Lakefront Biotherapeutics Plans 2027 Registrational Trials for Gamgertamig

Roche announced new one-year data from the Phase III MEERKAT and SANDCAT studies showing that investigational vamikibart sustained improvements in vision and reductions in macular thickness in adults with uveitic macular edema at 52 weeks compared with a sham procedure. The results were presented at the American Academy of Ophthalmology 2026 Annual Meeting in New Orleans. The FDA has accepted Roche's Biologics License Application for vamikibart for the treatment of UME, with an approval decision expected by July 2027; if approved, vamikibart would be the first non-steroid targeted treatment for UME. Regulatory submissions have also been filed and accepted in the European Union, China and Japan. In both trials, a numerically higher proportion of vamikibart-treated patients achieved vision gains than those on sham treatment on the primary endpoint, and key secondary endpoints showed sustained improvements in best corrected visual acuity and central subfield thickness. Vamikibart was well tolerated with a low incidence of treatment-related ocular adverse events and intraocular inflammation events, and approximately two-thirds of eligible patients required no retreatment after 16 weeks.

argenx halted its Phase 3 Sjögren's trial for futility while reporting encouraging data for FB102 in celiac disease, a mixed pipeline update that reshapes expectations for the company's future earnings. The news comes after argenx delivered a share price gain of 185.3% over the past 5 years. On valuation, argenx trades at about 29.7x earnings, above the broader biotech industry average of roughly 25.0x but below the peer group average of about 36.3x. The halted Sjögren's trial removes one potential earnings stream, while the FB102 celiac data points to a different route to future profits, leaving investors to weigh near-term pipeline risk against an already established earnings base. Community views on argenx are split, with a bull case putting the stock 43% undervalued and a bear case putting it 6% overvalued.

TRex Bio, an Eli Lilly-backed developer of immunoregulatory medicines targeting tissue regulatory T-cell biology, closed its first day of trading Friday at its IPO price of $14. Shares opened at $13.50 and traded mostly below $14 throughout the day, though they briefly shot up to $15.50 right before the market close. In after-hours trading, the share price stood at $14.52. The company had priced its $117M U.S. IPO at $14 per share, after earlier targeting up to $133M.

Johnson & Johnson will report its third-quarter 2026 results on Oct. 13, with the Zacks Consensus Estimate pegged at $25.37 billion in sales and $2.66 per share in earnings. Over the past 60 days, the consensus estimate for 2026 earnings has declined from $11.48 to $11.21 per share, while the 2027 estimate has fallen from $12.81 to $12.17. J&J has an Earnings ESP of +2.10% and a Zacks Rank #3 (Hold), and it exceeded earnings expectations in each of the trailing four quarters, delivering an average surprise of 1.39%. Within the Innovative Medicine segment, consensus estimates stand at $4.33 billion for Darzalex, $2.24 billion for Tremfya and $1.07 billion for Erleada, while Stelara sales are seen at $634.0 million and Imbruvica at $602.0 million, with Stelara's loss of exclusivity having cut the segment's growth by 760 basis points in the second quarter. The MedTech segment carries a consensus estimate of $8.77 billion, and J&J still expects to generate more than $100 billion in revenues in 2026 after $49.4 billion in the first half.