NOVARTIS

Innovent Biologics' earnings report shows revenue up 46% to 3.95 billion yuan, but net loss surges 182% to 393 million yuan. The delay in sales approval for anti-obesity drug mazdutide and the sudden retirement of R&D chief Liu Yongjun dampen investor enthusiasm. Innovent's focus shifts to cardiovascular and metabolic drugs, with mazdutide and teprotumumab in the pipeline.

OrsoBio raises $67M to advance weight loss drugs; Vor Bio's CRISPR-edited stem cells show success in AML therapy; Boehringer Ingelheim to test eye drug for geographic atrophy; Novartis licenses capsid from Voyager for gene therapy; Vaxcyte raises $1.3B on positive pneumococcal vaccine data.

Autolus Therapeutics' obe-cel, an autologous CAR-T cell therapy for relapsed/refractory adult B-cell Acute Lymphoblastic Leukemia, awaits FDA approval on November 16, 2024. The therapy targets CD-19 and has shown a 78% ORR in the FELIX study, with potential peak revenues of ~$300m. Despite a 25% share price drop, Autolus holds $700m in cash and has partnerships with BioNTech, Moderna, and Bristol Myers Squibb, positioning it for future growth.

Numerous hot targets like WRN helicase and KRAS G12V had patent applications in January 2024. A searchable table of over 200 patents from January 2024 includes key info for drug hunters, highlighting degraders and molecules targeting Nrf2, KRAS G12V, MAGL, WRN, etc.

FDA grants full approval to Travere Therapeutics' Filspari (sparsentan) for primary IgA nephropathy, expanding its use to slow kidney function decline without specific urinary protein level requirement. Filspari is the only oral, once-daily, non-immunosuppressive treatment for IgAN, targeting glomerular injury. The approval aligns with KDIGO's new guidelines, positioning Filspari as foundational care for IgAN.

Travere Therapeutics' drug Filspari, for IgAN, received full FDA approval based on long-term data showing significant kidney function decline slowing. This expands the eligible patient population beyond initial proteinuria thresholds, potentially increasing market opportunity. Filspari competes with Novartis' Fabhalta and Calliditas' Tarpeyo, both also approved for IgAN. Filspari carries a black box warning for liver toxicity and is under a REMS program. Travere reported $46.9 million in Filspari revenue for H1 2024, with growth expected as approvals expand globally.

Judge Andrews denied Novartis's request for a preliminary injunction against MSN Pharmaceuticals, finding Novartis unlikely to succeed on the merits of its patent infringement claim and that irreparable harm could be remedied through monetary damages.

The FDA granted full approval to Travere Therapeutics' Filspari for primary IgA nephropathy, removing the UPCR requirement. The approval includes boxed warnings for hepatotoxicity and birth defects, necessitating a REMS program and regular kidney function monitoring. Despite earlier data requests for FSGS treatment, the approval is based on the PROTECT trial's modified analysis showing Filspari's efficacy in slowing kidney function decline.

Vanda Pharmaceuticals' stock rose 1.8% since April, lagging the S&P 500's 7% gain. Fanapt, approved for bipolar 1 disorder, faces market challenges due to lack of differentiation from generic antipsychotics. Upcoming catalysts include FDA decisions on tradipitant for gastroparesis and motion sickness, and a Phase I study for a CFTR inhibitor to treat cholera. Vanda's cash position is strong, but its product pipeline is weak, with potential revenue declines from Hetlioz and Fanapt due to generic competition. The company rejected takeover bids, emphasizing the need for strategic cash management.