On December 16, 2020 Amgen (NASDAQ:AMGN) reported submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sotorasib, an investigational KRASG12C inhibitor for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, following at least one prior systemic therapy (Press release, Amgen, DEC 16, 2020, View Source [SID1234572953]).

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"Sotorasib was the first KRASG12C inhibitor to enter the clinic and now is on track to potentially be the first approved targeted therapy for patients with advanced NSCLC harboring the KRAS G12C mutation. In the U.S., about 13% of patients with NSCLC have the KRAS G12C mutation and face a significant unmet need," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "This submission, along with these other important regulatory achievements, underscore Amgen’s commitment to bringing this potential treatment option to patients as quickly as possible."

The NDA is being reviewed by the FDA under its Real-Time Oncology Review (RTOR) pilot program, which aims to explore a more efficient review process that ensures safe and effective treatments are made available to patients as early as possible.1

The submission is supported by positive Phase 2 results in patients with locally advanced or metastatic NSCLC from the CodeBreaK 100 clinical study, whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy. In the study, treatment with sotorasib provided durable anticancer activity with a positive benefit-risk profile.2 These results will be presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) Presidential Symposium in January 2021.

About Sotorasib
Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, an investigational KRASG12C inhibitor.3 Sotorasib was the first KRASG12C inhibitor to enter the clinic and is being studied in the broadest clinical program exploring 10 combinations with global sites spanning across four continents. In just over two years, the sotorasib clinical program has established the deepest clinical data set with more than 600 patients studied across 13 tumor types.

Sotorasib has demonstrated a positive benefit-risk profile with fast, deep and durable anticancer activity in patients with advanced NSCLC harboring the KRAS G12C mutation with a once daily oral formulation. Promising responses have also been observed in multiple other solid tumors.

KRAS G12C is the most common KRAS mutation in NSCLC.4,5 In the U.S., about 13% of patients with NSCLC harbor the KRAS G12C mutation.6 There is a high unmet need and poor outcomes in the second-line treatment of KRAS G12C-driven NSCLC and, currently, there are no KRASG12C targeted therapies approved.7

About CodeBreaK
The CodeBreaK clinical development program for Amgen’s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled more than 600 patients across 13 tumor types since its inception.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutated solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 123 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected in 2021.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) is currently recruiting. Amgen also has several Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment.

For information, please visit www.codebreaktrials.com.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. For more information, follow us on www.twitter.com/amgenoncology.

On December 15, 2020 Eli Lilly and Company (NYSE: LLY) reported its 2021 financial guidance, highlighted by volume-based revenue growth, increased investment in research and development, operating margin expansion and strong earnings performance (Press release, Eli Lilly, DEC 15, 2020, View Source [SID1234572860]). The company also revised certain elements of its 2020 financial guidance and reviewed potential key events for the upcoming year, including important data readouts for several investigational medicines in its clinical pipeline and the possibility of multiple regulatory submissions and approvals.

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The company’s 2020 and 2021 financial guidance are being provided on both a reported and a non-GAAP basis. Reported guidance is presented in accordance with U.S. generally accepted accounting principles (GAAP). Non-GAAP measures reflect adjustments for the items described in the associated reconciliation tables. The non-GAAP measures are presented to provide additional insights into the underlying trends in the company’s business.

Josh Smiley, Lilly’s chief financial officer, outlined the company’s near-term growth prospects and provided 2021 financial guidance. "We’re pleased with our performance despite the unprecedented challenges facing the world in 2020. We expect 2021 to be another exciting year for Lilly, characterized by robust volume-driven revenue growth for our key medicines, while we continue to invest in and progress our pipeline, expand operating margins and deliver impressive EPS and cash flow growth. Reflecting this growth, we have announced a 15 percent increase in our dividend for 2021. One year after we outlined our high-level outlook through 2025, we are increasingly confident in our ability to deliver top-tier revenue growth and operating margin percent expansion into the mid-to-high 30s during this timeframe."

Commenting on the company’s cash flow expectations, Smiley added, "We expect to deliver strong cash flow in 2021, which we will continue to deploy thoughtfully across our capital allocation priorities. We remain focused on funding our existing marketed products, new launches, lifecycle opportunities and replenishing our pipeline. We will continue to leverage bolt-on acquisitions and licensing opportunities to augment our future growth prospects with external innovation. Finally, we plan to return cash to shareholders through an increased dividend and our ongoing share repurchase program, while maintaining strong investment grade ratings."

"Lilly is in the midst of an exciting period of prolonged growth for the company, driven by an expanding portfolio of new medicines focused on diabetes, oncology, immunology, and neuroscience," said David A. Ricks, Lilly’s chairman and chief executive officer. "We enter 2021 emboldened by the lessons we have learned during the COVID-19 pandemic, the agility and persistence we have displayed, and the knowledge that we are supported by one of the fastest growing portfolios in the industry. With more exciting data readouts and innovation prospects on the way, we have a remarkable opportunity to make life better for many more patients who can benefit from Lilly medicines."

2020 Financial Guidance

The company has updated certain elements of its 2020 financial guidance. On a reported basis, earnings per share for 2020 are now expected to be in the range of $6.28 to $6.48. On a non-GAAP basis, earnings per share for 2020 are now expected to be in the range of $7.45 to $7.65.

Revenue for 2020 is now expected to be in the range of $24.2 billion to $24.7 billion, reflecting expectations of increased bamlanivimab sales due to an additional purchase agreement with the U.S. government.

Gross margin as a percent of revenue is still expected to be approximately 78 percent on a reported basis and is now expected to be approximately 79 percent on a non-GAAP basis, reflecting expectations of increased bamlanivimab sales.

Marketing, selling and administrative expenses are still expected to be in the range of $6.0 billion to $6.1 billion. Research and development expenses are still expected to be in the range of $5.8 billion to $5.9 billion.

Operating margin, defined as operating income as a percent of revenue, is still expected to be approximately 25 percent on a reported basis, and is now expected to be approximately 30 percent on a non-GAAP basis.

Other income (expense) is now expected to be income in the range of $600 million to $700 million, reflecting additional projected gains on investments in equity securities. The market valuations for these securities could fluctuate significantly throughout the remainder of the year, with current valuations placing other income (expense) above the revised 2020 guidance range.

The 2020 effective tax rate is still expected to be approximately 14 percent on both a reported basis and a non-GAAP basis.

Change in Non-GAAP Measures Beginning in 2021

Beginning in 2021, the company will exclude the gains and losses on investments in equity securities from its non-GAAP measures for other income (expense) and earnings per share. Reflecting this change in the company’s updated 2020 financial guidance as detailed above would result in the exclusion of approximately $900 million of expected other income, thereby lowering the company’s 2020 expectations for other income (expense) on a non-GAAP basis to be expense in the range of $200 million to $300 million, and lowering the company’s earnings per share expectations on a non-GAAP basis for 2020 by approximately $0.75 per share to be in the range of $6.70 to $6.90.

2021 Financial Guidance

The company today issued its 2021 financial guidance. Earnings per share for 2021 are expected to be in the range of $7.25 to $7.90 on a reported basis and $7.75 to $8.40 on a non-GAAP basis. As noted, 2021 financial results will exclude gains and losses on investments in equity securities from non-GAAP measures.

The company anticipates 2021 revenue between $26.5 billion and $28.0 billion, including an estimated $1 billion to $2 billion of revenue from COVID-19 therapies. Revenue growth is expected to be driven by volume from key growth products including Trulicity, Taltz, Verzenio, Jardiance, Olumiant, Cyramza, Emgality, Tyvyt, and Retevmo, as well as by COVID-19 therapies. Revenue growth is expected to be partially offset by lower revenue for products that have recently lost patent exclusivity. The company expects mid-single digit net price declines globally in 2021. In the U.S., the company expects low-to-mid-single digit net price declines, driven primarily by increased rebates to maintain broad commercial access and segment mix, partially offset by the benefit from the implementation of a limited distribution program in the company’s 340B program. Outside the U.S., the company expects net price declines in China, Japan and Europe.

Gross margin as a percent of revenue for 2021 is expected to be approximately 77 percent on a reported basis, and approximately 79 percent on a non-GAAP basis.

Marketing, selling and administrative expenses for 2021 are expected to be in the range of $6.2 billion to $6.4 billion. Research and development expenses for 2021 are expected to be in the range of $6.5 billion to $6.7 billion, including approximately $300 million to $400 million of continued investment in COVID-19 therapies.

Operating margin for 2021 is expected to be approximately 30 percent on a reported basis and approximately 32 percent on a non-GAAP basis.

Other income (expense) for 2021 is expected to be expense in the range of $200 million to $300 million on both a reported basis and on a non-GAAP basis.

The 2021 effective tax rate is expected to be approximately 15 percent on both a reported basis and on a non-GAAP basis.

Webcast of Conference Call

As previously announced, investors and the general public can access a live webcast of the 2021 financial guidance conference call through a link on Lilly’s website at www.lilly.com. The conference call will begin at 8:30 a.m. Eastern time (ET) today and will be available for replay via the website.

On December 15, 2020 Scopus BioPharma Inc. (Nasdaq: SCPS) reported the pricing of its initial public offering (Press release, Scopus BioPharma, DEC 15, 2020, View Source(Nasdaq%3A%20SCPS)%20today%20announced,price%20of%20%245.50%20per%20share [SID1234572871]).

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The company’s common stock is set to begin trading Wednesday, December 16, 2020 on the Nasdaq Global Market under the ticker symbol "SCPS".

The company is offering 500,000 shares of common stock at a public offering price of $5.50 per share.

The Benchmark Company, LLC acted as Sole Bookrunning Manager and Joseph Gunnar & Co., LLC acted as Co-Manager for the offering.

Greenberg Traurig, LLP is acting as counsel to the company. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is acting as counsel to the underwriters.

An offering statement relating to the shares of common stock was filed with the U.S. Securities and Exchange Commission and became qualified on December 14, 2020. The offering is being made only by means of an offering circular, copies of which may be obtained, when available, by contacting: The Benchmark Company, LLC, Attention: Prospectus Department, 150 E. 58th Street, 17th Floor, New York, NY 10155, by calling (212) 312-6700 or by e-mail at [email protected]; or Joseph Gunnar & Co., LLC, Attention: Prospectus Department, 30 Broad Street, 11th Floor, New York, NY 10004, by calling (212) 440-9600 or by email at [email protected]. The offering circular is also available on the U.S. Securities and Exchange Commission website at www.sec.gov.

Scopus BioPharma intends to use the proceeds of the offering principally to further development of the company’s lead drug candidate, a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification of these securities under the securities laws of any such state or jurisdiction.

On December 15, 2020 Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, reported that D. Keith Grossman, Nevro’s Chairman, CEO and President, will present at the 39th Annual J.P. Morgan Healthcare Conference on Tuesday, January 12, 2021, at 4:30 pm Eastern Time / 1:30 pm Pacific Time (Press release, Nevro, DEC 15, 2020, View Source [SID1234572890]).

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A live webcast of this event, as well as an archived recording, will be available in the Investors section of Nevro’s website at www.nevro.com.

Internet Posting of Information

Nevro routinely posts information that may be important to investors in the "Investor Relations" section of its website at www.nevro.com. The company encourages investors and potential investors to consult the Nevro website regularly for important information about Nevro.

On December 15, 2020 Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported that it has completed a capital raising of $25,000,410 (Press release, Clarity Pharmaceuticals, DEC 15, 2020, View Source [SID1234572814]).

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Dr Alan Taylor, Executive Chairman of Clarity Pharmaceuticals, commented, "It has been a pivotal year for Clarity with numerous critical milestones achieved in the development of our main products, advancement of our platform, as well as accelerated corporate and strategic activities despite facing an unprecedented global environment.

"The money raised will enable us to keep the momentum from 2020 going and provide financial resources to progress the following important initiatives:

SARTATE
Progress the Cu-64/Cu-67 SARTATE Neuroblastoma trial at the Memorial Sloan Kettering Cancer Center in children with neuroblastoma;
Expand the Cu-64/Cu-67 SARTATE Neuroblastoma trial to additional clinical sites across the US with the ultimate goal of developing better treatment options for children with cancer; and
Commence patient recruitment in Phase II Cu-64 SARTATE Neuroendocrine trial.
SAR-Bombesin
Progress and expand the Cu-64 BOmbesin in Breast CAncer Trial (C-BOBCAT) led by A/Prof Louise Emmett, Director of Theranostics and Nuclear Medicine, at St Vincent’s Hospital in Sydney with an aim of developing better treatment options to women with metastatic breast cancer, an area currently with a high unmet need;
Expand the C-BOBCAT trial to include prostate cancer patients; and
Seek US Food and Drug Administration’s (FDA) approval for an Investigational New Drug (IND) Application.
SAR-bisPSMA
Commence a clinical trial in the US for Cu-64/Cu-67 SAR-bisPSMA (theranostic) and in Australia for Cu-64 SAR-bisPSMA (diagnostic) to build on the promising pre-clinical data with the help of an internationally recognised team of key opinion leaders in the prostate cancer field; and
Seek US FDA approval for an IND Application.
Develop new targeted theranostic products for a broad range of cancer types, utilising Clarity’s SAR Technology Platform and the Cu-64/Cu-67 pairing."
Dr Taylor continued, "Clarity has a strong focus on getting its lead product SARTATE to market, supported by the US FDA granting both Cu-67 SARTATE and Cu-64 SARTATE Orphan Drug Designations and Rare Paediatric Disease Designations for the treatment and clinical management of neuroblastoma, as well as developing the copper platform in large and unmet clinical indications."

"It has been a very exciting year for Clarity" Dr Taylor added. "We would like to sincerely thank our long-term shareholders for their continued support of Clarity, as well as welcome and thank a broad range of new shareholders including institutions, family offices, high net-worth individuals and others who wanted to be part of the Clarity story. We would also like to thank Blue Ocean Equities for their contribution in assisting us with the capital raise."