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BioWorld - Saturday, May 2, 2026
Home » Authors » Randy Osborne

Articles by Randy Osborne

Hand pointing at digital M&A screen

Low frequency sounds good to Biocryst in $700M Astria HAE buy

Oct. 14, 2025
By Randy Osborne
No Comments
Biocryst Pharmaceuticals Inc.’s near-term dilution should “pave the way for entrenchment” in the hereditary angioedema (HAE) space, thanks to the buyout of Astria Therapeutics Inc., RBC analyst Brian Abrahams said.
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Stomach and esophagus

Gastroesophageal push goes on; Jazz data soon

Oct. 10, 2025
By Randy Osborne
No Comments
A paper last month in the Journal of Clinical Oncology reported on the pooled analysis of data showing that the use of neoadjuvant immune checkpoint inhibitors work better than the frequently used FLOT regimen (fluorouracil, leucovorin, oxaliplatin and docetaxel) in certain gastroesophageal adenocarcinoma (GEA) cancers. But there’s plenty more coming down the pike, even as scientific knowledge about the disease advances.
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Going public ticker

Stock skyrockets after Turn goes public

Oct. 9, 2025
By Randy Osborne
No Comments
An uncommon route to the public markets – direct listing – paid off for Turn Therapeutics Inc., with shares (NASDAQ:TTRX) closing Oct. 9 at $9.20, up $2.20, or 31%, having risen as high as $26.50 in its second day of trading. The firm is advancing late-stage clinical programs in eczema and onychomycosis. Also in the works are global health initiatives in thermostable vaccine delivery designed to serve underserved areas.
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Glucose monitor on arm with smartphone

SAB story? T1D competitors may cry on further ATG data

Oct. 3, 2025
By Randy Osborne
No Comments
Although type 2 diabetes tends to get more airtime, type 1 diabetes also had drawn a number of the developers to the table. Recently winning the attention of Wall Street is SAB Biotherapeutics Inc., which offered data during the European Association for the Study of Diabetes annual meeting. Vertex Pharmaceuticals Inc. and Biomea Fusion Inc. are among the other players.
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Abortion dispute active, FDA clears new generic pill

Oct. 3, 2025
By Randy Osborne
No Comments
With U.S. President Donald Trump’s administration vocally opposed to abortion, the U.S. FDA has approved a new generic version of the pill that makes the procedure possible medically: mifepristone, once better known as RU-486.
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Eye chart and teen with laser over eye

Magnum Opus: Street drinks in LCA5 gene therapy phase I/II data

Sep. 30, 2025
By Randy Osborne
No Comments
Opus Genetics Inc. will be sitting down with the U.S. FDA to talk about positive three-month data from the pediatric cohort of its ongoing phase I/II trial called OPGx-LCA5-1001 – partially funded by the agency – evaluating OPGx-LCA5, a gene augmentation therapy for ultra-rare Leber congenital amaurosis type 5 (LCA5). The affliction is a severe form of retinal dystrophy that renders babies blind in the first year of life.
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Generic injection pens

Larimar above par in FA despite anaphylaxis penalty

Sep. 29, 2025
By Randy Osborne
No Comments
Anaphylaxis rates caused Larimar Therapeutics Inc.’s stock (NASDAQ:LRMR) to take a hit on the latest data from an open-label study with nomlabofusp in the neuromuscular disease Friedreich’s ataxia (FA), but the company is targeting a BLA submission to seek accelerated approval in the second quarter of next year.
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Palsonify

Room for growth in acromegaly as Crinetics’ Palsonify cleared

Sep. 26, 2025
By Randy Osborne
No Comments
Crinetics Pharmaceuticals Inc.’s green light under priority review from the U.S. FDA for Palsonify (paltusotine) in first-line acromegaly sets up a not-uncommon David vs. Goliath-type scenario in the indication caused by excessive growth hormone made by the pituitary gland.
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3D illustration of pancreatic cancer

To vanquish pancreatic at last? Immuneering scores in phase II

Sep. 25, 2025
By Randy Osborne
No Comments
Nailing down what Oppenheimer analyst Jay Olson characterized as “a trifecta,” Immuneering Corp. unveiled positive updated survival and safety data from the ongoing phase IIa trial testing oral, once-daily MEK inhibitor atebimetinib (IMM-1-104) in combination with modified gemcitabine/nab-paclitaxe in first-line pancreatic cancer patients.
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One dice with a green checkmark, red X and gray question mark.

REMS in spotlight after Agios, Cytokinetics delayed

Sep. 24, 2025
By Randy Osborne
No Comments
Word Sept. 4 from Agios Pharmaceuticals Inc. that the U.S. FDA extended the PDUFA date for the sNDA related to Pyrukynd (mitapivat), after the Cambridge, Mass.-based firm submitted a proposed risk evaluation and mitigation strategy (REMS), drew Wall Street’s attention to the regulatory approach.
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