Positive top-line data from phase II and III studies of lorundrostat for treating uncontrolled or resistant hypertension had propelled Mineralys Therapeutics Inc.’s stock upward at midday. The phase III Launch-HTN study hit its primary endpoint in reducing systolic blood pressure and the phase II Advance-HTN study also met its primary endpoint of a clinically meaningful reduction in blood pressure. Oral lorundrostat targets dysregulated mineralcorticoid aldosterone as a selective aldosterone synthase inhibitor. Mineralys estimated there to be about 15- to 20-million patients with uncontrolled hypertension in the U.S. At midday, the company’s shares (NASDAQ:MLYS) were trading 67% upward at $17.68 each.

Bill could have epic impact on drugs selected for negotiations

Several drugs already selected for Medicare price negotiations, including Novo Nordisk A/S’ mega-blockbuster Ozempic/Wegovy franchise, could see up to a three-year delay in the negotiated prices kicking in if a bipartisan bill recently introduced in the U.S. House and Senate becomes law. The Ensuring Pathways to Innovative Cures (EPIC) Act would retroactively wipe out the so-called “pill penalty” included in the Inflation Reduction Act (IRA) negotiations provision that is already redirecting investment away from small-molecule drugs. Currently under the IRA, small-molecule drugs are eligible for selection seven years after FDA approval, with the negotiated price taking effect two years later. However, biologics become eligible for selection 11 years after approval, with the price controls going into effect in year 13. That four-year difference already has resulted in a 70% drop in investment in small-molecule R&D, according to the bill’s sponsors.

As tariffs threaten US imports of APIs, companies reshore manufacturing

While the U.S. has historically led the global pharmaceutical industry by pursuing both continual innovation and high quality, those strengths could become areas of weakness in times of political uncertainty, according to PA Consulting expert Andy Prinz. “The U.S. pharma industry has a strong history of innovation and reputation for meeting high quality standards and developing global supply networks,” Prinz recently told BioWorld, but those strengths are often based on high labor, infrastructure and regulatory costs that could undercut the country’s pharmaceutical prowess in terms of cost competition. The biggest casualties from tariffs, Prinz said, will likely be U.S. imports of active pharmaceutical ingredients and finished goods medicines, but the threats have had swift reactions from the industry, including pledges to build more manufacturing bases in the U.S.

(Bi-)specific gravity: Bambusa, others serious about approach

The recent series A financing by Bambusa Therapeutics Inc. to fund bispecific antibodies for immunological and inflammatory (I&I) disorders proved investor faith in the new approach with a proven mechanism. Boston-based Bambusa pulled down about $90 million Feb. 14 in a round led by new backer RA Capital Management, with participation from new investors that included Janus Henderson Investors, Redmile Group, Invus, and ADAR1 Capital Management. All of Bambusa’s existing supporters joined as well. The money will fuel advancement of Bambusa’s lead programs through phase I trials and help beef up the pipeline. Derek DiRocco, partner at RA Capital, took a seat on Bambusa’s board as part of the deal. Bispecifics for I&I conditions make scientific sense that has drawn biotechs along with big pharma to the table, and a number of companies have in-licensed assets in the space from Asia.

Also in the news

Acurx, Alk-Abello, Astrazeneca, Avacta, Atyr, Bavarian, Biocon, Bristol Myers Squibb, Eli Lilly, Ferring, Kancera, Medicus, Orgenesis, Rigel, Schrödinger, Scpharmaceuticals, Sernova, Sun, Torqur, Unity, Virpax