CSL LTD SP/ADR - CSLLY STOCK NEWS

Seqirus has renewed a five-year agreement with the Biomedical Advanced Research and Development Authority (BARDA) to enhance U.S. pandemic preparedness. This partnership, active since 2006, enables BARDA to request influenza vaccines like AUDENZ™ and adjuvants for emergency stockpiling. The agreement focuses on ensuring rapid vaccine production during public health crises. Seqirus's facility in Holly Springs, North Carolina, is equipped to produce up to 150 million doses in an emergency. Additionally, the company continues to innovate in vaccine technology, reinforcing its commitment to public health.

CSL Plasma announced a $125,000 donation to the American Red Cross to support disaster relief across the United States. This funding aims to assist recovery efforts following various disasters, including hurricanes and wildfires. CSL Plasma General Manager Michelle Meyer highlighted the company's commitment to aiding local communities, where their donors and employees reside. The donation will enhance the Red Cross's capacity to respond to disasters effectively, providing essential services like shelter and recovery support.

Seqirus, a unit of CSL Limited (ASX:CSL), announced a $40 million investment in a new 140,000 square foot R&D facility in Waltham, Mass, to enhance its self-amplifying mRNA technology for influenza vaccines. Expected to be operational by mid-2022, the facility will house 300 employees and transition ongoing projects from Cambridge. This investment aligns with Seqirus' goal to improve vaccine effectiveness and reduce dosage requirements. Clinical trials for sa-mRNA vaccines are set to begin this year, furthering CSL's commitment to pandemic preparedness.

CSL Behring released positive long-term results from the Phase 3 HOPE-B trial of etranacogene dezaparvovec (EtranaDez), a gene therapy for hemophilia B. The study showed a stable increase in mean Factor IX (FIX) activity, reaching 36.9 IU/dL at 18 months post-infusion. Participants experienced a 64% reduction in annual bleeding rates and 98% discontinued prophylactic treatment. The therapy was generally well-tolerated, though one unrelated death occurred. This data reinforces the potential of EtranaDez to transform hemophilia B management and may accelerate regulatory reviews in the U.S. and Europe.

CSL Behring AG, a subsidiary of CSL Limited (ASX: CSL; USOTC: CSLLY), has announced its public tender offer for all registered shares of Vifor Pharma Ltd. at an offer price of USD 179.25 per share. The transaction has received unanimous approval from both companies' Boards of Directors. The main offer period is set to begin on February 2, 2022 and end on March 2, 2022. Interested shareholders are advised to review the offer prospectus available on www.CSLtransaction.com.

CSL Behring AG, a subsidiary of CSL Limited (ASX: CSL; USOTC: CSLLY), announced its public tender offer for Vifor Pharma Ltd. at a cash price of USD 179.25 per share. The offer, which aims to enhance CSL’s portfolio in iron deficiency and nephrology, has been approved by both companies’ Boards of Directors. The main offer period is set to start on February 2, 2022, and end on March 2, 2022. Investors are encouraged to review the tender offer documents for complete terms and conditions, available at www.CSLtransaction.com.

CSL Behring announced that the European Medicines Agency's CHMP has accepted its request for an accelerated assessment of the etranacogene dezaparvovec Marketing Authorization Application (MAA) for hemophilia B. This gene therapy, currently in Phase 3 trials, could provide a significant long-term treatment option for patients. The accelerated review may cut the evaluation timeline from 210 to 150 days. The company aims to submit the MAA in the first half of 2022, highlighting their commitment to innovative treatments and addressing the unmet needs of hemophilia B patients.

On December 15, 2021, CSL Behring announced that the European Medicines Agency (EMA) approved an accelerated assessment for its investigational gene therapy, etranacogene dezaparvovec, intended for treating hemophilia B. This therapy, currently in the Phase 3 HOPE-B clinical trial, aims to provide a long-term solution for patients suffering from a life-threatening bleeding disorder. The EU application is expected to be submitted in H1 2022, following positive results from the HOPE-B trial, including achieving primary and secondary endpoints related to bleeding rate reduction.

CSL Limited (ASX: CSL; USOTC: CSLLY) has announced an all-cash offer of US$179.25 per share to acquire Vifor Pharma Ltd (SIX: VIFN) for an aggregate equity value of US$11.7 billion (CHF 10.9 billion). The offer includes a premium of 61% over the closing price of Vifor Pharma on 1 December 2021. Vifor Pharma’s largest shareholder, Patinex AG, holding 23.2% of shares, has agreed to tender its shares. The transaction is anticipated to complete by mid-2022, subject to regulatory approvals and an 80% minimum acceptance rate.