On October 20, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that the company has ranked first in the pharmaceuticals sector for the "2021 Award for Excellence in Corporate Disclosure" granted by the Securities Analysts Association of Japan (SAAJ) to promote the quality and fairness of corporate disclosure (Press release, Astellas, OCT 20, 2021, View Source [SID1234591566]).

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Astellas was highly evaluated mainly in the following areas:

Significant improvement in IR stance, with the top management’s proactive information dissemination and engagement in dialogue
IR group has sufficient accumulated information, and securities analysts and institutional investors are having a useful dialogue with IR personnel
Announcement of a medium-term plan ("Corporate Strategic Plan 2021" *1), a full explanation of subsequent progress with concrete measures for achievement, and a capital allocation policy
Stock market needs are incorporated into the disclosure materials of the medium-term plan
Astellas’ raison d’être is "to contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products." With research and development at the heart of the company, Astellas constantly takes on challenges to deliver innovative new drugs and medical solutions by leveraging its core capabilities. In addition, Astellas aims to sustainably enhance its enterprise value by being chosen and trusted by all the stakeholders including customers, shareholders, employees and community.

Upon receiving the award, Kenji Yasukawa, President and CEO, Astellas, stated as follows:
"Our disclosure philosophy is to make our products on the market and the clinical trial results known in a timely and appropriate manner, as well as proactively explain to the stakeholders not only the features of the projects under research and development, but also the potential impact on society when they are launched. In addition, we strive to make the opportunity to provide information flexibly in line with the requests and needs of the stakeholders so that we do not unilaterally disseminate information. As a result of these efforts, we believe that we were able to improve the perception of our advocacy activities and our disclosure philosophy, which led to this recognition."

Astellas will continue to disclose information in a timely, appropriate, and fair manner, as well as proactively engage in dialogue with stakeholders and further improve transparency. Astellas will continue to strive to enhance and improve the quality of its disclosure.

On October 20, 2021 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering (Press release, Crinetics Pharmaceuticals, OCT 20, 2021, View Source [SID1234591583]). In addition, Crinetics intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the shares to be sold in the offering are to be sold by Crinetics. 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.

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Crinetics intends to use the net proceeds from the proposed offering to fund the development of paltusotine, CRN04894, CRN04777 and its other research and development programs, and for working capital and general corporate purposes.

SVB Leerink, Evercore ISI and Cantor Fitzgerald are acting as joint bookrunning managers for the offering.

The securities described above are being offered by Crinetics pursuant to a shelf registration statement that became automatically effective upon its filing with the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: SVB Leerink 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]; from: Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at [email protected]; or from: Cantor Fitzgerald & Co., Attn: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, by telephone at 212-829-7122 or by email at [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at www.sec.gov.

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

On October 20, 2021 vTv Therapeutics Inc. (Nasdaq: VTVT) a clinical-stage biopharmaceutical company focused on the development of orally administered treatments for type 1 diabetes and psoriasis, reported that Deepa Prasad will lead the company as President and Chief Executive Officer, effective immediately (Press release, vTv Therapeutics, OCT 20, 2021, View Source [SID1234591603]). Stephen L. Holcombe who previously served as vTv’s President and Chief Executive Officer will be retiring.

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Deepa joins vTv as it sets to launch phase 3 pivotal studies for its most advanced product, TTP399, which was granted Breakthrough Therapy Designation by the FDA in April as an oral adjunctive therapy for the treatment of type 1 diabetes.

Recent positive results from the phase 2 study showed treatment with TTP399 resulted in a statistically significant improvement in HbA1c relative to placebo and a clinically meaningful decrease (40%) in the frequency of severe and symptomatic hypoglycemia.

Earlier this month, vTv announced positive results from a mechanistic study indicating no increased risk of ketoacidosis with TTP399 during acute insulin withdrawal in patients with type 1 diabetes. Patients taking TTP399 also reported no events of hypoglycemia, while four events of hypoglycemia were reported in the placebo arm.

"I am thrilled to have Deepa to step in to this role at an exciting time," said Robin E. Abrams, vTv Chairwoman. "Deepa is the right choice to steer the company through this final stage of TTP399 development, given her significant experience in leadership roles at several prominent healthcare companies during pivotal moments of change and growth."

Ms. Prasad brings over 20 years of healthcare experience spanning venture capital, biotech investment banking, general management, startups and legislation. She most recently served as Managing Director at WestRiver Group, where she led the firm’s investments in Design Therapeutics (Nasdaq: DSGN), Ginger (now $3B Headspace Health), and Curai. She currently sits on the Board of Design Therapeutics and is an Independent Advisor to Equilibre Biopharmaceuticals. In June 2021, Deepa was awarded the Falk Marques General Partners Rising Star Award sponsored by Deloitte.

"I am pleased to join vTv Therapeutics and lead us through our next phase of growth," said Prasad. "Hypoglycemia is a significant cause of morbidity and potential mortality, and vTv is well-positioned to address this serious issue for the worldwide and growing Type 1 diabetes patient population."

On October 20, 2021 NeoTX Therapeutics (NeoTX), a clinical-stage immuno-oncology company, reported that the first patient has been enrolled in the company’s phase 2a clinical trial of naptumomab estafenatox (NAP), its lead Tumor Targeted Superantigen (TTS) candidate, in combination with docetaxel in patients with advanced non-small cell lung cancer (NSCLC) (Press release, NeoTX, OCT 20, 2021, View Source [SID1234591620]).

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"Dosing of the first patient in this phase 2 trial represents a crucial step forward for the clinical advancement of NAP" said Asher Nathan, Ph.D., chief executive officer of Neo TX. "This trial is based on promising phase 1 data. NSCLC is one of the deadliest cancers, and we are looking forward to evaluating NAP in this setting".

The phase 2a, open label trial in the US, will assess NAP in combination with docetaxel in patients who had been previously treated with checkpoint inhibitors and have advanced or metastatic NSCLC. The primary endpoint is objective response rate as measured by RECIST 1.1 criteria. The trial will also evaluate safety, duration of response, progression free survival, overall survival, pharmacokinetics, and pharmacodynamics. For more information about the trial, visit View Source

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