STOCKS TELEGRAPH

Tag: healthcare

  • Galectin Therapeutics, Inc. (GALT) Stock Surges Following Success of Topline Data from Belapectin Clinical Trial

    Galectin Therapeutics, Inc. (GALT) Stock Surges Following Success of Topline Data from Belapectin Clinical Trial

    Galectin Therapeutics, Inc. (GALT) stock prices were down by a marginal 1.43% as of the market closing on July 8th, 2021, bringing it down to USD$2.76. Subsequent premarket fluctuations have seen the stock skyrocket by 47.10%, bringing it up to USD$4.06.

    Positive Topline Data

    July 9th, 2021 saw the company report positive topline data from its Phase 1b Clinical Trial Extension of Belapectin in conjunction with KEYTRUDA in the treatment of advanced metastatic melanoma, as well as head and neck cancer. The combination immunotherapy showed a cancer control rate of 56% in melanoma patients and 40% in head and neck cancer.

    Details of the Study

    The melanoma patients enrolled in the study had exceptionally severe prognoses, with four out of nine patients reporting choroidal primary tumors and six out of nine having liver metastasis. The study found no toxicities that were deemed even possibly related to Belapectin. As per the findings from the Phase 1 study, the frequency and intensity of toxicities recorded with the combination were less than the expected toxicity with KEYTRUDA alone.

    Net Loss Reports

    The quarter ended March 31st, 2021 saw the company report USD$6.3 million in net loss applicable to common stockholders, representing a net loss of USD$0.11 per share. This is up from the USD$3.6 million in net loss reported in the same time period of the prior year, representing a net loss of USD$0.06 per share. The year-over-year difference was largely driven by increases in R&D expenses related to GALT’s NAVIGATE trial.

    R&D and G&A Expenses

    In accordance with costs associated with the NAVIGATE trial, research and development costs were up to USD$4.9 million for the 2021 quarter, up from the USD$2.1 million reported for the quarter ended March 31st, 2020. General and administrative costs for the quarter were reported at USD$1.4 million, the same as for the prior year quarter.

    Solid Liquidity Position

    The company reported USD$20.8 million in cash and cash equivalents as of March 31st, 2021, indicating a solid liquidity position. This was further consolidated by the receiving of USD$10 million in proceeds on April 16th, 2021 from an unsecured convertible promissory note from the Chairman of its Board of Directors.

    Future Outlook for GALT

    Armed with the massive success and promise of its clinical trial, GALT is poised to capitalize on the opportunities afforded to it in light of this recent development. The company is keen to leverage its stellar liquidity position in order to usher in sustained and significant growth over the long term.

  • 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.

  • 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.

  • 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.

  • Cytosorbents Corp. (CTSO) Stock Continues Climb Following FDA Approval to Conduct STAR-T Trial in U.S

    Cytosorbents Corp. (CTSO) stock prices surged by 17.41% as of the market closing on July 6th, 2021, bringing the price per share up to USD$8.63 at the end of the trading day. Subsequent pre-market fluctuations have seen the stock dip by 7.76%, bringing it down to USD$7.96.

    FDA Approval of IDE Application

    July 6th, 2021 saw the company announce the full approval of its Investigational Device Exemption application to support FDA regulatory clearance to conduct the STAR-T trial in the U.S. The Safe and Timely Antithrombotic Removal – Ticagrelor is a double blind, randomized, controlled trial that is being performed under the recent FDA Breakthrough Designation. The Designation was granted for the removal of ticagrelor in a cardiopulmonary bypass circuit during critical cardiothoracic surgery using the company’s proprietary adsorption technology.

    STAR-T Trial

    STAR-T will enroll a maximum of 120 patients across 20 U.S clinical sites, with enrollment expected for the summer of 2021. The study’s primary endpoint will evaluate the reduction in risk of peri-operative bleeding complications arising from the use of DrugSorb-ATR in patients with ticagrelor who undergo cardiothoracic surgery, as compared to standard of care alone.

    Additional Details

    The trial will also facilitate the evaluation of the reduction in ticagrelor blood levels and various additional outcomes to encapsulate the comprehensive potential clinical and cost-economic benefits of the treatment. The company forecasts a completion in 2022 based on the promising activity exhibited by participating sites. CTSO plans to continue its collaboration with the FDA to leverage the priority review stemming from the granting of a Breakthrough Designation for its ticagrelor removal application.

    Scope of DrugSorb-ATR

    A very high risk of perioperative bleeding makes the conducting of cardiac surgery on patients that are on antithrombotic agents a major issue across all U.S cardiac surgery centers. This issue results in morbidity, mortality, as well as higher costs, thus proving a major problem for patient management by cardiac surgeons around the world. Currently, surgery needs to be delayed until the effects of antithrombotic agents wear off or, in cases of extreme urgency, surgery is conducted regardless of the elevated bleeding risk.

    Future Outlook for CTSO

    Armed with the approval and support of the FDA for its flagship treatment, CTSO is poised to push for the commercialization and proliferation of DrugSorb-ATR. Investors are hopeful that the company will be able to leverage its resources to accelerate the development of the treatment, resulting in substantial and sustained increases in shareholder value.

  • 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.

  • Adial Pharmaceuticals, Inc. (ADIL) Stock Surges Ahead of Inclusion in Russell Microcap Index

    Adial Pharmaceuticals, Inc. (ADIL) stock prices were up by a significant 16.21% as of the market closing on July 2nd, 2021, bringing the price per share up to USD$2.94 at the end of the trading day.

    Inclusion in Russell Microcap Index

    June 28th, 2021 saw the company announce its inclusion in the Russell Microcap Index, effective as of the market opening on the same day. Inclusion in the index is indicative of the company’s progress in advancing its lead investigational new drug product, AD04, through ADIL’s ONWARD Phase 3 trial for the treatment of alcohol use disorder. Further contributing to the addition in the index was the company’s recent acquisition of Purnovate, along with its adenosine drug development platform.

    Fast Track Designation Denied

    The company reported near the end of June 2021 that its request for Fast Track Designation for the use of AD04 in the treatment of Alcohol Use Disorder had been denied by the U.S. Food and Drug Administration. The FDA cited the company’s failure to adequately demonstrate the potential of its treatment, with the agency requesting additional comparative information in contrast to other alternative therapies.

    Gaining Approval

    As per the denial, ADIL will assess the FDA’s requirements to facilitate approval of a Fast Track Designation, which is designed to facilitate development and hasten the process of regulatory review of drugs. AD04 is currently undergoing a Phase 3 ONWARD trial, with the primary endpoint of efficacy being marked by the change from baseline in the monthly number of heavy drinking days during the last eight weeks of the 24-week treatment period.

    ONWARD Trial

    The ONWARD trial is a multicenter, randomized, double-blind, placebo-controlled, parallel group, Phase 3 clinical study that lasts a period of 24 weeks. It is designed to evaluate the efficacy, safety, and tolerability of AD04 in the treatment of patients with Alcohol Use Disorder and selected polymorphisms in the serotonin transporter and receptor genes. The ONWARD trial ensured only genetically positive patients were enrolled by genetically screening patients prior to enrollment. The primary endpoint is the change from baseline in the monthly number of heavy drinking days during the last 8 weeks of the 24-week treatment period.

    Future Outlook for ADIL

    Despite the speed bump presented by the FDA’s denial of Fast Track Designation for AD04, ADIL is poised to address and resolve the issue and continue the development of its flagship treatment. Investors are hopeful for a timely resolution and the resumption and acceleration of the commercialization of AD04.

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

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

    Clinical Hold for CTI-1601

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

    Contextualizing the Hold

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

    Effects of FDA Decision

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

    Deferral of Trials

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

    Future Outlook for LRMR

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

  • Pulse Biosciences, Inc. (PLSE) Stock Dips Following Announcement of USD$50 Million Private Placement

    Pulse Biosciences, Inc. (PLSE) Stock Dips Following Announcement of USD$50 Million Private Placement

    Pulse Biosciences, Inc. (PLSE) stock prices were down by 11.58% some time after market trading commenced on July 2nd 2021, bringing the price per share down to USD$18.41 early on in the trading day.

    Stock Purchase Agreement

    July 1st 2021 saw the company announce that it had entered into a stock purchase agreement with Robert Duggan, the Chairman of PLSE’s Board of Directors. The agreement will see Mr. Duggan purchase 3,048,780 shares of the company’s common stock, with each stock being priced at USD$16.40 per share, which is the last reported sale price of the shares as of the market closing on June 30th 2021.

    Details of the Agreement

    Any debt owed to Mr. Duggan by the company as per the loan agreement from March 11th 2021 will be paid through the cancellation and extinguishment of the debt. Rather, Mr. Duggan will be compensated with common stock shares in a private placement that will write-offUSD$41 million in principal balance and USD$0.6 million in accrued and unpaid interest. As per the private placement, Mr. Duggan will invest new capital in the amount of USD$8.4 million into the company.

    CellFX Milestone

    The company announced on June 30th 2021 that the first patient in Canada had been successfully treated with PLSE’s proprietary CellFX procedure. Marking the first commercial use of the ceillular-focused CellFX System in Canada, the treatment is proven to clear common benign lesions, such as sebaceous hyperplasia, seborrheic keratosis, and cutaneous non-genital warts. CellFX further expands the company’s Controlled Launch program that is currently ongoing in both Europe and the United States.

    Continued Development

    PLSE continues to build its global foundation of key opinion leader adoption of the unique NPS technology. To this end, it is continuing its strategic rollout with thought-leading skin specialists from across Canada aiming to expand the clinical and commercial potential of the CellFX System for multiple aesthetic and therapeutic applications.

    Future Outlook for PLSE

    Armed with the influx of capital generated from their private placement, PLSE is poised to capitalize on the proliferation of its CellFX system. Investors are hopeful that the company will be able to consolidate and expand its market footprint to usher in significant and sustained increases in shareholder value.

  • Provention Bio, Inc. (PRVB) Stock Undergoes Minor Volatility Ahead of PDUFA Meeting

    Provention Bio, Inc. (PRVB) stock prices were down by a marginal 1.19% as of the market closing on July 1st, 2021, bringing the price per share down to USD$8.33 at the end of the trading day. Subsequent pre-market fluctuations saw the stock rally by 3%, bringing it up to USD$8.58.

    EMDAC Approval

    May 27th, 2021 saw the company announce that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S Food and Drug Administration voted in favor of teplizumab. With 10 affirmations and 7 negations, the question asked was whether the data presented showed the treatment to have benefits that outweighed the risks in support of approval to delay clinical type 1 diabetes mellitus.

    TN-10 Study

    Safety and efficacy data from the pivotal TN-10 Study guided the EMDAC decision, which showed a single 14-day course of the treatment to have deferred insulin-dependent, clinical-stage disease. Stage 2 type 1 diabetes was delayed by a median of at least 2 years in presymptomatic patients as compared to the placebo. With early stage TID patients constituting a significant unmet need, the Committee Members evaluated the pros and cons of the clinical data.

    FDA Designations

    Teplizumab was granted Breakthrough Therapy designation by the FDA and a priority review designation for the Biologics License Application. The Prescription Drug User Fee Act (PDUFA) has been scheduled for July 2nd, 2021. Having been previously disclosed, the treatment’s Pharmacokinetic comparability was not a topic of discussion for the Advisory Committee meeting. PRVB maintains that the FDA’s insistence on PK comparability considerations is likely to delay potential BLA approval timelines.

    Scope of Teplizumab

    With over 1.6 million Americans being affected by TID, the autoimmune disease that results from beta cell destruction has a significant scope. TID is typically diagnosed in childhood or young adulthood, but TID onset can occur at any age after symptoms appear in the absence of sufficient insulin production. TID typically reduces life expectancy by more than a decade, with the average reduction being 16 years in people diagnosed before the age of 10.

    Future Outlook for PRVB

    With the PDUFA taking place later today, the company is hopeful for a positive outcome and additional opportunities to continue its trajectory of success. Investors are hopeful that PRVB will be able to see its trial candidates through to commercialization and proliferation of the large unaddressed TID market.