Novo Nordisk A/S – Share repurchase programme

On October 18, 2021 Novo Nordisk reported that it initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, OCT 18, 2021, View Source [SID1234591456]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 4 August 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 5 August 2021 to 1 November 2021.

Since the announcement 11 October 2021, the following transactions have been made:

With the transactions stated above, Novo Nordisk owns a total of 21,784,947 B shares of DKK 0.20 as treasury shares, corresponding to 0.9% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 15 October 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 22,977,781 B shares at an average share price of DKK 505.36 per B share equal to a transaction value of DKK 11,611,964,393.

Lucid Diagnostics Announces Closing of Nasdaq Initial Public Offering

On October 18, 2021 Lucid Diagnostics Inc. (Nasdaq: LUCD) ("Lucid") a commercial-stage, cancer prevention medical diagnostics company, and subsidiary of PAVmed Inc. (Nasdaq: PAVM, PAVMZ) ("PAVmed"), reported the closing on October 18, 2021 of its initial public offering (the "Offering") of 5,000,000 shares of common stock at a price to the public of $14.00 per share for total gross proceeds of $70,000,000 before deducting underwriting discounts and commissions and estimated offering expenses (Press release, Lucid Diagnostics, OCT 18, 2021, View Source [SID1234591472]).

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In addition, Lucid has granted the underwriters a 30-day option to purchase up to an additional 750,000 shares of common stock from Lucid at the initial public offering price less underwriting discounts and commissions.

Cantor and Canaccord Genuity are acting as joint book-running managers for the offering. BTIG and Needham & Company are acting as co-lead managers for the offering.

A registration statement relating to the securities being sold in the offering was declared effective by the Securities and Exchange Commission ("SEC") on October 13, 2021. This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification or publication of an offering prospectus under the securities laws of any such state or jurisdiction.

The offering is being made only by means of a written prospectus. Copies of the prospectus related to the offering can be accessed by visiting the SEC website at View Source Alternatively, copies of the prospectus relating to the offering can be obtained from either of the following:

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 under the securities laws of any such state or jurisdiction.

Roche announces collaboration with Ibex Medical Analytics to develop artificial intelligence-based digital pathology applications for improved patient care

On October 18, 2021 Roche (SIX: RO, ROG;OTCQX: RHHBY) reported that it has entered an agreement with Ibex Medical Analytics, a global leader in artificial intelligence (AI)-based cancer diagnostics (Press release, Hoffmann-La Roche, OCT 18, 2021, View Source [SID1234591406]). Under the agreement, the companies will jointly develop an embedded image analysis workflow for pathologists to seamlessly access Ibex’s AI algorithms, insights, and decision support tools using NAVIFY Digital Pathology, the cloud version of Roche’s uPath enterprise software. Collaborations with leading AI companies like Ibex are made possible through Roche’s Digital Pathology Open Environment, which allows pathologists to securely access third-party AI-powered technology alongside Roche’s growing menu of AI-based image analysis tools.

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Ibex’s Galen platform was recently granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) and is CE marked in Europe for breast and prostate cancer detection in multiple workflows. Through this alliance, customers using Roche Digital Pathology will gain access to Ibex’s innovative tools, such as algorithms that analyse prostate and breast biopsies, in addition to the AI tools already provided by Roche.

"With the addition of Ibex’s clinical-grade image analysis tools to our NAVIFY Digital Pathology menu, we can aid pathologists and providers in delivering value-based patient care by increasing their efficiency and accuracy for higher quality cancer diagnosis," said Jill German, Head of Roche Diagnostics Pathology Customer Area.

The clinical-grade AI algorithms and digital workflows included in this expanded menu of tools will enable pathologists to provide accurate, efficient and timely diagnoses for their patients and support them in the detection and grading of cancer, identification of important non-cancerous features, case reporting and more.

"Digital pathology provides the capability to introduce new, innovative ways for laboratories to improve quality and efficiency of cancer diagnosis. Together with Roche, we look forward to transforming pathology by delivering powerful AI-based tools to the fingertips of pathologists," said Joseph Mossel, CEO and Co-founder of Ibex Medical Analytics.

About Roche Digital Pathology

As the leading provider of pathology lab solutions, Roche is delivering the end-to-end digital pathology solution from tissue staining to producing high-quality digital images that can be reliably assessed using automated clinical image analysis algorithms. We minimise variables that can impact analysis, and it is this end-to-end development that produces the quality results healthcare providers and researchers can depend on. With the acceleration of immunotherapy and the development of more complex assays, Roche is moving these traditionally research-oriented tools into routine clinical practice and is committed to investing in and shaping the future of pathology.

Roche offers two deployment options for its uPath software: an on-premise solution and a cloud solution, marketed as NAVIFY Digital Pathology. The VENTANA DP 200 slide scanner and Roche uPath enterprise software are CE-IVD marked for in-vitro diagnostic use and are available in the U.S. for research use only (RUO). Image analysis algorithms developed by third-party entities and their utilisation are the responsibility of the third party provider.

Corporate Presentation October 2021

On October 18, 2021, PDS Biotechnology Corporation reported its corporate presentation (Presentation, PDS Biotechnology, OCT 18, 2021, View Source [SID1234591457]).

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ORPHAGEN PHARMACEUTICALS AWARDED SBIR PHASE II GRANT TO DEVELOP A FIRST-IN-CLASS DRUG FOR ADRENOCORTICAL CANCER

On October 18, 2021 Orphagen Pharmaceuticals, a privately-held pharmaceutical company, reported that the National Cancer Institute (NCI) has indicated its intention to award the company $2.0 million under the Small Business Innovation Research (SBIR) program to support preclinical development of OR-449, a small molecule drug candidate designed and synthesized by Orphagen, as a first-in-class therapy for adrenocortical carcinoma (ACC), a rare cancer of the adrenal gland with very limited treatment options and a poor prognosis (Press release, Orphagen, OCT 18, 2021, View Source [SID1234591500]).

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OR-449 is a potent and selective inhibitor of steroidogenic factor-1 (SF-1 or NR5A1), an orphan nuclear receptor and transcription factor that is essential for the growth and development of the adrenal gland. Multiple findings indicate that SF-1 has a crucial role in the pathogenesis of ACC.

"Orphagen has a strong platform for nuclear receptor discovery and our technology has allowed us to identify promising antagonists to a previously unexplored nuclear receptor, known as steroidogenic factor-1, or SF-1," said Scott Thacher, CEO of Orphagen and Principal Investigator of this grant. "The discovery and characterization of OR-449, which led to this prestigious award, was the product of an immensely talented team, with expertise in compound screening, medicinal chemistry, the implementation of novel tumor models, and small molecule drug development. The creation of this new drug candidate for ACC patients would not have been possible without the dedicated efforts of Orphagen’s multidisciplinary team."

Notice of first-year funding for this proposal can be found on the NIH web site at: RePORT ⟩ RePORTER (nih.gov).