Arena Pharmaceuticals, Inc.

United Therapeutics said its pulmonary arterial hypertension drug ralinepag succeeded in a Phase 3 study, setting the drugmaker up for an FDA approval request this year and a potential launch in 2027. Pulmonary arterial hypertension is a form of high blood pressure in the lungs that strains the heart’s ability to get blood to the rest of the body. In the seven-year-long pivotal trial, the oral medicine slashed the risk of “clinical worsening” events by 55% compared to placebo (p < 0.0001). Most of that benefit was due to fewer patients’ disease progressing, rather than reductions in hospitalizations or deaths, according to investment analysts at Cantor. CEO and chair Martine Rothblatt said during an analyst call on Monday that ralinepag worked in every subgroup analyzed. In addition to hitting the clinical worsening primary endpoint, it also hit “several important” secondary goals in the Phase 3 ADVANCE OUTCOMES trial, United said. United paid $800 million upfront to Arena Pharmaceuticals for ralinepag in 2018. Arena could also get up to $400 million in milestone payments and low double-digit royalties on drug sales under that deal. Pfizer bought Arena for $6.7 billion a few years later. An approval of ralinepag could greatly expand United’s reach. The drugmaker, which had a market value of about $23 billion prior to Monday’s readout, could treat “more patients than all of our current drugs combined” if the experimental medicine gets approved by regulators, Rothblatt said on the analyst call. The shares $UTHR were up about 3% on Monday. “There are days for which you work your entire life, and this is that day for me and dozens of my teammates at United Therapeutics,” said Rothblatt, who founded United in the mid-1990s. “When, like me, you have a daughter with pulmonary hypertension, slashing the likelihood of disease progression is everything,” Rothblatt said. United markets multiple medicines for PAH, including Tyvaso, Orenitram, Remodulin and Adcirca. Ralinepag is an oral prostacyclin, which relaxes vascular muscles to reduce pressure on blood vessels. Johnson & Johnson markets the selective prostacyclin IP receptor agonist known as Uptravi. Patients with PAH have gained access to new treatments in recent years with Merck’s activin signaling inhibitor Winrevair . Other drugmakers are looking to enter the field, with GSK saying last week it would pay $950 million for 35Pharma and its early-stage drug HS235.

Biotech showed 85% patient improvement in Phase 2a trial—zero approved treatments exist for persistent concussion symptoms BOSTON , Jan. 7, 2026 /PRNewswire/ -- Oxeia Biopharmaceuticals today launched an equity crowdfunding campaign on StartEngine to advance OXE103, a therapy for persistent concussion symptoms that demonstrated an 85% responder rate in Phase 2a clinical testing. The company is targeting Phase 2b enrollment of 160 patients beginning in 2026, positioning OXE103 as what could become the first approved treatment for a condition affecting millions of Americans. Between 1.4 and 4.2 million Americans develop persistent concussion symptoms each year. These patients experience headaches that last for months, cognitive impairment that makes work and school impossible, and lives upended by symptoms that stretch far beyond normal recovery timelines. Standard imaging detects no structural damage. Without visible pathology to treat, physicians offer rest as the only intervention—an approach that fails to address the underlying metabolic dysfunction driving persistent symptoms. "I watched teammates deal with symptoms for months with no treatment options," said Alex Smith, who suffered a career-altering concussion in 2012 playing quarterback for the San Francisco 49ers. Smith, now an ESPN analyst, joined Oxeia's board as investor after reviewing the Phase 2a data. "This is the first time I've seen real clinical evidence that a treatment could help patients recover." The Phase 2a clinical trial at University of Kansas Medical Center showed an 85% responder rate among patients treated with OXE103, compared to 33% of patients receiving standard care alone. Treated patients demonstrated reduction in symptom severity and improvement in quality of life, representing what the company believes is the first clinically meaningful improvement shown in persistent concussion patients. Oxeia's development timeline has been significantly accelerated through a licensing agreement providing access to over $100 million in development data from Daiichi Sankyo Pharmaceuticals, including clinical studies where more than 300 patients across multiple indications were treated with ghrelin. This eliminated an estimated 5 to 7 years of early-stage safety testing, allowing Oxeia to advance directly to Phase 2 efficacy trials. "We're funding the Phase 2b trial that could establish the first approved concussion treatment," said Michael Wyand, CEO of Oxeia Biopharmaceuticals. "We're validating the endpoints that create the regulatory pathway for the entire industry. For the first time, there's a real path to bringing treatment to millions of patients who have no options." The Phase 2b trial will enroll 160 patients at major academic medical centers beginning in 2026. Public investors can purchase equity through the SEC-qualified offering on StartEngine with a minimum investment of $500. To invest in Oxeia Biopharmaceuticals, visit About Oxeia Biopharmaceuticals Headquartered in Boston, MA, Oxeia Biopharmaceuticals is a privately held clinical-stage biotech company developing OXE103 for persistent concussion symptoms. The company's founding team has $9 billion in prior combined exits, including Arena Pharmaceuticals' $6.7 billion Pfizer acquisition and Kythera Biopharmaceuticals' $2.1 billion Allergan acquisition. For more information, visit This Reg CF offering is made available through StartEngine Primary LLC, member FINRA/SIPC. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment. Contact: Frank Pietrucha fpietrucha@oxeiabiopharma.com +1 (202) 253-7376 View original content to download multimedia: SOURCE Oxeia Biopharmaceuticals, Inc.

Biotech showed 85% patient improvement in Phase 2a trial—zero approved treatments exist for persistent concussion symptoms BOSTON, Jan. 7, 2026 /PRNewswire/ -- Oxeia Biopharmaceuticals today launched an equity crowdfunding campaign on StartEngine to advance OXE103, a therapy for persistent concussion symptoms that demonstrated an 85% responder rate in Phase 2a clinical testing. The company is targeting Phase 2b enrollment of 160 patients beginning in 2026, positioning OXE103 as what could become the first approved treatment for a condition affecting millions of Americans. Between 1.4 and 4.2 million Americans develop persistent concussion symptoms each year. These patients experience headaches that last for months, cognitive impairment that makes work and school impossible, and lives upended by symptoms that stretch far beyond normal recovery timelines. Standard imaging detects no structural damage. Without visible pathology to treat, physicians offer rest as the only intervention—an approach that fails to address the underlying metabolic dysfunction driving persistent symptoms. "I watched teammates deal with symptoms for months with no treatment options," said Alex Smith, who suffered a career-altering concussion in 2012 playing quarterback for the San Francisco 49ers. Smith, now an ESPN analyst, joined Oxeia's board as investor after reviewing the Phase 2a data. "This is the first time I've seen real clinical evidence that a treatment could help patients recover." The Phase 2a clinical trial at University of Kansas Medical Center showed an 85% responder rate among patients treated with OXE103, compared to 33% of patients receiving standard care alone. Treated patients demonstrated reduction in symptom severity and improvement in quality of life, representing what the company believes is the first clinically meaningful improvement shown in persistent concussion patients. Oxeia's development timeline has been significantly accelerated through a licensing agreement providing access to over $100 million in development data from Daiichi Sankyo Pharmaceuticals, including clinical studies where more than 300 patients across multiple indications were treated with ghrelin. This eliminated an estimated 5 to 7 years of early-stage safety testing, allowing Oxeia to advance directly to Phase 2 efficacy trials. "We're funding the Phase 2b trial that could establish the first approved concussion treatment," said Michael Wyand, CEO of Oxeia Biopharmaceuticals. "We're validating the endpoints that create the regulatory pathway for the entire industry. For the first time, there's a real path to bringing treatment to millions of patients who have no options." The Phase 2b trial will enroll 160 patients at major academic medical centers beginning in 2026. Public investors can purchase equity through the SEC-qualified offering on StartEngine with a minimum investment of $500. To invest in Oxeia Biopharmaceuticals, visit About Oxeia Biopharmaceuticals Headquartered in Boston, MA, Oxeia Biopharmaceuticals is a privately held clinical-stage biotech company developing OXE103 for persistent concussion symptoms. The company's founding team has $9 billion in prior combined exits, including Arena Pharmaceuticals' $6.7 billion Pfizer acquisition and Kythera Biopharmaceuticals' $2.1 billion Allergan acquisition. For more information, visit This Reg CF offering is made available through StartEngine Primary LLC, member FINRA/SIPC. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment. Contact: Frank Pietrucha [email protected] +1 (202) 253-7376 SOURCE Oxeia Biopharmaceuticals, Inc. 21% more press release views with Request a Demo