Here are the key catalysts that may impact biotech stocks in the unfolding week.
Conferences
Most conferences stand cancelled in the wake of the COVID-19 pandemic, but a few have opted to go ahead with virtual conferences.The American College of Cardiology or ACC’s, 69th Annual Scientific Session together with the World Congress of Cardiology, or WCC, Virtual Conference – ACC.20/WCC Virtual: March 28-30
PDUFA Dates
The FDA is set to rule on AstraZeneca plc’s AZN 0.33% sBLA for Imfinzi in previously untreated patients with extensive-stage small cell lung cancer. The PDUFA action date has been fixed for the first quarter.Acceleron Pharma Inc XLRN 6.12% and Bristol-Myers Squibb Co BMY 1.01% await FDA decision on their sBLA for luspatercept in myelodysplastic syndromes. (Saturday)
Clinical Readouts
Myokardia Inc MYOK 0.66% will present during a late-breaker session at ACC.20/WCC Virtual, data from the Phase 2 dose-ranging study of mavacamten in in non-obstructive hypertrophic cardiomyopathy and targeted patient populations with heart failure with preserved ejection fraction. The virtual presentation is scheduled for Monday.Mersana Therapeutics Inc MRSN 1.41% is scheduled to report Monday updated data from the ongoing XMT-1536 Phase 1 dose escalation study. XMT-1536 is the company’s antibody drug conjugate candidate, which is currently in Phase 1 proof-of-concept study in patients with ovarian cancer and NSCLC adenocarcinoma.
ProQR Therapeutics NV PRQR 9.28% is due to present and discuss findings from a planned 3-month interim analysis of its Phase 1/2 Stellar trial of QR-421 in adults with Usher syndrome and non-syndromic retinitis pigmentosa. The presentation is scheduled for Tuesday.
BioCardia Inc BCDA 0.36% will report an independent Data Safety Monitoring Board’s prespecified data review of the Phase 3 pivotal CardiAMP Heart Failure Trial that is evaluating its CardiAMP cell therapy. The release is scheduled for Tuesday.
Q1 Release Schedule
Biohaven Pharmaceutical Holding Co Ltd BHVN 1.9%: Phase 3 top-line data for rimegepant as a preventative treatment for migraineOvid Therapeutics Inc OVID 1.4%: Phase 1b/2a data for OV935/TAK935 in CDKL5 deficiency disorder and Dup15q syndrome
Axsome Therapeutics Inc AXSM 0.42%: top-line results from the STRIDE-1 Phase 3 trial of AXS-05 in treatment-resistant depression and top line results from the INTERCEPT Phase 3 trial of AXS-07 in migraine
Immunovant IncIMVT 4.43%: Initial results from ASCEND-GO 1, an open-label Phase 2a clinical trial of IMVT-1401 for the treatment of Graves’ ophthalmopathy
Myovant Sciences Ltd MYOV 4.02%: top-line results from Phase 3 SPIRIT 2 study that is evaluating its relugolix in women with pain associated with endometriosis
Regenxbio Inc RGNX 4.12% and Clearside Biomedical Inc CLSD 5.95%: two-year data from Cohorts 1-3 of the Phase 1/2a study of RGX-314 in wet age-related macular degeneration
Akero Therapeutics Inc AKRO 4.95%: Results of primary endpoint of the Phase 2a BALANCED study that is evaluating its AKR-001 in non-alcoholic steatohepatitis
Iterum Therapeutics PLC ITRM 1.82%: top-line data from the pivotal Phase 3 studies of sulopenem in complicated urinary tract infection and uncomplicated urinary tract infection.
Earnings
Monday- Aptinyx Inc APTX 2.25% (after the close)
- Alpine Immune Sciences Inc ALPN 3.33% (after the close)
- Dare Bioscience Inc DARE 1.91% (after the close)
- Dyadic International, Inc. DYAI (after the close)
- Titan Pharmaceuticals, Inc. common stock TTNP 2.15% (after the close)
- Plus Therapeutics Inc (NASDAQ: PSTV TTNP) (after the close)
- Trinity Biotech plc TRIB 2.17% (before the market open)
- China Pharma Holdings, Inc. CPHI 4.08% (before the market open)
- BioNTech SE – ADR BNTX (time not supplied)
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