Caelum Biosciences Inc. enhanced its cachet with an analysis of data from the phase Ib trial of its chimeric fibril-reactive monoclonal antibody (MAb), CAEL-101 (11-1F4), that showed a correlation between sustained decrease in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels and improvement in global longitudinal strain (GLS) in individuals with cardiac amyloid light chain (AL) amyloidosis.
Sun Pharmaceutical Industries Ltd., the Mumbai, India-based pharma giant known more for its footprint in generics than in novel drug development, gained FDA approval of Ilumya (tildrakizumab-asmn) to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Shares of Verona Pharma plc closed up 31.7 percent on London's AIM (LSE:VRP) and spiked on Nasdaq (NASDAQ:VRNA) after top-line data showed that RPL-554 met its primary endpoint, producing clinically and statistically significant improvement in peak forced expiratory volume in one second (FEV1) at four weeks, compared to placebo, as a maintenance therapy in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Peak FEV1 was improved at all time points over the four weeks of dosing, confirming the therapy's bronchodilator effect, according to Verona officials.
Chronic obstructive pulmonary disease (COPD) has an enormous global impact, thought to affect up to 10 percent of adults in countries where its epidemiology has been studied, according to Cortellis Disease Briefings.
Trogarzo (ibalizumab-uiyk) became the first HIV treatment with a new mechanism of action in more than a decade to gain FDA approval. The CD4-directed post-attachment HIV-1 inhibitor, developed by Theratechnologies Inc., of Montreal, and partner Taimed Biologics Inc., of Taiwan, China, gained the nod in combination with other antiretroviral treatments (ARTs) to treat HIV-1 infection in adults with multidrug-resistant HIV-1 infection who failed an existing ART regimen.
Sun Pharmaceutical Industries Ltd., the Mumbai, India-based pharma giant known more for its footprint in generics than in novel drug development, gained FDA approval of Ilumya (tildrakizumab-asmn) to treat adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
Shares of Zealand Pharma A/S (NASDAQ:ZEAL) popped 10 percent, closing Tuesday at $16.13 for a gain of $1.52, after the first multinational phase III trial of the company's lead candidate, dasiglucagon, met with success in treating severe hypoglycemia.
Heron Therapeutics Inc. hit a home run in dual phase III trials examining its non-opioid candidate, HTX-011, to control postoperative pain in patients following bunionectomy and hernia repair. Top-line data showed that HTX-011 achieved its primary and key secondary endpoints, producing statistically significant reductions in both pain intensity and need for opioids through 72 hours post-surgery compared both to placebo and to bupivacaine solution, the current standard of care. Importantly, fewer patients who received HTX-011 reported severe pain at any post-op time point, and more who received HTX-011 were opioid-free through 72 hours past surgery.
On the heels of last year's FDA nod for Privigen (immune globulin intravenous, human, 10 percent liquid), CSL Behring, a unit of Australia's CSL Ltd., gained the agency's green light for Hizentra (immune globulin subcutaneous [human] 20 percent liquid) as the first subcutaneous immunoglobulin (SCIg) therapy to treat chronic inflammatory demyelinating polyneuropathy (CIDP). The drug, approved by the FDA in 2010 to treat primary immunodeficiency (PI), is indicated as maintenance therapy in adults with CIDP to prevent relapse of neuromuscular disability and impairment.
