On April 23, 2021 Molecular Partners AG (SIX: MOLN), a clinical-stage biotech company that is developing a new class of custom-built protein drugs known as DARPin therapeutics, reported that it has filed a registration statement on Form F-1 with the U.S. Securities and Exchange Commission (the "SEC") relating to a proposed initial public offering of its American Depositary Shares ("ADSs"), representing common shares, in the United States (the "Offering") (Press release, Molecular Partners, APR 23, 2021, View Source(SIX%3A%20MOLN,SEC%E2%80%9D)%20relating%20to%20a%20proposed [SID1234578412]). All securities to be sold in the Offering will be offered by the Company. The number of common shares to be represented by each ADS, the number of ADSs to be offered and the price range for the ADSs in the proposed Offering have not yet been determined. The Company has applied to list its ADSs on the Nasdaq Global Market under the ticker symbol "MOLN." The Company’s common shares are listed on the SIX Swiss Exchange ("SIX") pursuant to its International Reporting Standard under the ticker symbol "MOLN."

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JP Morgan, SVB Leerink and Cowen & Co. are acting as joint lead bookrunners for the Offering. RBC Capital Markets is also acting as bookrunner and Kempen & Co is acting as lead manager for the Offering.

The securities referred to in this announcement are to be offered only by means of a prospectus. When available, copies of the preliminary prospectus may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105.

A registration statement on Form F-1 relating to the securities referred to herein has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities in any jurisdiction, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

The common shares underlying the ADSs are expected to be listed on the SIX. In connection with this listing, the registration statement on Form F-1, once declared effective, constitutes a foreign prospectus within the meaning of article 54 paras. 2 and 3 of the Swiss Financial Services Act of June 15, 2018 ("FinSA") and article 70 paras. 2-4 of the Swiss Financial Services Ordinance of November 6, 2019 ("FinSO").

On April 22, 2021 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that it is scheduled to report first quarter results on May 6, 2021 at 4:00 PM Eastern Time (Press release, Cytokinetics, APR 22, 2021, View Source,4%3A00%20PM%20Eastern%20Time. [SID1234578409]). Following the announcement, Cytokinetics’ senior management will host a conference call at 4:30 PM Eastern Time to discuss operational and financial results and the company’s outlook for the future.

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The conference call will be simultaneously webcast and can be accessed from the homepage and in the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. The live audio of the conference call can also be accessed by telephone by dialing either (866) 999-CYTK (2985) (United States and Canada) or (706) 679-3078 (international) and typing in the passcode 6097958.

An archived replay of the webcast will be available via Cytokinetics’ website until May 20, 2021. The replay will also be available via telephone by dialing (855) 859-2056 (United States and Canada) or (404) 537-3406 (international) and typing in the passcode 6097958 from May 6, 2021 at 7:30 PM Eastern Time until May 20, 2021.

On April 23, 2021 Anavo Therapeutics, a global leader in unlocking the full therapeutic potential of human phosphatase biology, reported with a EUR 20 million (approx. $24 million) seed financing (Press release, Anavo Therapeutics, APR 23, 2021, View Source [SID1234578407]). Anavo’s mission is to pioneer systematic drug discovery and development approaches aimed at phosphatases, a rich and largely untapped therapeutic target class. The funds will be used to advance a proprietary drug discovery portfolio in oncology and establish a versatile and robust platform to address the target space broadly across multiple indications. Anavo’s leadership team, Dr. Birgit Zech and Dr. Gerhard Müller, are building on several years of joint experience in the biopharmaceutical industry and have demonstrated the ability to navigate rapidly emerging sectors in biopharma most recently as co-founders of Gotham Therapeutics. The founding team is further complemented by Claus Schalper, a renowned finance expert and serial biotech entrepreneur.

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Phosphatases and kinases regulate the activity of numerous crucial signaling pathways by removing or adding a phosphate group from proteins or other biomolecules. Imbalances in this process can lead to a multitude of diseases. While kinases have been exploited by drug developers worldwide, phosphatases stayed largely untouched after setbacks earlier in this century.

Anavo’s approach focuses on combining profound understanding of phosphatase biology with deep drug discovery expertise and state-of-the-art technologies to design first-in-class and best-in-class small molecule modulators of phosphatase activity. The company has attracted world-leading phosphatase biology expertise to its advisory board in Mathieu Bollen, Professor of Molecular Cell Biology at University of Leuven, and Nicholas Tonks, Professor of Cancer Research at Cold Spring Harbor Laboratory. Taken together, both have authored and co-authored more than 500 scientific publications on phosphatases and related physiological processes.

"Anavo was founded to unlock the full potential of phosphatase-targeting allosteric modulators and has attracted one of the largest European biotech seed rounds to date. Recent progress especially around SHP2 has demonstrated that the time is ripe to address phosphatase drug discovery more systematically and on a much larger scale," said Dr. Birgit Zech, Chief Executive Officer of Anavo Therapeutics. "With Mathieu Bollen and Nicholas Tonks as our initial scientific advisory board members, we have attracted two world-leading scientists in phosphatase biology which complements our deep drug discovery know-how."

"Academic research on the human phosphatome has moved way ahead of the industry and we are now sitting on a real treasure trove of potential therapeutic avenues to explore, targets to validate, and programs worth translating into preclinical and clinical evaluation," said Dr. Gerhard Müller, Chief Scientific Officer of Anavo Therapeutics. "Among all target classes currently defined as ‘undruggable’, we expect phosphatases to have the deepest and most profound impact on clinical outcomes once addressed in a systematic and coherent fashion."

Therese Liechtenstein, Principal at M Ventures, added: "Anavo’s novel approach and its experienced management team provide us with the best tools and key ingredients to address challenges in phosphatase drug discovery, and unlock this rich target class. We are excited to be part of Anavo and their mission."

Simone Botti, Junior Partner at INKEF Capital, added: "The progress that has been made with SHP2 in our industry has revived the phosphatase sector but is only scratching the surface of this largely untapped attractive molecular target class. We are very pleased to support Anavo, a company poised to deliver first-in-class therapeutics in oncology and establish itself as a world leader in phosphatase drug discovery."

Therese Liechtenstein and Simone Botti will be joined by Sakae Asanuma, President and CEO of Taiho Ventures, and Debora Dumont, Managing Partner at Bioqube Ventures, on Anavo’s Board of Directors.

On April 23, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that it will present data at the American Academy of Dermatology’s Virtual Meeting Experience, being held April 23 – 25, 2021 (Press release, Castle Biosciences, APR 23, 2021, View Source [SID1234578406]). The Company has two poster presentations highlighting its DecisionDx-Melanoma and DecisionDx-SCC genomic tests.

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Data presentation information is as follows:

DecisionDx-Melanoma:

The poster is entitled, "Risk stratification of patients with stage I cutaneous melanoma (CM) using 31-gene expression profiling (GEP)."

DecisionDx-Melanoma is Castle’s 31-gene expression profile test that uses an individual patient’s tumor biology to predict risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node (SLN) positivity, independent of traditional staging factors.

Study methods and findings:

Data were analyzed from 852 patients diagnosed with Stage I cutaneous melanoma according to the American Joint Committee on Cancer staging guidelines and a median follow-up of 3.8 years, who also had DecisionDx-Melanoma test results. Kaplan-Meier and Cox regression analyses were used to assess recurrence-free survival (RFS). Prognostic accuracy was assessed by comparing outcomes for Class 1A to outcomes for Class 2B.
The study demonstrated that along with staging factors (Breslow thickness and ulceration), a DecisionDx-Melanoma Class 2B (highest risk) result was a significant, independent predictor of recurrence in the stage I population.
A Class 2B DecisionDx-Melanoma result among these patients was associated with a recurrence rate of 20.4%, compared to the overall stage I population’s recurrence risk of 4.6%.
Among all stage I melanoma patients, those with a Class 2B DecisionDx-Melanoma result had seven times the odds of experiencing a recurrence than patients with a Class 1A result.
In the subgroup of patients with a confirmed negative sentinel lymph node biopsy, those with a Class 2B DecisionDx-Melanoma result had five times the odds of experiencing a recurrence than patients with a Class 1A result.
Although the stage I population has a low aggregate risk of recurrence, the study demonstrated that DecisionDx-Melanoma identified patients within that population who may experience recurrence and benefit from increased management intensity.
DecisionDx-SCC:

The poster is entitled, "Prospective adjuvant therapy trial design using a prognostic 40-gene expression profile (40-GEP) test for high-risk cutaneous squamous cell carcinoma (cSCC) and BWH staging-based risk assessment."

DecisionDx-SCC is Castle’s prognostic 40-gene expression profile test for patients diagnosed with high-risk cutaneous squamous cell carcinoma (SCC) designed to use a patient’s tumor biology to predict individual risk of metastasis for patients with SCC and one or more risk factors.

Study methods and findings:

This analysis evaluated the impact of DecisionDx-SCC’s risk stratification as enrollment criteria into trial design involving adjuvant therapy for SCC.
Using data from 420 validation cases, Brigham and Women’s Hospital (BWH) T2a-T3 stage SCC patients with or without DecisionDx-SCC results of Class 2A/B (high risk) or 2B (highest risk) were used for two-arm sample size calculations.
Metastasis rates for cases with BWH T2a-T3 tumors were 20% without DecisionDx-SCC results and 27% or 57% when selecting for cases with Class 2A/B or 2B results, respectively.
In the absence of DecisionDx-SCC results, 1,234 T2a-T3 patients would be required for randomization in a trial to provide 80% power to detect a hazard ratio of 0.7 with at least three years of follow-up (alpha=0.05), correlating with studies using the addition of radiation to surgery. However, sample size could be reduced to 915 (26% reduction) or 432 (65% reduction) patients by focusing enrollment on T2a-T3 patients with a DecisionDx-SCC Class 2A/B or 2B result, respectively.
Use of DecisionDx-SCC could be applied to improve trial inclusion criteria as it has demonstrated additive value for patient stratification in other risk assessment methods such as AJCC staging, NCCN risk groups, and individual risk factors.
Overall, the study demonstrated that incorporation of DecisionDx-SCC testing into trial design to identify patients who are at the highest risk for metastasis could facilitate selection of those who are most appropriate for adjuvant therapy (e.g., Class 2B patients), expedite time to trial completion and optimize healthcare costs.
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 5,700 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. To predict likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithm, i31-GEP, to produce an integrated test result. i31-GEP is an artificial intelligence-based neural network algorithm (independently validated in a cohort of 1,674 prospective, consecutively tested patients with T1-T4 cutaneous melanoma) that integrates the DecisionDx-Melanoma test result with the patient’s traditional clinicopathologic features. Impact on patient management plans for one of every two patients tested has been demonstrated in four multicenter and single-center studies including more than 560 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. Through December 31, 2020, DecisionDx-Melanoma has been ordered more than 68,920 times for use in patients with cutaneous melanoma.

More information about the test and disease can be found at www.CastleTestInfo.com.

About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1, 2A or 2B risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.

More information about the test and disease can be found at www.CastleTestInfo.com.

On April 23, 2021 Bristol Myers Squibb (NYSE: BMY) reported the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Onureg (azacitidine tablets; CC-486) as a maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment and who are not candidates for, including those who choose not to proceed to, hematopoietic stem cell transplantation (HSCT) (Press release, Bristol-Myers Squibb, APR 23, 2021, View Source [SID1234578405]).

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The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). If approved, Onureg will be the first and only once daily frontline oral maintenance therapy to demonstrate significant overall survival in patients with a broad range of AML subtypes in first remission.

The CHMP adopted a positive opinion based on results from the QUAZAR AML-001 study, a Phase 3, international, randomized, double-blind trial. Eligible patients were ages 55 years or older, had newly diagnosed AML, intermediate or poor cytogenetics, had achieved first CR or CRi following intensive induction chemotherapy with or without consolidation treatment (per investigator preference prior to study entry), and were not candidates for HSCT at the time of screening.1

"Maintenance therapy options for acute myeloid leukemia that prolong overall survival have been urgently needed in Europe, especially oral options that can be taken at home. While many patients with acute myeloid leukemia achieve remission with induction therapy, responses to treatment may be of short duration and the risk of relapse remains high, especially for patients who are not eligible for stem cell transplant," said Noah Berkowitz, M.D., Ph.D., senior vice president, Hematology Development, Bristol Myers Squibb. "We look forward to the European Commission’s decision and to making Onureg available to appropriate patients, building on our commitment to deliver innovative therapies that improve long-term outcomes for patients."

The EC is expected to deliver its final decision within 67 days of receipt of the CHMP opinion. The decision will be applicable to all EU member states and Iceland, Norway and Liechtenstein.*

Onureg is approved in the United States for the continued treatment of adult patients with AML who achieved first CR or CRi following intensive induction chemotherapy and who are not able to complete intensive curative therapy.2 In Canada, Onureg is approved as a maintenance therapy for adult patients with AML who achieved CR or CRi following induction therapy with or without consolidation treatment, and who are not eligible for HSCT.3

*Centralized Marketing Authorization does not include approval in Great Britain (England, Scotland and Wales).

About QUAZAR AML-001

QUAZAR AML-001, is a Phase 3, international, randomized, double-blind study. Eligible patients were ages 55 years or older, had newly diagnosed AML, intermediate or poor cytogenetics, had achieved first CR or CRi following intensive induction chemotherapy with or without consolidation treatment (per investigator preference prior to study entry) within four months before randomization, and were not candidates for HSCT at the time of screening. The study enrolled 472 patients, randomized 1:1 to receive either Onureg 300 mg (N=238) or placebo (N=234) orally, once daily, for 14 days of a 28-day cycle, plus best supportive care.1

Median OS, the primary endpoint, from time of randomization was greater than two years (24.7 months; 95% CI: 18.7 to 30.5) in the Onureg arm compared to 14.8 months for placebo (HR: 0.69, 95% CI: 0.55 to 0.86; p=0.0009). A subgroup analysis showed consistency in the OS benefit for patients in either CR or CRi. The median duration of treatment was 12 cycles (1 to 82) for Onureg1 and 6 cycles with placebo (1 to 76).4

Serious adverse reactions occurred in 15% of patients who received Onureg. Serious adverse reactions in ≥2% of patients who received Onureg included pneumonia (8%) and febrile neutropenia (7%). One fatal adverse reaction (sepsis) occurred in a patient who received Onureg. The most common adverse reactions with Onureg versus placebo were nausea (65%, 24%), vomiting (60%, 10%), diarrhea (50%, 21%), fatigue/asthenia (44%, 25%), constipation (39%, 24%), pneumonia (27%, 17%), abdominal pain (22%, 13%) arthralgia (14%, 10%), decreased appetite (13%, 6%), febrile neutropenia (12%, 8%), dizziness (11%, 9%) and pain in extremity (11%, 5%). Of patients who received Onureg, permanent discontinuation due to an adverse reaction occurred in 8% of patients.

About AML

AML is one of the most common acute leukemias in adults.5 The worldwide incidence of AML has been estimated at more than 350,000 cases, and the estimated 5-year survival rate for AML in Europe is 17%.6 AML is characterized by the rapid growth of abnormal cells in the bone marrow and as such interferes with normal blood cell production and function. Because of the impaired production of red blood cells, platelets and white blood cells, it can present with signs of anemia, bleeding and infections.5 AML is a heterogeneous disease associated with diverse genetic mutations, and can rapidly progress and lead to death if not promptly treated. 7

AML response to treatment may be of short duration, meaning following patients’ initial response to chemotherapy, there is still a very high risk of relapse, thus representing a significant unmet need for maintenance treatment options that prolong overall survival. 8

About Onureg

Onureg, the first and only FDA-approved continued AML treatment for patients in first remission, is a once daily oral hypomethylating agent that incorporates into DNA and RNA. The main mechanism of action is thought to be hypomethylation of DNA, as well as direct cytotoxicity to abnormal hematopoietic cells in the bone marrow. Hypomethylation may restore normal function to genes that are critical for cell differentiation and proliferation.9,10 Onureg is approved in the U.S. for continued treatment of adult patients with AML who achieved first CR or CRi following intensive induction chemotherapy and are not able to complete intensive curative therapy. Onureg is also approved in Canada as maintenance therapy for adult patients with AML who achieved CR or CRi following induction therapy with or without consolidation treatment, and who are not eligible for HSCT.

U.S. IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

ONUREG is contraindicated in patients with known severe hypersensitivity to azacitidine or its components.
WARNINGS AND PRECAUTIONS

Risks of Substitution with Other Azacitidine Products: Due to substantial differences in the pharmacokinetic parameters, the recommended dose and schedule for ONUREG are different from those for the intravenous or subcutaneous azacitidine products. Treatment of patients using intravenous or subcutaneous azacitidine at the recommended dosage of ONUREG may result in a fatal adverse reaction. Treatment with ONUREG at the doses recommended for intravenous or subcutaneous azacitidine may not be effective. Do not substitute ONUREG for intravenous or subcutaneous azacitidine.
Myelosuppression: New or worsening Grade 3 or 4 neutropenia and thrombocytopenia occurred in 49% and 22% of patients who received ONUREG. Febrile neutropenia occurred in 12%. A dose reduction was required for 7% and 2% of patients due to neutropenia and thrombocytopenia. Less than 1% of patients discontinued ONUREG due to either neutropenia or thrombocytopenia. Monitor complete blood counts and modify the dosage as recommended. Provide standard supportive care, including hematopoietic growth factors, if myelosuppression occurs.
Increased Early Mortality in Patients with Myelodysplastic Syndromes (MDS): In AZA-MDS-003, 216 patients with red blood cell transfusion-dependent anemia and thrombocytopenia due to MDS were randomized to ONUREG or placebo. 107 received a median of 5 cycles of ONUREG 300 mg daily for 21 days of a 28-day cycle. Enrollment was discontinued early due to a higher incidence of early fatal and/or serious adverse reactions in the ONUREG arm compared with placebo. The most frequent fatal adverse reaction was sepsis. Safety and effectiveness of ONUREG for MDS have not been established. Treatment of MDS with ONUREG is not recommended outside of controlled trials.
Embryo-Fetal Toxicity: ONUREG can cause fetal harm when administered to a pregnant woman. Azacitidine caused fetal death and anomalies in pregnant rats via a single intraperitoneal dose less than the recommended human daily dose of oral azacitidine on a mg/m2 basis. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with ONUREG and for at least 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with ONUREG and for at least 3 months after the last dose.
ADVERSE REACTIONS

Serious adverse reactions occurred in 15% of patients who received ONUREG. Serious adverse reactions in ≥2% included pneumonia (8%) and febrile neutropenia (7%). One fatal adverse reaction (sepsis) occurred in a patient who received ONUREG.
Most common (≥10%) adverse reactions with ONUREG vs placebo were nausea (65%, 24%), vomiting (60%, 10%), diarrhea (50%, 21%), fatigue/asthenia (44%, 25%), constipation (39%, 24%), pneumonia (27%, 17%), abdominal pain (22%, 13%), arthralgia (14%, 10%), decreased appetite (13%, 6%), febrile neutropenia (12%, 8%), dizziness (11%, 9%), pain in extremity (11%, 5%).
LACTATION

There are no data regarding the presence of azacitidine in human milk or the effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with ONUREG and for 1 week after the last dose
Please see full Prescribing Information for ONUREG.

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision—transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.