Anavex Life Sciences to Present at the 2021 Cantor Virtual Global Healthcare Conference

On September 20, 2021 Anavex Life Sciences Corp. ("Anavex" or the "Company") (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, reported that Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, will present at the 2021 Cantor Virtual Global Healthcare Conference on Monday, September 27, 2021 at 10:40 AM (ET) (Press release, Anavex Life Sciences, SEP 20, 2021, View Source [SID1234587949]). The conference is being held September 27-30, 2021.

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A live audio webcast will be available at View Source or on the Company’s website at www.anavex.com. A webcast replay will be accessible for 30 days following the presentation.

Novo Nordisk A/S – Share repurchase programme

On September 20, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, SEP 20, 2021, View Source [SID1234587948]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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Under the programme initiated 4 August 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 5 August 2021 to 1 November 2021.

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 20,104,438 B shares of DKK 0.20 as treasury shares, corresponding to 0.9% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 17 September 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 21,297,972 B shares at an average share price of DKK 495.34 per B share equal to a transaction value of DKK 10,549,657,815.

HUTCHMED Initiates a Japan Bridging Study to Support Surufatinib Registration for Advanced Neuroendocrine Tumors

On September 20, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported that it has initiated a Japan registration-enabling bridging study for surufatinib to support the registration of surufatinib in the treatment of patients with advanced neuroendocrine tumors ("NETs") (Press release, Hutchison China MediTech, SEP 20, 2021, View Source [SID1234587947]). The first patient was dosed on September 15, 2021.

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Based on dialogue with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), it was agreed that the surufatinib Japanese new drug application ("NDA") for the treatment of advanced NETs include results from a pivotal study to be conducted in Japan, to complement the registration data package supporting the NDA to the U.S. Food and Drug Administration ("FDA") (accepted for review in June 2021) and the Marketing Authorization Application ("MAA") to the European Medicines Agency ("EMA") (validated in July 2021). The basis for the NDA and the MAA includes data from a U.S. Phase I/II study, as well as the completed Phase III SANET-ep and SANET-p studies used to support marketing authorization in China in advanced NETs, where surufatinib is currently marketed under the brand name SULANDA.

This Japan study is a two-stage, open label study of surufatinib where approximately 34 patients are expected to be recruited. In Part 1 of the study, the safety and tolerability of surufatinib 300mg once daily after 28 days of treatment will be assessed in patients with relapsed/refractory non-hematological malignancies; pharmacokinetics ("PK") and anti-tumor activity of surufatinib are secondary endpoints. In Part 2 of the study, efficacy will be assessed in patients with locally advanced or metastatic NETs; the primary outcome measure is objective response rate (ORR). The secondary outcome measures include disease control rate (DCR), progression free survival ("PFS"), duration of response (DoR), safety, and PK.

Surufatinib is the third potential new medicine discovered by HUTCHMED to enter into clinical development in Japan. A global Phase III registration study for fruquintinib, known as the FRESCO-2 study, is ongoing in patients with refractory metastatic colorectal cancer and is expected to enroll over 680 patients from over 150 sites in 14 countries, including Japan. A global single-arm, open-label study, known as the SAVANNAH study, is ongoing for savolitinib (partnered with AstraZeneca PLC) in combination with TAGRISSO in non-small cell lung cancer patients whose disease progressed following TAGRISSO due to MET amplification or overexpression.

About NETs

NETs form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. NETs are typically classified as pancreatic NET ("pNET") or extra-pancreatic (non-pancreatic) NET ("epNET").

According to Frost & Sullivan, there were 19,000 newly diagnosed cases of NET in the U.S. in 2020. Rates across the European Union (E.U.) appear largely similar to the U.S. This is supported by an analysis of global epidemiologic trends, which also show growth in the incidence of NETs worldwide.1 Importantly, NETs are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 140,000 estimated patients living with NET in France, Germany, Italy, Spain, and the United Kingdom in 2020.2 In Japan, approximately 6,700 people were diagnosed with gastro-entero-pancreatic neuroendocrine neoplasms in 2016.3

About Surufatinib

Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors (VEGFR) and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies, where there may be synergistic anti-tumor effects.

HUTCHMED currently retains all rights to surufatinib worldwide.

About Surufatinib Development

epNETs in China: On December 29, 2020, surufatinib was granted drug registration approval by the National Medical Products Administration of China ("NMPA") for the treatment of epNET. Surufatinib is marketed in China under the brand name SULANDA. The approval was based on results from the SANET-ep study, a Phase III trial (clinicaltrials.gov identifier: NCT02588170) in patients with advanced epNETs conducted in China. The study met the pre-defined primary endpoint of PFS at a preplanned interim analysis, and was published in The Lancet Oncology4. Median PFS was significantly longer for patients treated with surufatinib at 9.2 months, compared to 3.8 months for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib had an acceptable safety profile, with the most common treatment related adverse events of grade 3 or worse being hypertension (36% of surufatinib patients vs. 13% of placebo patients), proteinuria (19% vs. 0%) and anemia (5% vs. 3%).

pNETs in China: On June 16, 2021, surufatinib was granted drug registration approval by the NMPA for the treatment of pNET. The approval was based on results from the SANET-p study, a Phase III trial (clinicaltrials.gov identifier: NCT02589821) in patients with advanced pNET in China. The pre-defined primary endpoint of PFS was met at a preplanned interim analysis and was published in The Lancet Oncology5, demonstrating that surufatinib reduces the risk of disease progression or death by 51% in patients, with a median PFS of 10.9 months compared to 3.7 months on placebo (HR 0.491; 95% CI: 0.391-0.755; p=0.0011). The safety profile of surufatinib was manageable and consistent with observations in prior studies.

Immunotherapy combinations: HUTCHMED entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-PD-1 monoclonal antibodies, including with tislelizumab (BGB-A317), TUOYI (toripalimab) and TYVYT (sintilimab), which are approved as monotherapies in China.

NETs in the U.S. and Europe: A FDA NDA submission was accepted in June 2021, followed by a MAA submission to the EMA validated in July 2021. The basis to support these filings includes the completed SANET-ep and SANET-p studies, along with existing data from surufatinib in U.S. epNET and pNET patients (clinicaltrials.gov identifier: NCT02549937). In the U.S., surufatinib was granted Fast Track Designations for development in pNET and epNET in April 2020, and Orphan Drug Designation for pNET in November 2019.

HUTCHMED has initiated an Expanded Access Protocol (EAP) in the U.S. to ensure patients with NET with limited therapeutic options have access to this treatment. Regulatory clearance of this protocol has been granted by the FDA and this program is open for site activation (clinicaltrials.gov identifier: NCT04814732).

Theradiag announces its results for the first half of 2021

On September 20, 2021 THERADIAG (ISIN: FR0004197747, Ticker: ALTER), a company specializing in in vitro diagnostics and Theranostics, reported its half-year results to June 30, 2021, as approved by the Board of Directors on September 16, 2021 (Press release, Theradiag, SEP 20, 2021, View Source [SID1234587946]).

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Bertrand de Castelnau, CEO of Theradiag, commented: "Over the last year we have been reaping the fruit of the efforts undertaken on controlling our operating costs and on our marketing strategy. Indeed, the effectiveness of our strategic refocus is demonstrated by the considerable improvement in all our financial indicators in the first half despite an economic and public health context that remains uncertain. On the basis of buoyant activity for our innovative solutions and a healthier cost structure, we are intending to accelerate Theradiag’s development by implementing a strategic plan that is in keeping with our growth ambitions on our target markets. Biotherapy monitoring is a vast global market, and the coming semesters look promising for Theradiag".

"The solid improvement in these results demonstrate the success of the Company’s structuring phase initiated some semesters ago. They also materialize the work of Theradiag’s teams, who I would like to congratulate. We now have to accelerate our growth on our markets of choice, and in particular on the Theranostics market", added Chairman of the Board Pierre Morgon.

Revenue up 12.5% despite an uncertain public health situation

Over the six months to June 30, 2021, Theradiag generated revenue of €5.5 million, compared with €4.9 million in the first half of 2020, despite an economic and public health context characterized by persistent difficulties accessing hospital treatment for patients undergoing immunotherapy in all countries.

Theranostics activity continued its growth, increasing by +14.7% in H1, notably driven by dynamic sales of the automated i-Track10. Marked by strong growth for a number of semesters now, for the first time Theranostics activity accounted for the majority of Theradiag’s revenue over the first 6 months of 2021.

Theranostics activity undertaken in the United States in partnership with HalioDX generated revenue of €0.5 million, in line with the Company’s development plan, and was thus up by 33.6%. In its export business, the Company has maintained a buoyant level of activity, with sales increasing by 27.4% to €1.3 million. Penalized by the maintaining of plans blancs emergency plans in hospitals, activity in France slowed slightly, slipping 5.2% compared with the first half of 2020.

IVD (In Vitro Diagnostics) activity generated growth of +10.4%, with revenue totaling €2.7 million over the six months to June 30, 2021.

Substantial improvement in financial indicators thanks to better control over operating costs and a refocusing of Theradiag’s strategy on its fundamentals

Following strong growth in the second half of 2020, the operating loss continued to shrink significantly, by 57.9%, in the first half of 2021. This improvement illustrates Theradiag’s ability to develop commercially while continuing to ensure strict operating cost management. At the same time, as in previous semesters, Theradiag intensified its investments in R&D and in its commercial development in the United States in order to strengthen its leadership position in biotherapy monitoring in France and abroad. Furthermore, the Company has expanded its Quality team to be in a position to comply with the requirements of the new European Union directive with regard to in vitro diagnostic medical devices (IVDR).

In a similar vein, the net result before recurring items improved by a buoyant 84.3% compared with the same period of 2020. It is now close to breakeven, representing -0.4% of revenue.

The overall net loss, including non-recurring items, improved by 59.8% to -€92 thousand at June 30, 2021 versus -€229 thousand at June 30, 2020.

Cash position and financial structure

At June 30, 2021, Theradiag had €1.4 million in net available cash, compared with €3.5 million at December 31, 2020. This difference is the result of cash lags, now resolved, totaling €0.5 million, while investments in R&D and international development are in line with Theradiag’s strategic plan.

To finance its growth strategy on the biotherapy monitoring market while maintaining a solid financial structure, Theradiag is not ruling out the possibility of raising additional funds depending on market conditions and the progress of its strategic plan.

Reminder of the main H1 2021 highlights

· January 2021: CE marking for the four new i-Tracker test kits: i-Tracker Vedolizumab, i-Tracker Anti-Vedolizumab, i-Tracker Ustekinumab and i-Tracker Anti-Ustekinumab, on originator and biosimilar molecules

· January 2021: Signing of a contract to supply quality control reagents to Orgentec, a specialist in in vitro diagnostics notably in the field of autoimmunity, infectious diseases and molecular biology

May 2021: Participation in Humabdiag, a large-scale research project undertaken with the University of Tours targeting the bioproduction of monoclonal antibodies dedicated in particular to Theradiag and the entire biotherapy market.

AUA Presentation: Initial Results from a Phase 1/2 Trial of Large Surface Area Microparticle Docetaxel for High-Risk Non-Muscle Invasive Bladder Cancer

On September 12, 2021 NanOlogy Presented the Corporate Presentation (Press release, NanOlogy, SEP 12, 2021, View Source;utm_medium=rss&utm_campaign=aua21_results_trial_nmibc [SID1234590052]).

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