The Week Ahead In Biotech: Cardiology, Analyst Conferences In The Spotlight

The biotech space saw muted activity in the week ended Aug. 30. Among the notable news of the week: Amgen, Inc. AMGN's $13.4-billion deal to buy the psoriasis drug Otezla from Celgene Corporation CELG and Johnson & Johnson JNJ's $572-million settlement agreement with the state of Oklahoma in an opioid lawsuit. 

Plus Therapeutics Inc PSTV, which previously went by the name Cytori, was among the top performers in the biotech space, advancing in excess of 200% — with no clear catalyst driving the rally. 

The following are key catalysts for biotech investors to watch in the unfolding week.

Conferences

• European Society of Cardiology, or ESC, Congress 2019: Aug. 30-Sept. 4 in Paris, France.
• Society for the Study of Inborn Errors of Metabolism, or SSIEM, Annual Symposium 2019: Sept. 3-6 in Amsterdam, Netherlands.
• International Meeting on Dermatopathology & Skin Care: Sept. 4-5 in Paris.
• Citi 14th Annual Biotech Conference: Sept. 4-5 in Boston, Massachusetts.
• 2019 Wells Fargo Healthcare Conference: Sept. 4-5 in Boston. 
• Baird's 2019 Global Healthcare Conference: Sept. 4-5 in New York City.
• 4th International Congress on Addictive Behavior and Dual Diagnosis: Sept. 5-6 in Budapest, Hungary.
• International Association for the Study of Lung Cancer, or IASLC, 2019 World Conference: Sept. 7-10 in Barcelona, Spain.

See Also: Biotech Stock On The Radar: MyoKardia Bets On Precision Medicine For Heart Health

PDUFA Dates

The FDA is set to rule on Roche Holdings AG Basel ADR RHHBY's Tecentriq along with chemotherapy as first-line treatment of metastatic non-squamous non-small cell lung cancer in patients who do not have EGFR or ALK genomic tumor aberrations. The PDUFA date is set for Monday, Sept. 2.

Clinical Trial Readouts

ESC Congress Presentations

AstraZeneca plc AZN: already released Phase 3 data for Farxiga in heart failure as well as already released Phase 3 data for Brilinta in Type 2 diabetes (both scheduled for Sept. 1).

PhaseBio Pharmaceuticals Inc PHAS: Phase 1 data for PB2452 as a reversal agent for AstraZeneca's ticagrelor.

Alnylam Pharmaceuticals, Inc. ALNY and The Medicines Company MDCO: already released Phase 3 data for inclisiran that is being evaluated in a Phase 3 trial dubbed ORION 10 for atherosclerotic cardiovascular disease (Sept. 2).

SSIEM Annual Symposium Presentations

Aeglea Bio Therapeutics Inc AGLE: Phase 1/2, 20-week repeat dose data for pegzilarginase in arginase 1 deficiency (Sept. 3).

Orchard Therapeutics PLC – ADR ORTX: Phase 2 data for OTL-200 in metachromatic leukodystrophy (Sept. 4).

Synlogic Inc SYBX: Full Phase 2 data for SYNB1619 in phenylketonuria (Sept. 4).

Mid-2019 Readouts

AnaptysBio Inc ANAB: Phase 2 data for ANB019 in generalized pustular psoriasis.

Akcea Therapeutics Inc AKCA and Ionis Pharmaceuticals Inc IONS: Phase 2 pilot study data for AKCEA-ANGPTL3-LRx in rare hyperlipidemias.

Earnings

Tuesday

Zai Lab Ltd ZLAB

Thursday

PAVmed Inc PAVM