What happened since Friday
Market tape
XBI closed September 25 at $155.03, −0.65%.
IBB closed at $209.77, +0.25%.
The Nasdaq Biotechnology Index closed at 7,084.39, +0.07%.
The S&P 500 closed at 7,743.41, +0.51%.
The Nasdaq Composite closed at 27,068.72, +0.48%.
XBI underperformed IBB by 0.90 percentage points, underperformed NBI by 0.72 points, and underperformed the S&P 500 and Nasdaq Composite by 1.16 and 1.13 points, respectively.
Rates and brief impact
The 2-year Treasury yield ended September 25 at 4.81%, down 6 basis points from September 24; the 10-year Treasury yield was 5.17%, down 1 basis point. Lower yields reduce the discount-rate pressure on future biotech cash flows, although Friday’s XBI return lagged the broader indexes.
Deals, access and financing
OSE Immunotherapeutics (OSE), listed in Paris, reported €11.1 million of cash at June 30, down from €17 million at March 31, and said its runway extends through December 2026. In the same update, it moved the Phase 3 ARTEMIA Tedopi futility analysis to early 2027 because fewer deaths than expected had occurred. No verified post-news OSE quote was available as of the research cutoff.
NeuroSense Therapeutics (NRSN) reported just $231,000 in cash and equivalents at June 30 and said it is pursuing financing and strategic alternatives for its PrimeC ALS program. It targets a Canadian New Drug Submission in December 2026; its proposed US pivotal design remains subject to FDA alignment. Nasdaq shares last traded at $7.07, up 1.71% against Friday’s $6.95 regular close, at 19:37 EDT on September 25 in after-hours trading. No Monday premarket trade was verified.
Regulatory and clinical news
Kodiak Sciences (KOD) said both Zenkuda and tabirafusp-ted met the one-year Phase 3 DAYBREAK primary endpoint of visual-acuity noninferiority to aflibercept in treatment-naive wet age-related macular degeneration, with reported p-values of 0.0007 and 0.0036. It said 54% of Zenkuda patients reached 24-week dosing and plans a three-indication Zenkuda biologics application in the fourth quarter. Nasdaq shares were $52.44, up 62.10% from Friday’s $32.35 regular close, at 08:12 EDT on September 28 in premarket trading.
Mirum Pharmaceuticals (MIRM) and Incyte announced Friday evening that FDA approved Atebrioz, zilurgisertib, for patients aged 12 and older with fibrodysplasia ossificans progressiva to reduce new heterotopic bone formation. Mirum holds exclusive worldwide rights under its Incyte license. MIRM was $91.10, up 1.56% from Friday’s regular close, at 07:31 EDT on September 28 in premarket trading.
Pharming Group (PHAR), whose PHAR security is a Nasdaq ADS, said FDA accepted and granted priority review to lower-dose Joenja for children with APDS aged at least four and weighing 13–27 kg. The decision target is January 30, 2027; acceptance is not approval. PHAR last traded at $10.89, up 4.11% against Friday’s $10.46 regular close, at 19:46 EDT on September 25 after hours. No Monday premarket trade was verified.
Innovent Biologics (1801.HK) expanded the global Phase 3 MarsLight-11 trial of IBI363/TAK-928 to include non-squamous as well as squamous non-small-cell lung cancer after platinum chemotherapy and PD-1 or PD-L1 therapy. Its Hong Kong shares were HK$96.15, down 3.56% for the September 28 session at 16:08 HKT; the full-session move should not be attributed solely to the trial change.
Related listed read-through: 4502.T | Takeda | Direct co-development exposure, with exclusive rights outside the US and Greater China and shared US commercialization | ¥5,930, down 0.65%, at 15:30 JST on September 28, Tokyo regular close. No clear verified read-through.
Akeso (9926.HK) enrolled the first patient in global Phase 3 COMPASSION-37, comparing cadonilimab with nivolumab in first-line gastric cancer. Its Hong Kong shares were HK$92.00, down 1.66% at 16:08 HKT on September 28. The announcement arrived during Hong Kong trading, so the full-session return includes trading before the news.
What to watch
What to watch this week
The dated overview runs from the Monday research cutoff through Sunday, October 4 at 23:59 BST. Events with published times follow their actual chronological order; the date-only FDA target cannot be placed more precisely.
September 28, 08:30 EDT: Kodiak (KOD) holds its DAYBREAK Phase 3 results webcast. Confirmed. The topline result was already released before the cutoff.
September 28, 08:30 ET (EDT): Mirum (MIRM) is scheduled to share Phase 3 AZURE-1 brelovitug topline results in chronic hepatitis delta on an investor call. Confirmed; results had not been verified at the cutoff.
September 28, time and timezone unspecified: Egetis Therapeutics (EGTX) has an FDA target action date for Emcitate, tiratricol, in MCT8 deficiency. Confirmed target date; decision time unspecified, so its position relative to the cutoff cannot be established.
September 30, 07:00 CEST: Q32 Bio (QTTB) has a scheduled poster on Phase 2a SIGNAL-AA alopecia areata data. Confirmed.
September 30, 08:30 ET (EDT): The US Bureau of Economic Analysis schedules its GDP estimate and August personal income and outlays releases. Confirmed.
September 30, 15:15 CEST: Q32 Bio (QTTB) has the scheduled SIGNAL-AA oral presentation. Confirmed.
October 2, 08:30 ET (EDT): The US Bureau of Labor Statistics schedules its September employment report. Confirmed.