Genentech Inc. is covering more bases in multiple sclerosis, with its latest swing on fenebrutinib hitting a rare phase III noninferiority win against Ocrevus (ocrelizumab) in primary progressive multiple sclerosis.
Wall Street pushback against relaxin player Tectonic Therapeutic Inc. was sharp, but a trial design that differs could save the drug from the fate of Astrazeneca plc’s long-acting relaxin-2 analogue, AZD-3427, which the pharma giant has “removed from phase II,” where it was being tested in a trial called Re-phire, because of less than ideal efficacy.
Marking an important day for those with atopic dermatitis, shares of two biopharmas surged on clinical data suggesting new biologics are on their way to help address 40% of patients with uncontrolled disease.
Breye Therapeutics ApS reported positive phase Ib data for its oral gap junction modifier drug danegaptide in diabetic retinopathy and is now raising a €50 million (US$59.6 million) series A round to move into the next phase of development.
Bayer AG’s oral factor XIa inhibitor asundexian significantly reduced ischemic stroke by 26% in patients following a noncardioembolic ischemic stroke or high-risk transient ischemic attack in the phase III Oceanic-Stroke study.
On the heels of an NDA submission for brepocitinib in dermatomyositis, Priovant Therapeutics Inc. disclosed data showing the dual TYK2/JAK1 inhibitor surpassed expectations in a phase II study in cutaneous sarcoidosis, another chronic inflammatory skin condition with limited treatment options, setting the stage for a phase III study set to start this year.
Following on from a successful phase IIa proof-of-mechanism study in myasthenia gravis, NMD Pharma A/S has added clinical data on a second neuromuscular disorder, reporting positive phase IIa results for ignaseclant, in both type I and type II Charcot-Marie-Tooth disease.
Another data cut from Ultragenyx Pharmaceutical Inc. regarding UX-111 (rebisufligene etisparvovec), an AAV9 gene therapy for type A Sanfilippo syndrome, continued to brighten the picture for the compound, recently taken under review again by the U.S. FDA.
Nearly three months after winning a contentious bid to buy obesity drugmaker Metsera Inc. for $10 billion, Pfizer Inc. reported its first statistically significant top-line data of the acquired lead, ultra-long-acting glucagon-like peptide-1 (GLP-1) receptor agonist, showing a mean placebo-adjusted weight loss of up to 12.3% at 28 weeks, as well as competitive tolerability.
More than four years after a phase II/III trial with Sanofi SA’s oral glucosylceramide synthase inhibitor venglustat was stopped for lack of benefit in autosomal dominant polycystic kidney disease, the company rolled out mixed phase III data from two more efforts.
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