Xilio Therapeutics Inc. is banking $52 million up front from Abbvie Inc., including a $10 million equity investment, plus about $2.1 billion in contingent payments for option-related fees and milestones, plus tiered royalties, as the pair embarks on developing tumor-activated, antibody-based immunotherapies, including masked T-cell engagers.
The closely watched chronic spontaneous urticaria (CSU, or hives) space chalked more early stage KIT inhibitor data as Third Harmonic Bio Inc. rolled out results from the phase I single and multiple ascending-dose trial with THB-335 in healthy volunteers, along with plans to move the oral candidate into phase II development by the middle of 2025.
A mysterious turn in the phase IIb story with idiopathic pulmonary fibrosis (IPF) candidate bexotegrast sent shares of Pliant Therapeutics Inc. (NASDAQ:PLRX) down 60.6%, or $4.72, to close Feb. 10 at $3.07.
In a deal that Cantor Fitzgerald analyst Eric Schmidt characterized as “capital recycling at its best,” Alumis Inc. and Acelyrin Inc. are merging in an all-stock transaction. The combined pipelines include Alumis’ most advanced prospect, ESK-001, an oral, next-generation, allosteric inhibitor of tyrosine kinase 2 (TYK2). ESK-001 is undergoing the phase III Onward study for moderate to severe plaque psoriasis as well as the phase II Lumus bid in systemic lupus erythematosus.
Eli Lilly and Co.’s end last year to its PI3Kα inhibitor program didn’t mean the pharma player was giving up on the target – far from it, as signaled by the potential $2.5 billion deal signed recently to take over Scorpion Therapeutics Inc. and gain rights to phase I/II-stage STX-478 for breast cancer and other solid tumors. The list of developers at work in the space includes Roche AG plus smaller entities such as Celcuity Inc., Menarini Group, Onkure Therapeutics Inc., Relay Therapeutics Inc. and Totus Medicines Inc.
The first successful phase II trial in Duchenne muscular dystrophy (DMD) heart disease rolled out from Cumberland Pharmaceuticals Inc., which said top-line findings from the experiment called Fight DMD showed promising results in the indication that represents the main cause of death for such patients.
Major strides for the company on two fronts – psychedelic therapies and treatment-resistant depression (TRD) – came in the form of Dublin-based GH Research plc’s phase IIb data with GH-001, an inhalable mebufotenin (5-MeO-DMT) activator of serotonin 5-HT2A and 5-HT1A receptors that met not only its primary endpoint but all secondary goals in the TRD experiment. Shares of GH (NASDAQ:GHRS) closed Feb. 3 at $17.99, up $7.39, or 69.7%, on word that the fast-acting, short-duration compound led to a significant reduction from baseline of -15.2 points in Montgomery-Åsberg Depression Rating Scale total score on the eighth day of treatment compared with +0.3 points in the placebo group (a difference of -15.5 points, p<0.0001).
Complete response letter hurdles overcome and U.S. FDA clearance in hand, Axsome Therapeutics Inc. will disclose pricing in about four months, closer to the launch of Symbravo to treat adult migraine with or without aura.
Shares of Tectonic Therapeutic Inc. (NASDAQ:TECX) closed Jan. 30 at $54.84, up $29.12, or 113%, on what Leerink analyst David Risinger called in his report “the most impressive hemodynamic results we have seen” in heart failure with preserved ejection fraction. Watertown, Mass.-based Tectonic unveiled positive interim data from the phase Ib acute hemodynamic trial with lead candidate TX-45, a long-acting, Fc-relaxin fusion protein.
President Donald Trump’s recently issued executive order (EO) putting a stop to diversity, equity, and inclusion programs in the U.S. government is sending ripples far and wide, into areas that some might not have anticipated. The FDA has taken down from its website the guidelines regarding action plans related to achieving diversity in clinical trials.
