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ReAlta secures $40m to advance peptide for newborn brain injury

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ReAlta Life Sciences has announced the closing of an oversubscribed $40 million financing, bringing the total capital raised to date to more than $150 million. 

The company will use the proceeds to advance pegtarazimod through key clinical and regulatory milestones as the first potential treatment for Hypoxic Ischemic Encephalopathy (HIE).  

Upcoming milestones for this first-in-class programme include completion of the Phase II STAR trial in HIE (currently underway at 13 sites across the United States), the study’s top-line data readout, and an End-of-Phase II meeting with the FDA. 

Howard Berman, Chief Executive Officer, said: “Every year, thousands of newborns suffer devastating brain injury from HIE with no approved drug therapy to offer them. Rarely in a career does one have the opportunity to work on a programme with this level of both scientific rigor and human urgency.” 

Pegtarazimod is a 15-amino-acid peptide that uniquely targets both humoral and cellular inflammation. The peptide works by inhibiting complement activation at C1, as well as myeloperoxidase activity and neutrophil extracellular trap (NET) formation – key mechanisms implicated in the inflammatory cascade underlying a broad range of diseases driven by dysregulated neutrophils and complement activity.  

Pegtarazimod was derived from a mechanistic discovery of the human astrovirus HAstV-1, a virus known to cause non-inflammatory gastroenteritis, which provided a novel scaffold for innate immune modulation. 

It has received FDA Orphan Drug and Fast Track Designations and EMA Orphan Drug Designation for HIE. 

Kia Motesharei, ReAlta’s President and Chief Operating Officer, added: “Our team is creating a new category of medicine for HIE patients where currently no drug therapeutic option is available. The financing enables us to accelerate our work toward realising that vision. The goal here is not to provide incremental improvement, but to fundamentally change how doctors treat newborn babies who develop HIE.”

The post ReAlta secures $40m to advance peptide for newborn brain injury appeared first on Drug Discovery World (DDW).

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STAT+: Up and down the ladder: The latest comings and goings

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that AstronauTx hired Michelle Mellion as chief medical officer. Previously, she held the same role at PepGen and EveryONE Medicines.

But all work and no play can make for a dull chief medical officer.

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Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that AstronauTx hired Michelle Mellion as chief medical officer. Previously, she held the same role at PepGen and EveryONE Medicines.

But all work and no play can make for a dull chief medical officer.

Continue to STAT+ to read the full story…

Read More

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FDA imposes import alert on Indian plant after inspectors flag GMP failings

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Officials sanctioned Dabur India months after FDA inspectors found bird droppings and data integrity deficiencies during an inspection of the plant.

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STAT+: Pharmalittle: We’re reading about a discontinued cancer drug, a Novo security breach, and more

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda includes promenading with the official mascots, catching another round of live musical vibes here and there, and taking pride in some folks who are dear to us. We also hope to hold yet another listening party, where the rotation will likely include this, this, this, this and this. And what about you? This is a wonderful time of year to sample the many outdoor activities popping up — street fairs, festivals, and all sorts of gatherings can be sampled. If the weather fails to cooperate, though, you could curl up with a good book, sit in front of the telly to take in one or more sporting events, or plan a needed getaway. If none of this strikes your fancy, you could simply park yourself somewhere comfortable for a while and remain zen. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

In a rare move, the nonprofit organization Blood Cancer United announced it was buying the remaining supplies of Luvelta, a discontinued investigational cancer drug, STAT reports. As part of the transaction, Blood Cancer United, previously known as the Leukemia & Lymphoma Society, also will acquire the investigational new drug designation and manage the compassionate-use program for children with a rare form of blood cancer, distributing the medication to patients at no cost while supplies last. Sutro Biopharma discontinued development in March 2025 and also eliminated a compassionate use program.

Novo Nordisk identified a security incident in which certain information, ​including patient data from some clinical trials, was copied externally without ‌authorization from its internal IT systems, Reuters notes. The company said it launched a probe with the assistance of external ​cybersecurity experts and is in contact with the relevant authorities. The potential categories of ​personal data affected may include patient ID, year of birth, sex, and health or immunogenicity data among others. Novo did not provide further details, but does not ‌believe ⁠the incident will enable any third party to identify participants in its clinical trials.

Continue to STAT+ to read the full story…

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And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda includes promenading with the official mascots, catching another round of live musical vibes here and there, and taking pride in some folks who are dear to us. We also hope to hold yet another listening party, where the rotation will likely include this, this, this, this and this. And what about you? This is a wonderful time of year to sample the many outdoor activities popping up — street fairs, festivals, and all sorts of gatherings can be sampled. If the weather fails to cooperate, though, you could curl up with a good book, sit in front of the telly to take in one or more sporting events, or plan a needed getaway. If none of this strikes your fancy, you could simply park yourself somewhere comfortable for a while and remain zen. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

In a rare move, the nonprofit organization Blood Cancer United announced it was buying the remaining supplies of Luvelta, a discontinued investigational cancer drug, STAT reports. As part of the transaction, Blood Cancer United, previously known as the Leukemia & Lymphoma Society, also will acquire the investigational new drug designation and manage the compassionate-use program for children with a rare form of blood cancer, distributing the medication to patients at no cost while supplies last. Sutro Biopharma discontinued development in March 2025 and also eliminated a compassionate use program.

Novo Nordisk identified a security incident in which certain information, ​including patient data from some clinical trials, was copied externally without ‌authorization from its internal IT systems, Reuters notes. The company said it launched a probe with the assistance of external ​cybersecurity experts and is in contact with the relevant authorities. The potential categories of ​personal data affected may include patient ID, year of birth, sex, and health or immunogenicity data among others. Novo did not provide further details, but does not ‌believe ⁠the incident will enable any third party to identify participants in its clinical trials.

Continue to STAT+ to read the full story…

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