The Week Ahead In Biotech: Conferences, Clinical Trial Readouts, Earnings And IPOs

Last week could be termed as a mixed one for the biotech sectors. Big pharma earnings came in mostly positive, but the FDA rejected two NDAs, pressuring Nabriva Therapeutics PLC – ADR NBRV and Heron Therapeutics Inc HR.

The following are key catalysts for the unfolding week.

Conferences

• 16th International Conference on Breast Pathology and Cancer Diagnosis: May 10-11 in Montreal, Canada. 
• 2019 American Academy of Neurology annual meeting: May 4-10 in Philadelphia, Pennsylvania.
• American Urological Association 2019 annual meeting: May 3-6 in Chicago, Illinois.
• Hemostasis & Thrombosis Society 2019 Scientific Symposium: May 9-11 in New Orleans, Louisiana.

Clinical Trial Readouts

American Academy of Neurology Annual Meeting Presentations

Novartis AG NVS: Data from the Phase 3 SPRINT study for Zolgensma (pre-symptomatic patients with spinal muscular atrophy Types 1, 2 and 3 — as well Phase 1 data for Zolgensma in SMA Type 2 — on May 5.

Cytokinetics, Inc. CYTK: Phase 2 data for Reldesemtiv in a study dubbed FORTITUDE-ALS (amyotrophic lateral sclerosis) on May 5.

MediciNova, Inc. MNOV: additional Phase 2b data for MN-166 (progressive multiple sclerosis) on May 6.

PTC Therapeutics, Inc. PTCT and Roche Holdings AG Basel ADR RHHBY: Phase 2/3 data for RG7916 from a study dubbed SUNFISH (spinal muscular dystrophy) on May 7.

Ra Pharmaceuticals Inc RARX: already released Phase 2 data for RA101495, or zilucoplan, (myasthenia gravis) on May 7.

PTC Therapeutics: Phase 2/3 data for RG7916 from a study dubbed Firefish (spinal muscular dystrophy) on May 7.

See Also: Attention Biotech Investors: Mark Your Calendar For These May PDUFA Dates

American Urological Association 2019 Annual Meeting Presentations

Urovant Sciences Ltd UROV: already released Phase 3 data for Vibegron (overactive bladder) on May 5.

Urogen Pharma Ltd URGN: already released Phase 3 data for MitoGel (urothelial carcinoma) on May 5.

Progenics Pharmaceuticals, Inc. PGNX: Phase 2/3 data for PyL (prostate cancer) on May 6.

Earnings Highlights

Monday, May 6

• GW Pharmaceuticals PLC- ADR GWPH (after the market close)
• Ultragenyx Pharmaceutical Inc RARE (after the market close)

Tuesday, May 7

• Regeneron Pharmaceuticals Inc REGN (before the market open)
• Jazz Pharmaceuticals PLC JAZZ (after the market close)

Wednesday, May 8

• Portola Pharmaceuticals Inc PTLA (before the market open)
• Dynavax Technologies Corporation DVAX (after the market close)

Thursday, May 9

• Ionis Pharmaceuticals Inc IONS (before the market open)
• Puma Biotechnology Inc PBYI (after the market close)

IPOs

Applied Therapeutics, a biotech company developing therapies for diabetic cardiomyopathy, is due to offer 4 million shares in an IPO that are likely to be priced between $14 and $16. The shares are to be listed on the Nasdaq under the ticker symbol APLT.

Axcella proposes to offer 3.57 million shares in an IPO with an estimated price range of $20-$22. The biotech developing therapies and food to treat metabolic dysregulation in the liver seeks to list its shares on the Nasdaq under the ticker symbol AXLA.

Cortexyme, which develops a novel therapy for Alzheimer's disease, is expected to offer 4.412 million shares with an estimated price range of $16-$18. The company is to list its shares on the Nasdaq under the ticker symbol CRTX.

Milestone Pharmaceuticals, a Phase 3 biotech developing therapies for heart rate conditions, plans to offer 5 million shares to be priced between $14 and $16. The shares are to be listed on the Nasdaq under the ticker symbol MIST.

NextCure is scheduled to offer 5 million shares in an IPO, to be priced in the range of $14-$16. The shares of the cancer immunotherapy company are due to be listed on the Nasdaq under the ticker symbol NXTC.