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.

On April 24, 2020 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium" or "the Company") reported the closing of the Company’s previously announced underwritten public offering of 210,833,334 shares of common stock (or common stock equivalents in lieu thereof) at an effective public offering price of $0.15 per share of common stock (or common stock equivalent), which includes the full exercise of the underwriters’ option to purchase additional shares of common stock (Press release, Actinium Pharmaceuticals, APR 24, 2020, View Source [SID1234556594]).

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H.C. Wainwright & Co. acted as the sole book-running manager for the offering. Maxim Group LLC and JonesTrading acted as co-managers for the offering.

The gross proceeds from this offering to Actinium are expected to be approximately $31.6 million, before deducting underwriting discounts and commissions and other offering expenses payable by Actinium. Actinium intends to use the net proceeds from the offering to complete its ongoing pivotal, Phase 3 SIERRA trial for its lead product candidate, Iomab-B, and support its BLA filing. Net proceeds from this offering will also be used to progress Phase 1 trials from its refocused CD33 program to the proof of concept stage and support its AWE Technology Platform, Iomab-ACT program, research and development and general working capital needs.

The securities described above were offered by Actinium pursuant to a shelf registration statement (Registration No. 333-216748) filed by Actinium with the Securities and Exchange Commission ("SEC") that became effective on October 12, 2017. The offering is being made only by means of a prospectus supplement and accompanying prospectus. A final prospectus supplement and accompanying prospectus were filed with the SEC and may be obtained for free on the SEC’s website located at View Source Electronic copies of the final prospectus supplement and accompanying prospectus relating to the public offering may be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, or by telephone at (646) 975-6996, or by email to [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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.

On April 24, 2020 FibroGen, Inc. (NASDAQ: FGEN) reported that it will announce its first quarter 2020 financial results on Thursday, May 7, 2020 (Press release, FibroGen, APR 24, 2020, View Source [SID1234556592]). FibroGen will also conduct a conference call on that day at 5:00 p.m. ET (2:00 p.m. PT) with the investment community to further detail the company’s corporate and financial performance.

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Conference Call and Audio Webcast
Interested parties may access a live audio webcast of the conference call via the FibroGen website at View Source It is recommended that listeners access the website 15 minutes prior to the start of the call to download and install any necessary audio software.

Dial-In Information
Live (U.S./Canada): (877) 658-9081
Live (International): (602) 563-8732
Confirmation number: 9946439

A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international), and use passcode 9946439.

On April 24, 2020, vTv Therapeutics Inc. (the "Company") reported that it has entered into a Controlled Equity OfferingSM Sales Agreement (the "Sales Agreement") with Cantor Fitzgerald & Co. ("Cantor Fitzgerald"), pursuant to which the Company may offer and sell, from time to time, through or to Cantor Fitzgerald, as sales agent or principal, shares of the Company’s Class A common stock, par value $0.01 per share, having an aggregate offering price of up to $13.0 million (the "ATM Offering") (Filing, 8-K, vTv Therapeutics, APR 24, 2020, View Source [SID1234556591]).

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The Company is not obligated to sell any shares under the Sales Agreement. Subject to the terms and conditions of the Sales Agreement, Cantor Fitzgerald will use commercially reasonable efforts, consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations and the rules of the Nasdaq Stock Market, to sell shares from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. Under the Sales Agreement, Cantor Fitzgerald may sell shares by any method deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended. The Company will pay Cantor Fitzgerald a commission of up to 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements up to $50,000 and provide Cantor Fitzgerald with customary indemnification and contribution rights. The Sales Agreement may be terminated by Cantor Fitzgerald or the Company upon notice to the other party as provided in the Sales Agreement, or by Cantor Fitzgerald at any time in certain circumstances, including the occurrence of a material and adverse change in the Company’s business or financial condition that makes it impractical or inadvisable to market the shares or to enforce contracts for the sale of the shares.

The issuance and sale, if any, of the Shares by the Company under the Agreement will be made pursuant to the Company’s effective registration statement on Form S-3 (Registration Statement No. 333-223269) (the "Registration Statement"), filed with the U.S. Securities and Exchange Commission (the "SEC") on February 27, 2018 and declared effective on March 19, 2018. The offering is described in the Company’s Prospectus dated March 19, 2018, as supplemented by a Prospectus Supplement dated April 24, 2020, as filed with the SEC on April 24, 2020.

The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K and is incorporated herein by reference. The legal opinion of Paul, Weiss, Rifkind, Wharton & Garrison LLP relating to the validity of the shares of Class A common stock being offered pursuant to the Sales Agreement is filed as Exhibit 5.1 to this Current Report on Form 8-K and is incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy any shares under the Sales Agreement nor shall there be any sale of such shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.