Shares of Viatris Inc. (NASDAQ:VTRS) were trading midday at $11.18, up $1.48, or 15.2% on word of its plans to create an ophthalmology franchise by acquiring Oyster Point Pharma Inc. and the privately held Indian firm Famy Life Sciences Ltd. Viatris is paying $11 per share in cash upfront through a tender offer for Oyster, each stockholder of which will get one non-tradeable contingent value right, representing up to an additional $2 per share contingent upon Oyster achieving certain metrics based on full year 2022 performance. Viatris will pay about $281 million for Famy and said the total shell-out for both companies could be as a high as $750 million. Shares of Oyster (NASDAQ:OYST) were selling for $11.72, up $3.36, or 40.3%.
GSK blockbuster hopeful Blenrep in trouble as multiple myeloma trial misses target
There are doubts about the future of GSK plc’s multiple myeloma drug Blenrep (belantamab mafodotin) after it failed to meet its goal of improving progression-free survival compared with standard chemotherapy in a confirmatory trial, placing its conditional approvals in the U.S. and Europe at risk. London-listed shares in GSK (LSE:GSK) closed 4.7% lower following the announcement that the Dreamm-3 trial in relapsed or refractory multiple myeloma did not meet its primary endpoint.
Verve’s gene editing therapy for heart disease hit by clinical hold in US
Shares of Verve Therapeutics Inc. (NASDAQ:VERV) were down nearly 25% at market open Nov. 7 after the company reported the U.S. FDA had placed on hold its IND for a phase I trial of gene editing candidate VERVE-101 in heterozygous familial hypercholesterolemia. Details were few, with Verve expecting an official letter outlining the agency’s questions within the next month. In the meantime, phase I testing of the therapy continues in the U.K. and New Zealand. VERVE-101 is designed as a single-course treatment to permanently turn off the PCSK9 gene in the liver to reduce disease-driving LDL-cholesterol. It also includes an adenine base editor RNA licensed from Beam Therapeutics Inc., which is working to address its own FDA clinical hold for BEAM-201, a cancer-focused gene-edited CAR T candidate.
Telix’s imaging agent meets primary, secondary endpoints in phase III kidney cancer trial
Radiopharmaceutical company Telix Pharmaceuticals Ltd.’s TLX250-CDx (Zirconium (89Zr) TX250) met both primary and secondary endpoints in the phase III Zircon study in clear cell renal cell carcinoma, according to top-line data.
At AASLD 2022, polygenic risk score subtypes NAFLD
Modern molecular techniques have progressed to the point where sequencing can seem almost quaint. At the Basic Science Symposium of The Liver Meeting 2022, new techniques were on full display, with sessions devoted to epigenetics, microbiome analysis and spatial transcriptomics. But the first session was still on genetic variants in all their forms – rare variants, common variants, and non-germline mutations. “Genetics is very powerful because it defines the cause of the disease,” Liz Speliotes, professor of medicine at the University of Michigan, told the audience. “Your genome comes before any phenotype you could have had.”
SCOTUS to hear biopharma enablement case, passes on written description
It’s taken eight years of jury trials, court reversals and appeals for Amgen Inc. to get the nod to argue its case before the U.S. Supreme Court on what is needed to meet the enablement standard for patent claims. While the court agreed Friday to hear arguments on enablement in Amgen Inc. v. Sanofi SA, it closed the door today on a petition to reverse the Federal Circuit’s decision on a patent’s written description in Juno Therapeutics Inc. v. Kite Pharma Inc.
Biocytogen out-licenses CD40 antibody to Isu Abxis to develop tri-specific antibodies
Biocytogen Pharmaceuticals Co. Ltd.’s subsidiary Eucure Biopharma Co. Ltd. has granted Isu Abxis Co. Ltd. rights to use its humanized agonistic anti-CD40 antibody YH-003 to develop cancer drugs. Isu Abxis can now use the sequence of YH-003 to develop tri-specific antibodies for several cancer indications, while Beijing-based Eucure will receive an up-front payment, milestone payments and royalties of unspecified value.
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Akebia, Akeso, Aligos, Alpine Immune, Apellis, Aptar, Ascentage, Asher, Assembly, Astrazeneca, Beam, Bioatla, Biomind, Biontech, Biora, Certa, Cymabay, Eisai, Hc Bioscience, Incyte, Ionis, Iveric, Kezar, Laurent, Medincell, Mirati, Moderna, NGM, Nkgen, Nrx, Ocelot, Osteal, Pfizer, Redhill, Relief, Rivus, Scancell, Terns, Teva, Valenzabio, Vicore, Xortx