On November 22, 2021 Novo Nordisk reported that 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, NOV 22, 2021, View Source [SID1234595894]). This programme is part of the overall share repurchase programme of up to DKK 20 billion to be executed during a 12- month period beginning 3 February 2021.

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Under the programme initiated 5 November 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.7 billion in the period from 11 November 2021 to 1 February 2022.

Since the announcement 15 November 2021, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 28,892,732 B shares of DKK 0.20 as treasury shares, corresponding to 1.3% 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 20 billion during a 12- month period beginning 3 February 2021. As of 19 November 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 30,139,181 B shares at an average share price of DKK 558.06 per B share equal to a transaction value of DKK 16,819,478,634.

On November 22, 2021 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), a biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported it has dosed the first participants in its Altitude Trial (Press release, Diffusion Pharmaceuticals, NOV 22, 2021, View Source [SID1234595893]). The trial will evaluate the Company’s lead product candidate, trans sodium crocetinate ("TSC"), in normal healthy volunteers subjected to incremental levels of physical exertion while exposed to hypoxic and hypobaric conditions, or "simulated altitude."

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"It’s been exciting working with our internationally recognized partners to get this trial started, and we look forward to continuing to leverage their expertise in hypoxia research and their unique extreme exposure simulation facilities as the study proceeds," said Chris Galloway, M.D., Chief Medical Officer of Diffusion. "We designed the Altitude Trial not only to evaluate how TSC can enhance oxygen uptake in a simulated hypoxic environment while under stress, but also to evaluate how effectively oxygen is delivered and ultimately utilized under these conditions. We believe the Altitude Trial’s results can inform additional clinical uses of TSC to enhance oxygenation across a multitude of diseases complicated by hypoxia."

The Altitude Trial is a double-blind, randomized, placebo-controlled crossover study designed to evaluate the effects of TSC on maximal oxygen consumption, or VO2, and partial pressure of blood oxygen, or PaO2, in normal healthy volunteers subjected to incremental levels of physical exertion while exposed to "simulated altitude." Diffusion intends to enroll 30 healthy volunteers and give each volunteer a single dose of TSC at one of three different doses. This study will evaluate the effectiveness of TSC in enhancing oxygen delivery to the blood and tissues during exercise under hypoxic conditions. The Company anticipates completing the study in late December 2021 or early January 2022, subject to the pace of participant enrollment, and reporting topline results within two months of study completion.

The Altitude Trial is the second in a series of three, short-term studies Diffusion is conducting intended to provide the Company with additional information regarding TSC’s mechanism of action and dose-response characteristics. The results of the Altitude Trial, together with the results of the Company’s TCOM Trial (announced in June 2021) and its ILD-DLCO Trial, expected to commence in December 2021, will be used to further inform the design of clinical trials aimed at supporting the commercialization of TSC as a treatment for conditions complicated by hypoxia.

While the Company intends to continue developing data to support TSC’s broad potential uses, it recently announced that its near-term focus will be the design and execution of a clinical program to support the use of intravenously administered TSC as a treatment for hypoxic solid tumors, and that it intends to obtain input from the U.S. Food and Drug Administration on the program’s design in early 2022.

On November 22, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI), a clinical-stage biotechnology company developing eganelisib, a potentially first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic which addresses a fundamental biologic mechanism of immune suppression in cancer, reported that Adelene Perkins, Chief Executive Officer, will present at the upcoming Piper Sandler 33rd Annual Virtual Healthcare Conference (Press release, Infinity Pharmaceuticals, NOV 22, 2021, View Source [SID1234595891]).

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The presentation will be a fireside chat with Ted Tenthoff, Piper’s Senior Biotech Analyst, which will be available on the Company’s website beginning November 22nd. Management will also be available for 1-on-1 meetings with investors during the conference which will take place November 29th through December 2nd.

Presentation details can be found below:

33rd Annual Virtual Healthcare Conference
Format: Presentation and 1-on-1 meetings
Date and Time: Presentation available starting Monday, November 22nd at 10:00am ET; 1-on-1 meetings November 29th – December 2nd
The presentations and archived webcasts can be accessed in the Investors/Media section of Infinity’s website at www.infi.com and will be available on Infinity’s website for 30 days following the event.

On November 22, 2021 Perrigo Company plc (NYSE; TASE: PRGO), a leading provider of Consumer Self-Care Products, reported that it is taking steps to voluntarily delist the Company’s ordinary shares from trading on the Tel Aviv Stock Exchange (TASE) (Press release, Perrigo Company, NOV 22, 2021, View Source [SID1234595890]). Perrigo is delisting its shares from the TASE after divesting its Israeli-based operations earlier this year. As such, Perrigo has requested that the TASE immediately initiate the process to delist the Company’s ordinary shares.

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Under Israeli law, the delisting of Perrigo’s ordinary shares from the TASE is expected to become effective three months after the date of the Company’s request to the TASE to delist the Company’s ordinary shares, which occurred on November 22, 2021. Perrigo ordinary shares will continue to be listed on the New York Stock Exchange (NYSE), and all of its ordinary shares now traded on the TASE are expected to be transferred to the NYSE where they can continue to be traded.

Perrigo CEO and President Murray S. Kessler commented, "Perrigo has undergone a significant transformation over the past three years. Part of this transformation included the divestiture of our Israeli-based assets earlier this year and we believe now is the appropriate time to delist."

On November 22, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to CTX110, its wholly-owned allogeneic CAR-T cell therapy targeting CD19+ B-cell malignancies (Press release, CRISPR Therapeutics, NOV 22, 2021, View Source [SID1234595889]).

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"This RMAT designation is based on the encouraging clinical data we have presented thus far, and it is an important milestone that recognizes the transformative potential of CTX110 for the treatment of hematological malignancies," said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. "We look forward to working closely with the FDA as we continue our efforts to bring this important new therapeutic modality to patients."

Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the drug development and review processes for promising pipeline products, including genetic therapies. A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the drug or therapy has the potential to address unmet medical needs for such disease or condition. Similar to Breakthrough Therapy designation, RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with FDA to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, potential priority review of the biologics license application (BLA) and other opportunities to expedite development and review.

About CTX110
CTX110, a wholly owned program of CRISPR Therapeutics, is a healthy donor-derived gene-edited allogeneic CAR-T investigational therapy targeting Cluster of Differentiation 19, or CD19. CTX110 is being investigated in the ongoing CARBON trial.

About CARBON
The ongoing Phase 1 single-arm, multi-center, open label clinical trial, CARBON, is designed to assess the safety and efficacy of several dose levels of CTX110 for the treatment of relapsed or refractory B-cell malignancies.