Six months shy of the PDUFA date for its oral, selective glucocorticoid receptor antagonist, Relacorilant, to treat platinum-resistant ovarian cancer (PROC), Corcept Therapeutics Inc. reported a 35% reduction in the risk of death, meeting the second primary endpoint of overall survival after reaching statistical significance with progression-free survival last March. Shares of the company (NASDAQ:CORT) soared by nearly 20% to $43.50 in early trading Jan. 22. Relacorilant is currently before the U.S. FDA for PROC with a July 11, 2026, PDUFA date. H.C. Wainwright analyst Swayampakula Ramakanth said the data from the phase III Rosella trial “bodes well for the upcoming PDUFA.” His team projects sales of $190 million in 2026, growing to $2.1 billion in 2031, not accounting for indications outside of PROC. The latest news follows a Dec. 31 complete response letter for relacorilant to treat Cushing syndrome.
World Economic Forum report highlights unmet need in women’s health
The economic and societal implications of the underfunding of women’s health finally reached the agenda of the World Economic Forum (WEF), with the launch at the 2026 annual meeting in Davos, Switzerland, this week of the inaugural Women’s Health Investment Outlook. The neglect of women’s health is not only a public health issue, but also “a market inefficiency on a global scale,” the WEF report said. Women may have a longer life expectancy than men, but the report notes that despite this, women spend approximately 25% more of their lives in poor health, or with a disability. The gap reflects the “cumulative burden” of conditions that disproportionately affect women because of biological differences, distinct disease progression or higher prevalence.
Erasca raises $225M to sharpen RAS oncology focus
Erasca Inc. priced an upsized public offering to raise $225 million to fund development of its therapies for patients with RAS/MAPK pathway-driven cancers. The firm, which said it is looking to build an industry-leading RAS targeting franchise, plans to use the funds raised, together with its existing cash, to fund the research and development of its product candidates and other development programs as well as working capital.
Research active in IL-2, IL-15, and their common element CD122
The structurally similar cytokines IL-2 and IL-15, and their shared beta subunit CD122, are keeping developers busy across a range of indications. Though some scientific confusion has plagued the space historically, drug candidates have drawn deals and Wall Street interest aplenty. Amgen Inc., Novartis AG, and Incyte Corp. are among those who’ve made their interest known.
Lexicon rebounds on FDA nod for phase III non-opioid pain drug trial
Lexicon Pharmaceuticals Inc. announced that it received no objections from the U.S. FDA to move pilavapadin, its non-opioid candidate for diabetic peripheral neuropathic pain, into phase III study, pushing company shares up near 20% on the day. “Our end-of-phase-II meeting with FDA was productive and provided Lexicon with the insights needed to design a robust phase III program,” Lexicon CEO and director Mike Exton said. The phase III study is slated to include two placebo-controlled, 12-week, two-arm registrational studies comparing the 10-mg daily dose to placebo. The primary endpoint will be defined as the change in average daily pain score from baseline to week 12.
Janux’s tumor-activated platform draws BMS in potential $850M deal
On the heels of more positive early data from the lead program derived from its tumor-activated T-cell engager (TRACTr) platform, Janux Therapeutics Inc. inked a collaboration with Bristol Myers Squibb Co. that comes with $50 million in up-front and near-term milestones, with the possibility of up to $800 million more tied to development, regulatory and commercial milestones. Janux also would be entitled to tiered royalties on commercial sales if the product, currently described as a “novel, tumor-activated therapeutic targeting a validated solid tumor antigen expressed across several human cancer types,” should reach market.
Put options put biopharma researcher in SEC hot water
Another day, another insider trading settlement involving a biopharma company employee. This time the trading involved Mohit Verma, then an associate director of immunology at Infinitybio Inc. According to the U.S. SEC, Verma purchased nearly 200 out-of-the-money put options within the 34 hours or so leading up to Infinitybio’s disclosure that the FDA had issued a complete response letter (CRL) for its lead product, Anktiva, an immunotherapy for nonmuscle invasive bladder cancer. Verma began purchasing the put options late May 9, 2023 – less than an hour after learning of the CRL during an internal company meeting he attended remotely.
Also in the news
Angelini, Crystalys, Engene, Ervimmune, Genentech, Human Continuum, Hygtia, Immedica, Insilico, Intrabio, IO, Ionis, Kuva, LB, Lisata, Neurocrine, Ocugen, Ocular, Odyssey, Opna, Otsuka, Ouro, Qilu, Scynexis, Think, Variant, Veloxis, Vivos, Wugen, Zura