The U.S. FDA cleared Novavax Inc.’s COVID-19 vaccine Nuvaxovid 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. The go-head triggers a $175 million milestone payment from partner Sanofi SA. Shares of Gaithersburg, Md.-based Novavax were trading at $7.26, up 53 cents.

Street 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 its briefing document for Wednesday’s advisory committee meeting on UGN-102 (mitomycin). The 505(b)(2) instilled drug is in line to become the first U.S.-approved treatment for low-grade intermediate-risk non-muscle-invasive bladder cancer, but the FDA raised concerns about the lone, single-arm trial supporting the application. In a continuing downhill jaunt that began Friday when the document was released, Urogen shares (NASDAQ:URGN) dropped to $6.42 in early morning trading today – the lowest point in at least a year. After the bell, URGN regained some traction in heavy trading, reaching a high of $7.98 – down nearly 19% from Thursday’s close of $9.85.

Apnimed’s oral sleep apnea candidate hits phase III endpoints

Mirroring results reported in a phase IIb study, Apnimed Inc.’s first phase III trial testing AD-109 as an oral therapy in obstructive sleep apnea (OSA) hit primary and secondary endpoints. A second phase III is set to read out later this year, potentially paving the way for an NDA filing in 2026. If approved, AD-109 would be the second pharmaceutical alternative for direct treatment of OSA, following U.S. FDA approval of Eli Lilly and Co.’s Zepbound (tirzepatide) in late 2024, but could offer the first with a label across patients of all weight classes.

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

Regeneron Pharmaceuticals Inc. was the successful bidder for 23andme’s personal genome service, total health and research services business lines, including its biobank and associated assets, in the bankruptcy auction to sell the assets. The $256 million transaction, which is subject to bankruptcy court and regulatory approvals, as well as other customary closing conditions, is expected to close in the third quarter of 2025. Regeneron plans to operate 23andme as a subsidiary and continue its personal genomics services while working with the independent, court-appointed customer privacy ombudsman on its planned use of customer data.

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. The combined company will be known as Phytanix Inc. Protagenic’s stock (NASDAQ:PTIX) had taken flight at midday, with shares trading 325% higher at $12.87 each. Even with the share-price leap, Protagenic was still struggling to regain the 12-month high point of $25.19 each on May 22, 2024.

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. Chinese biotechs are struggling to raise funds during this economic “winter” of uncertainty, but the Hong Kong market is warming as evidenced by recent biotech IPOs. Suzhou, China-headquartered Pegbio is offering 19.283 million H shares in its global offering, priced at HK$15.60 per share. Under the ticker 02565, the shares will begin trading on May 19 and end trading on May 22.

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. April saw the approval of three new molecular entities (NMEs), matching the number approved in January and surpassing the two NMEs approved in both February and March.

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