Xpovio (selinexor), an oral selective inhibitor of nuclear transport from Karyopharm Therapeutics Inc., of Newton, Mass., received FDA approval today for treating adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. Xpovio will be available immediately in the U.S., the company said, and, due to COVID-19 restrictions, the launch will be a virtual one.
Evoke Pharma Inc., of Solana Beach, Calif., which has struggled in the past year through troughs in its stock price and doubts from the FDA in its quest for approval for Gimoti (metoclopramide), was vindicated today as the FDA approved the treatment for adults with acute and recurrent diabetic gastroparesis.
Against a backdrop of general economic uncertainty bolstered in part by a strong biopharma market, two IPOs launched June 19 and ended their first trading day well above their high-end asking prices.
Repare Therapeutics Inc., which identifies synthetic lethal precision oncology targets for drug candidates, and Forma Therapeutics Holdings Inc., which is developing therapeutics to treat rare hematologic diseases and cancers, launched IPOs with an anticipated combined value of $497.6 million in gross proceeds.
The worldwide option and license agreement Alpine Immune Sciences Inc. drew up with Abbvie Inc. for ALPN-101, a dual CD28/ICOS co-stimulation antagonist for treating systemic lupus erythematosus and other autoimmune diseases, heartily strengthened Alpine’s stock and supports its planned operations into 2023.
Orca Bio Inc.’s $192 million series D brings the company out of stealth and openly into the business of transforming allogeneic cell therapies. The new funding brings Orca’s total capital raised since 2016 to nearly $300 million.
All the primary and secondary efficacy endpoints were met in Boulder, Colo.-based Brickell Biotech Inc.’s pivotal phase III study of the anticholinergic sofpironium bromide in treating primary axillary hyperhidrosis, which involves excessive sweating in the armpits that interferes with daily life and work.
Glaxosmithkline plc (GSK) will collaborate in three of Ideaya Biosciences Inc.’s synthetic lethality programs, MAT2A (methionine adenosyltransferase 2a), Pol Theta (polymerase theta) and Werner Helicase, in a deal that Ideaya estimated could be worth billions.
All the primary and secondary efficacy endpoints were met in Boulder, Colo.-based Brickell Biotech Inc.’s pivotal phase III study of the anticholinergic sofpironium bromide in treating primary axillary hyperhidrosis, which involves excessive sweating in the armpits that interferes with daily life and work.
Selecta Biosciences Inc., of Watertown, Mass., and Stockholm’s Swedish Orphan Biovitrum AB (Sobi) signed a licensing agreement for SEL-212, which is designed to control serum uric acid, reduce immunogenicity and allow for repeated monthly dosing when treating chronic refractory gout.
In a bid to expand its presence in the cardiometabolic disease space and strengthen its core business in diabetes and obesity, Novo Nordisk A/S is buying Corvidia Therapeutics Inc., of Waltham, Mass., for $2.1 billion, which includes a $725 million up-front payment.
