The Week Ahead In Biotech: Clinical Readouts, COVID-19 News Flow In Focus Amid Continuing Uncertainty

After starting the week ended March 28 on the backfoot, biotech stocks recovered through the week. Activity in the space remained light, although coronavirus (COVID-19) news flow continued to dominate.

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

See Also: Abbott Labs To Launch Point-Of-Care Test That Can Detect Coronavirus Within 5 Minutes

PDUFA Dates

The FDA is set to rule on AstraZeneca plc's AZN 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 and Bristol-Myers Squibb Co BMY await FDA decision on their sBLA for luspatercept in myelodysplastic syndromes. (Saturday)

Clinical Readouts

Myokardia Inc MYOK 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 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 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 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: Phase 3 top-line data for rimegepant as a preventative treatment for migraine

Ovid Therapeutics Inc OVID: Phase 1b/2a data for OV935/TAK935 in CDKL5 deficiency disorder and Dup15q syndrome

Axsome Therapeutics Inc AXSM: 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: 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: top-line results from Phase 3 SPIRIT 2 study that is evaluating its relugolix in women with pain associated with endometriosis

Regenxbio Inc RGNX and Clearside Biomedical Inc CLSD: 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: Results of primary endpoint of the Phase 2a BALANCED study that is evaluating its AKR-001 in non-alcoholic steatohepatitis

Iterum Therapeutics PLC ITRM: 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 (after the close)
• Alpine Immune Sciences Inc ALPN (after the close)
• Dare Bioscience Inc DARE (after the close)
• Dyadic International, Inc. DYAI (after the close)
• Titan Pharmaceuticals, Inc. common stock TTNP (after the close)
• Plus Therapeutics Inc PSTV (after the close)

Tuesday

• Trinity Biotech plc TRIB (before the market open)
• China Pharma Holdings, Inc. CPHI (before the market open)
• BioNTech SE – ADR BNTX (time not supplied)