On February 2, 2022 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that Dr. Neal Walker, President and CEO of Aclaris, will participate in a fireside chat at the SVB Leerink Virtual 11th Annual Global Healthcare Conference on Wednesday, February 16, 2022 at 9:20 a.m. ET (Press release, Aclaris Therapeutics, FEB 2, 2022, View Source [SID1234607600]). Management will be available February 16th throughout the day for virtual 1×1 meetings.

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!

A webcast of the fireside chat may be accessed through the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.

On February 2, 2022 miReven scientists reported that it awarded an Australian competitive NHMRC Development grant for 2022-23 (Press release, MiReven, FEB 2, 2022, View Source [SID1234607598]). Prof Leedman and the team were successful in being awarded a Development Grant for two years to help drive the further development of mRx-7 into a therapy for liver cancer.

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!

On February 2, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that at the meeting of the Board of Directors held today, a resolution was adopted to acquire its own shares pursuant to the provision of its Articles of Incorporation in accordance with Article 459, paragraph 1 of the Companies Act (Press release, Astellas, FEB 2, 2022, View Source [SID1234607595]). The Company also announced that it decided to cancel its treasury stock pursuant to the provisions of Article 178 of the Companies Act. The details are as follows.

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!

1. Reasons for the acquisition of own shares
To improve capital efficiency and shareholder return.

2. Details of the acquisition of own shares
(1) Class of shares to be acquired: Common stock of the Company
(2) Total number of shares to be acquired: Up to 29 million shares
　(Ratio to the total number of shares outstanding [excluding treasury stock]: 1.57%)
(3) Total amount of acquisition cost: Up to 50 billion yen
(4) Period of acquisition: From February 3, 2022 to March 24 ,2022

3. Details of the cancellation of treasury stock
(1) Class of shares to be cancelled: Common stock of the Company
(2) Number of shares to be cancelled: All of the shares acquired as stated in 2 above
(3) Cancellation date: March 29, 2022 (planned)

* The actual number of shares to be cancelled will be announced after
completing the acquisition of own shares stated in 2 above.

(Reference) Status of treasury stock as of December 31, 2021:
Total number of shares outstanding (excluding treasury stock): 1,852,927,335 shares
Total number of treasury stocks: 8,859,740 shares

On February 2, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, "the Company") reported the financial results for the first nine months (April 1, 2021 – December 31, 2021) of the fiscal year 2021 (FY2021) ending March 31, 2022 (Press release, Astellas, FEB 2, 2022, View Source [SID1234607594]).

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!

Consolidated financial results for the first nine months of FY2021 (core basis)
1. Qualitative information on consolidated financial results for the first nine months of FY2021
(1) Business performance

Revenue
-Main products XTANDI for the treatment of prostate cancer, XOSPATA for the treatment of acute myeloid leukemia and PADCEV for the treatment of urothelial cancer showed steady growth as expected. In addition, the sales growth of EVRENZO for the treatment of renal anemia, Betanis / Myrbetriq / BETMIGA for the treatment of overactive bladder ("OAB") and EVENITY for the treatment of osteoporosis contributed to revenue growth as well.
-Moreover, another factor for the increase in sales in the first nine months of FY2021 was the sales of pharmacologic stress agent Lexiscan returning to prepandemic level which decreased mainly in the first three months of the previous fiscal year by the impact of the spread of COVID-19.
-The sales growth of the products above offset the sales decrease mainly due to the termination of sales agreements for Celecox for the treatment of inflammation and pain and Lipitor for the treatment of hypercholesterolemia, and the divestiture of Eligard for the treatment of prostate cancer.

As a result of the above, revenue in the first nine months of FY2021 increased by 5.5% compared to those in the corresponding period of the previous fiscal year ("year-on-year") to ¥992.3 billion.

Core operating profit / Core profit
-Gross profit increased by 6.0% year-on-year to ¥798.2 billion. The cost-to-revenue ratio fell by 0.4 percentage points year-on-year to 19.6%, mainly due to changes in product mix.
-Selling, general and administrative expenses increased by 11.9% year-on-year to ¥406.4 billion. The total amount increased mainly due to the increase of copromotion fees associated with the growth of sales of XTANDI in the United States (increase of ¥18.5 billion year-on-year), impact of the foreign exchange rates (increase of ¥16.5 billion year-on-year), investment in Digital Transformation (increase of approximately ¥6.0 billion year-on-year), and the increase in sales promotion expenses for new product launch readiness (increase of approximately ¥2.5 billion year-on-year), despite a decrease in expenses due to the global optimization of personnel aligned with transformation of product portfolio (decrease of approximately ¥5.0 billion year-on-year). Selling, general and administrative expenses, excluding co-promotion fees of XTANDI in the United States, increased by 9.1% year-on-year to ¥297.7 billion.
-Research and development (R&D) expenses increased by 5.2% year-on-year to ¥177.6 billion. While there was a decrease in development expenses for fezolinetant, a selective neurokinin-3 receptor antagonist, for which patient enrollment in Phase III trials in the United States and Europe has been completed, the total amount increased mainly due to increases in development expenses for zolbetuximab, an anti-Claudin 18.2 monoclonal antibody and R&D investment for Rx+ business (related to iota). 3
-Amortisation of intangible assets increased by 17.1% year-on-year to ¥20.2 billion.
-Gain on divestiture of intangible assets was ¥24.1 billion. Including such as transfer of five products to Cheplapharm which were sold in Europe and other regions (¥12.3 billion), transfer of a pipeline asset (¥9.2 billion) and transfer of Bendamustine (¥2.0 billion).

As a result of the above, core operating profit increased by 8.0% year-on-year to ¥220.0 billion, and core profit increased by 1.8% year-on-year to ¥169.7 billion.

Impact of exchange rate on financial results
The exchange rates for the yen in the first nine months of FY2021 are shown in the table below. The resulting impacts were a ¥42.8 billion increase in revenue and a ¥15.4 billion increase in core operating profit compared with if the exchange rates of the first nine months of FY2020 were applied.

On February 1, 2022 FIMECS, Inc. (CEO: Yusuke Tominari, Ph.D., "FIMECS") a private biotechnology company creating a new class of drugs based on targeted protein degradation, reported that FIMECS has entered into a research collaboration with Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") on small molecule protein degraders against multiple targets for a multi-year period (Press release, FIMECS, FEB 1, 2022, View Source [SID1234630696]). The collaboration will leverage FIMECS’ expertise in targeted protein degradation and its proprietary RaPPIDS platform and Astellas’ scientific, regulatory, and clinical capabilities to accelerate the development of life-saving medicines to patients around the world.

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!

Under the terms of the agreement, FIMECS will conduct research activities on multiple targets and Astellas will advance candidates for development and potential commercialization. Upon designation of a clinical development candidate, Astellas has the option to exclusively license degrader molecules against the designated target. FIMECS will receive an upfront payment and funding to support Astellas-related research. Additionally, FIMECS could earn from potential payments based upon the successful achievement of specified research, development, regulatory, and commercial milestones for all the targets initially selected by Astellas. In addition, FIMECS will receive single digit tiered royalties on future net sales on any products that may result from this collaboration. Astellas may, at its discretion, elect to expand the collaboration to include additional disease targets. This decision would trigger an additional one-time payment, as well as potential payment of milestones and royalties on a product-by-product basis.

"We are thrilled to partner with Japanese top-tier global pharmaceutical company, Astellas to combine their deep understanding of biology and strong clinical development capabilities with FIMECS’ proprietary protein degrader platform," said Yusuke Tominari, Ph.D., CEO, FIMECS. "We have already identified unique E3 ligase binders and established highly effective synthetic method as a degrader discovery platform, RaPPIDS. We are very pleased that our platform has been wellreceived by the organization. This strategic partnership will broaden the application of targeted protein degradation to address diseases with high unmet medical needs. We hope to continue this collaboration with Astellas with the goal of potentially delivering life-saving medicines to patients all over the world."