Shares of Novavax Inc. (NASDAQ:NVAX) dropped nearly 20% Oct. 16 to close at $10.15 after the company reported a serious adverse event had prompted a U.S. FDA clinical hold for its COVID-19-influenza combination and standalone flu vaccine candidates.
Continuing its streak of promising early clinical data, Jasper Therapeutics Inc.’s briquilimab impressed in a preliminary readout from a phase Ib/IIa study in chronic inducible urticaria (CIndU), showing a clinical response of 93%. CIndU, an inflammatory skin condition causing hives that is often induced by physical or environmental stimuli, is commonly treated with antihistamines, though some patients are refractory. Beyond antihistamines, there is no treatment available globally, explained Edwin Tucker, Jasper’s chief medical officer, so briquilimab has the potential to be “a new treatment paradigm for patients,” both in reducing disease burden and in improving quality of life.
Astrazeneca plc is adding a preclinical-stage candidate to its cardiovascular pipeline via a potentially $2 billion licensing agreement with CSPC Pharmaceutical Group Ltd., which includes a $100 million up-front payment for rights to YS-2302018, an oral Lp(a) disruptor. It’s an impressive figure for such an early program, but the Cambridge, U.K.-based pharma hailed the small molecule’s potential against a range of indications, both alone and in combination regimens that could include PCSK9 inhibitor AZD-0780.
Astrazeneca plc is adding a preclinical-stage candidate to its cardiovascular pipeline via a potentially $2 billion licensing agreement with CSPC Pharmaceutical Group Ltd., which includes a $100 million up-front payment for rights to YS-2302018, an oral Lp(a) disruptor. It’s an impressive figure for such an early program, but the Cambridge, U.K.-based pharma hailed the small molecule’s potential against a range of indications, both alone and in combination regimens that could include PCSK9 inhibitor AZD-0780.
Recordati SpA is shelling out $825 million up front for global rights to Enjaymo (sutimlimab), the only therapy approved for treating the rare disease cold agglutinin disease. In the deal with Sanofi SA, which won U.S. FDA approval of the antibody drug in 2022, the Italian pharma agreed to pay up to $250 million more should net sales reach certain thresholds.
As Eli Lilly and Co. launches its recently approved Ebglyss (lebrikizumab) in an atopic dermatitis market already dominated by established biologic Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), investors tuned into an Amgen Inc. investor call disclosing positive top-line phase III results for rocatinlimab, a monoclonal antibody that could potentially offer patients a new mechanism of action. While data from the Rocket Horizon study showed rocatinlimab hit all co-primary and secondary endpoints, the early findings fell below expectations in a highly competitive market.
Following the recent recommendation of its advisory committee, the U.S. FDA gave the nod to Zevra Therapeutics Inc.’s arimoclomol, a day ahead of its Sept. 21 PDUFA date, as the first treatment for Niemann-Pick disease type C (NPC), a rare genetic disease linked to progressive neurological symptoms that is almost always fatal. Branded Miplyffa, it is indicated for use in combination with enzyme inhibitor miglustat in adults and children, ages 2 and older.
Investors reading into the U.S. FDA’s decision to skip an advisory committee meeting to discuss the NDA for Applied Therapeutics Inc.’s govorestat, seeking approval as the first therapy for treating classic galactosemia, clearly saw reasons for optimism, as shares of Applied (NASDAQ:APLT) jumped 69% to close Sept. 18 at $7.85.
Eli Lilly and Co.’s Ebglyss (lebrikizumab) becomes the latest U.S. entrant in the increasingly competitive atopic dermatitis space, following FDA approval of the IL-13-targeting antibody, which will now go up against other biologics such as established blockbuster Dupixent (dupilumab, Regeneron Pharmaceuticals Inc.), as well as more recently approved Adbry (tralokinumab, Leo Pharma Inc.).
More than three months ago, investors first learned that ivonescimab, a PD-1/VEGF-targeting bispecific antibody from Summit Therapeutics and Akeso Pharmaceuticals Inc., bested Keytruda (pembrolizumab) in PD-L1-positive non-small-cell lung cancer (NSCLC). At the 2024 World Conference on Lung Cancer over the weekend, Summit rolled out detailed data from the phase III Harmoni-2 trial, which included a nearly doubling of progression-free survival for ivonescimab compared to Merck & Co. Inc.’s established blockbuster drug.
