, with the company’s stock being given a USD$22 price target. Burns cited the transformative nature of the merger as being the driving force behind the upgrading of the company. Furthermore, the merger is expected to facilitate the transition to a self-sustaining, commercial-stage enterprise, with a distinguished flagship product that boasts applicability across a myriad of oncology indications.

    Merger with Aadi Bioscience

    May 16th, 2021 saw the company announce its strategic merger with Aadi Bioscience, Inc. and Aspen Merger Subsidiary, Inc. The agreement will see Aadi surviving the merger as a wholly-owned subsidiary of ARPO, with both companies’ Board of Directors having given their approval. Following the merger, ARPO will continue as Aadi Bioscience and will focus on the development of FYARRO.

    PIPE Financing

    In connection to the merger, ARPO entered into subscription agreements to raise up to USD$155 million in Private Investment in Public Equity (PIPE) financing. The PIPE will see shares of the company’s common stock and pre-funded warrants being used to purchase Aerpio’s common stock. This move is expected to be executed at the same time as the closing of the merger, as per customary closing conditions and the closing of the merger itself.

    Solid Liquidity Position

    March 31st, 2021 saw the company report USD$39 million in cash and cash equivalents, down from the USD$42.6 million reported as of December 31st, 2020. ARPO reported a total of almost 47.4 million common shares outstanding as of March 31st, 2021, with weighted average common shares, both basic and diluted, outstanding totaling 47.3 million as of the end of the quarter.

    R&D Expenses

    The first quarter of fiscal 2021, ended March 31st, 2021, saw ARPO report USD$2.2 million in research and development costs, up 21.8% from the USD$1.8 million reported for the three-month period ended March 31st, 2020. This year-over-year difference was largely driven by increased expenses associated with the company’s clinical programs.

    Net Loss Reports

    Net loss attributable to common stockholders was USD$4.4 million for the quarter ended March 31st 2021, representing a net loss of USD$0.09 per common share. This is comparable to the USD$3.9 million in net loss reported for Q1 2020, which came out to a net loss of USD$0.10 per common share.

    Future Outlook for ARPO

    Armed with the massive scope in light of its recent merger, ARPO is poised to capitalize on the expanded opportunities afforded to it. The company is keen to leverage its combined resources to usher in sustained and organic growth over the long term. With a target price of USD$22.00, investors are snowballing the growth as it climbs higher and higher towards that goal.

  • Odonate Therapeutics, Inc. (ODT) Stock Skyrockets as Latest Potential Target of Meme Stock Phenomenon

    Odonate Therapeutics, Inc. (ODT) stock prices were up by 2.97% as of the market closing on July 2nd 2021, bringing the price per share up to USD$3.47 at the end of the trading day. Subsequent premarket fluctuations saw the stock skyrocket by 32.85%, bringing it up to USD$4.61.

    Cessation of Texetaxel Development

    The company recently announced the discontinuation of the development of its flagship tesetaxel treatment, along with the intent to wrap up operations related to the treatment’s development. ODT is collaborating with clinical sites to transition patients from their ongoing studies to relevant and applicable alternative therapies. Compassionate use programs will see the continuation of treatment with tesetaxel, as deemed appropriate in extreme cases.

    Financial Reports

    March 31st 2021 saw the company announce USD$133.2 million in cash, indicating a stellar liquidity position. December 31st 2020 had reported USD$157.3 million, with the difference being largely attributable to a USD$24.9 million cost of operating activities for the three month period ended March 31st 2021. Net loss at the end of the quarter was reported at USD$33.8 million, representing a net loss of USD$0.90 per share. The same time period over the previous year saw the company reported USD$30.2 million in net loss, representing a net loss of USD$0.99 per share.

    Meme Stock Phenomenon

    With the company having closed operations for its primary driving force, the recent surge in equity value is truly confounding. In the absence of recent news developments or changes in the company’s fundamentals, it seems ODT has become the latest target of the meme stock phenomenon that has been raging through stock markets since the AMC and GME debacles earlier in the year.

    About Meme Stocks

    With very little reason to invest in the company, ODT owes its fortuitous surge in equity value to the proliferation of meme stocks. Meme stocks are underperforming companies, with little to no reason to justify an investment in, that are heavily pumped by retail investors. These investors target underdog companies with high short interests in a coordinated short squeeze on the social media platform, Reddit. Understandably, meme stocks come packed with high risk and volatility. Upward movement relies on the strength of each link in the chain of coordination. While many profit heavily on this confounding stock movement, as many or more investors lose their investments if they are late to the pump and dump.

    Future Outlook for ODT

    As it stands, ODT is poised to collapse, but it seems to be kept afloat by its recent surge in equity value. Unless it comes out with significant news in the very near future or manages to leverage its additional capital to generate more organic growth, the future for ODT does not look bright.

  • Diffusion Pharmaceuticals, Inc. (DFFN) Stock Undergoes Minor Volatility Ahead of TCOM Trial Findings

    Diffusion Pharmaceuticals, Inc. (DFFN) Stock Undergoes Minor Volatility Ahead of TCOM Trial Findings

    Diffusion Pharmaceuticals, Inc. (DFFN) stock prices were down by 3.33% as of the market closing on June 29th, 2021, bringing the price per share down to USD$0.7557 at the end of the trading day. Subsequent pre-market fluctuations saw the stock surge by 5.99%%, bringing it up to USD$0.801.

    Phase 1 Trial

    The company announced topline results from its Phase 1 trial of trans sodium crocetinate (TSC), its lead product candidate, on June 30th, 2021. Transcutaneous oxygen monitoring (TCOM) was used to measure the direct pharmacodynamic effects of TSC on peripheral tissue oxygenation in healthy normal volunteers enrolled for the trial. Topline results were founded on analyses of the primary endpoint data, indicating a positive dose-response trend in TCOM readings after TSC administration during the measurement period, as compared to a placebo.

    Trial Results

    Statistical significance was not reached in the magnitude of the treatment’s effect, largely because of the small number of healthy subjects in each cohort, as well as the inherent variability of tcp02 measurement. Despite this, primary endpoint data trends indicated improved peripheral oxygenation as compared to the placebo, with no evidence of hyperoxygenation. TSC was found to be safe and well-tolerated at all doses tested in the trial, with no major adverse events or dose-limiting toxicities.

    Scope of TSC Data

    The data collected served to further elucidate TSC’s exposure-response relationship, which the company will use to build on their clinical development strategy. Upcoming study designs for future trials will be informed by the collected data, as will the ongoing investigation of the timing of administration to maximize clinical efficacy. DFFN believes the data will complement findings from the company’s Covid-19 trial, as well as supporting the ongoing execution of its three well-controlled Oxygenation Trials.

    Supporting TSC Trials

    Each trial is uniquely designed to differentially explore TSC’s unique mechanism of action, with the individual and collective data from these studies forecasted to inform the company’s late phase programs and clinical indications in the push for the commercialization of TSC. The first of the trials was the TCOM Trial, with the primary endpoint evaluating the relative change in TCOM readings from baseline after TSC administration as compared to the placebo.

    Future Outlook for DFFN

    Armed with the recent results of their most recent clinical trial, DFFN is poised to capitalize on the opportunities afforded to it by the expanded scope of options made available to it. Investors are confident that the company will continue to ensure a continued trajectory of success by making use of the resources at their disposal and trial findings as they arise.

  • PLx Pharma Inc. (PLXP) Stock Trends Lower as Preparations for VAZALORE Launch Continue

    PLx Pharma Inc. (PLXP) Stock Trends Lower as Preparations for VAZALORE Launch Continue

    PLx Pharma Inc. (PLXP) stock prices were down by 4.03% as of the market closing on June 28th, 2021, bringing the price per share down to USD$13.58 at the end of the trading day. Subsequent pre-market fluctuations saw the stock fall by a significant 5.30%, bringing it down to USD$12.86.

    Public Offering

    March 2021 saw the company complete an underwritten public offering wherein PLXP sold 8,924,700 shares of its common stock. Each share was priced at USD$8.00, with the offering having generated gross proceeds in the amount of USD$71.4 million, before the deduction of expenses related to the offering. The company plans to allocate the resources raised towards general corporate purposes, which include, but are not limited to, additions to working capital and capital expenditures.

    Revenue and R&D Expenses

    The company reported no revenue for the first quarter of fiscal 2021, as compared to the USD$2,523 reported for the first quarter of the prior year. The absence of revenue serves as the company’s baseline, with revenue in the 2020 period being attributable to operations under an award of a NIH grant, which concluded in the second quarter of 2020. Research and development expenses for the first quarter of 2021 were up to USD$1 million from the USD$0.5 million reported in the same quarter of the previous year. This difference is largely driven by increases in manufacturing-related activities for the company’s flagship VAZALORE.

    G&A Costs

    Q1 2021 saw the company report USD$2.6 million in general and administrative expenses, marginally higher than the USD$2.5 million reported for Q1 2020. The difference is largely driven by increased pre-launch marketing costs, as well as higher non-cash stock-based compensation. Lower compensation-related expenses and absence of travel costs because of the pandemic resulted in a partial offsetting of the initial year-over-year difference in G&A costs.

    FDA Approval

    The U.S Food and Drug Administration approved PLXP’s sNDA for its lead products, VAZALORE 325 mg and VAZALORE 81 mg. the company is allocating resources towards their commercialization as it strengthened its balance sheet by paying off the balance for a term loan that was due in February of 2021. The commercial launch of VAZALORE is scheduled for the third quarter of 2021

    Future Outlook for PLXP

    Armed with a consolidated balance sheet and the upcoming launch of its new VAZALORE products, PLXP is poised to expand its market footprint with the proliferation of its offerings. The company is poised to capitalize on the opportunities afforded to it and to continue its trajectory of success.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.