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• The FDA approved Utebzi (tebipenem pivoxil) for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, making it the first oral carbapenem antibiotic available in the US for this indication.

• The approval offers a new treatment pathway for patients who have historically required intravenous (IV) therapy, particularly in cases involving drug-resistant pathogens.

• The FDA approval is supported by results from the phase 3 PIVOT-PO trial, which were presented as a late-breaking oral abstract at IDWeek 2025. The trial was stopped early for efficacy following a planned interim analysis in May 2025. (Contemporary OB/GYN)

• Sanofi’s antibody therapy Tzield (teplizumab-mzwv) is now approved for the treatment of type 1 diabetes in pediatric patients—an approval that comes amid reported internal disagreements about the drug at the agency and the use of a controversial voucher program for accelerating review times.

• Tzield’s label expansion, granted under the FDA’s accelerated pathway, extends the drug’s use to patients ages eight through 17 years who have recently been diagnosed with stage 3 type 1 diabetes, delaying the decline in endogenous insulin production in these patients.

• Tzield’s continued approval in this setting and indication will depend on the validation of clinical benefit in a confirmatory study.

• Sanofi has launched the Phase 3 BETA-PRESERVE trial to fulfill this requirement. The trial is currently recruiting participants and is expected to readout in 2028. (BioSpace)

• Merck & Co.’s first-in-class HIF-2 alpha inhibitor Welireg (belzutifan) is touching down in the clear cell renal cell carcinoma (ccRCC) treatment space, notching a Keytruda combination nod that stands to pad the landing for the company’s post-Keytruda outlook.

• The FDA approval is the first for a PD-1 and HIF-2a inhibitor combo, stipulating the regimen’s use as an adjuvant treatment for adults with ccRCC who are at intermediate-high or high risk of recurrence following kidney removal surgery.

• Welireg can be used in the disease setting with standard Keytruda or subcutaneous Keytruda Qlex.

• With that, Welireg can reach earlier-stage ccRCC for the first time following its 2023 clearance in advanced RCC. (Fierce Pharma)

• At the meeting, the FDA said a three-year analysis from a phase 1/2 study would be acceptable as the primary basis of a filing for accelerated approval of AMT-130 in Huntington’s, uniQure said in a June 17 release.

• The FDA previously ruled the three-year analysis insufficient to support a filing for accelerated approval.

• The biotech’s share price surged 80% to $48.51 in premarket trading on the back of the news.

• Investors also drove small upticks in the share price of biotechs, including Rezolute and Regenxbio, potentially reflecting hopes that the U-turn indicates the FDA is increasingly flexible on rare disease evidence requirements.

• Former FDA leaders Marty Makary, M.D., and Vinay Prasad, M.D., held top positions at the agency when uniQure first discussed filing for accelerated approval, but both have since left the agency.

The agency “seeks to align on the confirmatory study design” before the submission for accelerated approval, uniQure said.

UniQure and the FDA are seeking alignment on using concurrent control in standard-of-care therapy rather than the previously requested sham procedure.

• Confirmatory trials typically need to be underway before the FDA grants accelerated approval.

• In some cases, the FDA may require the sponsor to have fully enrolled the confirmatory trial at the time of approval. (Fierce Biotech)

• Edgewise Therapeutics said its experimental heart disease drug hit the goals of a phase 2 clinical trial, reducing signs of disease and biological markers in two types of cardiomyopathy and supporting advancement of the medicine into pivotal studies.

• The biotechnology company is testing its pill, called EDG-7500, in both the obstructive and non-obstructive forms of cardiomyopathy, seeking to improve blood flow and relieve heart failure symptoms in people whose hearts have thickened and weakened as their disease progressed.

• The trial data come two weeks after Edgewise wagered the company’s future on cardiovascular disease by selling off its experimental muscular dystrophy pipeline.

• In cardiomyopathy, Edgewise will have hefty competition, however, as it would face Bristol Myers Squibb’s Camzyos and Cytokinetics’ Myqorzo in the obstructive form of the disease. (BioPharma Dive)

• Corvus Pharmaceuticals’ founder and CEO Dr. Richard Miller isn’t as interested in simply making incremental treatment improvements.

• “Why not change the game if you can?” he said. As co-founder of Idec, the company that developed the first FDA-approved monoclonal antibody for cancer, Rituxan, Miller knows something about changing the game.

• Now, at Corvus, Miller believes he’s once again at the helm of something transformative, thanks to the company’s lead candidate, soquelitinib, which showed the possibility of long-term remission in atopic dermatitis even after stopping therapy.

• “It’s Rituxan all over again,” said Miller. “I mean, it’s different. It’s not an antibody. But philosophically, I think it’s Rituxan all over again.”

• Like Rituxan, which is approved in both oncology, autoimmune and rheumatologic indications, Corvus believes soquelitinib has potential to treat cancers as well as allergic and autoimmune diseases. (PharmaVoice)

• Lundbeck reported positive mid-stage results with Cushing's disease therapy asedebart, one of four experimental drugs the Danish pharma group is banking on to deliver growth as it prepares for a patent cliff before the end of the decade.

• Anti-adrenocorticotropic hormone (ACTH) asedebart is designed to reduce the production of the stress hormone cortisol in Cushing's disease, a condition caused by a non-cancerous tumor on the pituitary gland.

• In preliminary data from a phase 2a trial reported at the ENDO 2026 conference, asedebart was shown to normalize levels of urinary free cortisol (UFC) – a biomarker for Cushing's disease – in seven of eight evaluable patients. (Pharmaphorum)

• The American Civil Liberties Union tracked 530 anti-LGBTQ bills across dozens of states this year.

• Nearly 40% of US workers say their employers rolled back diversity, equity and inclusion programs.

• More than a quarter of LGBTQ+ adults reported being less out in the workplace over the past 12 months.

• That’s why, for Endpoints News’ annual special report on LGBTQ+ leaders in biopharma this year, we are taking a look at how trends around inclusion and individual experiences cut through the various job functions that make up the industry.

• We’re showcasing six voices from some pockets of the industry not previously highlighted, including an HR leader, an analyst and a lawyer.