Csl Ltd - CSLLY STOCK NEWS

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.

Seqirus, part of CSL Limited (ASX:CSL), announced new real-world evidence supporting the effectiveness of FLUAD® (adjuvanted trivalent vaccine) against hospitalization and respiratory issues in adults aged 65+ across 18 seasons in Italy. The findings indicated a 12% lower risk of hospitalization and a 37% lower risk of respiratory-related hospitalizations with FLUAD® compared to standard vaccines. Additionally, studies in Spain and France highlighted cost-effectiveness, suggesting FLUAD® QUADRIVALENT could yield health benefits and cost savings. The data was presented at the ESWI 2021 conference.

The FDA has granted approval for a multi-dose vial presentation of AUDENZ™, the first adjuvanted, cell-based influenza vaccine aimed at protecting against influenza A(H5N1) for individuals six months and older. Originally approved in February 2020, this new format will enhance pandemic preparedness, allowing Seqirus to deliver 150 million doses to the U.S. government within six months. AUDENZ utilizes proprietary MF59® adjuvant technology, which improves immune response and reduces the antigen needed per dose, thus expediting vaccine availability.

CSL Plasma has opened its 300th U.S. plasma donation center in Greenacres, Florida. As a significant player in the plasma collection industry, CSL Plasma emphasizes the critical need for plasma to produce therapies for serious diseases. Each center employs about 60 staff members and contributes approximately $4 million annually to local economies. The company aims to enhance community engagement through its Adopt-a-Patient Program, which raises awareness about plasma-derived therapies. CSL Plasma is part of CSL Behring, which serves patients in over 100 countries.