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BioWorld - Friday, May 22, 2026
Home » Topics » Clinical

Clinical
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Pfizer, Valneva post mixed results for Lyme disease vaccine

March 23, 2026
By Jennifer Boggs
No Comments
Overall, results from the phase III Valor trial testing Lyme disease vaccine PF-07307405 “strengthen confidence” in the candidate, according to partners Pfizer Inc. and Valneva SE, with the big pharma now looking toward regulatory submissions. Investors, however, focused on the fact that the study, which demonstrated more than 70% efficacy in preventing Lyme disease in individuals, ages 5 and older, failed to hit the statistical criterion for the first prespecified analysis.
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Hand weight, sneakers, scale, measuring tape, apple, injector and glucose monitor

Triple crown: T2D purse for Lilly’s phase III retatrutide?

March 19, 2026
By Randy Osborne
No Comments
Further weight loss details are yet to come this year, but Eli Lilly and Co. scored positive top-line results in Transcend-T2D-1, a phase III trial evaluating the efficacy and safety of retatrutide, an investigational first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, as an adjunct to diet and exercise in type 2 diabetes (T2D).
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Simcere’s PD-L1/IL-15 bispecific sees early edge in bladder cancer

March 18, 2026
By Tamra Sami
No Comments
Early clinical data from Simcere Pharmaceutical Group Ltd. suggest its PD-L1/IL-15 bispecific antibody, SIM-0237, could emerge as a next-generation contender in Bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer.
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Blue and green pill with barbell

Promise of exercise in a pill as Atrogi pivots from type 2 diabetes to obesity

March 18, 2026
By Nuala Moran
No Comments
Atrogi AB is making a bid for a slice of the obesity market and has dosed the first overweight subjects with ATR-258, an oral therapy it says mimics the effects of exercise, driving loss of fat whilst sparing muscle.
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GLP-1 capsule

Structure’s oral GLP-1 data mark bullish year for obesity pills

March 17, 2026
By Marian (YoonJee) Chu
No Comments
The GLP-1 fight has moved from injectables to pills, and Structure Therapeutics Inc. is in the ring with phase III-ready aleniglipron. According to the Bay Area biotech, its oral once-daily glucagon-like peptide-1 (GLP-1) drug candidate, aleniglipron, demonstrated an absolute weight loss of “up to 39 pounds” in the 44-week Access II trial.
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Silhouette and psychedelic sky

Australia publishes first clinical practice guideline for psychedelics

March 17, 2026
By Tamra Sami
No Comments
Australia has released the first clinical practice guideline for the appropriate use of methylenedioxymethamphetamine-assisted psychotherapy for post-traumatic stress disorder, but clinicians caution that evidence, infrastructure and access remain works in progress.
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Imcivree

Post-Emanate, Rhythm’s next Imcivree news aHO lot better?

March 17, 2026
By Randy Osborne
No Comments
Low expectations for Rhythm Pharmaceuticals Inc.’s phase III study dubbed Emanate with Imcivree (setmelanotide) in a handful of rare genetic obesities meant hardly any share price consequence, and the stock (NASDAQ:RYTM) closed March 17 at $87.68, down $2.83. “We’re not going to file [for approval] on any of these,” CEO David Meeker said, but the latest findings together represent “a solid building block going forward,” he added.
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Molecule illustration

Otsuka’s repinatrabit shows phase II efficacy in PKU adolescents

March 17, 2026
By Marian (YoonJee) Chu
No Comments
Otsuka Pharmaceutical Co. Ltd. reaped positive results from an open-label phase II study of repinatrabit (JNT-517) in adolescents with phenylketonuria (PKU), a rare disease marked by the inability to break down the amino acid phenylalanine.
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Immutep stock plummets 90% on efti phase III failure in NSCLC

March 17, 2026
By Tamra Sami
No Comments
Immutep Ltd.’s stock on Australia’s Securities Exchange plummeted nearly 90% on March 13 on the news that its phase III TACTI-004 trial evaluating eftilagimod alfa (IMP-321, efti) in first-line non-small-cell lung cancer was discontinued due to futility.
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Fibroblast illustration
Cancer

Mestag raises $40M to take fibroblast program into phase I cancer trial

March 17, 2026
By Nuala Moran
No Comments
Mestag Therapeutics Ltd. has raised a $40 million round from existing investors as it completes final preparations for its lead program MST-0312 to enter clinical development in mid-2026. MST-0312 is a bispecific antibody aimed at the lymphotoxin-β receptor (LTBR), which is essential for the development of lymphoid tissues.
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