On December 15, 2021 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported that CEO Snehal Patel participated in a TD Ameritrade interview to discuss the Phase IIb poster presented at the 2021 San Antonio Breast Cancer Symposium on December 9, 2021 (Press release, Greenwich LifeSciences, DEC 15, 2021, View Source [SID1234597195]).

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Mr. Patel appeared for a second time as a featured guest in a live interview on TD Ameritrade Network’s The Watch List with host Nicole Petallides. A webcast of the interview can be seen here.

In the interview, Mr. Patel discussed how the new Phase IIb clinical trial findings could lead to a new treatment that complements GP2 peptide therapy and allows doctors to detect metastatic breast cancer recurrences earlier. The newly published Phase IIb clinical trial data shows that 22.8% of 145 patients had an immune response to GP2 prior to any treatment with GP2. Typically, no response to GP2 would be expected until after treatment with GP2. However, an immune response was seen in these patients before any treatment with GP2, suggesting that their cancer was already recurring. The data suggests that patients with an immune response to GP2 prior to treatment recurred twice as fast and approximately 7 to 11 months sooner than those without an immune response prior to treatment did. The number of recurrences was low in the Phase IIb clinical trial, so these observations will be confirmed further in the larger Phase III trial, and the data will be available as early as 2022.

Mr. Patel continued to discuss how in the Phase III clinical trial, T cells will be fully characterized and identified at the DNA level to better understand the initial immune response to GP2. GP2 immunotherapy trains T cells to attack metastatic breast cancer. By identifying the GP2 specific T cells that are attacking the cancer, the most effective T cells could be developed as drug candidates and given directly to patients as a treatment using CAR-T cell technology. Thus the Company could use this new patentable T cell technology for both diagnosis and treatment, expanding the Company’s pipeline beyond just GP2 and further benefiting patients.

About FLAMINGO-01 and GLSI-100

The Phase III clinical trial will be called FLAMINGO-01 and the combination of GP2 + GM-CSF will be called GLSI-100. The Phase III trial is comprised of 2 blinded, randomized, placebo-controlled arms for approximately 500 HLA-A*02 patients and 1 open label arm of up to 100 patients for all other HLA types. An interim analysis has been designed to detect a hazard ratio of 0.3 in IDFS, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. The trial is currently being registered on clinicaltrials.gov and the link and trial identifier will be published shortly. For future updates about FLAMINGO-01 please visit the Company’s clinical trial tab at View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 282,000 new breast cancer patients and 3.8 million breast cancer survivors in 2021. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On December 15, 2021 Idera Pharmaceuticals, Inc. ("Idera," the "Company," "we," "us," and "our") (Nasdaq: IDRA) reported clinical updates regarding tilsotolimod, its synthetic Toll-like receptor 9 agonist (Press release, Idera Pharmaceuticals, DEC 15, 2021, View Source [SID1234597194]).

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ILLUMINATE-206 Trial for the Treatment of Previously Treated Patients with Immunotherapy-Naïve Micro-Satellite Stable Colorectal Cancer (MSS-CRC)
Preliminary data from the second 10 patients dosed in the safety cohort of ILLUMINATE-206, which involves tilsotolimod in combination with ipilimumab and nivolumab, showed a safety profile consistent with the first 10 patients in ILLUMINATE-206 and with prior studies. Eight patients had a post-baseline disease assessment evaluated per Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1). Of those, one patient experienced Stable Disease (SD) with disease control for more than six months; the remaining patients experienced Progressive Disease (PD). However, one of the RECIST v1.1 PD patients was determined to have experienced pseudo-progression, meaning that the initial increase from baseline in overall tumor burden was followed by a decrease from baseline in overall tumor burden. At the most recent disease assessment, the total decrease from baseline was 46.2%, which is considered an Immune-Related Partial Response (irPR) by Immune-Related RECIST (irRECIST). Per protocol, the patient is continuing in active treatment. No further enrollment in ILLUMINATE-206 is planned at this time.

Collaboration with AbbVie for the Treatment of Head and Neck Squamous Cell Carcinoma
AbbVie Inc. ("AbbVie") is conducting a Phase 1b study for treatment of patients with recurrent/metastatic head and neck squamous cell carcinoma with ABBV-368 plus tilsotolimod and other therapy combinations. AbbVie has discontinued further patient enrollment in the study; this decision was not related to safety concerns. Current patient treatment and follow-up is ongoing. AbbVie is solely responsible for the conduct of the study, with Idera contributing tilsotolimod supply.

Investigator-Sponsored Trial for the Intradermal Treatment of Melanoma
The VU University Medical Center (VUmc) Amsterdam, which is conducting a randomized, controlled trial of a single, intradermal injection of tilsotolimod at the primary melanoma excision site in 214 patients, recently shared with the Company early translational data supporting the mechanism of action of tilsotolimod. "As expected, immune activation, including elevated frequencies of key dendritic cells, was seen in early analysis by flow cytometry of sentinel lymph node biopsies collected seven days post-injection," said Dr. Tanja de Gruijl of VUMC. "These data are consistent with previously reported translational data relating to tilsotolimod in other pre-clinical and clinical settings. We are eager to see if this evidence of immune system stimulation will translate to clinical benefit in this patient population." Enrollment in this study is ongoing.

Investigator-Sponsored Trial for the Treatment of Advanced Cancers
The Gustave Roussy Cancer Campus in Paris is conducting an open-label, Phase 1b study of intratumoral tilsotolimod in combination with intratumoral ipilimumab and intravenous nivolumab in advanced cancers, including non-squamous cell lung cancer, refractory advanced melanoma, and MSS-CRC. Dosing in Part A of the study, which involved 24 patients across two different dose frequencies of ipilimumab and tilsotolimod, is complete; patient follow up is ongoing.

Out-Licensing Consideration
"While our clinical trials with tilsotolimod have not yet translated into a new treatment alternative for patients, data supporting tilsotolimod’s mechanism of action and encouraging safety profile from across the array of pre-clinical and clinical work to date, together with its intellectual property protection, are noteworthy," stated Vincent Milano, Idera’s Chief Executive Officer. "As a result, we will consider an out-licensing arrangement for tilsotolimod so that its full potential may continue to be explored on behalf of patients who do not respond to traditional immunotherapy. We also continue both to preserve cash and to identify and explore potential development or commercial-stage assets for Idera’s portfolio, and we are encouraged by the opportunities presented to us."

About Tilsotolimod (IMO-2125)
Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate (Type-I IFN, antigen presentation) and adaptive (T cells) immune activation. Tumors with an active immune response appear to respond better to checkpoint inhibitors (CPIs) than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.

Tilsotolimod is being evaluated in multiple tumor types and in combination with multiple CPIs. For more information on tilsotolimod trials, please visit www.ClinicalTrials.gov.

On December 15, 2021 Exelixis, Inc. (Nasdaq: EXEL) reported initiation of the dose-escalation stage of STELLAR-002, a phase 1b trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors (Press release, Exelixis, DEC 15, 2021, View Source [SID1234597193]). The objective of the study is to evaluate the safety, tolerability and efficacy of XL092, Exelixis’ novel next-generation tyrosine kinase inhibitor (TKI), in combination with: nivolumab (OPDIVO); nivolumab and ipilimumab (YERVOY); and nivolumab and bempegaldesleukin.

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Exelixis is sponsoring STELLAR-002, and Bristol-Myers Squibb Company (NYSE: BMY) is providing nivolumab, ipilimumab and bempegaldesleukin for use in the trial, in accordance with their clinical trial collaboration and supply agreement announced in June. Nektar Therapeutics (Nasdaq: NKTR) will supply bempegaldesleukin to Bristol Myers Squibb through their existing global development and commercialization collaboration.

"The initiation of the dose-escalation stage of STELLAR-002, our second phase 1b trial of XL092, is an important step toward evaluating the potential of this next-generation tyrosine kinase inhibitor in combination with three additional immuno-oncology therapies for patients with advanced genitourinary tumors," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "We are pleased to continue our successful collaboration with Bristol Myers Squibb through this trial and look forward to identifying the recommended doses for the cohort-expansion stage."

The dose-escalation stage will determine the recommended dose in patients with advanced solid tumors for each of the XL092 combination therapy regimens. Once the recommended dose is established, the trial will begin to enroll tumor-specific expansion cohorts for patients with advanced renal cell carcinoma, urothelial carcinoma and metastatic castration-resistant prostate cancer. The primary efficacy endpoint of the expansion stage will be objective response rates, except for the cohort of patients with metastatic castration-resistant prostate cancer, for which the primary endpoint will be duration of radiographic progression-free survival.

About XL092

XL092 is a next-generation oral tyrosine kinase inhibitor that targets kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. In designing XL092, Exelixis sought to build upon its extensive experience with cabozantinib, the company’s flagship medicine, retaining the target profile while improving key characteristics, including pharmacokinetic half-life. XL092 is currently being developed for the treatment of advanced solid tumors, including genitourinary cancers, as a monotherapy and in combination with immune checkpoint inhibitors. XL092 is the first internally discovered Exelixis compound to enter the clinic following the company’s reinitiation of drug-discovery activities.

About Genitourinary Cancers

Genitourinary cancers are those that affect the urinary tract, prostate, testicles or penis — parts of the body involved in reproduction and urine production and excretion — and include renal cell carcinoma (RCC), castration-resistant prostate cancer (CRPC) and urothelial carcinomas.1

The American Cancer Society’s (ACS) 2021 statistics cite kidney cancer as among the top 10 most commonly diagnosed forms of cancer among both men and women in the U.S.2 Clear cell RCC is the most common type of kidney cancer in adults.3 Papillary RCC accounts for about 15% of all renal cell cancers.4,5 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 13%.2 Approximately 32,000 patients in the U.S. and over 71,000 worldwide will require systemic treatment for advanced kidney cancer in 2021, with nearly 15,000 patients in need of a first-line treatment in the U.S.6
According to the ACS, in 2021, approximately 250,000 new cases of prostate cancer will be diagnosed, and 34,000 people will die from the disease.2 Prostate cancer that has spread beyond the prostate and does not respond to androgen-suppression therapies — a common treatment for prostate cancer — is known as metastatic CRPC.7 Researchers estimate that in 2020, 43,000 people were diagnosed with metastatic CRPC, which has a median survival of less than two years.8,9,10
Urothelial cancers encompass carcinomas of the bladder, ureter and renal pelvis at a ratio of 50:3:1, respectively.11 Bladder cancer occurs mainly in older people, with 90% of patients aged 55 or older.12 With an estimated 84,000 new cases expected to be diagnosed in 2021, bladder cancer accounts for about 5% of all new cases of cancer in the U.S. each year.2,13 It is the fourth most common cancer in men.2

On December 15, 2021 Eli Lilly and Company (NYSE: LLY) reported that extensive updates across its research and development (R&D) programs to highlight the company’s strong pipeline and potential for future growth (Press release, Eli Lilly, DEC 15, 2021, View Source [SID1234597192]). At an investment community meeting today, the company is sharing key information across its four therapeutic areas – including pipeline updates and future R&D investments – along with 2022 financial guidance and updated 2021 guidance.

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The company is on track to meet its goal of launching 20 new medicines over the 10-year period from 2014 to 2023. Over the last eight years, Lilly has delivered 16 new medicines and plans to launch five more medicines over the next two years, if approved, including tirzepatide, donanemab, pirtobrutinib, lebrikizumab and mirikizumab. These potential launches contribute to the company’s expectations for top-tier, volume-driven growth over the next decade, as the number of people that can benefit from Lilly’s innovative new medicines continues to increase.

"Lilly’s accomplishments in recent years are impressive, but it’s where we are going that most excites us. We’ve driven results over the last four years, successfully launched new medicines, and invested in high-impact R&D that has set us up for a truly exciting new era," said David A. Ricks, Lilly’s chairman and CEO. "Bringing new practice-changing medicines to patients is our top priority. We have a remarkable opportunity ahead of us to make life better for millions more people around the world."

The company is providing details on its diabetes and obesity, immunology, oncology and neuroscience R&D programs, sharing a number of new pipeline updates and previously undisclosed data. Lilly also will provide insight into its ongoing R&D investments that reflect the company’s conviction around key emerging trends in biopharma innovation.

"I’m very optimistic about the future for Lilly and the patients we serve. In addition to our promising late-stage pipeline, our labs are making new discoveries to bring life-changing medicines to patients who need them," said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories. "Lilly has significantly improved our development speed and clinical success rates and will continue to apply this focus as we work to maximize the impact of our existing medicines and create new ones.

"Genetic medicines, including modalities such as RNA therapeutics and viral-delivered gene therapies, are poised to contribute to the next generation of breakthrough treatments for a wide array of diseases," Skovronsky continued. "Today, Lilly will share more about our new capabilities and increased investment in this space, along with new preclinical and clinical data for genetic medicines in our neuroscience and cardiovascular disease research portfolios."

Diabetes and Obesity

Building on its historic foundation of helping people with diabetes, Lilly is expanding its strategic focus to breakthrough medications that disrupt the disease cascade caused by obesity and type 2 diabetes progression, highlighted by tirzepatide and supported by several early-phase incretin assets.

2

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted Lilly’s New Drug Application and Marketing Authorization Application, respectively, for tirzepatide for the treatment of adults with type 2 diabetes. Lilly also submitted tirzepatide to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan and in six additional markets. Lilly plans to initiate additional tirzepatide studies that include phase 3 studies in obesity related outcomes and obstructive sleep apnea, as well as a phase 2 mechanism of action study in kidney disease.

Lilly is disclosing new data from several assets in its robust early-phase incretin platform focused on obesity. The company’s incretin platform is focused on delivering therapeutics with bariatric surgery-like weight loss with related metabolic benefits and developing convenient, easy-to-use oral incretins.

As it has for nearly 100 years, Lilly continues to work to transform diabetes care through insulin innovation. Lilly’s novel weekly insulin is on track to progress to phase 3 studies in 2022, and the company is advancing a new generation of insulin medicines with its pre-clinical efforts in glucose-sensing insulin.

Immunology

Over the last decade, Lilly has established a presence in immunology, with Taltz and Olumiant addressing patient needs across dermatology and rheumatology. Positive late-stage readouts in 2021 for mirikizumab in moderate-to-severely active ulcerative colitis and lebrikizumab in moderate-to-severe atopic dermatitis provide the potential to help even more patients suffering from disease.

In addition, Lilly has built a deep early-and mid-stage portfolio of novel immunology opportunities that represent potential first-in-class or best-in-class assets from both internal and external innovation. Lilly is sharing new data from several of these molecules, including proof of concept phase 1b atopic dermatitis data for its IL-2 conjugate, in collaboration with Nektar Therapeutics, and is announcing plans to move into additional phase 2 studies.

Oncology

Propelled by the acquisition of Loxo Oncology, Lilly has established a renewed presence in oncology, with a portfolio focused on high-conviction assets. The company’s oncology portfolio, including Verzenio, Retevmo and pirtobrutinib, has the potential to deliver meaningful growth over the course of the decade.

3

Lilly initiated a rolling submission to the FDA for pirtobrutinib, seeking accelerated approval in mantle cell lymphoma, with expectations to complete the submission in 2022 and regulatory action anticipated in early 2023. Lilly continues to invest to maximize the potential of Verzenio for patients, and intends to initiate a phase 3 study to evaluate earlier treatment of prostate cancer in mid-2022.

The company also is providing an overview of several promising early-phase and pre-clinical programs that are expected to deliver new data and potential new trials starting in 2022.

Neuroscience

Lilly is an established leader in neuroscience with a more than 30-year commitment to advancing Alzheimer’s disease research. The company is focused on its work to slow, then halt and eventually prevent age-related neurodegeneration in the decades ahead.

Lilly is providing new biomarker data from donanemab from the phase 2 TRAILBLAZER-ALZ study. Lilly initiated a rolling submission for donanemab to the FDA for accelerated approval in early Alzheimer’s disease, which it expects to complete in the coming months, likely by the end of the first quarter.

The company is also sharing phase 1 data from its next-generation amyloid-lowering antibody, N3PG-IV, noting plans to move this antibody into pivotal trials in 2022. The company has a number of early phase and pre-clinical programs for Alzheimer’s and other neurodegenerative diseases with novel targets and new modalities and is highlighting the significant growth in its early pain pipeline.

Strong Financial Outlook Fueled by New Innovative Medicines

"We believe the continued uptake of our key growth products – which we expect will account for more than two-thirds of core business revenue in 2022 – coupled with our anticipated upcoming launches will allow Lilly to deliver top-tier, volume-driven revenue growth through at least 2030," said Anat Ashkenazi, Lilly senior vice president and chief financial officer. "Lilly remains committed to prioritizing long-term growth, as we maintain significant investment in our exciting pipeline, fund new launches to ensure we can reach more patients in the coming years and continue to expand operating margin."

Updated 2021 Financial Guidance

The company has updated certain elements of its 2021 financial guidance on both a reported and non-GAAP basis. Earnings per share for 2021 are now expected to be in the range of $6.18 to $6.23 on a reported basis and $8.15 to $8.20 on a non-GAAP basis. The company’s 2021 financial guidance reflects adjustments shown in the reconciliation table below.

Numbers may not add due to rounding

(a)includes costs related to business development transactions with Foghorn Therapeutics Inc., Rigel Pharmaceuticals, Inc., Precision Biosciences, Inc., Protomer Technologies Inc., Kumquat Biosciences Inc., Merus N.V., Lycia Therapeutics Inc., Regor Therapeutics Group, ProQR Therapeutics N.V., MiNA Therapeutics Limited, and Asahi Kasei Pharma Corporation.

(b)updated to include additional asset impairment primarily related to a contract-based intangible asset recognized as a result of our acquisition of Loxo Oncology. This impairment is a result of a decision by Bayer to discontinue the development of a phase 1 molecule related to our contact-based intangible asset.

Revenue for 2021 is now expected to be in the range of $28.0 billion to $28.3 billion, reflecting additional revenue from COVID-19 antibodies associated with the recent purchase agreement with the U.S. Government and the channel impact of the updated 2022 NRDL formulary in China. Estimated revenue from COVID-19 antibodies is now expected to be approximately $2.1 billion.

Gross margin as a percent of revenue is still expected to be approximately 75 percent on a reported basis and is now expected to be approximately 78 percent on a non-GAAP basis.

Marketing, selling and administrative expenses are still expected to be in the range of $6.2 billion to $6.4 billion. Research and development expenses are still expected to be in the range of $6.9 billion to $7.1 billion.

Operating margin, defined as operating income as a percent of revenue, is now expected to be approximately 23 percent on a reported basis and still expected to be approximately 30 percent on a non-GAAP basis.

Other income (expense) is still expected to be expense in the range of $250 million to $150 million on a reported basis and is still expected to be expense in the range of $100 million to $0 on a non-GAAP basis. The estimate on a reported basis does not reflect fourth quarter mark-to-market activity for equity investments.

The 2021 effective tax rate is still expected to be approximately 11 percent on a reported basis and approximately 13 percent on a non-GAAP basis.

The following table summarizes the company’s updated 2021 financial guidance.

2022 Financial Guidance

Earnings per share for 2022 are expected to be in the range of $8.00 to $8.15 on a reported basis and $8.50 to $8.65 on a non-GAAP basis.

The company anticipates 2022 revenue between $27.8 billion and $28.3 billion. Revenue growth is expected to be driven by volume growth from key products including Trulicity, Verzenio, Taltz, Jardiance, Cyramza, Emgality, Tyvyt, Retevmo and Olumiant. This growth is expected to be partially offset by lower revenue for Alimta due to its loss of patent exclusivity, and significantly lower anticipated COVID-19 antibody revenue.

Gross margin as a percent of revenue is expected to be approximately 78 percent on a reported basis and 80 percent on a non-GAAP basis.

Marketing, selling and administrative expenses are expected to be in the range of $6.4 billion to $6.6 billion. Research and development expenses are expected to be in the range of $7.0 billion to $7.2 billion.

Operating margin for 2022 is expected to be approximately 30 percent on a reported basis and approximately 32 percent on a non-GAAP basis.

Other income (expense) is expected to be expense between $100 million and $0 on both a reported basis and on a non-GAAP basis.

The 2022 effective tax rate is expected to be approximately 13 to 14 percent on both a reported basis and non-GAAP basis, assuming no significant changes to U.S. tax policy.

Webcast of Conference Call and Investor Materials

As previously announced, investors and the general public can access a live webcast of the Investment Community Meeting, including a presentation of the company’s 2022 and updated 2021 guidance, through a link on Lilly’s website at www.lilly.com. The conference call will begin at 9 a.m. Eastern time today and will be available for replay via the website.

On December 15, 2021 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that it has been selected for addition to the Nasdaq Biotechnology Index (NASDAQ: NBI) and the iShares Biotechnology ETF (NYSE: IBB) (Press release, Curis, DEC 15, 2021, View Source [SID1234597191]).

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The Nasdaq Biotechnology Index is a modified market capitalization-weighted index designed to track the performance of a set of qualifying NASDAQ-listed securities classified as either biotechnology or pharmaceuticals, according to the Industry Classification Benchmark. For more information about the Nasdaq Biotechnology Index visit www.nasdaq.com.

The iShares Biotechnology ETF is an exchange-traded fund designed to better represent the biotech industry by excluding pharmaceuticals, in favor of a modified market capitalization-weighted set of qualifying U.S.-listed biotechnology securities. For more information about the iShares Biotechnology ETF, visit www.ishares.com.

The additions will become effective prior to market open on Monday, December 20, 2021.