On April 26, 2022 Priothera Ltd, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound, mocravimod, reported that the U.S. Food and Drug Administration (FDA) has provided clearance to proceed with the Company’s Investigational New Drug (IND) application to begin its pivotal Phase 2b/3 study of mocravimod (named MO-TRANS) (Press release, Priothera, APR 25, 2022, View Source [SID1234612910]).

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Priothera will initiate the MO-TRANS global Phase 2b/3 study in Europe, US and Japan, assessing the efficacy and safety of mocravimod as an adjunctive and maintenance therapy in adult Acute Myeloid Leukemia (AML) patients undergoing allogenic hematopoietic stem cell transplant (HSCT). The MO-TRANS study is expected to start in the second half of 2022 and preliminary data from this study are expected by the end of 2024.

Allogenic stem cell transplantation is the only potentially curative approach for AML patients, however current treatment options are still associated with a high number of side effects, and high mortality rates.

Florent Gros, Co-Founder and CEO of Priothera, commented "The FDA IND clearance to initiate the MO-TRANS study assessing mocravimod in AML patients undergoing allogeneic HSCT is another major milestone for Priothera. We are on track to initiate this pivotal Phase 2b/3 clinical trial and are looking forward to working alongside a large team of enthusiastic investigators across the US, Europe and Asia, who share our goal of bringing mocravimod to patients as an adjunctive and maintenance treatment for AML and potentially other hematologic malignancies."

About Mocravimod
Mocravimod (also known as KRP203), is a synthetic, sphingosine 1-phosphate receptor (S1PR) modulator. This novel investigational drug has been assessed in Phase 1 and Phase 2 trials for safety and tolerability, as well as for efficacy in several autoimmune indications. Promising data from a Phase 1b/2a clinical study in patients with hematological malignancies led Priothera to further develop mocravimod for the treatment of blood cancers.

Mocravimod will be investigated as an adjunctive and maintenance treatment in a Phase 2b/3 study as a potential treatment for patients with Acute Myeloid Leukemia (AML) receiving allogeneic hematopoietic stem cell transplantation (HSCT). Allogenic HSCT is the only potentially curative approach for AML patients, but current treatments have unacceptably high mortality and morbidity rates.

Priothera leverages S1PR modulator’s unique mode of action to maintain anti-leukemia activity – graft-versus leukemia (GVL) while reducing tissue damage resulting from graft-versus-host disease (GVHD), a consequence of allogenic HSCT. This novel treatment approach – mocravimod being the only S1PR modulator treating blood cancers – tackles a high unmet medical need and intends to add quality life to patients.

On April 25, 2022 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, APR 25, 2022, View Source [SID1234612909]). This programme is part of the overall share repurchase programme of up to DKK 22 billion to be executed during a 12-month period beginning 2 February 2022.

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Under the programme initiated 2 February 2022, Novo Nordisk will repurchase B shares for an amount up to DKK 4.4 billion in the period from 2 February 2022 to 2 May 2022.

Since the announcement 11 April 2022, the following transactions have been made:

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

Transactions related to Novo Nordisk’s incentive programmes have resulted in a net transfer from Novo Nordisk of 16,116 B shares in the period from 11 April 2022 to 22 April 2022. The shares in these transactions were not part of the Safe Harbour repurchase programme.

With the transactions stated above, Novo Nordisk owns a total of 37,365,302 B shares of DKK 0.20 as treasury shares, corresponding to 1.6% 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 22 billion during a 12- month period beginning 2 February 2022. As of 22 April 2022, Novo Nordisk has since 2 February 2022 repurchased a total of 5,595,250 B shares at an average share price of DKK 713.28 per B share equal to a transaction value of DKK 3,990,957,709.

Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 47,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisk’s B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, and YouTube.

On April 25, 2022 Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing engineered natural killer cell therapies to treat cancer, reported that it has commenced a proposed underwritten public offering to issue and sell $150 million of shares of its common stock (Press release, Nkarta, APR 25, 2022, View Source [SID1234612908]). The Company also intends to grant the underwriters a 30-day option to purchase up to an additional $22.5 million of shares of its common stock on the same terms and conditions. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed or as to the actual size or terms of the offering. All shares in the offering are to be issued and sold by Nkarta.

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Nkarta intends to use the net proceeds from the offering to fund the continued clinical development of NKX101 and NKX019, preclinical studies for research stage programs and the continued buildout of internal manufacturing capabilities, and for working capital and for general corporate purposes.

Cowen, SVB Securities and Evercore ISI are acting as joint book-running managers for the offering.

The offering is being conducted pursuant to a shelf registration statement (File No. 333-258766), which was filed with the Securities and Exchange Commission ("SEC") on August 12, 2021 and declared effective by the SEC on September 2, 2021. The proposed offering will be made only by means of a prospectus supplement and accompanying prospectus describing the terms of the offering. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained by contacting Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (833) 297-2926, or by email at [email protected]; SVB Securities LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; and Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]. These documents may also be obtained for free on the SEC’s website located at View Source The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

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

On April 25, 2022 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company will release its financial results for the first quarter 2022 after the market closes on Tuesday, May 3, 2022 (Press release, MacroGenics, APR 25, 2022, View Source [SID1234612907]). MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Tuesday, May 3, 2022, at 4:30 pm ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID# 6791448.

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The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On April 25, 2022 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that senior leadership plans to present at the following conference (Press release, Iovance Biotherapeutics, APR 25, 2022, View Source [SID1234612906]):

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Chardan Genetic Medicines and Cell Therapy Manufacturing Summit
Fireside Chat: April 26 at 1:30 p.m. ET
The live and archived webcast will be available at View Source