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Tag: biopharma

  • 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.

  • Aligos Therapeutics, Inc. (ALGS) Stock Plummets Following Pricing of Public Offering of Common Shares

    Aligos Therapeutics, Inc. (ALGS) stock prices were down by a hefty 17.19% shortly after market trading commenced on July 1st, 2021, bringing the price per share down to USD$16.88 early on in the trading day.

    Public Offering

    June 30th, 2021 saw the company announce the pricing of its previously announced underwritten public offering, wherein ALGS will put up 4.4 million shares of its common stock for sale. As per the announcement, the public offering price will be USD$19.00 per share of common stock. Underwriters have also been granted a 30-day option to purchase up to an additional 660,000 shares of common stock in the case of over allotments.

    Details of the Offering

    The public offering is expected to generate gross proceeds in the amount of roughly USD$83.6 million before the deduction of any expenses related to the offering. This total also does not include capital generated from the exercising of the underwriters’ option to purchase addition shares. The offering is expected to close on July 6th, 2021, pending the satisfaction of customary closing conditions.

    Net Loss Reports

    Net loss for the quarter ended March 21st, 2021 was reported at USD$27.7 million, representing a net loss of USD$0.74 per basic and diluted common share. This is up from the USD$20 million reported for the same quarter of the prior year, representing a net loss of USD$7.56 per basic and diluted common share. The company reported cash, cash equivalents, and marketable securities in the amount of USD$213.4 million for the quarter, as compared to the USD$243.5 million reported as of December 31st2020.

    R&D Expenses

    Research and development costs were up to USD$22.9 million for the quarter ended March 31st, 2021, an increase from the USD$17.3 million reported for the prior-year quarter. This difference was largely driven by expenses related to the company’s ongoing development of ALG-010133 and ALG-000184 clinical trial activities. Further contributing to the year-over-year difference were increases in salaries and employee-related expenses and preclinical programs. The company reported USD$1.7 million in total R&D stock-based compensation expense for the 2021 quarter, as compared to the USD$0.2 million reported in the prior-year quarter.

    Future Outlook for ALGS

    Armed with a solid liquidity position that is to be further consolidated with the closing of its public offering, ALGS is poised to capitalize on the expanded opportunities in front of it. Investors are hopeful that management will continue to leverage the resource at their disposal to facilitate significant and sustained increases in shareholder value.

  • HUTCHMED (China) Ltd. (HCM) Stock Surges Following Listing on Hong Kong Exchange

    HUTCHMED (China) Ltd. (HCM) Stock Surges Following Listing on Hong Kong Exchange

    HUTCHMED (China) Ltd. (HCM) stock prices were up down by a minor 0.81% as of the market closing on June 29th, 2021, bringing the price per share down to USD$33.23 at the end of the trading day. Subsequent pre-market fluctuations saw the stock surge by 14.35%, bringing it up to USD$38.00.

    Hong Kong Listing

    The company had a massively successful first day of trading in Honk Kong, having been listed after a delayed previous attempt earlier in 2019. The earlier plan to list was shelved amid market uncertainties at the time. The biopharmaceutical company’s shares that were already trading on in the U.S and U.K jumped a massive 51%, with the company raising USD$537 million in their offering.

    Global Offering

    June 23rd2021 saw the company announce the pricing of its global offering which comprises an international offering and a Hong Kong public offering in connection with a primary listing of its ordinary shares on the Stick Exchange of Hong Kong Ltd.’s Main Board. The offering will see the sale of up to 104 million new ordinary shares of HCM.

    Pricing of Global Offering

    Both the International Offering and the Hong Kong Public Offering final offer price has been set at roughly USD$25.82 per American depositary share (ADS), with each ADS representing 5 ordinary shares of the company. The offer price was determined by the closing price of the company’s ADSs on the Nasdaq Global Select Market and shares on the AIM market of the London Stock Exchange on June 22nd, 2021. Shares are expected to begin trading on June 30th, 2021, pending approval from the SEHK.

    Offering Details

    The offering is expected to generate USD$0.54 billion in gross proceeds, before the deduction of expenses related to the offering. The agreement also comes equipped with an option for international underwriters to buy up to 15.6 million new issued Shares at the offer price, in case of over-allotments. This option is available for 30 days after the last day of lodging applications under the Hong Kong Public Offering.

    Allocation of Resources

    Net proceeds generated from the global offering are forecasted to be allocated towards the advancement of the company slate-stage clinical programs, as well as its pipeline of clinical-stage and preclinical stage candidates. This move serves to consolidate the company’s commercialization, clinical, regulatory, and manufacturing capability, as well as fund future opportunities and acquisitions.

    Future Outlook for HCM

    Armed with a solid liquidity position, HACM is poised to capitalize the added resources generated from its global offering. 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.

  • VBI Vaccines Inc. (VBIV) Stock Dips Despite Promising Data from Covid-19 Vaccine Trial

    VBI Vaccines Inc. (VBIV) Stock Dips Despite Promising Data from Covid-19 Vaccine Trial

    VBI Vaccines Inc. (VBIV) stock prices were down by 8.5586% some time after market trading commenced on June 29th 2021, bringing the price up to USD$3.6668 earlier on in the trading day.

    Positive Trial Data

    The company announced on June 29th the positive Phase 1 data from its Phase 1/2 of its Covid-19 vaccine candidate, VBI-2902a. The trial saw the administering of the enveloped virus-like particle (eVLP) in healthy adults between the ages of 18 and 54. The 5µg dose expressed an optimized Covid-19 spike antigen, having been adjuvanted with aluminum phosphate.

    Trial Results

    It was generally well-tolerated and exhibited potent immune responses from subjects that were significantly higher than those seen in human convalescent sera. The potency of the eVLP particulate delivery platform against Covid-19 was demonstrated with the findings establishing a robust human proof-of-concept at a low dose and without the use of a next-generation adjuvant.

    Developing eVLPs

    The highly encouraging data furthers the development of the treatment that is being pushed towards commercialization with the support of the Canadian government, CEPI, and the National Research Council of Canada. The next phase of the ongoing adaptive Phase 1/2 study involved the assessment of VBI-2905a, with the commencement of this part of the trial anticipated for the third quarter of 2021.The company is also allocating resources towards developing multivalent eVLP candidates, which are designed to increase the scope of protection against Covid-19. A clinical study of one of these candidates is expected to commence in the first half of 2022.

    Details of the Trial

    The ongoing adaptive Phase 1/2 clinical study is randomized and placebo-controlled, with observers also being blind. Phase 1 assessed a 5µg dose of VBI-2902a, adjuvanted with aluminum phosphate. Treatment regimens included both one and two doses, with the second being administered 28 days after the initial jab. The Phase 1 part of the study saw a total of 61 healthy adults between the ages of 18 and 54, with no history of having been vaccinated against Covid-19.

    Future Outlook for VBIV

    With the world hurtling towards universal immunizations, VBIV is poised to continue its trajectory of success. The company is keen to usher in further growth as it continues to push for increased market penetration. 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

  • CTI BioPharma Corp. (CTIC) Stock Trends Higher Following Progress in Commercialization of Pacritinib

    CTI BioPharma Corp. (CTIC) stock prices stayed stable over the course of the trading day on June 25th, 2021. After-hours trading saw the stock climb by 6.84%, bringing it up to USD$2.50.

    Pacritinib Progress

    The company recently announced progress in their goal of providing pacritinib to myelofibrosis patients with thrombocytopenia, with current treatments leaving a large unaddressed need. The U.S Food and Drug Administration set a PDUFA action date of November 30th, 2021, following the acceptance of an NDA for the innovative drug.

    Ready for Commercialization

    Pushing for the commercialization and proliferation of their treatment, CTIC forecasts launching the drug in the US later in fiscal 2021. The most recent quarter has seen the ramping up of essential pre-commercial activities to facilitate a successful launch. These activities include, but are not limited to, coordinating market access, distribution, and supply chain, disease education, and force field planning and deployment.

    Operating and Net Loss Reports

    Operating loss for the first quarter of the fiscal year 2021 came out to USD$17.1 million, up from the USD$11.9 million reported for the three-month period ended March 31st, 2020. This difference is largely attributable to increases in research and development costs, as well as expenses from general and administrative activities associated with the build to the commercial launch of pacritinib.Net loss for the quarter came out to USD$17.3 million, representing a net loss of USD$0.23 per basic and diluted share. This is up from the USD$12.2 million reported in the prior-year quarter, which represented a net loss of USD$0.20 per basic and diluted share.

    Solid Liquidity Position

    The company reported a solid liquidity position as of March 31st, 2021, with cash, cash equivalents, and short-term investments coming out to USD$37.2 million. Despite being lower than the USD$52.5 million reported as of December 31st, 2021, the company forecasts being set to see its operations through to the fourth quarter of 2021. Significant contributions to this momentum was the equity financing that culminated on April 6th, 2021, generating net proceeds of USD$53.8 million.

    Future Outlook for CTIC

    Armed with a solid liquidity position, CTIC is poised to continue its trajectory of success. The company is keen to continue pushing for the eventual commercialization and proliferation of pacritinib. 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.

  • Keros Therapeutics, Inc. (KROS) Stock Trending Lower Despite Success of Phase 2 Clinical Trial of KER-050

    Keros Therapeutics, Inc. (KROS) stock prices were down by 11.98% shortly after market trading commenced on June 23rd, 2021, bringing the price per share down to USD$46.28.

    Success of Phase 2 Trial

    June 22nd, 2021 saw the company announce preliminary results rom Cohorts 1 and 2 of its Phase 2 clinical trial. The trial is designed to evaluate KER-050 for the treatment of anemia and thrombocytopenia in patients with very low- to intermediate-risk myelodysplastic syndromes. Patients may or may not have ring sideroblasts and may or may not have been previously treated with an erythroid stimulating agent.

    Details of the Trial

    The ongoing trial is an open-label, two-part, multiple ascending dose trial that is designed to assess the trial’s safety, tolerability, pharmacokinetics, and pharmacodynamics of the treatment in MDS patients. 12 patients had received at least one dose of the treatment as of May 14th, 2021, 9 of whom had been administered the treatment for a period of 8 weeks. Patients in Cohort 1 were administered 0.75mg/kg of KER-050, while Cohort 2 patients received 1.5 mg/kg. Both cohorts were treated once every four weeks for 12 weeks.

    Scope of KER-050

    The preliminary results were promising, with increases being observed in hematological parameters in the two lowest Part 1 dose cohorts, who were dosed monthly, in both RS and non-RS patients with MDS. This initial success signals proof-of-concept of the treatment in patients with very low- to intermediate-risk MDS, which support the scope of KER-050 as a treatment for disease associated with ineffective hematopoiesis.

    Expansion of Trial

    Furthermore, based on the success of the preliminary results, the company plans to extend the duration of the trial from 12 weeks to up to two years. This is to better facilitate the defining of response rate following six months of treatment with KER-050, as well as to confirm the durability of response. KROS also plans to update the protocol to expand the size of Part 2 of the trial to consolidate response rates, as well as to help guide the design of the expected registration program. Part 2 trial designs are expected by the end of 2021.

    Future Outlook for KROS

    Armed with the success of its clinical trial, KROS is poised to capitalize on the opportunities afforded to it to push for the commercialization and proliferation of KER-050. The company is keen to usher in further growth with the potential of its expanded footprint. Current and potential investors are hopeful that management will leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Aytu BioPharma, Inc. (AYTU) Stock Surges Following Developments Stemming from Merger with Neos

    Aytu BioPharma, Inc. (AYTU) Stock Surges Following Developments Stemming from Merger with Neos

    Aytu BioPharma, Inc. (AYTU) stock prices were up a significant 13.85% shortly after market trading commenced on June 21st, 2021, bringing the price up to USD$5.39 early on in the trading day.

    Net Revenue Reports

    Net revenue for the third quarter of the fiscal year 2021 was reported at USD$13.5 million, up from the USD$8.2 million reported for the same quarter of the prior fiscal year. This increase is largely attributable to the continued increase in sales through organic product growth, as well as through the realization of the recently completed Neos transaction.

    Net Revenue Breakdown

    Net revenue generated from the consumer health division was reported at USD$8.4 million, a significant increase over the USD$3.5 million reported for the same quarter of the prior fiscal year. This increase was largely attributable to the multiple product launches over the 2021 quarter. Further compounding the year-over-year increases, the growth of the company’s e-commerce channel has greatly increased its scope. The Rx division reported generating net revenue in the amount of USD$5.1 million, up from the USD$4.7 million reported in the year-ago quarter.  The increase was largely driven by product revenue arising from the transaction with Neo, which closed on March 19th, 2021.

    Net Loss Reports

    Net loss for the first quarter of fiscal 2021 came in at USD$25.5 million, representing a net loss of USD$1.41 per share of common stock The year-over-year increase primarily resulted from expenses related to the Neos merger, amounting to a total of USD$10.6 million. A USD$7.1 million write-offs in slow-moving inventory for the quarter also contributed to the yearly difference.

    Solid Liquidity Position

    The company reported a solid liquidity position, with cash, cash equivalents, and restricted cash amounting to USD$46.8 million as of March 31st, 2021. This report comes after the company made a principal payment of USD$15 million toward the Deerfield Note held by Neos.

    Future Outlook for AYTU

    Armed with a solid liquidity position, AYTU is poised to continue its trajectory of success in light of the opportunities afforded to it by its merger with Neos. 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.

  • X4 Pharmaceuticals, Inc (XFOR) Stock Continues Downward Trend Since Disclosure of Positive Preliminary Mavorixafor Data

    X4 Pharmaceuticals, Inc (XFOR) Stock Continues Downward Trend Since Disclosure of Positive Preliminary Mavorixafor Data

    X4 Pharmaceuticals, Inc. (XFOR) stock prices were down by 8.40% as of the market closing on June 18th, 2021, bringing the price per share down to USD$7.42 at the end of the trading day.

    Mavorixafor Clinical Trial

    June 11th, 2021 saw the company announce positive preliminary efficacy and safety data from the ongoing Phase 1b clinical trial of movorixafor. The lead candidate was being administered in conjunction with ibrutinib to patients with Waldenstrom’s macroglobulinemia exhibiting MYD88 and CXCR4 mutations. The findings were published in a post at the European Hematology Association 2021 Annual Congress.

    Promising Start

    The promising results of the ongoing trial already exhibit robust decreases in IgM levels, despite still being in the low- to mid-dose ranges of the treatment. This crucial signal of clinical response shows the potential benefit of administering mavorixafor in combination with ibrutinib. The combined therapy has demonstrated adequate tolerability and promising results across various pharmacodynamic parameters, including increases in total hemoglobin and mobilization of white blood cells. Longer-term data and an expanded dataset from the trial are expected for later in the fiscal year 2021.

    Scope of Trial

    With ibrutinib having substantially addressed the treatment of Waldenstrom’s macroglobulinemia, the company continues to observe a significant unmet clinical need for patients with concurrent CXCR4 and MYD88 mutations. The encouraging preliminary safety and efficacy data from the ongoing combined treatment trials has significantly advanced treatment in this challenging patient population.

    Details of the Trial

    The Phase 1b clinical trial had 8 patients enrolled as of April 15th, 2021, with a median duration of treatment of 156 days. The data presenting primarily concerns patients from Cohort A, who were administered low- to mid-range doses of mavorixafor and ibrutinib. Four of the patients were treated for more than six 28-day cycles.

    Preliminary Results

    Reductions in serum IgM were reported by 100% of the patients that were a part of the trial, with none of them exhibiting a progression of the disease while undergoing treatment. All of the patients who exhibited below normal baseline hemoglobin level reported increases while being administered the treatment, with a median change in hemoglobin of more than 20 g/L. This closes the gap between patient’s and normal levels of hemoglobin, suggesting a reduction in cancer burden in the bone marrow.

    Future Outlook for XFOR

    Armed with the recent success of its clinical trial, XFOR is poised to continue its trajectory of success as it pushes its flagship treatment through to commercialization. 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.

    Tags: X4 Pharmaceuticals, X4 Pharma, XFOR, XFOR stock, biopharmaceutical, biopharma, healthcare, mavorixafor

  • Zymeworks, Inc. (ZYME) Stock Undergoes Minor Volatility AsZanidatamab Development Continues

    Zymeworks, Inc. (ZYME) Stock Undergoes Minor Volatility AsZanidatamab Development Continues

    Zymeworks, Inc. (ZYME) stock prices were down by 5.05% as of the market closing on June 18th, 2021, bringing the price per share down to USD$36.25 at the end of the trading day. After-hours trading saw the stock climb by 7.56%, bringing it up to USD$38.99.

    Zanidatamab Development

    The company continues to enroll patients for its global pivotal trial for zanidatamab, a HER2-targeted bispecific antibody, monotherapy for patients previously treated HER2 gene-amplified BTC (HerIZON-BTC-01. Enrolment is continuing throughout sites across North and South America, Europe, and Asia, with the trial having been initiate based on encouraging data. This data highlighted a 40% confirmed objective response rate for zanidatamab monotherapy in BTC. The development of the treatment has been supported by various special designations in the U.S and EU.

    FDA Clearance

    ZYME also recently received clearance from the U.S Food and Drug Administration for the first randomized Phase 3 clinical trial for zanidatamab. HeriZON-GEA-01 is a randomized study of zanidatamab that is conducted across multiple centers, in combination with chemotherapy with or without BeiGene’s PD-1 targeted antiboy, tislelizumab. The regimen is designed as a first line treatment for patients with HER2-positive unrespectable locally advanced or metastatic GEA. Clinical data that supports the study from an ongoing Phase 2 clinical trial evaluating zanidatamab is expected to be presented in the second half of 2021.

    Presenting Zanidatamab Data

    April saw the presentation of preclinical data at the American Association for Cancer Research, which will reveal new insights into the unique mechanisms of action of zanidatamab. The presentation will also facilitate the introduction of the company’s fourth therapeutic platform, ProTECT, as well as describe two new preclinical assets focused on both the cykotine, IL-12, and the immune-oncology target, 4-1BB.

    Revenue Reports

    Revenue for the quarter ended March 31st, 2021 was reported at USD$0.6 million, down from the USD$8.3 million reported for the same quarter of the prior year. The revenue for 2021 was primarily related to support for research from partners. The massive year-over-year difference is largely attributable to the USD$5 million from BeiGene for a development milestone and USD$3.3 million from our partners for research support, drug supply, and other payments.

    Future Outlook for ZYME

    Armed with the continued development of zanidatamab, ZYME is poised to continue its trajectory of success. The company is keen to push for the commercialization and proliferation of its flagship treatment to usher in continued growth. Current and potential investors are hopeful that management will leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Osmotica Pharma PLC (OSMT) Stock Recovering Following Continued Growth of Upneeq

    Osmotica Pharma PLC (OSMT) Stock Recovering Following Continued Growth of Upneeq

    Osmotica Pharma PLC (OSMT) stock prices stayed stable over the course of the market day on June 17th, 2021. Subsequent pre-market fluctuations have seen the stock climb by 3.74%, bringing it up to USD$3.05.

    Upneeq Snowball Effect

    The first quarter of the fiscal year 2021 saw the company ride the momentum generated by the earlier launch of Upneeq, the first and only FDA-approved ophthalmic solution for the treatment of acquired ptosis in adults. The growth accelerated since the launch, with Q1 2021 having reported a 74% quarter-over-quarter growth in paid subscriptions. Paid subscriptions for the month of April were 17% higher than the previous month, reflecting the increased exposure of Upneeq and the familiarity of more and more eye care professionals with it. The company is keen to spearhead its market penetration and expand the scope of exposure of Upneeq.

    Upneeq Developments

    Upneeq established itself as an invaluable asset with it being awarded the 2021 Medtech Breakthrough Award. The company’s partner, Santen Pharma, had a successful meeting with the Japanese equivalent of the FDA, the PMDA, and subsequently made plans to initiate clinical trials in the very near future. The success of the meeting was reflected by the USD$10 million milestone as per its licensing agreement, which it anticipates receiving in the second quarter of 2021.

    Arbaclofen

    The company has submitted a revised study protocol of arbaclofen to the FDA, with the belief that the treatment has the potential to play an essential role in MS spasticity. OMST is also in advanced discussions with several parties as a part of the previously announced execution of its strategic process focus on its legacy portfolio.

    Financial Reports

    Revenues for the first quarter of the fiscal year 2021 came in at USD$23.9 million, down from the USD$48.6 million reported in the prior year quarter. Net loss was on the rise, with Q1 2021 reporting USD$9.6 million, up from the USD$3.1 million net loss reported for the first quarter of 2020. As of March 31st, 2021, the company reported cash and cash equivalents on the amount of USD$109.2 million, against a debt of USD$219.8 million.

    Future Outlook for OSMT

    Armed with the continuously expanding actualization of the commercial potential of Upneeq, OSMT is poised to return to its trajectory of growth after a consistent few days of the stock trending down. Current and potential investors are hopeful that management will leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.