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BioWorld - Thursday, December 25, 2025
Home » Topics » Clinical, BioWorld

Clinical, BioWorld
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Early data in PD lift spirits of Yumanity and others, but stock price depressed

Nov. 10, 2021
By Randy Osborne
Yumanity Therapeutics Inc. CEO Richard Peters said his firm is “in the driver’s seat” with regard to partnering options or going it alone, after YTX-7739 hit the primary endpoints in a phase Ib Parkinson’s disease (PD) study. Wall Street seemed less than certain about the success, knocking shares (NASDAQ: YMTX) down $2.83, or 33.4%, to close at $5.65.
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In the clinic for Nov. 10, 2021

Nov. 10, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Abbvie, Aldeyra, Alligator, Alx, Amylyx, Aravive, Ascletis, Beigene, Compass, Curasen, Eli Lilly, Exelixis, Helixmith, Horizon, Immatics, Immunocore, Incyte, Iterion, Moderna, Neuroplast, Noxopharm, Oncoimmune, Praxis, Scynexis, Sinovac, Suzhou Alphamab, Tonix, Ultimovacs, Vigeo, Xencor, Zymeworks.
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Psilocybin drug trips on side effects in TRD as Compass nails phase IIb endpoint

Nov. 9, 2021
By Randy Osborne
Compass Pathways plc rolled out favorable top-line findings from the largest randomized, controlled, double-blind psilocybin therapy study ever completed, showing that COMP-360 at 25 mg yielded a highly statistically significant and clinically relevant reduction in symptom severity after three weeks in patients with treatment-resistant depression (TRD) .
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In the clinic for Nov. 9, 2021

Nov. 9, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acurx, Affimed, Alnylam, Asklepios, Astrazeneca, Bayer, BMS, Bugworks, Crinetics, Curis, Diamedica, Diamond, Galmed, GSK, Ionctura, Kalvista, Neoimmune, Nkgen, Novartis, Oncoinvent, Pieris, Regeneron, Selecta, Servier, Teva, TFF, Urovant.
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Kidney illustration

Follow your BlyS, or not? Chinook, Vera findings in IgAN compared

Nov. 8, 2021
By Randy Osborne
Data from Chinook Therapeutics Inc. from an ongoing phase I/II trial with BION-1301 in IgA nephropathy (IgAN) at the American Society of Nephrology Kidney Week, and from Vera Therapeutics Inc. with atacicept, set Wall Street abuzz about chances for the two compounds relative to each other.
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GSK strengthens its case for daprodustat in CKD-associated anemia

Nov. 8, 2021
By Michael Fitzhugh
Results from two pivotal phase III trials testing Glaxosmithkline plc's daprodustat against anemia due to chronic kidney disease (CKD) found the oral hypoxia-inducible factor prolyl hydroxylase inhibitor helped both non-dialysis and dialysis patients improve or maintain hemoglobin levels without increased cardiovascular risk vs. standard-of-care erythropoietin stimulating agents. Though already approved in Japan as Duvroq, what future the drug might face in the U.S., where the same-class drug roxadustat garnered an FDA complete response letter, remained an open question.
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REGEN-COV packaging

Cocktail time: Regeneron’s COVID-19 monoclonal antibodies post strong phase III data, could dilute mRNA market share

Nov. 8, 2021
By Lee Landenberger
New positive phase III study results for Regeneron Pharmaceuticals Inc.’s COVID-19 monoclonal antibody cocktail show a single dose reduced the risk of contracting the virus by 81.6% during a two- to eight-month follow-up period. The strong data go along with Pfizer Inc.’s recent positive results for its oral antiviral, Paxlovid, hinting that COVID-19 therapeutics could begin cutting into powerful mRNA vaccine margins from Pfizer Inc.-Biontech SE and Moderna Inc.  
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In the clinic for Nov. 8, 2021

Nov. 8, 2021
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Biocryst, Calithera, Chinook, Cyclacel, Deciphera, Dicerna, Karyopharm, Medicure, Morphosys, Novartis, Novo, Omeros, Pfizer, Vascular Therapies.
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Lungs

Double trouble: Calithera stops telaglenastat development

Nov. 5, 2021
By Lee Landenberger
Calithera Biosciences Inc.’s stock took a severe beating Nov. 5 as shares closed 54.5% downward due to the company’s phase II stumble of telaglenastat in treating non-small-cell lung cancer. It was the therapy’s second clinical failure in the past 12 months.
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Endpoint for GIST missed in surprise twist; Deciphera’s Qinlock defrocked as second-line bid

Nov. 5, 2021
By Randy Osborne
Shares of Deciphera Pharmaceuticals Inc. (NASDAQ:DCPH) plunged $27.18, or 75.5%, to close at $8.82 on top-line results from the phase III study called Intrigue with Qinlock (ripretinib) in gastrointestinal stromal tumors (GIST) previously treated with kinase inhibitor Gleevec (imatinib, Novartis AG).
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