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Odyssey raises more than $300M as biotech goes public in IPO

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Odyssey Therapeutics pulled together $279 million from its initial public offering, the autoimmune disease drug developer said Thursday night.

With its IPO now priced, Odyssey is slated to begin trading on the Nasdaq on Friday …

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ParcelBio Unveils Programmable mRNA Platform Backed by $13M Financing

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Biotechnology company ParcelBio said this week that it has raised $13 million in a seed financing round led by Breyer Capital with participation from General Catalyst, Y Combinator, Metaplanet, SurgePoint Capital, ZAKA VC, and other investors. The financing will support the development of the company’s proprietary Amplified and Prolonged EXpression mRNA (APEXm™) platform and advance its pipeline including an in vivo CAR T program for autoimmune disease, as well as additional programs in oncology and encoded protein therapeutics.

The company, which is developing what it describes as a new class of durable mRNA medicines, will debut APEXm and share some preclinical data at the American Society of Gene and Cell Therapy annual meeting. This year’s meeting is being held in Boston, Massachusetts and will run from May 11-15. The company claims that its data will demonstrate that ParcelBio’s APEXm RNA drives significantly higher and more durable protein expression compared to another clinical mRNA design, and yields more complete target cell depletion in in vivo CAR T models. 

“mRNA has transformed medicine, but today’s technologies are fundamentally limited in how much protein they can produce and for how long,” said David Weinberg, PhD, chief executive officer and co-founder of ParcelBio. His company’s proprietary technology addresses this problem by engineering RNA molecules to recruit the cell’s native RNA-stabilizing machinery, which enables higher and more durable protein expression. The company claims that its approach will result in medicines that reach thresholds that have historically been challenging for mRNA-based therapeutics. “We engineered RNA to work with the cell’s machinery rather than against it, enabling meaningful improvements in both expression and durability that we believe are essential for true disease modification,” Weinberg said. 

Furthermore, ParcelBio’s platform maintains a simple, linear RNA architecture unlike circular RNA and other approaches, whose structure introduces manufacturing complexity or reduces output. Its broad applicability across proteins and cell types makes it suited for various therapeutic applications including immune programming and protein replacement. 

“Most RNA platforms force a tradeoff between potency, durability, and manufacturability,” said Chris Carlson, PhD, chief scientific officer and co-founder of ParcelBio. “Our approach eliminates that tradeoff, enabling both higher peak expression and longer duration within a manufacturable system, and opening the door to entirely new classes of medicines.”

ParcelBio’s lead program focuses on in vivo CAR T therapies that target pathogenic B cells across autoimmune diseases, with the goal of achieving deep B-cell depletion for durable, drug-free remission. By enabling sustained CAR expression without viral delivery or ex vivo manufacturing, the company aims to develop scalable, off-the-shelf therapies. Additional programs leveraging the technology are currently in development in oncology and encoded protein therapeutics.

The post ParcelBio Unveils Programmable mRNA Platform Backed by $13M Financing appeared first on GEN – Genetic Engineering and Biotechnology News.

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FDA to reevaluate spurned cell therapy; Under-the-skin Leqembi review extended

Pierre Fabre claims to now be “aligned” with U.S. regulators on the path forward for a twice-rejected treatment. Elsewhere, Argenx swapped CEOs and Blackstone made a $250 million biotech investment.

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Pierre Fabre claims to now be “aligned” with U.S. regulators on the path forward for a twice-rejected treatment. Elsewhere, Argenx swapped CEOs and Blackstone made a $250 million biotech investment.

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STAT+: Pharmalittle: We’re reading about an FDA gender rule change, its program for one-day inspections, 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 is still shaping up, but will certainly include promenading with the official mascots, catching up on our reading, and taking a nap or two. We also hope to hold another listening party, where the rotation will likely include this, this, this, this and this. And what about you? The possibilities are endless this time of year, yes? You could enjoy the great outdoors, stream the hours away if the weather fails to cooperate, or rifle through your ever-growing to-do list. Or maybe you simply plan the rest of your life. Well, whatever you do, have a grand time. But be safe. And if mom is around somewhere, remember to say hello. See you soon. …

A proposal by the U.S. Food and Drug Administration to remove references to “gender” from its regulations sparked concerns about unintended consequences on research on gender minority populations, Bloomberg News explains. The FDA issued its proposed rule this week, citing instructions laid out in a 2025 executive order from President Trump, as the administration emphasizes “biological sex” across federal government policies and practices. The Trump administration has supercharged efforts to signal there are only two biological sexes. The FDA said the policy is unlikely to change much, stating the proposal “does not impact industry practice” and they “do not anticipate any measurable change in industry.” But some legal experts see potential for broader impacts on how drugs are tested or who is represented in clinical trials, especially among groups that are traditionally underrepresented in research.

Louisiana urged the U.S. Supreme Court to prevent abortion pills from being prescribed through telemedicine and distributed by mail, as the Republican-led state presses its case to overturn a 2023 federal rule that made access to ​the medication easier, Reuters writes. In a filing, Republican Louisiana Attorney General Liz Murrill asked the justices to deny emergency requests by two manufacturers of ‌the abortion pill to lift a lower court’s decision that narrowed access to it by blocking the regulation nationwide while the state’s legal challenge continues. The regulation concerning the medication, called mifepristone, was issued by the FDA during Democrat Joe Biden’s presidency. Murrill’s office said the regulation has allowed medication abortions to skyrocket despite the state’s near-total ban on abortion.

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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 is still shaping up, but will certainly include promenading with the official mascots, catching up on our reading, and taking a nap or two. We also hope to hold another listening party, where the rotation will likely include this, this, this, this and this. And what about you? The possibilities are endless this time of year, yes? You could enjoy the great outdoors, stream the hours away if the weather fails to cooperate, or rifle through your ever-growing to-do list. Or maybe you simply plan the rest of your life. Well, whatever you do, have a grand time. But be safe. And if mom is around somewhere, remember to say hello. See you soon. …

A proposal by the U.S. Food and Drug Administration to remove references to “gender” from its regulations sparked concerns about unintended consequences on research on gender minority populations, Bloomberg News explains. The FDA issued its proposed rule this week, citing instructions laid out in a 2025 executive order from President Trump, as the administration emphasizes “biological sex” across federal government policies and practices. The Trump administration has supercharged efforts to signal there are only two biological sexes. The FDA said the policy is unlikely to change much, stating the proposal “does not impact industry practice” and they “do not anticipate any measurable change in industry.” But some legal experts see potential for broader impacts on how drugs are tested or who is represented in clinical trials, especially among groups that are traditionally underrepresented in research.

Louisiana urged the U.S. Supreme Court to prevent abortion pills from being prescribed through telemedicine and distributed by mail, as the Republican-led state presses its case to overturn a 2023 federal rule that made access to ​the medication easier, Reuters writes. In a filing, Republican Louisiana Attorney General Liz Murrill asked the justices to deny emergency requests by two manufacturers of ‌the abortion pill to lift a lower court’s decision that narrowed access to it by blocking the regulation nationwide while the state’s legal challenge continues. The regulation concerning the medication, called mifepristone, was issued by the FDA during Democrat Joe Biden’s presidency. Murrill’s office said the regulation has allowed medication abortions to skyrocket despite the state’s near-total ban on abortion.

Continue to STAT+ to read the full story…

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