On March 15, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS") reported the finalization of arrangements for the completion of the investigational new drug ("IND") package for the company’s lead drug candidate and its submission to the United States Food and Drug Administration ("FDA") (Press release, Scopus BioPharma, MAR 15, 2021, View Source,the%20treatment%20of%20multiple%20cancers. [SID1234576652]). The IND submission is expected in Q2 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Scopus is a biopharmaceutical company developing transformational therapeutics based on groundbreaking scientific and medical discoveries. The company’s lead drug candidate is a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers.

Joshua R. Lamstein, Chairman of Scopus BioPharma, stated, "We are extremely excited about the forthcoming submission of the IND for the Phase 1 clinical trial for our lead drug candidate. We believe investors will recognize this milestone as an important near-term driver of shareholder value."

The company’s lead drug candidate is highly distinctive, encompassing both gene therapy and immunotherapy by synthetically linking siRNA to an oligonucleotide TLR9 agonist, creating the potential for targeted gene silencing with simultaneous TLR stimulation and immune activation in the tumor microenvironment.

On March 15, 2021 Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), a commercial-stage biopharmaceutical company with a marketed drug for the acute treatment of migraine and a portfolio of innovative, late–stage product candidates targeting neurological diseases, including rare disorders, reported that it has commenced an underwritten public offering of $200 million of its common shares (Press release, Biohaven Pharmaceutical, MAR 15, 2021, View Source [SID1234576672]). All of the common shares to be sold in the offering will be offered by Biohaven. In addition, Biohaven expects to grant the underwriter a 30-day option to purchase up to an additional $30 million of common shares at the public offering price, less underwriting discounts and commissions. 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 the actual size or terms of the offering.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Goldman Sachs & Co. LLC is acting as the book-running manager of the offering.

The offering is being made only by means of a prospectus supplement and the accompanying prospectus, copies of which, when available, may be obtained from the offices of Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1–866-471-2526, facsimile: 212-902-9316 or by emailing [email protected].

The shares will be issued pursuant to an effective shelf registration statement on Form S-3. Before investing in the offering, interested parties should read the prospectus and related prospectus supplement for this offering, the documents incorporated by reference therein and the other documents Biohaven has filed with the Securities and Exchange Commission. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of these securities, 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 under the applicable securities laws of such state or jurisdiction.

On March 15, 2021 Genmab A/S (Nasdaq: GMAB). On February 23, 2021 Genmab announced the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, MAR 15, 2021, View Source [SID1234576633]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from March 8, 2021 to March 12, 2021:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 145,477 shares as treasury shares, corresponding to 0.22% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.

On March 15, 2021 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, reported that John Climaco, CEO of CNS Pharmaceuticals will present at the inaugural Emerging Growth Virtual Conference presented by M Vest LLC and Maxim Group LLC (Press release, CNS Pharmaceuticals, MAR 15, 2021, View Source [SID1234576673]). The conference will take place virtually on March 17th and 18th and will feature roundtable discussions with C-suite executives moderated by Maxim Research Analysts, fireside chats with live Q&A, and presentations from hundreds of issuers both domestically and internationally.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In addition to the presentation, Mr. Climaco will participate in a live glioblastoma panel discussion on Wednesday, March 17th from 9:30-10:30 am ET.

Interested parties are invited to attend the virtual conference and access exclusive content by becoming an M-Vest member and registering HERE. To learn more about the event, please visit the conference website: Emerging Growth Virtual Conference.

On March 14, 2021 PharmaEssentia Corporation (TPEx: 6446), a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the company’s Biologics License Application (BLA) for ropeginterferon alfa-2b-njft for the treatment of polycythemia vera (PV), a rare blood cancer (Press release, PharmaEssentia, MAR 14, 2021, View Source [SID1234576612]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The rationale for the CRL was COVID-related travel restrictions, which delayed a required pre-approval inspection of the company’s manufacturing facility in Taiwan. The FDA also indicated a need for additional data about the administration format with the product. Importantly, no concerns were raised about the clinical profile of the product.

"We are confident that we can work with the Agency to address the requests highlighted in the response letter and resubmit in an expeditious manner," said Meredith Manning, U.S. General Manager. "We remain fully committed to introducing ropeginterferon alfa-2b-njft to the U.S. PV community."

Ropeginterferon alfa-2b-njft has Orphan Drug designation for the treatment of PV in the United States. Marketed as Besremi in Europe, the product was approved by the European Medicines Agency (EMA) in 2019. The molecule was invented and is manufactured by PharmaEssentia.