Tokens Available to K-12 for CubeSat Launches of Waterbears




Tokens Available to K-12 for CubeSat Launches of Waterbears

LA JOLLA, Calif.–(BUSINESS WIRE)–#Biosciences–With over 49 million K-12 students in the US and hundreds of millions worldwide, Vector Space Biosciences (token symbol: SBIO), is now offering students the ability to participate in VSB’s first of several biological satellite (CubeSat) launches sending Waterbears (Tardigrades) to space. Any student holding at least 1 SBIO token will have access to real-time pictures, visualizations and other snapshots related to the launch while it’s happening. Schools, enterprises or individuals holding certain amounts of SBIO will have the option of designing and launching their own payloads with VSB.

Waterbears are unique in that they are ‘extremophiles’ with superhuman-like abilities including being able to withstand great amounts of radiation, repair their DNA thousands of times faster than humans or go into suspended animation for decades. Some have even landed on the Moon. VSB’s mission is to develop ‘countermeasures’ against diseases resulting from ‘stressors’ during human space exploration by generating data related to how certain organisms adapt to the stress of space, such as Waterbears. These countermeasures can double as new forms of precision medicine. Biotechnology and pharmaceutical companies such as Ely Lilly are benefiting from this approach today.

VSB product offerings include packages for life sciences companies and organizations which provide the ability to design, develop and launch their own payloads with Vector Space Biosciences services which include the generation of high-value data where language modeling, the tip of the spear in AI today, is applied to uncover and visualize hidden relationships between genes, proteins, sequences, pathways, biochemicals, drug compounds, phytochemicals, and micronutrients leading to new discoveries in medicine. For more information contact: support@vectorspacebio.science

About Vector Space Biosciences

VSB develops AI models with data from the space industry based on enabling biotechnology, pharmaceutical, and AI semiconductor customers to launch payloads via CubeSats enabling development of new drug compounds to radiation-hardening of AI semiconductors. Data from biological payloads along with AI modeling (language modeling) can be used to develop new forms of precision medicine related to human aging and cancer or provide insights into radiation’s effect on AI semiconductors used in data centers being built in space today. Our primary goal connects to understanding how to develop countermeasures against stressors on the human body during spaceflight, like microgravity and radiation, resulting in new forms of precision medicine for all mankind. VSB maintains the token symbol SBIO, a utility token based in Dubai and parent company to VXV and other spinoffs in the space and precision medicine industry. More information can be found here: https://vectorspacebio.science/technology

Contacts

Christopher Bartlett

chris@thinkgem.com
203-494-4806

support@vectorspacebio.science | Reddit | Telegram | Discord | twitter

Genentech’s Vabysmo Improved Vision in Underrepresented Populations With Diabetic Macular Edema (DME) in a First-Of-Its-Kind Study




Genentech’s Vabysmo Improved Vision in Underrepresented Populations With Diabetic Macular Edema (DME) in a First-Of-Its-Kind Study

– The ELEVATUM study showed clinically meaningful improvement in vision and reduction in retinal fluid in people with DME treated with Vabysmo who identify as African American, Black, Hispanic and Latino –

– Efficacy and safety from this Phase IV study were consistent with data from the Vabysmo Phase III DME studies –

– These racial and ethnic groups are disproportionately affected by diabetes and at higher risk of developing DME, a leading cause of vision loss –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today positive topline one-year results from the open-label, single-arm Phase IV ELEVATUM study evaluating Vabysmo^® (faricimab-svoa) for the treatment of diabetic macular edema (DME) in people from racial and ethnic groups that are often underrepresented in clinical trials.

Initial data from 124 participants in the United States showed that after one year of treatment with Vabysmo, administered every eight weeks, participants could read an additional 12.3 letters on average – equivalent to about two and a half lines on an eye chart. Results among major racial and ethnic groups represented in this study were similar. Hispanic and Latino participants started the study with the most severe disease and had an average vision gain of 14.1 letters from baseline at one year, equivalent to nearly three lines on an eye chart. African American and Black participants gained an average of 11.3 letters from baseline at one year. Vabysmo was well tolerated, with no new safety events identified.

These data were presented in a late-breaking oral presentation at the American Academy of Ophthalmology (AAO) 2024 Annual Meeting in Chicago on October 18. The study is the first retina trial for historically underrepresented populations.

“Vabysmo has been shown to be an effective first-line treatment for diabetic macular edema, and for the first time, we now have data demonstrating its ability to improve vision in Black, African American, Hispanic, and Latino patients who are disproportionately impacted by this condition,” said investigator Jeremiah Brown, M.D., of Retina Consultants of Texas, who presented the data at AAO. “As a clinician who serves patients from these communities, I felt it was important to take part in this groundbreaking study and hope the findings will inform and improve the care we provide to our patients in the clinic daily.”

Results were consistent with the Phase III YOSEMITE and RHINE DME studies. A secondary endpoint showed robust retinal drying with Vabysmo across these racial and ethnic groups, who, on average, achieved a decrease of 206.3 microns in central subfield thickness (CST) from baseline. Reducing CST indicates retinal drying, which is an important clinical measure, as swelling from excess fluid in the back of the eye is associated with distorted and blurred vision.

“Though certain ethnic and racial groups are disproportionately affected by DME, they lag far behind in clinical trial representation,” said Gregory A. Rippon, M.D., M.S., vice president, U.S. Medical Affairs. “We conducted the ELEVATUM study to specifically address this issue and understand how underrepresented patient populations respond to treatment with Vabysmo to help deliver better, more equitable care, and change how clinical trials are designed in the future.”

Among the 124 patients, 45% self-identified as Hispanic or Latino, and 48% as Black or African American. The study was designed to facilitate enrollment and promote retention of underrepresented patients. For example, ELEVATUM was conducted at sites that treat a high proportion of these populations, in urban, rural, and community-based locations. In addition, eligibility criteria allowed participants with a hemoglobin A1c (HbA1c) level up to 12%. An HbA1c test measures a person’s average blood sugar levels over the past three months and is used to diagnose diabetes. Typically, the threshold for DME trials is an HbA1c level of 10%. However, HbA1c levels can be higher in Black, African American, Hispanic and Latino populations compared with Caucasians, meaning a lower HbA1c threshold can inadvertently lead to the exclusion of patients from various ethnic and racial groups.

“At Genentech we’re challenging the status quo and pioneering a new era of inclusive research that aims to directly address long standing health disparities,” said Quita Highsmith, vice president and chief diversity officer at Genentech. “The ELEVATUM study is a significant milestone that not only establishes a blueprint of best practices to enroll more diverse patients, but confirms our continued commitment to advancing inclusive research for all patients.”

To date, Vabysmo is approved in more than 100 countries for DME and wet, or neovascular, age-related macular degeneration (AMD), and in over 30 countries for macular edema following retinal vein occlusion (RVO). More than five million doses of Vabysmo have been distributed globally since its initial U.S. approval in 2022.

Genentech is committed to helping people access the medicines they are prescribed and offers comprehensive services for people prescribed Vabysmo to help minimize barriers to access and reimbursement. Patients can call 833-EYE-GENE for more information. For people who qualify, Genentech offers patient assistance programs through Genentech Access Solutions. More information is also available at (866) 4ACCESS/(866) 422-2377 or https://www.Genentech-Access.com.

Visit https://www.Vabysmo.com for additional information.

About ELEVATUM

ELEVATUM (NCT05224102) is a Phase IV, multicenter, open-label, single-arm study designed to evaluate Vabysmo as a treatment for diabetic macular edema (DME) in patients that have been historically underrepresented in clinical trials, including people who self-identify as Black, African American, Hispanic or Latino. Trial participants have not been treated with an anti‑vascular endothelial growth factor before the study. They receive treatment every 4 weeks with Vabysmo up to week 20, followed by treatment every 8 weeks up to week 52.

The primary endpoint is change from baseline in best corrected visual acuity at week 56. Secondary endpoints include safety and change in central subfield thickness from baseline over time.

About Diabetic Macular Edema

Affecting approximately 750,000 people in the United States, diabetic macular edema (DME) is a vision-threatening retinal condition associated with blindness and decreased quality of life when left untreated. DME occurs when damaged blood vessels in the retina leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving. The number of people with DME is expected to grow as the prevalence of diabetes increases.

About the Vabysmo^® (faricimab-svoa) Clinical Development Program

Genentech has a robust Phase III clinical development program for Vabysmo. The program includes AVONELLE-X, an extension study of TENAYA and LUCERNE, evaluating the long-term safety and tolerability of Vabysmo in wet age-related macular degeneration (AMD), and RHONE-X, an extension study of YOSEMITE and RHINE, evaluating the long-term safety and tolerability of Vabysmo in diabetic macular edema (DME). The POYANG study is evaluating Vabysmo in adult treatment-naive patients with choroidal neovascularization secondary to pathologic myopia. Genentech has also initiated several Phase IV studies, including the ELEVATUM study of Vabysmo in underrepresented patient populations with DME and the SALWEEN study of Vabysmo in a subpopulation of people with wet AMD that is highly prevalent in Asia. Genentech has also initiated the VOYAGER study, a global real-world data collection platform, and supports several other independent studies to further understand retinal conditions with a high unmet need.

About Vabysmo^® (faricimab-svoa)

Vabysmo is the first bispecific antibody approved for the eye. It targets and inhibits two signaling pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). While research is underway to better understand the role of the Ang-2 pathway in retinal disease, Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels.

Vabysmo U.S. Indications

Vabysmo (faricimab-svoa) is a prescription medicine given by injection into the eye, used to treat adults with neovascular (wet) age‑related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).

Important Safety Information

Contraindications

Vabysmo is contraindicated in patients who have an infection in or around their eye, have active swelling around their eye that may include pain and redness, or are allergic to Vabysmo or any of the ingredients in Vabysmo.

Warnings and Precautions

• Injections like the one for Vabysmo can cause an eye infection (endophthalmitis) or separation of layers of the retina (retinal detachment). Patients should seek medical care if they experience increasing eye pain, vision loss, sensitivity to light, or redness in the white of the eye.
• Vabysmo may cause a temporary increase in pressure in the eye (intraocular pressure), which occurs 60 minutes after the injection.
• Although not common, Vabysmo patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes (thromboembolic events). In clinical studies for wet AMD during the first year, 7 out of 664 patients treated with Vabysmo reported such an event. In DME studies from baseline to week 100, 64 out of 1,262 patients treated with Vabysmo reported such an event. In clinical studies for RVO during 6 months, 7 out of 641 patients treated with Vabysmo reported such an event.
• Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of Vabysmo. Healthcare providers should discontinue treatment with Vabysmo in patients who develop these events. Patients should be instructed to report any change in vision without delay.

Adverse Reactions

The most common adverse reactions (≥5%) reported in patients receiving Vabysmo were cataract (15%) and blood on the white of the eye (conjunctival hemorrhage, 8%). These are not all the possible side effects of Vabysmo.

Pregnancy, Lactation, Females and Males of Reproductive Potential

• Based on how Vabysmo interacts with your body, there may be a potential risk to an unborn baby. Patients should use birth control before their first injection, during their treatment with Vabysmo, and for 3 months after their last dose of Vabysmo.
• It is not known if Vabysmo passes into breast milk. Patients should talk to their healthcare provider about the best way to feed their baby if they receive Vabysmo.

Patients may report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in the full Vabysmo Prescribing Information or visit https://www.Vabysmo.com.

About Genentech in Ophthalmology

Genentech is researching and developing new treatments for people living with a range of eye diseases that cause significant visual impairment and blindness, including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR), geographic atrophy (GA) and other retinal diseases, including rare and inherited conditions.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit https://www.gene.com.

Contacts

Media Contact:

Shirley Dang, (650) 467-6800

Advocacy Contact:

Danielle Haney, (240) 805-4810

Investor Contacts:

Loren Kalm, (650) 225-3217

Bruno Eschli, +41 61 687 5284

Vertex to Present Phase 3 Data Highlighting Suzetrigine’s Potential as a First-in-Class, Highly Selective Pain Signal Inhibitor at the American Society of Anesthesiologists Annual Meeting




Vertex to Present Phase 3 Data Highlighting Suzetrigine’s Potential as a First-in-Class, Highly Selective Pain Signal Inhibitor at the American Society of Anesthesiologists Annual Meeting

— Phase 3 abstract selected for presentation in “Best Abstract” session —

BOSTON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the company will present its pivotal Phase 3 data on suzetrigine, an investigational, oral, highly selective NaV1.8 pain signal inhibitor for the treatment of moderate-to-severe acute pain, at the annual meeting of the American Society of Anesthesiologists (ASA), taking place from October 18-22, 2024 in Philadelphia, Pennsylvania.

• Abstract A1187 — “Randomized, Placebo-Controlled, Phase 3 Trials of Suzetrigine, a Non-Opioid, Pain Signal Inhibitor for Treatment of Acute Pain After Abdominoplasty or Bunionectomy” will be presented as an oral presentation on Sunday, October 20, during the “Best Abstract” session, which runs from 8:00-11:00 a.m. ET, as well as the Education session which runs on Monday, October 21, from 1:30-2:30 p.m. ET.
• Abstract A2074 — “A Phase 3, Single-Arm Study of Suzetrigine, a Non-Opioid, Pain Signal Inhibitor For Treatment of Acute Pain From Surgical and Non-surgical Conditions” will be presented in a poster session on Saturday, October 19, from 10:00-11:30 a.m. ET.

This will be the first time the suzetrigine Phase 3 data will be presented to the medical community following the January 2024 announcement that the Phase 3 trials were positive. The Phase 3 program included two randomized, double-blind, placebo-controlled trials, one following abdominoplasty surgery and one following bunionectomy surgery, as well as a single arm safety and effectiveness study which enrolled patients with a broad range of surgical and non-surgical pain conditions. Results from all three studies demonstrate compelling and consistent efficacy and safety across multiple acute pain conditions and settings.

“Our goal in developing suzetrigine is to deliver the first non-opioid acute pain treatment in more than two decades and to change the paradigm of pain management as we know it,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. “We are very pleased to have these Phase 3 data selected for presentation in the “Best Abstract” session at the annual ASA meeting and the opportunity to share these important results in this forum.”

“For decades, pain treatment options have been extremely limited,” said Todd Bertoch, M.D., a practicing anesthesiologist and researcher, CEO of CenExel JBR Clinical Research in Salt Lake City, and lead presenter for the suzetrigine Phase 3 data. “This research has brought about a renewed optimism for the future of pain management, and I’m looking forward to sharing our findings with the ASA community. Suzetrigine offers the potential to fill the critically important treatment gap between opioids and other currently available therapies that have either limited efficacy and/or poor tolerability.”

Suzetrigine Program Updates

The company continues to progress its peripheral neuropathic pain (PNP) clinical development program for suzetrigine and has initiated its Phase 3 pivotal program of suzetrigine in patients with painful diabetic peripheral neuropathy (DPN). Additionally, Vertex remains on track to share results in late 2024 from its Phase 2 study of suzetrigine in painful lumbosacral radiculopathy (LSR).

Investor Event and Webcast

Vertex will host an investor event on Sunday, October 20, 2024, at 6:00 p.m. ET in Philadelphia to discuss suzetrigine and the Phase 3 clinical trial results in acute pain. A live webcast of the presentation and Q&A portions can be accessed through the Investor Relations section of Vertex’s website at https://investors.vrtx.com/. An archived webcast will be available on the company’s website.

About Acute Pain

Acute pain is a disabling condition and is defined as pain lasting less than 3 months. It is estimated that over 80 million people are prescribed a medicine for acute pain every year in the U.S. Due to limited treatment options, there is an unmet need in acute pain management to improve the patient experience and reduce the economic and societal burden.

About Suzetrigine

Suzetrigine is an investigational oral, highly selective pain signal inhibitor that is selective for NaV1.8 relative to other NaV channels. NaV1.8 is a voltage-gated sodium channel that is selectively expressed in peripheral pain-sensing neurons (nociceptors), where its role is to transmit pain signals (action potentials). Vertex’s approach is to selectively inhibit NaV1.8 using small molecules with the objective of creating a new class of pain signal inhibitors that have the potential to provide effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids. Suzetrigine has demonstrated a favorable benefit/risk profile in multiple Phase 2 and Phase 3 studies in patients with moderate-to-severe acute pain and has been granted FDA Fast Track and Breakthrough Therapy designations in moderate-to-severe acute pain in the U.S. It is currently under priority review by the FDA for the treatment of moderate-to-severe acute pain with a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2025. Vertex is also evaluating suzetrigine in peripheral neuropathic pain (PNP) with the goal of pursuing a broad PNP label. Vertex recently initiated a Phase 3 pivotal program of suzetrigine in patients with painful diabetic peripheral neuropathy (DPN) and has completed enrollment in its Phase 2 study of suzetrigine in painful lumbosacral radiculopathy (LSR) — both are PNP conditions. Suzetrigine is investigational and has not been approved by any health authority.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continues to advance clinical and research programs in these diseases. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1.

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry’s top places to work, including 14 consecutive years on Science magazine’s Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex’s history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube and X.

Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements by Carmen Bozic, M.D., and Todd Bertoch, M.D., in this press release, and statements about Vertex’s plans to present pivotal Phase 3 data on suzetrigine at ASA, Vertex’s beliefs about the potential benefits of suzetrigine, plans to continue to progress the PNP clinical development program for suzetrigine and the goal of a broad PNP label, Vertex’s plans to host an investor event to discuss suzetrigine and Phase 3 results in acute pain, and plans to share results from the Phase 2 study of suzetrigine in LSR in late 2024. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company’s beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from a limited number of patients may not be indicative of final clinical trial results, that clinical trial data might not be available on the expected timeline, that data from the company’s research and development programs may not support registration or further development of its compounds due to safety, efficacy, and other risks listed under the heading “Risk Factors” in Vertex’s most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at www.sec.gov and available through the company’s website at www.vrtx.com. You should not place undue reliance on these statements, or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

Contacts

Vertex Pharmaceuticals Incorporated
Investors:
InvestorInfo@vrtx.com
Susie Lisa, CFA: +1 617-341-6108

or

Miroslava Minkova: +1 617-341-6135

Media:
mediainfo@vrtx.com
or

International: +44 20 3204 5275

or

U.S.: 617-341-6992

or

Heather Nichols: +1 617-839-3607

Audax Private Equity Completes Carveout of Avantor, Inc.’s Clinical Services Business and Rebrands the Company as Resonant Clinical Solutions




Audax Private Equity Completes Carveout of Avantor, Inc.’s Clinical Services Business and Rebrands the Company as Resonant Clinical Solutions

SAN FRANCISCO & BOSTON–(BUSINESS WIRE)–Audax Private Equity (“Audax”) has completed its acquisition of the clinical services business of Avantor, Inc. (NYSE: AVTR) and, in close collaboration with the employees, has re-branded the business as Resonant Clinical Solutions (“Resonant” or “the Company”).

Resonant is comprised of three well-respected brands – EPL Archives, MESM, and Therapak. These long-standing brands, whose roots and lineage extend as far back as the 1970s, provide a comprehensive, quality-focused service offering to its pharmaceutical, biotechnology, contract research organization (CRO), and diagnostic laboratory customers. Beyond investing in the business and operations of Resonant, Audax will look to drive organic and inorganic growth to enhance the brands’ existing solution sets while adding complementary capabilities through M&A.

“We are grateful for Avantor’s stewardship and support of Resonant’s growth over the last seven years and are excited to support the Company in its next phase of growth as an independent platform in the outsourced clinical trial services sector,” said Stephen Weaver, Managing Director at Audax Private Equity. “We have a plan in place to effect a seamless transition as Resonant.”

“We believe Resonant’s long-tenured customer relationships — built on years of partnership with clients — position the Company well to accelerate growth,” said David Wong, Partner at Audax Private Equity. “Increasing complexity of clinical trial services is driving pharma sponsors and CROs to outsource these services to specialists. Resonant’s solution set allows its clients to better manage this complexity and focus their energy on drug discovery and R&D.”

Moelis & Company LLC served as financial advisor and Ropes & Gray LLP served as legal counsel to Audax Private Equity. J.P. Morgan Securities LLC served as exclusive financial advisor to Avantor and Arnold & Porter served as Avantor’s legal advisor.

ABOUT AUDAX PRIVATE EQUITY

Headquartered in Boston, with offices in San Francisco, New York, and London, Audax Private Equity manages three strategies: its Flagship and Origins private equity strategies, seeking control buyouts in the core middle and lower middle markets, respectively, and its Strategic Capital strategy that provides customized equity solutions to PE-backed portfolio companies to help drive continued growth. With approximately $19 billion of assets under management as of June 2024, over 270 employees, and 100-plus investment professionals, Audax has invested in more than 170 platforms and 1,300 add-on acquisitions since its founding in 1999. Through our disciplined Buy & Build approach, across six core industry verticals, Audax seeks to help portfolio companies execute organic and inorganic growth initiatives with the aim of fueling revenue expansion, optimizing operations, and significantly increasing equity value. For more information, visit www.audaxprivateequity.com or follow us on LinkedIn.

ABOUT RESONANT CLINICAL SOLUTIONS

With over 850 employees, Resonant Clinical Solutions provides clinical trial and laboratory supply chain services to pharmaceutical and biotechnology companies, contract research organizations (CROs), and diagnostic laboratories. The Company operates 10 facilities across the US, UK, and Europe and maintains a global logistics and equipment services network that distinguishes the business as a partner of choice to help its clients manage complex and evolving supply chain needs.

Contacts

Audax Private Equity Media
Zachary Tramonti / Catherine Livingston

FGS Global

Audax@fgsglobal.com

Zai Lab Announces Participation in November and December Investor Conferences




Zai Lab Announces Participation in November and December Investor Conferences

SHANGHAI & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that members of the Company’s senior management team will participate in the following investor conferences in November and December 2024:

Goldman Sachs APAC Healthcare Corporate Day 2024
Time: November 5-8, 2024

Location: Hong Kong, Hong Kong

Jefferies London Healthcare Conference
Fireside Chat: Tuesday, November 19, 2024,1:30 p.m. GT

Location: Aldwych, London

Citi’s 2024 Global Healthcare Conference
Time: December 3-5, 2024

Location: Miami, Florida

About Zai Lab

Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide.

For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global.

Contacts

Investor Relations:
Christine Chiou / Lina Zhang

+1 (917) 886-6929 / +86 136 8257 6943

christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com

Media:
Shaun Maccoun / Xiaoyu Chen

+1 (415) 317-7255 / +86 185 0015 5011

shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com

Actineer, a Joint Venture of ITM and CNL, Begins Actinium-225 Production




Actineer, a Joint Venture of ITM and CNL, Begins Actinium-225 Production

Successful Cyclotron Irradiation of Ra-226 Sets the Stage for Actineer’s Large-Scale Ac-225 Production for Cancer Therapies

CHALK RIVER, Ontario–(BUSINESS WIRE)–Actineer, the joint venture between ITM and Canadian Nuclear Laboratories (CNL) Ltd., has successfully produced Actinium-225 (Ac-225) by irradiating Radium-226 (Ra-226) in a cyclotron. This production milestone achievement will enable the joint venture to provide GMP-grade Ac-225 to customers by mid-2025, alongside the submission of a US Drug Master File (DMF).

“Actineer is proud to have reached this important milestone,” said Ram Mullur, President of Actineer. “This achievement represents a critical step towards fulfilling our commitment to becoming a major global supplier of Ac-225. Together, we are dedicated to serving customers, the medical community, and, most importantly, patients who rely on Ac-225’s potential to advance Targeted Alpha Therapy.”

Actinium-225 serves as a vital precursor in the development of innovative cancer therapies. It is especially valuable for use in drug research and clinical trials focused on Targeted Alpha Therapy (TAT), where it is combined with molecules designed to seek out and bind to cancer cells. Once linked, the Ac-225 is delivered to the tumor, where it has the potential to treat various types of cancers by attacking cancerous cells while minimizing harm to nearby healthy tissues. Future drug products using Ac-225, once fully developed and approved, could offer powerful treatments that precisely target and destroy cancerous tissue with limited side effects.

“Actinium-225 represents a transformative opportunity in the realm of cancer treatment. As we look ahead, the global demand for Ac-225 is poised to rise sharply, driven by the urgent need for innovative therapies that can target hard-to-reach tumors and metastases.” said Dr. Andrew Cavey, CEO, ITM and Actineer Board Chairman. “Actineer is leading the effort to deliver a stable and scalable supply of Ac-225 which is essential for advancing clinical trials and also for making life-saving treatments accessible to patients worldwide.”

Alpha-emitters such as Ac-225 are known for emitting high-energy alpha particles with a short penetration range, enabling precise targeting of tumor cells. Preclinical studies of TATs have shown impressive results, with Ac-225 effectively breaking the DNA bonds of cancer cells, leading to their destruction.

Actineer is focused on expanding manufacturing capacity and increasing the supply of Ac-225, ensuring that patients worldwide will benefit from this promising isotope as a foundation for future cancer therapies.

About Actineer, Inc.

Actineer™ Inc. is a joint venture company between Canadian Nuclear Laboratories (CNL) and ITM Isotope Technologies Munich SE (ITM) dedicated to advancing Ac-225 technologies, quickly securing supply, and producing industrial-scale quantities of this valuable, rare medical radioisotope for the treatment of cancer. Founded in October 2023, Actineer™ Inc. together with its strong supply chain collaborators will progress Ac-225 development, production and processing technologies. It has established short-term production capabilities that is expected to lead to significantly boosting international supplies, while working long-term towards the construction of a new Actinium Production Facility (APF) in Canada. The joint venture’s mission is to fulfil the unmet global manufacturing and production needs of this coveted radioisotope with significant potential in the fight against cancer.

Contacts

Actineer, Inc

Science Collaboration Centre

286 Plant Road

Chalk River, Ontario, KOJ 1J0 Canada

info@actineer.com

For media inquiries only: actineer@trophic.eu

Kenvue to Announce Third Quarter 2024 Results on November 7, 2024




Kenvue to Announce Third Quarter 2024 Results on November 7, 2024

SKILLMAN, N.J.–(BUSINESS WIRE)–Kenvue Inc. (NYSE: KVUE) (“Kenvue”), the world’s largest pure-play consumer health company by revenue, will announce its third quarter 2024 financial results before market open on November 7, 2024.

The company will host a conference call and webcast at 8:00 a.m. Eastern Time to discuss its financial results. The conference call can be accessed by dialing 877-407-8835 from the U.S. or +1 201-689-8779 from international locations. A live webcast of the conference call can also be accessed at investors.kenvue.com, with a replay made available after the live event.

About Kenvue

Kenvue is the world’s largest pure-play consumer health company by revenue. Built on more than a century of heritage, our iconic brands, including Aveeno^®, BAND-AID^® Brand, Johnson’s^®, Listerine^®, Neutrogena^® and Tylenol^®, are science-backed and recommended by healthcare professionals around the world. At Kenvue, we believe in the extraordinary power of everyday care and our teams work every day to put that power in consumers’ hands and earn a place in their hearts and homes. Learn more at www.kenvue.com.

Contacts

Investor Relations:
Sofya Tsinis

Kenvue_IR@Kenvue.com

Media Relations:
Melissa Witt

Media@Kenvue.com

KalVista Pharmaceuticals to Present Data at the 2024 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI)




KalVista Pharmaceuticals to Present Data at the 2024 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI)

CAMBRIDGE, Mass. & SALISBURY, England–(BUSINESS WIRE)–KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that five abstracts have been accepted for e-Poster presentation at the 2024 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (ACAAI), taking place in Boston, MA from October 24-28. Presentations include:

• Patient-Reported Anxiety Impacts Utilization of Injectable On-demand Treatment of Hereditary Angioedema Attacks: Cristine Radojicic, Autumn Burnette, Sally van Kooten, Neil Malloy, Markus Heckmann, Hilary Longhurst. Results shared as an e-Poster Presentation on Friday, October 25 at 2:00pm ET, Monitor 20, Exhibit Hall A.
• On-demand Treatment of Laryngeal Hereditary Angioedema Attacks with Sebetralstat: Pooled Analysis from KONFIDENT and KONFIDENT-S: Emel Aygören-Pürsün, Jonathan A. Bernstein, William R. Lumry, Paul K. Audhya, James Hao, Michael D. Smith, Christopher M. Yea, Marc A. Riedl. Results shared as an e-Poster Presentation on Friday, October 25 at 5:00pm ET, Monitor 20, Exhibit Hall A.
• Substantial Reduction of Hereditary Angioedema Attack Symptom Burden in the Sebetralstat Phase 3 KONFIDENT Trial: William R. Lumry, Danny M. Cohn, Jonathan A. Bernstein, Paul K. Audhya, James Hao, Michael D. Smith, Christopher M. Yea, Marc A. Riedl. Results shared as an e-Poster Presentation on Friday, October 25 at 5:00pm ET, Monitor 19, Exhibit Hall A.
• Indirect treatment comparison of oral sebetralstat and intravenous rhC1-INH as on-demand treatments for hereditary angioedema: H. Henry Li, Markus Magerl, Timothy Craig, Michael E. Manning, Noemi Hummel, Alice Wang, Paul K. Audhya, Jonathan A. Bernstein. Results shared as an e-Poster Presentation on Friday, October 25 at 5:15pm ET, Monitor 19, Exhibit Hall A.
• Correlation of Time to Treatment with Attack Duration in the Sebetralstat KONFIDENT Phase 3 Trial: Timothy J. Craig, Jonathan A. Bernstein, Hilary Longhurst, James Hao, Michael D. Smith, Paul K. Audhya, Christopher M. Yea, Marcus Maurer. Results shared as an e-Poster Presentation on Friday, October 25 at 5:30pm ET, Monitor 19, Exhibit Hall A.

Links to all posters and presentations can be found on the KalVista website under “Publications”.

About Sebetralstat

Discovered and developed entirely by the scientific team at KalVista, sebetralstat is a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE). Sebetralstat received Fast Track and Orphan Drug Designations from the U.S. FDA, as well as Orphan Drug Designation and an approved Pediatric Investigational Plan from the European Medicines Agency (EMA).

About Hereditary Angioedema

Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the location affected. All currently approved on-demand treatment options require either intravenous or subcutaneous administration.

About KalVista Pharmaceuticals, Inc.

KalVista Pharmaceuticals, Inc. is a global pharmaceutical company that seeks to develop and deliver oral medicines for diseases with significant unmet need. The Company is focused on understanding the needs of patients and the limitations of current therapies to design treatments that empower people to better manage their disease and improve their lives. In August 2024, the Company announced its NDA for sebetralstat for hereditary angioedema (HAE) was accepted by the U.S. FDA with a PDUFA goal date of June 17, 2025. In addition, KalVista received validation of its MAA for HAE from the EMA and has submitted MAA applications to regulators in the United Kingdom, Switzerland, Australia, and Singapore.

For more information about KalVista, please visit www.kalvista.com or follow on social media at @KalVista and LinkedIn.

Forward-Looking Statements

This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2024, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contacts

Jenn Snyder

Vice President, Corporate Affairs

(617) 448-0281

jsnyder@kalvista.com

Ryan Baker

Head, Investor Relations

(617) 771-5001

ryan.baker@kalvista.com

Biodesix to Report Third Quarter 2024 Financial Results on November 1, 2024




Biodesix to Report Third Quarter 2024 Financial Results on November 1, 2024

LOUISVILLE, Colo.–(BUSINESS WIRE)–Biodesix, Inc. (Nasdaq: BDSX), a leading diagnostic solutions company with a focus in lung disease, today announced that it will release financial results for the third quarter ended September 30, 2024 before the start of trading on Friday, November 1. Biodesix management will host a conference call and webcast to discuss its financial results and provide a general business update at 8:30 a.m. Eastern Time on the same day.

Listeners can register for the webcast via this link. Analysts who wish to participate in the question and answer session should use this link. A replay of the webcast will be available via the company’s investor website approximately two hours after the call’s conclusion. Participants are advised to join 15 minutes prior to the start time.

About Biodesix

Biodesix is a leading diagnostic solutions company with five Medicare-covered tests available for patients with lung diseases. The blood-based Nodify Lung^® Nodule Risk Assessment evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood-based IQLung™ test portfolio for lung cancer patients integrates the GeneStrat^® targeted ddPCR™ test, the GeneStrat NGS^® test, and the VeriStrat^® test to support treatment decisions across all stages of lung cancer and expedite personalized treatment. In addition, Biodesix collaborates with the world’s leading biopharmaceutical companies to provide biomarker discovery, diagnostic test development, and clinical trial support services. For more information, visit biodesix.com.

Note: Biodesix, Nodify Lung, IQLung, GeneStrat, GeneStrat NGS, VeriStrat, Nodify XL2 and Nodify CDT are trademarks or registered trademarks of Biodesix, Inc. ddPCR is a trademark of Bio-Rad Laboratories, Inc.

Note Regarding Forward-Looking Statements

This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. Biodesix has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions. Forward-looking statements may include information concerning the impact of backlog and the timing and assumptions regarding collection of revenues on projections, availability of funds and future capital including under the term loan facility, expectations regarding revenue and margin growth and its impact on profitability, and the impact of a pandemic, epidemic, or outbreak, including the COVID-19 pandemic, on Biodesix and its operations and financial performance. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. The Company’s ability to continue as a going concern could cause actual results to differ materially from those contemplated in this press release and additionally, other factors that could cause actual results to differ materially from those contemplated in this press release can be found in the Risk Factors section of Biodesix most recent annual report on Form 10-K, filed March 1, 2024. Biodesix undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.

Contacts

Media:
Natalie St. Denis

Natalie.StDenis@biodesix.com
1-720-925-9285

Investors:
Chris Brinzey

chris.brinzey@westwicke.com
(339) 970-2843

Acadia Pharmaceuticals to Announce Third Quarter Financial Results on November 6, 2024




Acadia Pharmaceuticals to Announce Third Quarter Financial Results on November 6, 2024

Company to host conference call and webcast on Wednesday, November 6, 2024, at 4:30 p.m. Eastern Time

SAN DIEGO–(BUSINESS WIRE)–Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that it will report third quarter financial results on Wednesday, November 6, 2024, after the close of the U.S. financial markets. Acadia’s management team will also host a conference call and webcast on November 6, 2024, at 4:30 p.m. Eastern Time to discuss financial results and operations.

The conference call will be available on Acadia’s website, Acadia.com under the investors section and will be archived there until December 6, 2024. The conference call may also be accessed by registering for the call here. Once registered, participants will receive an email with the dial-in number and unique PIN number to use for accessing the call.

About Acadia Pharmaceuticals Inc.

Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis and multiple other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at Acadia.com and follow us on LinkedIn and X.

Contacts

Investor Contact:
Acadia Pharmaceuticals Inc.

Al Kildani

(858) 261-2872

ir@acadia-pharm.com