STOCKS TELEGRAPH

Tag: healthcare

  • AzurRx BioPharma, Inc. (AZRX) Stock Suffers Following Upsizing of Previously Announced Public Offering

    AzurRx BioPharma, Inc. (AZRX) stock prices were down 19.66% as of the market closing on July 23rd, 2021, bringing the price per share down to USD$0.5690. Subsequent premarket fluctuations saw the stock rally by 12.48%, bringing it up to USD$0.64.

    AZRX Upsizes Offering

    July 22nd, 2021 saw AZRX stock announce the increasing of the size of its previously announced public offering because of unexpected demand. The underwriter has agreed to purchase on a firm commitment basis 9,090,910 shares of common stock of the company. The price was the same as the public offering, with each share being priced at USD$0.55. The closing of the transaction is expected for July 27th, 2021.

    Details of the Offering

    the offering comes equipped with a 30-day option to purchase up to an additional 1,363,636 shares of common stock at the same public offering price. AZRX stock expects generating USD$5 million in gross proceeds before the deduction of expenses related to the offering and the execution of the option to purchase additional shares. The capital raised is expected to be used to pay milestone payments as per existing license agreements.

    AZRX Stock Hits RESERVOIR Milestone

    Earlier on June 7th, 2021, AZRX stock announced the administration of the first dose of FW-1022 to a volunteer in its ongoing Phase 2 RESERVOIR clinical trial. The proprietary treatment comes in tablet form and is designed to treat Covid-19-related GI infections. The company forecasts topline results from the trial for the first quarter of 2022. This development marks a significant milestone for the company and the development of niclosamide.

    Scope of FW-1022

    With no existing approved treatments for GI infections stemming from Covid-19, the success of AZRX’s development program could help prevent reinfection and, therefore, the spread of Covid-19. FW-1022 also has the potential to treat severe complications that are believed to results from SARS-CoV-2’s ability to hide in reservoirs within the GI tract. The company is confident that its micronized oral niclosamide therapy can target the virus directly in the gut. This will play a critical role in the treatment of Covid-19 patients that suffer from the damage caused by Covid-19-related GI infection.

    Future Outlook for AZRX

    With the world hurtling towards universal immunizations, AZRX stock is poised to capitalize on the burgeoning market. Keen to continue its trajectory of success, the company plans to regain momentum with its added capital and reverse the recent downward trend. Investors are confident in management’s ability to produce significant and sustained increases in shareholder value.

  • Arvinas, Inc. (ARVN) Stock on the Rise Following Global Partnership with Pfizer

    Arvinas, Inc. (ARVN) stock prices were up by 8.68% some time after market trading commenced on July 22nd, 2021, bringing the price per share up to USD$84.28 early on in the trading day.

    Partnership with Pfizer

    July 22nd, 2021 saw the company announce its global collaboration with Pfizer in order to develop and commercialize ARV-471, an investigational oral PROTAC, estrogen receptor protein degrader. The estrogen receptor has been shown to drive diseases in most cases and forms of breast cancer. The treatment is currently in Phase 2 dose expansion clinical trial, designed to treat patients with estrogen receptor (ER) positive/human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-).

    Details of the Agreement

    As per the agreement, the partnering company will make an upfront payment of USD$650 million to ARVN, as well as a USD$350 million equity investment in the company. Global development costs, commercialization expenses, and profits will be split equally between the partnering companies. The combination of the company’s leadership in targeted protein degradation with Pfizer’s global capabilities and extensive expertise in breast cancer is expected to prove transformational.

    Scope of ARV-471

    This, in turn, will substantially enhance and accelerate the development and eventual commercialization of ARV-471 while concurrently advancing the company’s strategy of building a global and integrated biopharmaceutical company. Despite the advancement of the oncology space over recent years, there is still a sizeable unmet need that persists in the treatment of HR+ breast cancer. The partnership with Pfizer will see the deployment of PROTAC technology in a bid to help mitigate the devastation caused by the disease.

    ARV-471’s Potential

    December 2020 saw the company present interim data for its Phase 1 dose-escalation clinical trial of ARV-471 in patients with locally advanced or metastatic ER+/HER2- breast cancer. The treatment is indicated for its potential as a novel oral ER targeted therapy. Patients enrolled in the study were heavily pretreated, having been administered with cyclin-dependent kinase (CDK) 4/6 inhibitors. Despite the extensive pretreatment and the advanced stage of disease, the interim results demonstrated the treatment’s ability to promote substantial ER degradation and exhibits an encouraging clinical efficacy and tolerability profile.

    Future Outlook for ARVN Stock

    Armed with a massively expansive collaboration with Pfizer, the company is keen to make the most of the opportunities afforded to it as it expands and consolidates its market footprint. Current and potential investors are hopeful that management will be able to leverage the resources at their disposal to usher in organic growth over the long term.

  • 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.

  • TRACON Pharmaceuticals, Inc. (TCON) Stock Plummets Following Upsizing of Underwritten Public Offering

    TRACON Pharmaceuticals, Inc. (TCON) stock prices were down 4.27% as of the market closing on July 21st, 2021, bringing the price per share down to USD$4.93 at the end of the trading day. Subsequent premarket fluctuations saw the stock plummet by 23.33%, bringing it down to USD$3.78.

    Upsizing of Public Offering

    July 21st, 2021 saw the company announce the upsizing of its previously announced public offering as a result of the level of demand. The upsizing will consist of a firm commitment to purchase 3,926,702 shares of common stock, with each share being priced at USD$3.82. Furthermore, the agreement comes equipped with a 30-day option to purchase up to an additional 589,005 shares of common stock at the public offering price. The closing of the public offering is expected to close on July 26th, 2021.

    Details of the Offering

    The public offering is expected to generate gross proceeds in the amount of roughly USD$15 million, before the deduction of expenses related to the offering and excluding the exercising of the over-allotment option. The capital raised is forecasted to be allocated towards the supporting of the continued clinical development of envafolimab, as well as for working capital and general corporate purposes.

    Orphan Drug Designation

    June 29th, 2021 saw the company announce the granting of Orphan Drug Designation to envafolimab by the U.S Food and Drug Administration. The innovative, single-domain antibody against PD-L1 is being developed for the treatment of patients with soft tissue sarcoma. This development followed the submissions of a revised application that consisted of data from the Phase 1 clinical trial from sarcoma patients treated with single-agent envafolimab.

    Basis of Envafolimab ODD

    The Orphan Drug Designation submission for the use of envafolimab in sarcoma included clinical data that signaled confirmed objective partial responses by RECIST with response durations exceeding six months. This promising development was observed in two out of five patients with refractory metastatic alveolar soft part sarcoma (ASPS), with the patients having been administered single-agent envafolimab in Phase 1 clinical trials. The trials were conducted by the company’s partner, 3D Medicines and Alphamab Oncology. The Phase 1 trials did not include patients with undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) were not treated as part of Phase 1 trials.

    Future Outlook for TCON

    Armed with the added influx of capital generated from the company’s public offering, TCON is poised to capitalize on the opportunities afforded to it as a result of the granting of Orphan Drug Designation for its flagship treatment. Investors are hopeful that management will be able to facilitate the hasty commercialization and effective proliferation of the treatment as it continues to work closely with the FDA.

  • NeuroMetrix, Inc. (NURO) Stock Soars Following Breakthrough Designation for Quell Device

    NeuroMetrix, Inc. (NURO) Stock Soars Following Breakthrough Designation for Quell Device

    NeuroMetrix, Inc. (NURO) stock prices skyrocketed by 145.51% some time after market trading commenced on July 20th, 2021, bringing the price per share up to USD$8.00 early on in the trading day.

    Breakthrough Designation Granted

    July 20th, 2021 saw the company announce that the United States Food and Drug Administration granted Breakthrough Designation for NURO’s Quell device, which is designed to treat symptoms of fibromyalgia in adults. With the company reporting moving forward with regulatory filing, it hopes to launch Quell for fibromyalgia indication by the second half of 2021.

    Fibromyalgia

    Fibromyalgia is a form of chronic pain that is associated with fatigue, sleep, cognitive, and mood disturbances. With nearly 2 to 6% of the population of the U.S being affected, diagnoses are most often made between the ages of 30 and 50. While the cause of the illness is unclear, studies have indicated abnormalities in the way the brain processes normal sensations and pain. Despite the FDA having approved several drugs for the management of fibromyalgia pain, there is still a significant unmet need for safe and effective non-pharmacological treatments.

    Quell Technology

    Quell is an innovative, non-invasive, nerve stimulation device that is designed to mitigate the effects of fibromyalgia. Covered by 18 U.S utility patents, it sets itself apart as the only wearable neurostimulator that functions with the use of a custom designed microchip. The device provides flexible, accurate, high-power nerve stimulation in a form factor not bigger than a credit card. The device uses position and motion sensing to automatically adjust stimulation output for an optimal patient experience over the course of the entire day. Bluetooth low energy is supported by the device in communication with its app, which is available on both Android and Apple mobile devices.

    Breakthrough Device Designation

    The FDA Breakthrough Device Program is designed to facilitate the accessibility of breakthrough technologies for the patients that need them urgently. As per the program, the FDA will provide a priority review for NeuroMetrix, as well as interactive communication regarding its development. Furthermore, government policies and programs currently in the works have the potential to facilitate Medicare reimbursement for FDA Breakthrough Devices after they have been granted marketing authorization.

    Future Outlook for NURO

    Armed with the support of the FDA, NURO is poised to capitalize on the massive market space it finds at its disposal. Current and potential investors are hopeful for the accelerated development and commercialization of Quell so as to maximize gains in shareholder value.

  • Immunome, Inc. (IMNM) Stock Skyrockets Following Promising Results of IMM-BCP-01 in Neutralizing Delta Variant of Covid-19

    Immunome, Inc. (IMNM) Stock Skyrockets Following Promising Results of IMM-BCP-01 in Neutralizing Delta Variant of Covid-19

    Immunome, Inc. (IMNM) stock prices soared by 20.85% shortly after market trading commenced on July 20th, 2021, bringing the price per share up to USD$20.11 early on in the trading day.

    IMM-BCP-01

    July 20th, 2021 saw the company announced the potent neutralizing activity demonstrated by its three-antibody cocktail (IMM-BCP-01) against the Delta variant of the coronavirus pandemic. The treatment also showed in-vitro activity via non-neutralizing mechanics, such as complement fixation, which the company anticipates enabling viral clearance for the treatment.

    Addressing Delta Variant Concerns

    With the highly concerning evolution of the Covid-19 virus taking the world by storm, the company is hopeful that its drug candidate is adequately positioned to become a leader in the global fight against the deadly coronavirus. The treatment’s ability to maintain neutralizing activity against the newer Covid-19 variants is highly promising, with its mechanisms of action targeting at least three non-overlapping epitopes. The mechanisms are informed by an authentic human immune response and provide a robust defense against future mutational drift.

    Expediting Development

    With the majority of the current cases in the United States reporting infection with the Delta variant of the coronavirus, the company was awarded USD$17.6 million as a technology award to aid the development of the treatment. Granted by the U.S. Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense in collaboration with the Defense Health Agency, the award serves to accelerate the availability of the treatment as the world hurtles towards universal immunizations.

    Ahead of the Curve

    With cases finally dwindling down, the United States is on high alert for the near-term potential for a resurgence of coronavirus infections, as a result of the emerging variants. The company is exploring all options to expedite the development of IMM-BCP-01, with plans to submit an IND application with the U.S Food and Drug Administration as early as this quarter. The biopharmaceutical company leverages its proprietary human memory B cell platform in a bit to aid the discovery and development of first-in-class antibody therapeutics.

    Future Outlook for IMNM

    Armed with a promising drug candidate that could address the massive gap that arose in the marketspace as a result of the proliferation of the Delta variant, IMNM is poised to capitalize on the expanded scope of the opportunities afforded to it. Investors are hopeful that management will be able to spearhead the commercialization and proliferation of IMM-BCP-01, thus resulting in increases in shareholder value over the long term.

  • 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.

  • NRx Pharmaceuticals, Inc. (NRXP) Stock Surges ZYESAMI Role in Pandemic Response

    NRx Pharmaceuticals, Inc. (NRXP) Stock Surges ZYESAMI Role in Pandemic Response

    NRx Pharmaceuticals, Inc. (NRXP) stock prices skyrocketed by 42.84% shortly after market trading commenced on July 19th 2021, bringing the price per share up to USD$12.17 early on in the trading day.

    ZYESAMI’s Role in Covid-19

    July 21st, 2021 saw the company announce data about ZYESAMI (aviptadil) at the Disease Control and Prevention Summit., in regard to the role of the treatment in preventing Cytokine Storm in Covid-19 patients. The presentation will showcase the statistically significant effect of ZYESAMI in mitigating the sharp rise in cytokines, which are closely linked to mortality in Covid-19 patients. This was consolidated by the completion of a recent Phase 2b/3 trial of ZYESAMI, wherein the change in cytokine level was a prespecified endpoint.

    Details of the Study

    Patients treated in the study showed a minimal increase in IL-6, as compared to patients treated with a placebo reported a statistically significant elevation in interleukin 6 cytokine levels. The patient set was diverse, with varying levels of the severity of Covid-19 infection and distribution among both tertiary care and community hospitals.

    Accelerated Development

    The findings have been submitted to the U.S. Food and Drug Administration as supplements to the Emergency Use Authorization application that has been submitted as is currently pending. The company is also submitting a biomarker letter of intent to the FDA as a part of its biomarker program, as pre the authorization of the 21st Century Cures Act.

    Scope of ZYESAMI

    With Covid-19 hospitalizations continuing to rise around the world, the placebo-controlled biomarker data signals the critical role that ZYESAMI has the potential to play in the prevention of the sudden elevation of cytokines that is linked to mortality. A biomarker-based regulatory path seems cleared on the basis of the link established between the clinical effect of ZYESAMI on survival and recovery in conjunction with measurable biologic chance in cytokine levels. The effects of a cytokine storm are lethal and are associated with mortality resulting from a variety of fatal conditions, including, but not limited to, Acute Respiratory Distress Syndrome, a common cause of death in sepsis, and amniotic fluid embolus.

    Future Outlook for NRXP

    Armed with a highly promising advancement in the fight against the continuing global coronavirus pandemic, NRXP is poised to capitalize on the prospective market space that has become accessible to it. With such spearheaded market penetration, current and potential investors are hopeful that management will be able to leverage their resources to facilitate effective distribution of the offering in a timely manner to ensure maximum profitability.

  • Conformis, Inc. (CFMS) Stock on the Rise as it Prepares to Present at Canaccord Genuity 40th Annual Growth Conference

    Conformis, Inc. (CFMS) Stock on the Rise as it Prepares to Present at Canaccord Genuity 40th Annual Growth Conference

    Conformis, Inc. (CFMS) stock prices were up 7.62% as of market trading closing on July 16th, 2021, bringing the price per share up to USD$1.13 at the end of the trading day. Subsequent premarket fluctuations have seen the stock rise by 6.19%, bringing it up to USD$1.23.

    Settlement Agreement

    July 7th, 2021 saw the company announce having entered into a settlement agreement with Stryker Corp., thus putting to rest ongoing patent litigation in regard to Wright Medican Technology and Tornier, which were acquired by Stryker in November of 2020. The resolution of the patent litigation over the Wright Medical dispute signals the strength and value of the company’s intellectual property, as well as their unwavering commitment.

    Details of the Lawsuit

    April 24th, 2020 had seen CFMS file a lawsuit against Wright Medical in the United States District Court for in Delaware. The lawsuit alleged that the defendant’s various lines of patient-specific shoulder instruments infringed existing patents, as did implant components used in conjunction with the instruments. As per the terms of the settlement agreement, Stryker is set to make a one-time payment to CFMS, which will grant it a non-exclusive license for some of the company’s patents.

    Distribution Agreement

    June 23rd, 2021 had seen the company announce the execution of an agreement with XR Medical Group, which would see the company enter the Asia-Pacific market through an exclusive distribution relationship. As per the distribution agreement, XR Medical will be granted exclusive rights for the sale, marketing, and distribution of CFMS’ patient-specific iTotal CR and PS total knee replacement systems. Also included in the agreement are the iTotal CR and PS patella devices, as well as the iUni and iDuo partial knee replacement systems. The agreement also allows for the proactive additional of CFMS’s expanding product portfolio into the terms of the agreement.

    Scope of Market

    With the global market for knee joint reconstruction being pegged in excess of USD$9 billion, the Asia-Pacific region makes up an estimated USD$1.7 billion of the burgeoning marketspace. The company is keen to see the fruition of Fortune Business Insights’ forecasts of continued increases in the rate of growth, stemming largely from an increased prevalence of knee disorders, surges in medical tourism, higher disposal incomes, as well as improved healthcare infrastructure.

    Future Outlook for CFMS

    Armed with the resolution to their litigation issues, the company is poised to allocate its resources towards penetrating the newly accessed Asia-Pacific market. CFMS is keen to push for the continued commercialization and increased proliferation of its myriad of treatment options. Investors are hopeful that management will be able to usher in significant and sustained increases in shareholder value over the long term.

  • Windtree Therapeutics, Inc. (WINT) Stock Exhibits Minor Volatility Despite Promising Istaroxime Developments

    Windtree Therapeutics, Inc. (WINT) Stock Exhibits Minor Volatility Despite Promising Istaroxime Developments

    Windtree Therapeutics, Inc. (WINT) stock prices were down by 6.56% as of the market closing on July 16th2021, bringing the price per share down to USD$1.71 at the end of the trading day. Premarket fluctuations saw the stock rise by 6.43%, bringing it up to USD$1.82.

    Istaroxime Study

    May 2021 saw the company reiterate the expansion of the counties and sites participating in its Phase 2 global clinical study. The study is for istaroxime, which is being evaluated as a viable treatment option for Early Cardiogenic Shock in patients having suffered from severe acute heart failure. A severe form of heart failure, cardiogenic shock is marked by critically low blood pressure. The development of the treatment is founded in observations from the acute heart failure program and will serve to assess istaroxime’s ability to improve blood pressure. The study is expected to be completed by the second half of 2021.

    Istaroxime Patent Protection

    The company has also been seeking additional expedited patent protection for istaroxime, their lead asset. To facilitate this, WINT filed a Track One prioritized patent application with the U.S Patent and Trademark Office, with the associated patent being derived from an application previously filed under the Patent Cooperation Treaty. As per the Track One program, the new patent for istaroxime is forecasted to receive a review and final disposition according to an accelerated timeline. The priority status being granted, the company expects finalizations within a year, as compared to the typical three-year examination for non-prioritized examinations.

    Solid Liquidity Position

    The first quarter of 2021 saw WINT complete an equity financing program, which saw the company generate almost USD$30 million in gross proceeds, before the deduction of expenses related to the offering. Net proceeds from the offering came out to roughly USD$27.4 million, contributing to the company’s solid liquidity position as of March 31st, 2021, when WINT announced having cash and cash equivalents in the amount of USD$38.5 million.

    Net Loss Reports

    WINT reported a net loss of USD$9 million on 17.7 million weighted-average common shares outstanding as of the end of the first quarter of 2021, representing a net loss of USD$0.57 per basic share. The is comparable to the UD$6.5 million net loss reported for the prior-year period, which had 13.7 million weighted average common shares outstanding, representing a net loss of USD$0.48 per basic share.

    Future Outlook for WINT

    Armed with a comfortable liquidity position and strategic partnerships that aim to develop treatments through to commercialization and proliferation, WINT is poised to capitalize on the opportunities afforded to it. 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.