“We’re launching at the right time,” said Frank Sanders, president of Zealand Pharma A/S’s business in the U.S., in the wake of clearance granted by the FDA for the Copenhagen, Denmark-based firm’s glucagon analogue Zegalogue (dasiglucagon) in severe hypoglycemia.
As the firm doubles down on a therapy for the rare and terrible lung disease called autoimmune pulmonary alveolar proteinosis (aPAP), Savara Inc. met with little trouble raising money, disclosing March 15 a public offering that grossed $130 million.
Now that Johnson & Johnson (J&J), through its Janssen Pharmaceuticals unit, has won the FDA’s nod for Ponvory (ponesimod), market factors will decide how the once-daily oral selective sphingosine-1-phosphate receptor 1 modulator fares against several others already approved in the class.
Libtayo (cemiplimab-rwlc) became the first PD-1 therapy to score a phase III win in cervical cancer, a pleasing development not only for investors in Regeneron Pharmaceuticals Inc. and partner Sanofi SA but for patients with the stubborn disease.
When Amgen Inc. won approval of the oncolytic virus (OV) therapy Imlygic (talimogene laherparepvec, t-vec) for melanoma in late October 2015, hopes ran high for the space. The mood has since faded in some quarters – but hardly all.
The question of whether Rubius Therapeutics Inc. would disclose data with its cellular therapy, RTX-240, ahead of the American Association for Cancer Research (AACR) meeting next month was answered in a market-satisfying way as the Cambridge, Mass.-based firm rolled out positive findings from the ongoing phase I/II experiment.
The sad phase III fate of Abbvie Inc.’s rovalpituzumab tesirine, also known as rova T, in advanced small-cell lung cancer (SCLC) has not discouraged other drug developers targeting delta-like ligand 3 (DLL3) – not all of them, anyway.
Aveo Oncology Inc. CEO Michael Bailey said the shifting treatment paradigm in renal cell carcinoma (RCC) represents “an advantageous opportunity” for the company with Fotivda (tivozanib), approved March 10 for adults with relapsed or refractory, advanced disease who have received two or more systemic therapies.
Having rung the bell in phase II last summer, Ovid Therapeutics Inc. and Takeda Pharmaceutical Co. Ltd. signed a pact giving the latter global rights to develop and commercialize soticlestat, a first-in-class inhibitor of cholesterol 24-hydroxylase for the treatment of developmental and epileptic encephalopathies including Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS).
Concert Pharmaceuticals Inc. CEO Roger Tung said determining who leads isn’t easy in the phase III race that pits his firm against Eli Lilly and Co. and Pfizer Inc. in alopecia areata. That’s because neither of the other companies has “been very direct about the timelines they’re on,” he told BioWorld. “We’ve been pretty clear that our goal is to have an NDA filing in early 2023.”
