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Home » Newsletters » BioWorld

BioWorld

May 19, 2025

View Archived Issues
Elderly person receiving shot

With FDA vaccine nod, Novavax takes ACIP of new COVID-19 rules

Frets about how the new federal administration might affect prospects for vaccines were quelled at least somewhat by the U.S. FDA green light for Novavax Inc.’s COVID-19 vaccine Nuvaxovid, indicated for adults 65 and over and people 12-64 years old with at least one underlying condition that puts them at risk of severe outcomes from infection by the virus. Read More

Street a bit uneasy ahead of Urogen adcom

With a PDUFA date less than four weeks away, Urogen Pharma Inc. has been having a rough ride on the Street since the U.S. FDA released a joint briefing document for the May 21 Oncologic Drugs Advisory Committee meeting on UGN-102 (mitomycin). Read More
Sleep apnea illustration

Apnimed’s oral sleep apnea candidate hits phase III endpoints

Mirroring results reported in a phase IIb study, Apnimed Inc.’s first of two pivotal trials testing AD-109 as an oral therapy in obstructive sleep apnea hit primary and secondary endpoints. Should similar findings emerge from a second phase III trial, expected to read out in a couple of months, the privately held firm anticipates a U.S. NDA filing in early 2026. Read More
23andme saliva collection kit

Regeneron plans to buy 23andme from bankruptcy for $256M

Regeneron Pharmaceuticals Inc. was the successful bidder for 23andme Holding Co.’s personal genome service, total health and research services business lines, including its biobank and associated assets, in the bankruptcy auction to sell 23andme's assets. Read More
Stock-market-up-arrow3.png

Protagenic and Phytanix merger prompts a stock surge

The merger of Protagenic Therapeutics Inc. and Phytanix Bio Inc. combines two different approaches to treating obesity and metabolic issues. The all-stock deal will merge Protagenic’s peptide candidate in IND-enabling development for treating depression, anxiety, posttraumatic stress disorder and additional indications, along with Phytanix’s cannabinoid and cannabinoid-like molecules for bladder pain syndrome and treatment-resistant focal seizures. Read More
HKEX exterior

China’s Pegbio launches HK$300M Hong Kong IPO

China’s Pegbio Co. Ltd. launched its IPO on the Hong Kong stock exchange May 19, to raise up to HK$300.82 million (US$38.4 million) to advance visepegenatide (PB-119), its glucagon-like peptide 1 (GLP-1) receptor agonist. Read More
Abstract molecules illustration

Atzumi and Vanrafia among 3 NMEs approved by US FDA in April

The U.S. FDA approved 20 drugs for market in April, slightly down from 22 in March, 16 in February and 12 in January. This brings the total number of FDA approvals for the first four months of 2025 to 70, a decrease from 77 in the same period last year but higher than the 50 drugs approved during the first four months of 2023 and 48 in 2022. Despite the decrease from last year, the 2025 total remains the second-highest in BioWorld’s records for this time frame. Read More

ICYMI: Week in review, May 12-16, 2025

A quick look back at top stories. Read More

Biggest gainers and losers for May 12-16, 2025

The top 10 biopharma stock gainers and losers for the week. Read More

In the clinic for May 19, 2025

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ark, Camp4, Neurocrine, Rocket, Sarepta. Read More

Other news to note for May 19, 2025

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocryst, Diant, Eli Lilly, Mitsubishi, Neurogene, Quiver, Quralis, Rznomics, Sparx. Read More

Regulatory actions for May 19, 2025

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Incyte, Pharmather, Travere, Sihuan, Xuanzhu. Read More

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