On September 2, 2021 Alkermes plc (Nasdaq: ALKS) reported that management will participate in a fireside chat at the Citi 16th Annual BioPharma Virtual Conference on Thursday, Sept. 9, 2021 at 8:50 a.m. ET (1:50 p.m. BST) (Press release, Alkermes, SEP 2, 2021, View Source [SID1234587168]). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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On September 2, 2021 Redx Pharma plc (AIM: REDX), the drug discovery and development company focused on cancer and fibrosis, reported that a milestone payment of $3 million from Jazz Pharmaceuticals plc (NASDAQ: JAZZ) has been triggered as a result of the initiation of IND-enabling studies of JZP815, a preclinical Pan-RAF inhibitor, for the potential treatment of RAF driven tumours (Press release, Redx Pharma, SEP 2, 2021, View Source [SID1234587167]). Mutations leading to uncontrolled signalling in the RAS-RAF-MAPK pathway are seen in around one third of all cancers.

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The milestone payment is due under the agreement with Jazz Pharmaceuticals announced on 10 July 2019 for Redx’s Pan-RAF inhibitor. Under the deal, Redx is entitled to up to $203 million in development, regulatory and commercial milestone payments. The Company is also eligible for royalties based on any future net sales. The next milestone payment under the agreement is due on acceptance of an Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA). As part of a separate ongoing collaboration agreement, Jazz paid Redx to perform research and preclinical development activities to progress the programme to this stage, with the goal of completing IND-enabling studies.

The Pan-RAF inhibitor programme aims to overcome resistance mechanisms associated with clinically approved B-RAF selective drugs. The RAF kinases A-RAF, B-RAF and C-RAF are an integral part of the RAS-RAF-MAPK pathway, with B-RAF mutations commonly seen in the clinic. Although most B-RAF V600E/K mutant skin cancers are initially sensitive to approved B-RAF selective drugs, treatment resistance often develops leading to disease progression. Moreover, B-RAF V600E mutant colorectal cancers are surprisingly insensitive to these B-RAF selective drugs as single agents due to the functions of other RAF family members. Importantly, B-RAF selective therapies fail to show clinical benefit against the more prevalent RAS-mutated tumours. This Pan-RAF inhibitor aims to overcome these resistance mechanisms.

Lisa Anson, Chief Executive Officer of Redx Pharma commented: "We are extremely pleased that Jazz Pharmaceuticals has initiated IND-enabling studies for the Pan-RAF inhibitor programme that Jazz acquired. The continuing success of this programme highlights, once again, Redx’s ability to generate molecules that have significant potential as novel medicines for unmet medical needs."

On September 2, 2021 Invivoscribe, Inc., a technology-driven international company focused on precision diagnostics with best-in-class products and services that optimize patient care and accelerate drug approvals worldwide, reported licensing of key software and two new MRD clinical services (Press release, Invivoscribe Technologies, SEP 2, 2021, View Source [SID1234587166]).

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"Clinical labs need to be able to analyze large amounts of clonality and MRD data quickly and easily. Current bioinformatics software generally requires that technicians click through software to analyze data one patient at a time; this is both tedious and prone to human errors. With such a large volume of patients samples we need to get from data to report as easily and accurately as possible," says Dr. Sean Glenn of Roswell Park Comprehensive Cancer Center, New York.

Invivoscribe’s new pipeline LymphoTrack Enterprise Software enables high volume customers to meet ever increasing testing demands. Laboratories require a high throughput platform that is both compliant with HIPAA requirements and provides seamless visualization to help interpret the raw data. They also want to be able to mine data from antigen receptor CDR3 regions. We’ve addressed both of these needs with the new pipeline software. The pipeline software for LymphoTrack on MiSeq is available now with raw data access, CDR3 mining and reporting capabilities.

Tony Lialin, Chief Commercial Officer at Invivoscribe shared, "Software has been a hugely undervalued asset at Invivoscribe. We have developed tools for internal use that our customers would love to have access to in order to streamline their workflow and reduce bottlenecks in testing. This is a bioinformatics package we can commercialize to help support our partners, so we are doing just that."

The new B-cell MRD Clonality and MyMRD-Myeloid Assays will be offered as LabPMM services using Illumina’s NextSeq 550Dx and/or NovaSeq. The release of these clinical services will rapidly follow the release of the LymphoTrack Enterprise Software. The new MRD services will be available for research studies in late 2021 and are slated for CAP/CLIA accreditation in early 2022.

With internationally standardized kits and services, custom assay development solutions, clinical trial management, regulatory expertise, and most recently, expanding availability and support for our bioinformatics analysis software, Invivoscribe continues to innovate to provide comprehensive support to our global partners.

On September 2, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it will present at the following virtual conferences in September (Press release, RedHill Biopharma, SEP 2, 2021, View Source [SID1234587165]):

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H.C. Wainwright 23rd Annual Global Investment Conference (September 13-15, 2021)
Presentation: Available from Monday, September 13, 2021, 7:00 a.m. EDT
Speaker: Guy Goldberg, Chief Business Officer

Cantor Global Healthcare Conference (September 27-30, 2021)
Fireside chat: will be broadcast live on Thursday, September 30, 2021, 8:40 a.m. EDT and available for replay
Moderator: Brandon Folkes, CFA, Director, Equity Research – Healthcare, Biopharma
Speaker: Guy Goldberg, Chief Business Officer

The webcasts will be available for 30 days on the Company’s website under the Investors page: www.redhillbio.com.

On September 2, 2021 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX: 13) reported that on September 1, 2021, it granted share options under the Share Option Scheme adopted by HUTCHMED in 2015 as refreshed in April 2020 (the "Share Option Scheme") and conditional awards ("LTIP Awards") under the Long Term Incentive Plan adopted by HUTCHMED in 2015 ("LTIP") (Press release, Hutchison China MediTech, SEP 2, 2021, View Source [SID1234587164]).

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Aimed at attracting and retaining top talent, the Remuneration Committee of HUTCHMED appointed an independent advisor to conduct a compensation benchmarking research on peer group U.S. and China biotech companies. The Remuneration Committee comprehensively reviewed the compensation and share-based incentives policies of HUTCHMED and its subsidiaries (the "Group") and established an attractive policy to ensure the Group is able to recruit and retain top talent. Vesting of share-based awards under the policy is in line with that peer group.

HUTCHMED granted share options under its Share Option Scheme to 18 employees to subscribe for a total of 1,086,000 Ordinary Shares represented by 217,200 American Depositary Shares ("ADSs", each equating to five Ordinary Shares) subject to the acceptance of the grantee. Details of such share options granted prescribed are as follows:

Exercise price of share options granted :
US$39.74 per ADS (equivalent to HK$62.00 per Ordinary Share at the conversion rate HK$7.8=US$1) (such exercise price has been determined by reference to the price of the Ordinary Shares on The Stock Exchange of Hong Kong Limited ("HKEX"))

Number of share options granted :
1,086,000 represented by 217,200 ADSs (five share options shall entitle the holder thereof to subscribe for one ADS)

Closing market price of ordinary shares at HKEX on the date of grant

US$39.74 per ADS (equivalent to HK$62.00 per Ordinary Share at the conversion rate HK$7.8=US$1)

Validity period of the share options : From September 1, 2021 to August 31, 2031

At the same time, HUTCHMED also granted three employees of the Group with non-performance LTIP Awards, and 119 employees of the Group with performance-related LTIP Awards.

None of the grantees is a director, chief executive nor substantial shareholder of the Company, or an associate (as defined under the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited) of any of them.