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 1.73%.
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 0.82%: 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 4.73%: Phase 2 data for Reldesemtiv in a study dubbed FORTITUDE-ALS (amyotrophic lateral sclerosis) on May 5.
MediciNova, Inc. MNOV 3.13%: additional Phase 2b data for MN-166 (progressive multiple sclerosis) on May 6.
PTC Therapeutics, Inc. PTCT 1.74% and Roche Holdings AG Basel ADR RHHBY 0.97%: Phase 2/3 data for RG7916 from a study dubbed SUNFISH (spinal muscular dystrophy) on May 7.
Ra Pharmaceuticals Inc RARX 1.17%: 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.
American Urological Association 2019 Annual Meeting Presentations
Urovant Sciences Ltd UROV 3.37%: already released Phase 3 data for Vibegron (overactive bladder) on May 5.
Urogen Pharma Ltd URGN 0.46%: already released Phase 3 data for MitoGel (urothelial carcinoma) on May 5.
Progenics Pharmaceuticals, Inc. PGNX 4.56%: Phase 2/3 data for PyL (prostate cancer) on May 6.
Earnings Highlights
Monday, May 6
- GW Pharmaceuticals PLC- ADR GWPH 1.44% (after the market close)
- Ultragenyx Pharmaceutical Inc RARE 4.35% (after the market close)
Tuesday, May 7
- Regeneron Pharmaceuticals Inc REGN 0.51% (before the market open)
- Jazz Pharmaceuticals PLC JAZZ 2.12% (after the market close)
Wednesday, May 8
- Portola Pharmaceuticals Inc PTLA 2.5% (before the market open)
- Dynavax Technologies Corporation DVAX 4.03% (after the market close)
Thursday, May 9
- Ionis Pharmaceuticals Inc IONS 1.69% (before the market open)
- Puma Biotechnology Inc PBYI 1.34% (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.
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