Clinical Trials
The Phase III study’s principal investigator said that if Xpovio doesn’t win approval, NCCN Guidelines could enable off-label use, as has occurred with BMS’s Reblozyl.
CEO Alex Zhavoronkov talks about the firm’s progress in AI-driven R&D, hitting the right level of drug novelty, partnering with Eli Lilly and its goal of outperforming China’s biopharma engine.
Pfizer, which licensed the candidate from Valneva, said the vaccine demonstrated clinically meaningful efficacy for preventing Lyme disease, even though the study failed to accrue enough cases.
The company announced positive Phase III data and plans to file an sNDA for Arikayce in newly diagnosed patients with MAC lung disease, a potential blockbuster indication.
With Phase III plans underway and Part B data from its APEX trial due in 2026, Apogee is banking on zumilokibart's extended dosing advantage compared with rivals.
Dizal's Zegfrovy (sunvozertinib), already approved in the US and China for the second-line treatment of NSCLC with EGFR exon 20 insertion mutations, triumphs in the WU-KONG28 Phase III study in the first-line setting.
Underwhelming efficacy led to the myostatin inhibitor's discontinuation of in SMA and FSHD, but Roche will continue a separate study in obesity. Meanwhile, Scholar Rock’s rival apitegromab could soon be back on track for approval.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
The German biotech hopes to start Phase IIb trials soon of the oral complement C5a inhibitor in the extremely competitive hidradenitis suppurativa market.
Newly published guidelines for treating dyslipidemia recommend testing for Lipoprotein(a), a cardiovascular disease risk factor with no treatments, but with multiple candidates in the clinic.
The company announced the first Phase III data testing the GIP/GLP-1/glucagon agonist in diabetic patients, showing reductions in blood sugar and superior weight loss to Mounjaro.
Phase II results evaluating the anti-TSLP drug bosakitug are expected in the fourth quarter. Aclaris is pitching the asset as having best-in-class potential in a currently open field.
The China-only result bodes well for Merck’s global studies, with Jefferies analysts convinced Sac-TMT will confirm superiority to TROP2 ADC competitors and more.
Kintor's topical androgen receptor inhibitor KX-826 posts win in China Phase III trial in male androgenetic alopecia, following a Phase III setback in 2023.
The company aims to restore near-normal muscle regrowth with its novel in vivo gene therapy PBGENE-MD, which it is now pursuing alone.
Near-term focus for Rhythm will be on the upcoming regulatory decision for Imcivree in acquired hypothalamic obesity, with an FDA decision expected in the coming days.
Spanish firm's CSO Karl Ziegelbauer shares with Scrip his views on potential alliances with Chinese and other companies and what Almirall can bring to the table.
The drugmaker announced that its Phase II trial of atirmociclib, a CDK4 inhibitor, succeeded in patients who had progressed on CDK4/6 inhibitors and had better tolerability than the earlier class.
The company received a complete response letter from the US FDA for reproxalap for dry eye disease for the third time.
The EU remains a major global player in biopharma but needs to act quickly or risk falling further behind its rivals, according to EFPIA.