Clinical Trials

DBV Finally Cracks It With Peanut Patch Win

 
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After a developmental rollercoaster ride, the French firm is getting ready to refile Viaskin Peanut for 4-7 -year-olds in the first half of 2026.

Nektar Blames Eligibility Violations For Phase II Rezpeg Miss, Backs Alopecia Development Plans

 
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The San Francisco, CA-based firm looks to keep its pipeline-in-a-product hopes alive for rezpeg with alopecia areata push.

OrsoBio To Advance TLC-6740 After Successful Obesity Combo Trial

 

The California firm announced positive data from its early-stage randomized study of TLC-6740 combined with Lilly’s tirzepatide in patients with obesity.

Abivax Q3 Results Fail To Dampen M&A Speculation

 
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The France-based biotech is making solid progress amid mounting talk of a sale.


In Brief: InnoCare’s BTK Inhibitor For SLE Hits Primary Endpoint In World-First

 

Clinical Data Readout: As a worldwide first mover, InnoCare’s BTK inhibitor orelabrutinib has hit its monotherapy primary endpoint of SRI-4 response rate at 48 weeks in a China-only Phase IIb trial in systemic lupus erythematosus.

Immunome’s Phase III Varegacestat Data Show Best-In-Class Potential In Desmoid Tumors

 
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Phase III results for gamma secretase inhibitor varegacestat in the treatment of desmoid tumors appear superior on both efficacy and safety to Merck KGaA’s Ogsiveo (nirogacestat).

Takeda/Protagonist’s Rusfertide All Dressed Up And Ready To Go After ASH Data

 

The companies presented 52-week data from the pivotal Phase III VERIFY study at the recent American Society of Hematology meeting, after releasing 32-week data earlier this year.

Sanofi Upbeat Despite Latest Tolebrutinib Trials And Tribulations

 
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The French firm has been hit with a double whammy for its oral BTK inhibitor for multiple sclerosis but analysts at Jefferies say it is premature to write the drug off.


Pipeline Watch: Two Approvals & Seven Phase III Readouts

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.

GSK Sees Community Niche For Blenrep, But Bispecifics Are Making Inroads

 

The drugmaker presented multiple posters of data for the recently reapproved BCMA-targeting antibody-drug conjugate at the just concluded ASH meeting.

Arcus Calls Quits On Anti-TIGIT Candidate After Phase III Termination

 
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Arcus is ending development of its TIGIT-targeted antibody domvanalimab after it was determined a Phase III study would not show a survival benefit in gastrointestinal cancers.

AC Immune Perks Up On Positive Parkinson’s Data

 
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The Switzerland-based group’s alpha-synuclein-targeted immunotherapy shows promise in slowing progression of the degenerative brain condition.


ASH: Early Results Ready Lupeng’s Rocbrutinib For Potential Head-To-Head With Jaypirca

 

Lupeng's BTK inhibitor rocbrutinib has shown an 80.0% ORR in a Phase I trial in patients who had received a covalent or non-covalent BTK inhibitor plus BCL-2 inhibitor, setting the stage for a comparative trial, possibly with Jaypirca.

Scrip Awards 2025 Spotlight Industry Triumphs

Now in their 21st year, the Scrip Awards celebrated biopharma successes at the 2025 ceremony in London’s Mayfair, where AstraZeneca and Noubar Afeyan took home the top prizes.

Lilly’s Retatrutide Raises Weight-Loss Bar In First Phase III Readout

 
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Triple agonist retatrutide yielded 28.7% weight loss at 68 weeks, besting Zepbound’s Phase III data, while also showing benefit in knee osteoarthritis pain.

Roivant Updates Investors On Mosliciguat Development Plans

 

Subsidiary Pulmovant plans to report Phase II data in pulmonary hypertension associated with interstitial lung disease in 2026, one of several programs highlighted during an investor event.


ASH: J&J’s Tecvayli Set For Stronger Competition With CAR-Ts In Myeloma

 

J&J's late-breaking Phase III MajesTEC-3 data at the American Society of Hematology meeting highlighted curative potential for the bispecific T-cell engager in multiple myeloma.

Finance Watch: Biopharma Firms Price $3.2bn In Follow-On Offerings In One Night

 
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FOPO Edition: Capitalizing on positive data, eight drug developers priced follow-on public offerings that brought in $3.2bn, including $650m each for Terns and Structure plus $602m for Kymera.

Pfizer Could Claim Tukysa First-Line HER2+ Metastatic Breast Cancer Indication

 
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Pfizer’s Phase III data show an 8.6-month increase in progression-free survival for Tukysa as first-line maintenance treatment of HER2+ breast cancer, a setting where the standard of care hasn’t changed since 2012.

Roche’s Giredestrant Data Could Set The Stage For A New Standard Of Care

 

The selective estrogen receptor degrader reduced the risk of invasive disease recurrence or death by 30% in ER-positive early stage breast cancer.