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• The FDA expanded the label for the subcutaneous hemophilia drug Hympavzi, now including patients age 6 and older who have hemophilia A or B.

• The anti-tissue factor pathway inhibitor was initially approved in October of 2024 for those age 12 and older with hemophilia A or B who have not developed the antibodies—also known as inhibitors—produced by the immune system that block or destroy infused clotting factor medications.

• The new expansion covers all patients 6 and older, regardless of their inhibitor status. The new nod also opens up the treatment to those 12 and older who have developed the inhibitors.

• Hympavzi, which is the first hemophilia medicine administered by way of a pre-filled, auto-injector pen, is administered weekly and is used as a prophylactic to reduce the risk of the painful bleeding episodes that accompany the disorder. (Fierce Pharma)

• After a period of induction therapy with subcutaneous injections every two weeks, Ebglyss (lebrikizumab) can now be given every eight weeks, rather than every four weeks, which could give it a competitive edge over current IL-13-targeting drugs.

  • These drugs are namely Sanofi/Regeneron's Dupixent (dupilumab) and LEO Pharma's Adbry/Adtralza (tralokinumab), which are dosed every two or four weeks depending on patient characteristics.

• That dosing advantage – along with more selective IL-13 inhibition and strong efficacy and safety data – could translate into a $6 billion peak sales opportunity for Lilly and Almirall, which has licensed rights to the drug in Europe from Dermira.

• Lilly claimed its rights to the treatment in 2020 when it spent $1.1 billion to acquire Dermira. (Pharmaphorum)

• The FDA approved Zaynich as an intravenous treatment for complicated urinary tract infections, including pyelonephritis, in adults.

• “The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat patients facing these aggressive pathogens,” Wockhardt Chief Medical Officer Dennis Deruelle, MD, FHM, said in a company release.

• Zaynich (cefepime/zidebactam) “targets multiple penicillin-binding protein (penicillin-binding proteins 1a/b, 2, 3) simultaneously in most clinically important gram negatives expressing diverse resistance mechanisms,” providing “bactericidal activity against the most challenging drug-resistant gram-negative bacteria for which there are currently very limited treatment options,” Deruelle said. (Healio)

• Despite all the noise around massive upcoming IPOs for AI giants, a drug developer was able to attract enough investor interest to achieve the biggest Nasdaq debut the biopharma industry has ever seen.

• On Tuesday evening, Parabilis Medicines said it would sell 33.5 million shares at $20 apiece, for a total of $670 million. It will raise another $75 million in a private stock sale to its new partner Regeneron Pharmaceuticals.

• Shares of the oncology company began trading Wednesday under the ticker $PBLS.

• The IPO tops Kailera Therapeutics’ record-setting $625 million raise in April that backs phase 3 obesity trials, as well as Moderna’s 2018 IPO that raised $604 million, a record at the time. (Endpoints)

• GSK is sustaining its streak of bolt-on acquisitions, announcing Tuesday it will pay $11 billion to buy Nuvalent, a Massachusetts-based biotechnology company with two cancer medicines under FDA review.

• With the buyout, GSK plans to use the two drugs to build a franchise of lung cancer treatments that can expand further should a dual-acting therapy the London-based company is developing also gain approval.

• Nuvalent’s drugs under review are intended to treat people with lung cancer whose tumors express mutations called ROS1 and ALK, respectively.

• While drugs like Xalkori have been on the market for years treating patients with these mutations, Nuvalent has sought to develop alternatives that provide a more durable response without resistance and have fewer side effects. (Biopharma Dive)

• Lilly is keeping its spending spree going, this time investing in a back-loaded Alzheimer’s disease deal with Swedish biotech AlzeCure Pharma.

• The alliance, announced Tuesday, will involve $10 million in cash from the pharma, as well as unspecified development and commercial milestone payments, resulting in a total deal that could top $1 billion.

• AlzeCure will also be eligible for tiered mid-single-digit royalties on sales, according to the press release.

• The centerpiece of the licensing agreement is ACD680, a small-molecule modulator of the gamma-secretase enzyme that works by lowering the production of Aβ42, a pathologic form of amyloid-beta that acts as the building blocks of characteristic Alzheimer’s plaques in the brain.

• ACD680 also helps boost the production of shorter forms of amyloid-beta that don’t contribute to the toxic clumps. (BioSpace)

“We find ourselves with a biopharma industry that is in a decidedly in a more positive and optimistic position than when we spoke this time last year,” EY analyst Ashwin Singhania said during a media roundtable last week, while cautioning that there are still many challenging headwinds to navigate.

Those include economic and political disruption, cost pressures, looming patent cliffs and regulatory uncertainties.

• The analysts also cited an uptick in IPOs and the recovery of venture capital funding.

• The report is full of interesting nuggets, including the fact that a record 72 companies generated revenue of more than $500 million in 2025.

• This is occurring despite an unusual paradox in the funding landscape: While “megarounds” are being signed, more and more biotechs are in a “liquidity trap,” EY wrote.

• The landscape has produced an imbalance in the biotech industry. While total funding and revenues are up, there are fewer companies overall, with the numbers shrinking each year. Five years ago, there were 977 biotechs. Today, there are 750.

“Some non-traditional capital flew into this space that proliferated, spawned these biotechs with a concept and that kind of normalization; I would like to believe we are at the end of that cycle.”

• The studies are correlative, but appear to show that the drugs not only reverse the carcinogenic risks that come with obesity, they may also have additional anti-inflammatory effects that help suppress tumors.

• The group highlighted four studies — some of which were published in its affiliated Journal of Clinical Oncology.

• The most prominent among them tracked medical and prescription records of over 10,000 patients with early-stage cancer, and found GLP-1s reduced cancer risk in 6 out of 7 cancers — four of them at statistically significant levels.

  • Breast, liver, colorectal and non-small cell lung cancer risks declined significantly; kidney and prostate declined somewhat; pancreatic cancer rates were affected the least.

  • It's notable that the effects were seen across cancers, not just those with a known connection to obesity. For non-small cell lung cancer, for example, the incidence of progression to Stage IV disease was 22.3% for patients not on a GLP-1 versus 10% among people taking GLP-1s.

• Because the drugs act on powerful metabolic levers, they've also since proven useful against obesity, heart disease, sleep apnea, as well as potentially addiction and now cancer.

• These analyses used retrospective medical databases that did not include relevant nuances like a patient's comorbidities, or their exercise or eating habits, for example, says Dr. Julie Gralow, chief medical officer of ASCO.

"It ties into a body of knowledge about exercise and healthy lifestyles after a cancer diagnosis."