NOVARTIS

Sarepta Therapeutics, known for its focus on Duchenne muscular dystrophy, made a $500 million upfront deal with Arrowhead Pharmaceuticals, investing $325 million and up to $10 billion in milestones. The deal aims to diversify Sarepta's pipeline with RNA drugs and expand its portfolio into new disease areas. Despite Elevidys failing a confirmatory trial, Sarepta secured full FDA approval and a label expansion, generating $181 million in Q3. The deal reflects Sarepta's ability to secure regulatory success and diversify its portfolio, potentially offering new options for patients with rare diseases.

Nearly 20 drug approvals, including Novartis’ Alhemo and Lexicon’s Zynquista, are expected by the US FDA in December.

DelveInsight's report highlights a robust lupus nephritis pipeline with 30+ companies developing 35+ therapies, including key players like AstraZeneca and Novartis. Promising therapies like Anifrolumab and Ianalumab are in various clinical phases, with recent updates from companies like Adicet Bio and Kyverna Therapeutics. The report provides comprehensive insights into the pipeline, therapeutic assessments, and market dynamics.

Takeda, Novartis, and Gilead announced separate licensing agreements for medications targeting hematologic cancers, tumors, and Huntington disease. Takeda will develop elritercept for anemia in MDS and myelofibrosis, Novartis secured rights to PTC518 for Huntington disease, and Gilead partnered with Tubulis to develop an ADC for solid tumors.

Janux Therapeutics' shares surged 75% after Phase 1a study results for JANX007, a T cell engager for metastatic, castration-resistant prostate cancer, showed promising efficacy and safety, with 16 patients achieving at least a 50% reduction in prostate-specific antigens.

Johnson & Johnson filed two sBLAs for Tremfya, seeking expanded use in pediatric patients with moderate-to-severe plaque psoriasis and active juvenile psoriatic arthritis. Tremfya, an IL-23 inhibitor, is already approved for adult patients with psoriasis and psoriatic arthritis. The filings are based on phase III studies and PK data. Tremfya sales grew 21.6% year-over-year to $2.7 billion in the first nine months of 2024. J&J expects Tremfya to reach $5 billion with approvals for inflammatory bowel disease conditions.

T.C. has consulted/advised/spoken for ASCO Post, AstraZeneca, Bio Ascend, Bristol Myers Squibb, Clinical Care Options, Daiichi Sankyo, Genentech, IDEOlogy Health, Medical Educator Consortium, Medscape, Merck, OncLive, oNKo-innate, PEAK Medicals, PeerView, Pfizer, Physicians’ Education Resource, RAPT Therapeutics, Regeneron, Targeted Oncology. W.N.W.Jr. has consulted/advised/spoken for Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, Daiichi-Sankyo, Eli Lilly, Genentech/Roche, Ipsen, Janssen, Merck, MSD, Novartis, Pfizer, Sanofi-Aventis, Takeda, United Medical.

Chinese pharmaceutical and bio industry's technology exports surged to 80 cases in 2022, nearly doubling from 41 in 2021. Major deals include Merck's $9.475 billion investment in Kelun's ADC technology and J&J's CAR-T therapy 'Carvykti' developed with Legend Biotech. FDA approvals for Chinese drugs like Junshi Biosciences' 'Toripalimab' and Bio-Thera Solutions' 'Avitinib' highlight China's growing influence in global bio market.

Olema Oncology collaborates with Novartis for Phase III trial of palazestrant and Kisqali in ER+/HER2-negative metastatic breast cancer, funded by $250m private placement. Palazestrant, a CERAN and SERD, aims to improve outcomes in resistant cancers, with potential revenue of $855m by 2030.

Novartis pays $1 billion upfront to license PTC518, a Huntington's disease drug, with potential for $1.9 billion in milestone payments and royalties. PTC retains 40% of U.S. profits and leads Phase 2 completion and FDA discussions. The deal is expected to close in Q1 2025.