Every biotech catalyst, with the filing sentence it came from.

Zai Lab plans to submit IND for ZL-1311 in the U.S. by YE'26.

Vopimetostat plus daraxonrasib demonstrated 82% ORR, median PFS not reached, and 88% 9-month PFS rate in 22 patients with 2L/3L MTAP-deleted PDAC.

Vopimetostat plus zoldonrasib showed 54% ORR, 61% 9-month PFS rate, and 97% DCR in 35 efficacy-evaluable PDAC patients.

ASPIRE trial passes pre-planned futility analysis with iDMC recommending continuation without modification; 52-week topline results expected mid-2027.

Company submitted supplemental NDA to FDA for a second supplier for ONAPGO, with potential approval by mid-year 2027.

Izicopan demonstrated significant renal protection in pre-clinical hamster models of kidney injury.

Revita met six-month co-primary endpoint in REMAIN-1 Pivotal Cohort with high statistical significance in weight regain versus sham.

FDA accepts NDA resubmission for troriluzole in SCA with PDUFA goal date in Q1 2027 and plans advisory committee meeting.

Ultomiris received accelerated FDA approval as the first and only C5 complement inhibitor to reduce proteinuria in adults with primary IgAN.

argenx submitted an sBLA for VYVGART in ocular myasthenia gravis (oMG) to the FDA.

The FDA assigned a PDUFA date of February 18, 2027 for VYVGART in ocular MG.

OPTIMAL-PSMA Phase 2 study completed enrollment of 120 patients, with data readout expected in first half of 2027.

CLARITY-1 met its primary endpoint of time to treatment failure: HR 0.27 (95% CI 0.17-0.43), week-48 failure 35.4% vs 78.7% on placebo, p<0.0001; all key secondaries significant.

CLARITY-2 met its primary endpoint of time to treatment failure: HR 0.22 (95% CI 0.14-0.34), week-48 failure 32.4% vs 77.8% on placebo, p<0.0001; all key secondaries significant.

B-WELL phase III trials demonstrated 19% functional cure rate with bepirovirsen versus 0% with placebo in adults with ≤3000 IU/ml HBsAg.

Randomized Phase 2 (n=253) met primary endpoint: 3.1-point placebo-adjusted YMRS improvement at Week 3 (15.4 vs 12.3 points, p=0.045); CGI-BP-S secondary also met (0.4, p=0.024); well tolerated.

Single-patient compassionate use case report shows QRX003 improved skin from severe to clear with complete elimination of pruritus over 21 months.

Open-label Phase 2a induction met primary endpoint: mean 2.4-point reduction in modified Mayo score at Week 12 (p<0.001); clinical remission 27% at 20 mg BID (n=41) and 20% at 10 mg BID (n=15).

OD-001 Phase 2a trial met primary endpoint of mean 2.4-point reduction in modified Mayo score at Week 12 (p<0.001) in ulcerative colitis patients.

ACCCESS U.S. pivotal study met co-primary efficacy endpoints with 77.2% AHI responder rate and zero serious adverse events in Complete Concentric Collapse patients.

Submitted a PMA supplement to the FDA to expand Genio's U.S. indication to Complete Concentric Collapse patients under Breakthrough Device Designation.

FDA approves Hibsago (bepirovirsen) for chronic hepatitis B treatment in combination with nucleos(t)ide analogue therapy in adult patients without cirrhosis.

INmune Bio submitted final pre-MAA package for Ebstrocel to UK MHRA on October 20, 2026, and plans full MAA submission in early February 2027.

FDA approved Hibsago (bepirovirsen) for chronic hepatitis B in adults without cirrhosis on nucleos(t)ide analogue therapy with HBsAg <=3000 IU/ml; B-Well functional cure 19% vs 0%.

US FDA approves Hibsago (bepirovirsen) for the treatment of chronic hepatitis B in adult patients without cirrhosis receiving NrtI therapy.

SimpleScreen Lung achieved 85% sensitivity at 50% specificity and 99.8% negative predictive value in an independent cohort of adults ages 50 to 80 with ≥20 pack-year smoking history.

DDI study fully enrolled with 65 healthy volunteers on 30 mg blarcamesine; clinical conduct complete, no serious adverse events on preliminary observation.

ADME study enrolled 8 healthy volunteers on 30 mg blarcamesine; clinical conduct complete, no serious adverse events on preliminary observation.

FDA approved a new manufacturing process for SIMLANDI that more than doubles drug substance output per batch.

Positive 4-year first-in-human data (N=21 evaluable): 37% mean IOP reduction, 86% (18 of 21) off all drops, 90% kept >=20/25 BCDVA, no product-related AEs.

SpyGlass Pharma reports positive 4-year interim data from first-in-human trial of BIM-IOL System showing 37% IOP reduction with 86% of patients off drops.

Phase 3 Study 304 met all primary and secondary endpoints: non-vellus TAHC +28.6 (QD) and +36.4 (BID) hairs/cm2 vs +6.6 placebo at Month 6, p<0.0001; PRO improved/much improved 55.7%/68.7% vs 15.0%.

Phase 3 Study '304' of VDPHL01 in 536 males with mild-to-moderate pattern hair loss met both co-primary endpoints and all secondary endpoints with high statistical significance.

Phase 3 APOLLO met both co-primary endpoints and all secondary endpoints: PPIX -41.4% vs placebo (p<0.0001), +12.2 hr monthly time in light without pain (p=0.0010), phototoxic reactions reduced 71% (IRR 0.29); n=183, no new safety signals.

FDA granted accelerated approval to Jemperli as the first immunotherapy for MSI-H/dMMR locally advanced rectal cancer, ahead of the PDUFA date.

AZUR-1 interim: investigator-assessed cCR12 in 68% (98/144) of evaluable patients; independent-review cCR12 47% (54/116) and still maturing; no recurrences among responders.

FDA accepted for filing the sNDA for REZZAYO (rezafungin) for prophylaxis of invasive fungal disease with Priority Review; PDUFA target action date in Q1 2027.

FDA accepted for Priority Review the supplemental NDA for REZZAYO for prophylaxis of invasive fungal diseases with PDUFA target action date in Q1 2027.

ArriVent announces Cancer Cell publication of FURTHER Phase 1b results showing firmonertinib achieved 43% (160 mg) and 68% (240 mg) confirmed overall response rate in treatment-naïve EGFR PACC-mutant NSCLC.

NVG-291 for SCI is currently subject to a partial clinical hold by the FDA.