Shares of Tharimmune Inc. shot up more than 100% in early trading Oct. 30 as the firm disclosed regulatory backing to launch a phase II trial this quarter testing TH-104, a transdermal buccal film version of nalmefene, to treat pruritus that is associated with primary biliary cholangitis.
Only three years after it was co-founded by Johnson & Johnson, Aliada Therapeutics Inc. is being acquired by Abbvie Inc. in a deal valued at $1.4 billion that gives the big pharma firm another shot at the Alzheimer’s disease space. The all-cash deal, expected to close in the fourth quarter of 2024, will give Abbvie access to Aliada’s blood-brain barrier-crossing Modular Delivery, or MODEL, as well as rights to ALIA-1758, an anti-pyroglutamate amyloid beta antibody designed using MODEL, which is in phase I testing for Alzheimer’s disease.
Despite positive findings from an earlier trial, Alto Neuroscience Inc.’s BDNF-targeting candidate, ALTO-100, failed to best placebo in a phase IIb study in major depressive disorder, sending shares of the company to their lowest price since going public in a February 2024 IPO, as investors worried about readthrough to Alto’s biomarker-based approach for treating psychiatric disorders.
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.
