Abbvie shares plummeted more than 12% after its schizophrenia experimental treatment Emraclidine failed to meet clinical trial goals, a decrease of more than $40 billion in the company’s market value. Abbvie originally paid Cerevel $8.7 billion for Emraclidine last year, hoping to compete with Bristol Meyers Squibb‘s schizophrenia drug Cobenfy which was approved by the U.S. FDA in September 2024. Following Abbvie’s announcement, BMS shares soared more than 12%. Read more here.
Pfizer has plans to invest $1 billion in the Chinese market over the next five years, including constructing a new R&D facility of Beijing. The Company’s China president referred to this initiative as “China 2030” with the aim to accelerate biotech innovation in the country. Read more here.
AstraZeneca released a statement that although it does not know the reason why its China president Leon Wang is in custody with Chinese authorities, it did not believe it was linked to health insurance fraud according to a report by Reuters. The Company stated the ongoing probe over an investigation of suspected medical insurance fraud by employees began three years ago. AZN lost > $60 billion in maret cap since its 52-week high in late August. Read more hereand here.
Aditum Bio and Leads Biolabs announced the formation of Oblenio Bio, in addition to an exclusive option and license agreement for Oblenio Bio to develop LBL-051, a first-in-class CD19xBCMAxCD3 tri-specific T-cell engager antibody for autoimmune diseases. Aditum Bio will fund Oblenio Bio as both parties collaborate to bring LBL-051 to clinical studies. Read more here.
Dizal submitted an NDA to the U.S. FDA for sunvozertinib for the treatment of patients with relapsed or refractory NSCLC with EGFR exon20ins whose disease has progressed on or after platinum-based chemotherapy. Read more here.
HuidaGene received FDA clearance for the IND application of HG202, the world’s first CRISPR/Cas13 RNA-editing therapy for clinical use in treating neovascular age-related macular degeneration. It is the first CRISPR/Cas13 RNA-editing therapy to ever enter clinical trials and the only clinical-stage RNA-targeting therapy for nAMD. Read more here.
Syndax Pharma and Royalty Pharma entered a $350 million synthetic royalty funding agreement based on U.S. net sales of Niktimvo™ (axatilimab-csfr) for the treatment of chronic graft-versus-host disease, expected to fund the Company through profitability and support upcoming planned launches. Read more here.
Neurogene (Nasdaq: NGNE) announced an oversubscribed $200 million private placement, expected to fund the Company into the second half of 2027. Read more here.
Non-Deal Road Show Highlights
Biomea Fusion(NASDAQ: BMEA) will present at Diabetes Conference in Singapore and meet investors in Singapore, Kuala Lumpur, and Hong Kong from Nov 18th to 22nd.
Duoning Biotech announced a strategic partnership with Branca Bunús to develop next-generation transfection reagents. Read more here.
Formosa Pharma announced successful top-line results from the Phase 3 trial of APP13007 to treat inflammation and pain in Chinese patients after cataract surgery. APP13007 is a novel ophthalmic nanosuspension formulation of clobetasol propionate that was recently approved and launched in the U.S. Read more here.
Harbour BioMed submitted an IND application for HBM9378/SKB378, a fully human antibody targeting TSLP, in the treatment of chronic obstructive pulmonary disease. Read more here.
Y-mAbs Therapeutics and Nobelpharma announced an exclusive license and distribution agreement under which Nobelpharma will be responsible for the development and commercialization for DANYELZA in Japan. Y-mAbs will receive a $2 million upfront payment and up to $31 million in potential milestones. Read more here.
Nxera Pharma and Antiverse entered a collaboration to design novel GPCR-targeted antibody therapeutics using generative AI. Antiverse will receive an undisclosed upfront payment and research funding and is eligible for milestone payments. Nxera will retain an exclusive worldwide license to the antibody assets. Read more here.
Daiichi Sankyo and AstraZeneca won the Galien Foundation 2024 Prix Galien USA Award for Best Biotechnology Product for ENHERTU, a HER2 directed DXd ADC. Read more here.
Hanmi provided updated research results for its obesity treatment HM17321, showing that it significantly increases lean muscle mass. Current GLP-1-based therapies often lead to muscle loss as a side effect of significant weight reduction. Read more here.
Esaote Group is expanding production in India with a new manufacturing site in New Delhi which will produce a full range of ultrasound systems for the Indian market. Read more here.
Ring Therapeutics announced new strategic partnerships with the Agency for Science, Technology, and Research, Singapore’s lead public sector R&D agency; and the Singapore Eye Research Institute to advance ophthalmology and oncology gene therapy candidates. Read more here.
Bionomics received a milestone payment of AUS$1 million from Carina Biotech for BNC101, a monoclonal antibody targeting the cancer stem cell antigen LGR5. Read more here.
National Comprehensive Cancer Network joined with Vietnam National Cancer Hospital in a collaboration to improve cancer care standards with treatment recommendation guidelines throughout the country. Read more here.
Disc Medicine obtained a $200 million non-dilutive term loan facility from Hercules Capital. Funding will supported upcoming catalysts in the company’s pipeline. Read more here.
Acadia Pharma entered into a a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher for $150 million upon the closing of the transaction. Read more here.
Nektar entered a definitive agreement with Amerpsand Capital Partners to sell its Alabama manufacturing facility and reagent supply business for $90 million in total, comprised of $70 million in cash and $20 million equity ownership in a new portfolio company. Read more here.
Inquis Medical completed a $40 million Series B financing, led by Marshall Wace. Proceeds will be used to advance its Aventus Precision Thrombectomy System for thromboembolic diseases. Read more here.
Ocugen entered a new $30 million credit facility that has a term of four years with Avenue Venture Opportunities Fund. Proceeds will be used for general corporate purposes. Read more here.
Avid Bioservices is being acquired by GHO and Ampersand in a $1.1 billion deal, as reported by Reuters. The transaction is expected to close in Q1 of 2025. Read more here.
Kewaunee completed its acquisition of Nu Aire for $55 million. Read more here.
PURE Bioscience and Quip Labs entered a multi-year distribution agreement for the purchase and selling of SDC antimicrobial products. Read more here.
Surrozen and TCGFB entered a strategic research collaboration to develop antibody therapeutics targeting TGF-β for the potential treatment of patients with idiopathic pulmonary fibrosis. Read more here.
The U.S FDA is proposing to remove oral phenylephrine as an active ingredient that can be used in over-the-counter monograph drug products for the temporary relief of nasal congestion after an agency review determined that oral phenylephrine is not effective for this use. Read more here.
LumiThera obtained FDA authorization of Valeda Light Delivery System for treatment of patients with dry age-related macular degeneration. Read more here.
Amgen and AstraZeneca announced positive top-line results from the Phase 3 WAYPOINT trial in patients with chronic rhinosinusitis with nasal polyps, showing a statistically significant and clinically meaningful reduction in nasal polyps size and congestion compared to placebo in patients treated with TEZSPIRE. Read more here.
Altimmune completed its end-of-Phase 2 meeting with the FDA for pemvidutide in the treatment of obesity and agreed on the design of a Phase 3 registrational program. Read more here.
CytoDyn received FDA clearance for the Phase 2 oncology trial studying leronlimab, a CCR5 antagonist for patients with relapsed/refractory microsatellite stable colorectal cancer. Read more here.
Xencor dosed the first subject in its Phase 1/2 study of XmAb®942, an investigational high-potency extended half-life anti-TL1A antibody. Read more here.
Sutro Biopharma initiated its registration-enabling clinical trial of luvelta in pediatric patients with CBF/GLIS acute myeloid leukemia and it is now open for enrollment. Read more here.
HiFiBio Therapeutics received FDA clearance of the IND application for HFB200604, a best-in-class BTLA agonist monoclonal antibody to treat inflammatory and immunology diseases by stimulating BTLA signaling in immune cells. Read more here.
Click here to view more upcoming conferences.
Nov 15-19, 2024: AASLD The Liver Meeting (San Diego)
Nov 18-19, 2024: Stifel Healthcare Conference (New York)
Nov 19, 2024: Future of Health Asia Conference (Singapore)
Nov 19-21, 2024: Stephens Annual Investment Conference (Nashville)
Nov 19-21, 2024: Wolfe Healthcare Conference (New York)
Nov 26-28, 2024: CPHI & PMEC India (India)
Nov 20-Dec 2, 2024: BioMed Innovation and Investment Conference (Guangdong)
Dec 3-5, 2024: Citi Global Healthcare Conference (Miami)
Dec 3-5, 2024: Piper Sandler Healthcare Conference (New York)
Dec 10-13, 2024: San Antonio Breast Cancer Symposium (San Antonio)
Dec 11, 2024: Mizuho Global Investor Conference (New York)
Mar 13-15, 2025 BioChina International Convention (Suzhou, China) Please email
info@gobyglobal.com for discount code.
Contact Information:
info@gobyglobal.com
发表评论