On April 24, 2020 ADC Therapeutics SA, a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates for patients suffering from hematological malignancies and solid tumors, reported that it has filed a registration statement on Form F-1 with the U.S. Securities and Exchange Commission relating to a proposed initial public offering of its common shares (Press release, ADC Therapeutics, APR 24, 2020, View Source [SID1234556637]). The number of shares to be offered and the price range for the proposed offering have not yet been determined. ADC Therapeutics intends to list its common shares on the New York Stock Exchange under the ticker symbol "ADCT."

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Morgan Stanley, BofA Securities and Cowen will act as joint book-running managers for the offering.

The offering will be made only by means of a prospectus. Copies of the preliminary prospectus relating to the offering may be obtained, when available, from Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at (866) 718-1649 or by email at [email protected]; BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (833) 297-2926 or by email at [email protected].

A registration statement relating to these securities has been filed with the U.S. Securities and Exchange Commission, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. 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. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended. There is no intention to publicly offer, solicit, sell or advertise, directly or indirectly, these securities, or invest in securities of ADC Therapeutics SA, such as the common shares, in, into or from Switzerland and these securities will not be listed on the SIX Swiss Exchange or on any other exchange or regulated trading venue in Switzerland. The common shares may not be publicly offered, directly or indirectly, in Switzerland within the meaning of the Swiss Financial Services Act ("FinSA") and no application has or will be made to admit the common shares to trading on any trading venue (exchange or multilateral trading facility) in Switzerland. Neither this document nor any other offering or marketing material relating to these securities, such as the common shares, constitutes or will constitute a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares constitutes a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares may be publicly distributed or otherwise made publicly available in Switzerland.

On April 24, 2020 AkesoBio, a Zhongshan developer of novel mono- and bi-specific antibodies, reported that $335 million Hong Kong IPO and climbed 50% higher in its first trading session (Press release, Akeso Biopharma, APR 24, 2020, View Source [SID1234556599]). The company’s general strategy is to develop bispecific antibodies using a PD-1 antibody as a backbone. It has built a portfolio of 18 mAbs that are in either CMC or clinical stages of development. Last year, Akeso formed a $100 million JV with a Sino Biopharma subsidiary to develop and commercialize AK105, its clinical-stage anti-PD-1 mAb.

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On April 24, 2020 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that an independent Data Safety Monitoring Board (DSMB) has confirmed that it is safe to start patient recruitment for the middle dose cohort for the Phase 1/2 NOX-A12 plus radiotherapy brain cancer trial (Press release, NOXXON, APR 24, 2020, View Source [SID1234556597]).

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The study investigates three dose regimens of NOX-A12 (200, 400 and 600 mg/week), each combined with external-beam radiotherapy in newly diagnosed brain cancer patients. The decision to proceed followed the analysis of safety data stipulated in the study protocol after all patients in the first cohort completed at least 4 weeks of treatment.

The clinical trial centers participating in the study have therefore initiated patient recruitment for the second of three escalating dose groups who will receive NOX-A12 at a weekly dose of 400 mg/week. Once the first patient in this second cohort has received a four-week treatment of NOX-A12 and radiotherapy, the DSMB will reconvene to determine whether it is safe to recruit the remaining two patients in this cohort.

"The confirmation of the initial safety profile of NOX-A12 in combination with radiotherapy in all patients of the first cohort is very encouraging," commented Aram Mangasarian, CEO of NOXXON. "Following this analysis, the trial can progress to the second cohort as planned at the next dose level. We remain focused on reaching our goal of obtaining data from the first cohort of patients in October 2020, and from the second and third cohorts in the end of Q1 2021 and mid-2021, respectively."

On April 24, 2020 Sumitovant Biopharma Ltd. reported that Myovant Sciences, one of five healthcare companies in the Sumitovant family of companies, achieved multiple milestones with its relugolix therapies for the treatment of advanced prostate cancer and endometriosis (Press release, Sumitovant Biopharma, APR 24, 2020, View Source [SID1234556596]).

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Myovant, a healthcare company focused on redefining care for women’s health and prostate cancer, announced on April 21, 2020 its submission of a New Drug Application(NDA) to the U.S. Food and Drug Administration (FDA) for once-daily, oral relugolix (120 mg) for the treatment of men with advanced prostate cancer. The NDA submission is supported by the positive results from the Phase 3 HERO study with a 96.7% response rate in men with advanced prostate cancer. The randomized pivotal study compared relugolix versus leuprolide acetate and also demonstrated superiority to leuprolide acetate on six key secondary endpoints. If approved, relugolix could provide men with an important oral alternative to leuprolide injections, the current standard of care.

In addition, on April 22, 2020 Myovant announced positive results from SPIRIT 2, the first of two Phase 3 studies evaluating once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis and from a separate ovulation inhibition study. SPIRIT 2 met both co-primary endpoints with 75.2% of women achieving a clinically-meaningful reduction in dysmenorrhea (menstrual pain) versus 30.4% of women in the placebo group (p<0.0001), and a 66.0% response rate versus 42.6% response rate in the placebo group (p<0.0001) for non-menstrual pelvic pain. Six key secondary endpoints were also met. Women receiving once-daily relugolix combination therapy, on average, had a 75.1% reduction on the Numerical Rating Scale for dysmenorrhea from 7.2 (severe pain) to 1.7 (mild pain). Relugolix combination therapy was generally well-tolerated and bone mineral density changes were minimal. In a separate ovulation inhibition study, relugolix combination therapy demonstrated 100% ovulation inhibition and 100% return of ovulation or menses upon discontinuation of treatment. Myovant expects to submit another NDA for once-daily relugolix combination tablet for women with uterine fibroids in May 2020.

"We are pleased with Myovant’s progress developing once-daily, oral relugolix monotherapy and relugolix combination therapy," said Myrtle Potter, CEO of Sumitovant Biopharma, a wholly-owned subsidiary of Sumitomo Dainippon Pharma. "Myovant’s mission to redefine care for women’s health and prostate cancer aligns with Sumitovant’s goal to make a difference in the lives of people globally by rapidly developing innovative medicines with our technology-enabled approach to drug development and commercialization. In doing so we believe we have the potential to become a core growth engine for our parent company, Sumitomo Dainippon Pharma."

On April 24, 2020 Mylan N.V. (NASDAQ: MYL) reported that it will release its first quarter 2020 financial results on Monday, May 11, before the open of the U.S. financial markets (Press release, Mylan, APR 24, 2020, View Source [SID1234556595]). The company also will host a webcast at 10:30 a.m. ET on May 11 to discuss the results.

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The briefing can be accessed live by calling 855.493.3607 or 346.354.0950 for international callers (ID#: 5977277) or at the following address on the company’s website: investor.mylan.com. A replay of the webcast also will be available on the website.