STOCKS TELEGRAPH

Tag: biopharmaceutical

  • Travena, Inc. (TRVN) Stock Exhibits Minor Volatility Following First Patient Enrolment in ACTIV-4 Host Tissue Trial

    Travena, Inc. (TRVN) Stock Exhibits Minor Volatility Following First Patient Enrolment in ACTIV-4 Host Tissue Trial

    Travena, Inc. (TRVN) stock prices were down 3.24% shortly after market trading commenced on July 27th, 2021, bringing the price per share down to USD$1.3464.

    First Patient Enrolment

    July 26th, 2021 saw TRVN stock announce the enrollment of its first patient in the ACTIV-4 Host Tissue (Accelerating Covid-19 Therapeutic Interventions and Vaccines) trial. With the end of Covid-19 requiring a multi-pronged solution, TRVN stock is excited to be developing TRV027 as a pioneering active treatment arm available for patient randomization.

    ACTIV-4 Host Tissue Trial

    The ACTIV-4 Host Tissue trial serves to evaluate four investigational agents that fight dysregulation of the renin-angiotensin-aldosterone system (RAAS) and immune system irregularities caused by Covid-19 infections. The treatment is a novel AT1 receptor selective agonist that targets the AT1 receptor to bind to within the RAAS, thereby obstructing the damaging pathway that results in acute lung damage and abnormal blood clotting. TRVN stock’s treatment activates the cellular pathway that selectively targets reparative actions that improve lung function and promote anti-inflammatory effects.

    TRVN Stock’s Efforts Against Pandemic

    More than 1600 patients will be enrolled across 50 sites spanning the United States for the TRVN stock’s trial. TRV027 is part of the initial trial launch, with additional study arms being added to the trial over time. The study will serve to evaluate the impact of each intervention on recovery, supplemental oxygen use, need for mechanical ventilation, organ failure, and mortality. As the global Covid-19 pandemic continues to devastate the globe, the development of interventions remains a top priority, aiming to combat the vascular, fibrotic, and inflammatory damage done by the virus.

    About the Trial

    The ACTIV-4 Host Tissue is a multi-site, randomized, placebo-controlled clinical trial with multiple treatment arms. Each arm is expected to enroll roughly 300-400 Covid-19 patients that are 18 years of age or older. The four trial arms will test investigational agents that target the RAAS or immune system through distinct mechanisms of action. The trial is designed for TRVN stock to determine whether modulation of these systems is a viable solution to preventing progression to critical illness in hospitalized Covid-19 patients.

    Future Outlook for TRVN Stock

    Armed with the initiation of patient testing in its ACTIV-4 Host Tissue trial, TRVN stock is poised to capitalize on the opportunities afforded to it. The company is keen to leverage the resources at its disposal to usher in significant long-term growth, which investors hope will translate into gains in shareholder value.

  • Abeona Therapeutics, Inc. (ABEO) Stock Relatively Stable Following Positive Data for Sanfilippo Syndrome Treatment

    Abeona Therapeutics, Inc. (ABEO) stock prices were up 0.76% as of the market close on July 26th, 2021, bringing the price per share up to USD$1.32 at the end of the trading day. Subsequent current market fluctuations saw the stock fall by 5.30%, bringing it down to USD$1.25.

    Promising Topline Data

    July 26th, 2021 saw ABEO stock announce magnetic resonance imaging (MRI) data from the Phase 1/2 Transpher A clinical study. The study indicated that ABO-102 increases grey matter, corpus callosum, and amygdala volumes in the brain. The study consisted of three young patients with Sanfilippo Syndrome Type A (MPS IIIA) at 24 months, compared to afflicted patients who did not receive treatment. The findings were presented by ABEO stock during an oral presentation at the 16th International Symposium on MPS and Related Diseases.

    Scope of Findings

    Brain volume loss is typical in children with MPS IIIA and is linked to long-term cognitive and physical disability. Grey matter has been found to be important for cognitive development, whereas the corpus callosum is crucial for motor function. The amygdala plays a critical role in fear learning as well as social/emotional development. The findings highlight the potential of ABO-102 to increase brain grey matter, corpus callosum, and amygdala volumes. This potential is in line with ABEO stocks’ previously reported results of preservation of neurocognitive development in the three young patients in the Transpher A study.

    ABEO Stock’s Study Endpoints

    The Transpher A study primary endpoints targeted neurodevelopment and the treatment’s safety. Secondary endpoints include, but are not limited to, brain volume, behavior evaluations, quality of life, enzyme activity in cerebrospinal fluid (CSF) and plasma, heparan sulfate levels in CSF, plasma, and urine, and liver volume.

    About the Study

    The Transpher A Study is a two-year process that is currently ongoing as an open-label, dose-escalation, Phase 1/2 global clinical trial. It is designed to assess the treatment of patients with Sanfilippo syndrome type A (MPS IIIA) with the use of ABEO stock’s ABO-102. The study is known as ABT-001 and is intended for patients ranging from birth to 2 years of age, or for patients older than 2 years with a cognitive developmental quotient of 60% or above.

    Future Outlook for ABEO

    Armed with the latest data from its highly promising study, ABEO stock is poised to capitalize on the opportunities ahead of it. The company is keen to push for the accelerated development and proliferation of ABO-102, which investors hope will translate into long-term gains in shareholder value.

  • ObsEva SA (OBSV) Stock Skyrockets Following Global License Agreement with Organon

    ObsEva SA (OBSV) stock prices were up by 2.02% as of the market closing on July 26th, 2021, bringing the price per share up to USD$2.52 at the end of the trading day. Subsequent premarket fluctuations saw the stock surge by 32.94%, bringing it up to USD$3.35.

    OBSV Stock Partners with Organon

    July 27th 2021 saw OBSV stock announce having entered into an agreement with Organon, wherein Organon will license the global development, manufacturing, and commercial rights to ebopriprant (OBE022). The treatment is an investigational, orally active, selective prostaglandin F2α receptor antagonist that is being evaluated as a potential treatment for preterm labor. It is designed to reduce inflammation and uterine contractions. Pending approval, the treatment has the potential to be a first-in-class innovation for a problem that is widespread and serious. Currently, there are no approved therapies for the acute treatment of preterm labor in the United States.

    Ebopriprant (OBE022)

    The asset is currently in the development-stage and is being studied to address a leading unmet need for women around the world. The agreement is set to consolidate the company’s path to sustained growth over the long term as it helps build Organon’s women’s health research and development portfolio. The partners share a vision to improve the women’s health landscape around the world, hoping to revolutionize the healthcare space.

    Facilitating Development

    Organon is an ideal strategic partner for OBSV stock in the collaborative drive to develop and commercialize ebopriprant. Collaboration is a critical step in advancing the investigational agent. While preterm births are on the rise, no other known compounds are currently in development. For this reason, the company is focused on evaluating the treatment of a significant area of unmet need.

    Details of Agreement

    As per the terms of the agreement, Organon is set to acquire exclusive global rights to develop and commercialize the treatment. OBSV stock will receive compensation via tiered double-digit royalties on commercial sales, as well as up to USD$500 million paid upfront and through milestone payments. Upon signing, OBSV is set to receive USD$25 million, up to USD$90 million in development and regulatory milestones, and up to USD$385 million sales based milestones.

    Future Outlook for OBSV

    Armed with its expansive new strategic partnership, OBSV stock is poised to capitalize on the additional opportunities within its reach. The company is keen to leverage the resources at its disposal to drive organic growth over the long term, thereby facilitating 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.

  • 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.

  • IMV, Inc. (IMV) Stock Plummets Following Announcement of Pricing of its Registered Public Offering

    IMV, Inc. (IMV) stock prices were down by 24.52% shortly after market trading commenced on July 15th, 2021, bringing the price per share down to USD$1.57 early on in the trading day.

    Public Offering

    July 15th, 2021 saw the company announce the pricing of its underwritten public offering, wherein the company would oversee the sale of 14,285,714 units to the public. Each unit will be priced at USD$1.75 per unit, with the offering expected to generate gross proceeds in the amount of roughly USD$25 million, before the deduction of expenses related to the offering. The capital generated is exclusive of ay proceeds expected from the exercising of underlying warrants.

    Details of the Offering

    Each unit will be comprised of a single common share and three quarter of one common share purchase warrant. Each warrant will allow its bearer to purchase one common share at a price of USD$2.10 per common shares, with an expiry date of 60 months following the closing date of the offering. Given the satisfaction of customary closing conditions, the offering is expected to close around July 20th, 2021.

    Allocation of Capital

    The company plans to use the net proceeds from the offering for the continued clinical development of maveropepimut-S in diffuse large B cell lymphoma, breast cancer, ovarian cancer, bladder cancer, and microsatellite instability high. The funds will also be allocated towards the start of the clinical development of a new product, DPC-SurMAGE, in bladder cancer, as well as the continued development of the company’s proprietary drug delivery platform (DPX).

    Solid Liquidity Position

    IMV reported a solid liquidity position of USD$30.5 million in cash and cash equivalents as of March 31st, 2021, in addition to having access to working capital in the amount of USD$31.6 million. This is up from the USD$26.3 million in cash and cash equivalents, and USD$25.6 million in working capital as of December 31st, 2020. As per its existing plan of operations, and discounting the USD$47.7 million remaining under its USD$50 million ATM facility executed in October 2020. The company expects its funds to see its operations through to Q1 2022.

    Future Outlook for IMV

    Armed with the influx of capital from its offering further consolidating an already strong liquidity position, IMV is poised to capitalize on the opportunities afforded to it. The company is keen to leverage its extensive resources to push for a continued trajectory of success. Investors are hopeful that the management will be able to facilitate significant and sustained increases in shareholder value.

  • Galapagos NV (GLPG) Stock Trending Lower Despite Successful Topline Results from GLPG3667 and GLPG 3970 Studies

    Galapagos NV (GLPG) stock prices were down a marginal 1.79% as of the market closing on July 14th, 2021, bringing the price per share down to USD$65.80. Subsequent premarket fluctuations have seen the stock fall by 11.14%, bringing it down to USD$58.47.

    GLPG3667

    July 14th, 2021 saw the company announce positive topline results from the evaluation of GLPG3667, a proprietary TYK2 compound. The randomized, placebo-controlled, double-blind Phase 1b study had a total of 31 patients enrolled, each with a diagnosis ranging from moderate to severe plaque psoriasis. Patients were randomized in a 1:1:1 ratio and were administered a daily oral dose of GLPG3667 or a placebo over the course of four weeks. The main objectives of the study were to evaluate the safety and tolerability of the treatment, as well as signs indicating clinical activity.

    Success of the Study

    The treatment was found to be well tolerated during the course of the trial, barring one patient in the low dose group having interrupted the study for one day on account of the exacerbation of psoriasis. Any treatment related adverse events were mild in nature and transient, with no deaths or serious adverse events being reported. By Week 4, 40% of patients in the high dose group had a PASI 50 response, which is indicative of a minimum 50% improvement in PASI from baseline.

    GLPG3970

    Concurrently, the company announced the success of topline results from three patient studies for GLPG3970. The study evaluated the proprietary salt inducible kinase 2/3 inhibitor. The studies were randomized, placebo-controlled, double blind, with a Phase 1b study in patients with moderate to severe psoriasis. Two Phase 2a studies were also conducted in patients with moderate to severely active UC and RA.

    Continued Success

    With the treatment being administered orally once-daily for a period of 6 weeks, the main objectives were to evaluate the safety and tolerability of GLPG3970, as well as early signs of biologic and clinical effect. The treatment was generally safe and well tolerated across all three studies. No deaths or serious adverse events were reported, while the majority of treatment emergent adverse events were mild to moderate in nature.

    Future Outlook for GLPG

    Armed with the success of its various studies, GLPG is poised to capitalize on the opportunities presented to it as it further develops its flagship treatments. The company is keen to push for the accelerated development and eventual commercialization of its pipeline of products. Investors are hopeful that the proliferation of the treatment will result in sustained and significant increases in shareholder value.

  • Humanigen, Inc. (HGEN) Stock Trending Higher Following MHRA Acceptance of Lenzilumab Marketing Authorization Submission

    Humanigen, Inc. (HGEN) Stock Trending Higher Following MHRA Acceptance of Lenzilumab Marketing Authorization Submission

    Humanigen, Inc. (HGEN) stock prices were up by 1.96% as of the market closing on July 8th, 2021, bringing the price per share up to USD$16.65. Subsequent premarket fluctuations saw the stock rise by 17.24%, bringing it up to USD$19.52.

    Market Authorization Submission Accepted

    July 9th 2021 saw the company announce the acceptance of its Market Authorization submission of lenzilumab as a treatment for Covid-19, having begun in June 2021. The UK’s Medicine and Healthcare Products Regulatory Agency (MHRA) gave the green light for accelerated Covid-related rolling review, with the assessment expected to occur on a short timescale than a standard rolling review.

    Working Towards the Acceptance

    HGEN held various meetings with different UK authorities in the time leading up to the initiation of the submission for Marketing Authorization. This included, but was not limited to, a Rapid C-19 multiagency meeting with representatives from the MHRA, the Therapeutics Taskforce (TTF), the Dept. of Health and Social Care (DHSC), National Health Service England (NHSE), and the National Institute for Health and Care Excellence (NICE).

    Scope of Lenzilumab

    The proliferation of various strains of the coronavirus across the globe emphasize the continued need for effective treatments that can treat various strains for the millions that are still left unvaccinated. Despite an 86% first dose vaccination rate across the UK, current week-long hospitalization rates were nearly 2,500, a 45% increase over the prior period. Deaths in the UK resulting from Covid-19 were up to 161 over the prior week, a 40% increase from the numbers reported in the week before.

    Waiting Game

    The company continues to collaborate with its partners to situate themselves for the most effective distribution of lenzilumab, as they wait for the pending conditional approval of the use of the treatment in patients hospitalized because of Covid-19. With Market Authorization pending, HGEN is also waiting on Emergency Use Authorization in the United States. Should they be awarded concurrently, the company is preparing itself to ensure the appropriate allocation of the treatment in both the U.K and the U.S.

    Future Outlook for HGEN

    With the world hurtling towards global immunizations, HGEN is capitalizing on the available market space as newer variants of the coronavirus continue to devastate the globe. Current and potential investors are hopeful that the company will be able to leverage its resources to consolidate and expand its market footprint in order to usher in significant growth over the long term.

  • Silverback Therapeutics, Inc. (SBTX) Stock Trending Higher Following Announcement of Clinical Supply Agreement with Regeneron

    Silverback Therapeutics, Inc. (SBTX) Stock Trending Higher Following Announcement of Clinical Supply Agreement with Regeneron

    Silverback Therapeutics, Inc. (SBTX) stock prices were up by 1.02% just around the market opening on July 7th 2021, bringing the price per share up to USD$28.83 at the start of the trading day.

    Clinical Supply Agreement

    July 7th 2021 saw the company announce a clinical supply agreement for the PD-1 inhibitor, Libtayo, (cemiplimab) with Regeneron. The supply agreement will facilitate the evaluation of the treatment in combination with SBT6050, the pioneer of targeted immune-oncology agents. These agents are designed to route a TLR8 agonist linker-payload to activate myeloid cells in tumors expressing levels of HER2 that are moderate and higher.

    SBT6050

    The treatment’s unique capacity to activate both innate and adaptive immune responses could potentially enhance and expand the effectiveness of a PD-1 inhibitor in HER2-expressing solid tumors. The company is keen to complete the ongoing dose escalation of SBT6050 combined with a PD-1 inhibitor as it begins tumor-specific expansion cohorts.

    Clinical Trial of SBT6050

    The first quarter of 2021 saw the company commence treatment in Part 3 of the Phase 1/1b study to evaluate the activity of SBT6050 administered in conjunction with PD-1 inhibitor in dose escalation. As per the agreement, the company will expand its ongoing Phase 1/1b trial to evaluate the combination of SBT6050 and Libtayo in tumor-specific dose expansion cohorts. The treatment will initially be used in HER2-expressing non-small cell lung cancer and gastric cancer.

    Libtayo

    Libtayo is being collaboratively developed and commercialized by Regeneron and Sanofi as a PD-1 blocking antibody. It has been approved for the first-line treatment of patients with advanced NSCLC that have tumors that exhibit a high PD-L1 expression. This was determined by an FDA-approved test for adults with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. The treatment was also for patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor or for patients where HHI is not a valid option, being either locally advanced (full approval) or metastatic (accelerated approval).

    Future Outlook for SBTX

    Armed with its recent clinical supply agreement, the company is poised to capitalize on the tenured profitability it has secured for the contract term. 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.

  • MediciNova, Inc. (MNOV) Stock Undergoes Minor Volatility Ahead of Patent for MN-166

    MediciNova, Inc. (MNOV) stock prices were down by a marginal 0.96% as of the market closing on July 2nd, 2021, bringing the price per share down to USD$4.11 at the end of the trading day. Subsequent premarket fluctuations have seen the stock climb by 4.14%, bringing it up to USD$4.20.

    Patent for MN-166

    July 6th 2021 saw the company announce that it had received a Notice of Allowance from the U.S Patent and Trademark Office for a pending patent application in regard to the treatment of ophthalmic disease with MN-166 (ibudilast). Upon issuance, the patent resulting from the application process is expected to last until at least October 2039.

    Details of the Patent

    The patent covers the administration of effective amounts of MN-166 to human patients in the interest of treating ophthalmic disease/disorder or injury associated with a neurodegenerative disease/disorder or a neuro-opthalmologic disorder. The allowed claims specifically cover macular injury treatment while also covering a wide range of doses and formulations of the treatment, across a range of different dosing frequencies.

    MN-166

    The small molecule compound, MN-166, inhibits PDE4 and inflammatory cytokines, including macrophage migration inhibitory factor. The treatment is in late-stage clinical development, with the aim of treating neurodegenerative diseases such as ALS, progressive MS, and DCM. The treatment also has the potential to treat glioblastoma, CIPN, and substance abuse disorders.

    Scope of MN-166

    Previous positive data from a glaucoma animal model study and a retinal damage animal model study have already established the potential of MN-166 as a treatment for ophthalmic neurodegenerative diseases. November 2020 saw the company report positive Optical Coherence Tomography results from the SPRINT-MS Phase 2b trial of MN-166 in the treatment of progressive multiple sclerosis. Patent approval will significant increase the potential commercial value of MN-166, having been provided with more opportunities for further development.

    About MNOV

    The company is a clinical-stage biopharmaceutical entity that develops a varied, late-stage pipeline of innovative small molecule therapies. These therapies are designed to treat inflammatory, fibrotic, and neurodegenerative diseases. The company has 11 programs currently in clinical development, based on its two compounds, MN-166 and MN-001, with each having multiple mechanisms of action and strong safety profiles.

    Future Outlook for MNOV

    Armed with the massive unlocked potential of the commercialization of MN-166 with the recent patent approval, MNOV is poised to capitalize on the expanded arsenal of opportunities ahead of it. Current and potential investors are keen for the proliferation of the treatment that will usher in unprecedented gains in shareholder value.