Juvena Therapeutics Inc. co-founder and CEO Hanadie Yousef had the company’s name picked out several years before it was officially incorporated in 2017 to combine Yousef’s work in the mechanics of aging with an underutilized class of biologics and an advanced proteomics platform to tackle chronic and age-related diseases.
Trex Bio Inc., which kicked off 2022 with a big pharma partnership, is back at it again, starting the new year with a potential $1.1 billion agreement with original backer Eli Lilly and Co. targeting immune-mediated diseases. Under the terms, Trexbio gets $55 million up front, with Lilly picking up an exclusive worldwide license for candidates from three programs.
Geron Corp. executives highlighted a potential billion-dollar market opportunity for imetelstat on the back of positive phase III data for the telomerase inhibitor in patients with lower-risk myelodysplastic syndromes (MDS), news that sent shares (NASDAQ:GERN) rising 36% and could portend the first regulatory win for a scientific approach the company has pursued since the 1990s.
Despite pipeline setbacks in 2022, TG Therapeutics Inc. ended the year on a positive note, with U.S. FDA approval of its glycoengineered CD20 monoclonal antibody, ublituximab, in relapsing multiple sclerosis (MS). Branded Briumvi, the drug is set to go up against approved anti-CD20 antibodies Kesimpta (ofatumumab, Novartis AG) and Ocrevus (ocrelizumab, Roche Holding AG).
Over the past few years, the pandemic clearly has put a spotlight on vaccines and the infectious disease space. But the struggle to adjust in COVID-19’s wake also brought into stark relief another high unmet need. “Coming out of COVID, there was a mental health focus coming into play,” said Andrew Levin, partner and managing director at investment firm RA Capital Management who is also serving as interim CEO at Lusaris Therapeutics Inc., a 2021 startup targeting neuropsychiatric and neurological conditions, with an initial focus on treatment-resistant depression.
“Far superior to what almost anyone expected,” was how H.C. Wainwright analyst Ed Arce described the top-line readout for Madrigal Pharmaceuticals Inc.’s phase III study of resmetirom, which hit both of its dual endpoints in patients with nonalcoholic steatohepatitis (NASH) and is expected to form the basis of an accelerated approval application to the U.S. FDA in the first half of 2023.
As largely expected, Mirati Therapeutics Inc.’s adagrasib gained U.S. FDA accelerated approval ahead of its Dec. 14 PDUFA date, cleared for second-line use in patients with non-small-cell lung cancer (NSCLC) harboring the KRAS G12C mutation, in which it will go up ahead Amgen Inc.’s Lumakras (sotorasib), which has the advantage of a year and a half head start.
Shares of Oncopeptides AB dropped 35% Dec. 7 on the U.S. FDA’s request to withdraw marketing authorization of Pepaxto (melflufen), a drug that had gained accelerated approval in early 2021 for use in relapsed/refractory multiple myeloma. The move followed a negative advisory committee vote in September 2022 and is based on the outcome of the confirmatory phase III Ocean study.
Six months after a merger deal fell through, leaving the company to face possible bankruptcy, Therapeuticsmd Inc. agreed to license U.S. commercialization rights for its women’s health care products to Australian firm Mayne Pharma Group Ltd. in exchange for $140 million up front plus milestone and royalty payments.
Six months after a merger deal fell through, leaving the company to face possible bankruptcy, Therapeuticsmd Inc. agreed to license U.S. commercialization rights for its women’s health care products to Australian firm Mayne Pharma Group Ltd. in exchange for $140 million up front plus milestone and royalty payments.
