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News ReleaseRolnick Kramer Sadighi LLP (RKS)
Yesterday, New Jersey Chancery Court Judge Margaret Goodzeit declined to set a preliminary injunction hearing to enjoin Bausch Health Companies Inc. (“Bausch Health”) from completing its corporate spin-off of its vision care business (“Bausch + Lomb”) after Bausch Health expressly represented to the Court that it has not yet determined that the last step of the spin-off — a share dividend of its Bausch + Lomb shares — will occur. Given Bausch Health’s representation that the dividend is merely “speculative” and that there will be at least 55 days’ public notice if the dividend is going to proceed, the Court found that it was not appropriate to set an injunction hearing at this time. However, in order to protect the potential judgment creditor plaintiffs in the event Bausch Health decides to change course, the Court ordered Bausch Health to provide Rolnick Kramer Sadighi LLP (“RKS”), attorneys representing plaintiffs in the case, “at least 14 days notice of any action, vote, or decision which could result in the modification or elimination of the 55 day advance public notice...” “Although we are relieved that Bausch represented that the spin-off was not imminent and might not happen at all, we are pleased that the Court ordered Bausch to provide timely advance notice of any attempt to proceed with its ill-conceived spin-off," said Larry Rolnick of RKS. "Timely advance notice will help ensure that creditors have a meaningful opportunity to obtain an injunction," he added. The Court’s ruling means that if Bausch Health decides to complete the divestiture of its Bausch + Lomb assets through a share dividend or any other means, RKS’s clients will have a court-ordered opportunity to seek to enjoin the transaction. About RKS: Rolnick Kramer Sadighi, LLP (RKS) provides strategic litigation solutions for the investment management community. Launched in 2020, RKS is a premier securities litigation boutique dedicated to serving the investment management industry, including hedge funds, mutual funds, private equity, credit, real estate, and structured finance firms. For more information, visit RKS online: https://www.rksllp.com/. Contact Details Arielle Goren +1 212-717-5863 agoren@kivvit.com Company Website https://www.rksllp.com/
December 14, 2022 08:35 AM Eastern Standard Time
News ReleaseBriaCell Therapeutics Corp.
Small and big pharma companies such as Pfizer Inc. (NYSE: PFE), Celldex Therapeutics Inc. (NASDAQ: CLDX), and Hologic Inc. (NASDAQ: HOLX) are ramping up efforts to help reduce or eliminate the growing breast cancer mortality rate. As it stands now, breast cancer is the second most common cause of cancer death in women in the U.S. It is estimated that 43,780 people — 43,250 women and 530 men — will die from breast cancer this year alone. Globally, female breast cancer is the fifth leading cause of death. An estimated 684,996 women worldwide died from breast cancer in 2020, with metastatic breast cancer causing the vast majority of the deaths. The increasing death rate has led companies like BriaCell Therapeutics Corp. (NASDAQ: BCTX) (NASDAQ: BCTXW) (TSX: BCT) to advance research and development into therapies that could prove more effective against breast and other cancers. Focusing initially on breast cancer, BriaCell is dedicated to enhancing the lives of people with cancer with limited therapy options by developing novel immunotherapies to fight the disease. Immunotherapies have become the forefront of cancer treatments because they use the body’s immune system to destroy cancer cells, offer the potential for higher levels of safety and efficacy than chemotherapy and may also prevent cancer recurrence. BriaCell currently has a non-exclusive clinical trial collaboration with Incyte Corporation (NASDAQ: INCY) to evaluate the effects of combinations of novel clinical candidates. BriaCell is currently conducting a Phase I/II clinical trial of its lead product candidate, Bria-IMT™, in combination with the immunotherapy development candidate retifanlimab, an anti-PD-1 antibody provided by Incyte, for the treatment of advanced breast cancer. Positive Clinical And Quality Of Life Data On December 8, BriaCell presented positive safety/tolerability and efficacy data from its lead product candidate – Bria-IMT™ – summarized in three poster sessions during the 2022 San Antonio Breast Cancer Symposium ® (SABCS). Summary Of The Positive Data Positive clinical data reported includes tumor shrinkage, disease control, progression-free survival, and potential long-term survival benefit in advanced metastatic breast cancer patients treated with the Bria-IMT™ combination regimen. “Better quality of life” and “less pain” reported by many gravely ill advanced metastatic breast cancer patients treated with the Bria-IMT™ combination regimen. Notably, many patients remained in their study longer than other prior therapies, suggesting excellent tolerability and clinical effectiveness of the Bria-IMT™ combination regimen. More positive data is expected as patients remain in the study. Treatment remained well-tolerated with no dose-limiting toxicities. The posters are summarized below and also available to view here: https://briacell.com/scientific-publications/. Mayo Clinic Professor and Principal Clinical Investigator Saranya Chumsri, M.D., stated in an audio summary of the poster: “First, this is a heavily pretreated group of end-stage metastatic breast cancer (“MBC”) patients. For many of these patients, other therapies don’t exist or cannot be tolerated.” “Bria-IMT™ does not have any theoretical cross-resistance or overlapping toxicity with other MBC treatments, which is why it is so encouraging to see responses across all MBC subtypes and a very manageable adverse event experience,” he added. Dr. William V. Williams, BriaCell’s President and CEO, also commenting on the data, said, “We are impressed with the positive clinical and quality of life data in this very difficult-to-treat patient population who have failed multiple prior treatments. We’re delighted that many patients stayed on our study longer than their last therapy, suggesting the Bria-IMT™ combination regimen is both well tolerated and clinically effective.” According to him, “these results have positive implications, both for our ongoing, randomized phase II study and for planned meetings with the U.S. Food and Drug Administration (FDA) on the design of our pivotal study. Advanced MBC remains one of the most difficult cancers to treat.” “There remains an urgent, unmet medical need to find well-tolerated and effective treatments for these gravely ill cancer patients who have only months to live and cannot tolerate the harsh side effects of other cancer treatments,” Williams concluded. Read a detailed insight into the positive clinical and quality of life data in advanced metastatic breast cancer here. BriaCell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer. This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. Contact Details CORE IR investors@briacell.com Company Website https://briacell.com/
December 14, 2022 08:00 AM Eastern Standard Time
News ReleaseAiViva BioPharma
Interested in investing in AiViva’s campaign? Click here to get started! Cancer is one of the most dreaded diseases in the modern world. In the United States. S kin cancer is the most common form of cancer with current estimates indicating that one in five Americans could potentially develop skin cancer in their lifetime. Research estimates that non-melanoma skin cancer (NMSC), including basal cell carcinoma (BCC) and squamous cell carcinoma (SCC), affects more than 3 million Americans a year. Basal cell carcinoma (BCC), a non-melanoma skin cancer, is the most common form of skin cancer and also the most frequently occurring of all cancers. BCC is said to occur when changes are triggered in the basal cells in the outermost layer of the skin (called the epidermis) due to DNA damage resulting from exposure to ultraviolet (UV) radiation from the sun, or from indoor tanning. These changes result in the abnormal and uncontrolled growth of basal cells giving rise to BCC. When detected early, most basal cell carcinomas (BCCs) can be treated and cured but prompt treatment is vital, and certain rare, aggressive forms can be fatal if not treated promptly. A Promising Potential Treatment For Basal Cell Carcinoma? One company that is testing a novel approach to treating BCC and believes it could potentially produce transformative outcomes is AiViva Biopharma. AiViva says that its treatment is unique because it avoids surgery entirely, and comprises injecting the AiViva compound AIV001 directly into the cancer area. Its proprietary technology enables a prolonged release of AIV001 directly to the targeted cancer without systemic side effects or visible scarring. AiViva’s clinical trial is ongoing, targeting two of the four main clinical subtypes of basal cell carcinoma: nodular and superficial in patients. The company says that the preliminary data available from this study is promising, and notes that AIV001 is able to demonstrate its ability for histological clearance of BCC skin cancer. This preliminary result affirms AiViva’s belief that AIV001 could potentially treat and cure superficial and nodular basal cell carcinomas. “We believe that AIV001 has the potential to transform the treatment paradigm for BCC by offering a disease-modifying therapy providing physicians and patients with an effective treatment. We look forward to sharing data from our trial at its conclusion.” said Dr. Diane Tang-Liu, President and CEO of AiViva. The company expects the topline results from the AIV001 trial for BCC to be available in 2023. About AiViva Biopharma: AiViva is a clinical stage biotech company founded in 2015 by four pharmaceutical industry veterans with more than 300 years of combined industry experience. AiViva's founders have demonstrated a successful track record across the full spectrum of drug development and commercialization, in addition to raising capital, and IPOs on the NYSE and NASDAQ.AiViva was formed with the mission of developing novel, innovative pharmaceutical products through an efficient, risk-mitigated development strategy to address major unmet medical needs.We are developing drug products with the potential to transform treatment paradigms or significantly reduce the treatment burden for patients and physicians. Our approach leverages our proprietary JEL™ Technology to prolong the therapeutic effects of drugs and enhance their benefit-risk profiles. AiViva has a diverse pipeline of multiple novel drug candidates in development areas of dermatology, ophthalmology, oncology, and urology with the potential to expand to other areas of interest. Click here to invest in AiViva and be a part of their growth story. If you would like to learn more about the company, check out its website. AiViva is a clinical stage biotech company which has created proprietary technology and new treatments to address significant, unmet medical needs in ophthalmology, dermatology, urology, and oncology. The company is led by a team of seasoned industry experts who have an outstanding track record in successful drug development, commercialization, and multiple IPOs on the NYSE and NASDAQ. The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. Benzinga may receive monetary compensation from the issuer, or its agency, for publicizing the offering of the issuer’s securities. This content is for informational purposes only and is not intended to be investing advice. This is a paid ad. Please see 17(b) disclosure linked in the campaign page for more information. Contact Details Michael office@aiviva.com Company Website https://aiviva.com/
December 13, 2022 03:45 PM Eastern Standard Time
News ReleaseCoorsTek
CoorsTek Bioceramics announced today that the US PTO Trademark Trial and Appeal Board (TTAB) has ruled in its favor cancelling CeramTec GmbH’s trademarks in the color pink. The ruling again affirms CoorsTek Bioceramics’ right to market and sell its pink CeraSurf®-p ceramic hip replacement components in the US. The proceeding was initiated by CoorsTek Bioceramics (formerly C5 MedicalWerks) in 2014 in response to an attempt by CeramTec to enforce its claimed trademark and trade dress in the color pink for its ceramic hip implant components. In its order, the TTAB found the color pink covered by the CeramTec trademark registrations to be functional, and therefore unregistrable. CoorsTek Bioceramics CeraSurf®-p material is a state-of-the-art technical ceramic material containing a chromium oxide additive for improved performance including increased hardness. The pink coloring of products manufactured from CeraSurf®-p ceramic is a natural byproduct of the additive. “Recent global events have cast a bright light on the dangers of singular or limited supply sources in key markets,” said Jonathan Coors, CEO of CoorsTek. “This decision will not only ensure a consistent supply of crucial components, it will foster competition, drive innovation, and enable efficiencies in the surgical marketplace—ultimately benefitting patients receiving critical medical care.” Clinical evidence shows femoral heads (hip balls) manufactured from CeraSurf®-p ceramic material demonstrate exceptional mechanical performance and durability. Hip systems incorporating CeraSurf®-p hip components were initially cleared for regulatory use in Brazil in 2011and have since been registered for use by customers of CoorsTek Bioceramics in the US, China, the EU, and Japan. Additional worldwide regulatory clearances are pending. “CoorsTek Bioceramics offers increased confidence to medical device OEMs and the surgeons reliant on these products,” said Lucian Strong, Vice President of CoorsTek Bioceramics. “With the growing popularity of ceramic bearing surfaces used in hip arthroplasty, it is essential for healthcare providers to have access to high-quality, substantially equivalent options.” The ruling comes at a good time for CoorsTek Bioceramics, as the company recently broke ground on a major expansion of its manufacturing facility in Grand Junction, CO USA. The expansion will vastly increase the company’s capacity for manufacturing the advanced ceramic hip components. CeramTec GmbH has until early February 2023 to file an appeal of the TTAB trademark cancellation order. Similarly in the EU in 2021, the Paris Court of Appeals upheld the cancellations of the three EU trademarks and the dismissal of CeramTec’s trademark infringement and parasitic competition claims against CoorsTek. The Court confirmed the trademarks were filed in bad faith and additionally ordered CeramTec to pay damages for abuse of trademark law, thus clearing the pathway for CoorsTek to market CeraSurf®-p products in the European Union. Read more on the 2021 decision. About CoorsTek Bioceramics CoorsTek Bioceramics is dedicated to leading edge manufacturing of technical ceramic implant components for the medical device industry. A wholly owned subsidiary of CoorsTek, Inc., CoorsTek Bioceramics is backed by over 100 years of technical ceramics expertise. With a focus on ceramic bearing surfaces for total joint arthroplasty, CoorsTek Bioceramics components can also be found in implant devices for neurological, cardiological, spinal, and radiation applications. Since 2005, over six million CoorsTek Bioceramics components have been sold and distributed for clinical use. About CoorsTek Founded in 1910 and continuously owned and operated by the Coors family, CoorsTek is a leading global manufacturer of technical ceramics. By leveraging expertise in engineering and materials science, CoorsTek provides solutions to complex challenges in the medical, semiconductor, automotive, aerospace, and other industries. With over 400 proprietary material formulations, vertically integrated systems, and unparalleled process capabilities, CoorsTek partners with its customers to make the world measurably better. Visit www.coorstek.com Contact Details CoorsTek Megan Maguire +1 303-503-2287 mmaguire@coorstek.com Company Website https://www.coorstek.com
December 13, 2022 11:39 AM Eastern Standard Time
Digital Asset DirectFutura Medical PLC
Contact Details Proactive Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com
December 13, 2022 08:08 AM Eastern Standard Time
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