A few FDA approvals and the impending 2018 American Society of Clinical Oncology annual meeting gave some impetus to the biotech space in the week ending June 1.
The FDA greenlighted Pfizer Inc. PFE's sNDA for Xeljanz, while TherapeuticsMD Inc TXMD finally secured a FDA nod for its vaginal pain medication Imvexxy.
The iShares NASDAQ Biotechnology Index (ETF) IBB has been higher for the week.
Here are a few catalytic events biotech investors should watch in the unfolding week:
Medical, Health Care And Biotech Conferences
- 2018 American Society of Clinical Oncology Annual Meeting: June 1-5, McCormick Place, Chicago.
- Jefferies 2018 Global Healthcare Conference: June 5-8 in New York City.
- American Society for Microbiology 2018 meeting: June 7-11 in Atlanta.
Clinical Trial Outcomes
- Cidara Therapeutics Inc CDTX is due to present Phase 2 data for its candidemia treatment rezafungin IV at the ASM meeting at 11 a.m. on Friday, June 8. The data from Cidara's STRIVE study released in March showed that the study met the primary objectives.
ASCO Presentations Pick Up Steam
Sunday, June 3
- Merck & Co., Inc. MRK is presenting the following:
- Phase 3 data from KEYNOTE-042 study for non-small cell lung cancer, or NSCLC.
- Phase 2 data for a Keytruda and chemo combo for first-line non-squamous NSCLC.
- Data for Keytruda and carboplatin-paclitaxel or nab-paclitaxel from the KEYNOTE-407 study evaluating the combo for squamous NSCLC.
- Data for MK-3475-189 from the KEYNOTE-180 study that evaluated the pipeline candidate for treating first-line metastatic non-squamous NSCLC.
- Celgene Corporation CELG: Updated Phase 1 data for Lico-cel in B cell non-Hodgkin lymphoma
- Novartis AG (ADR) NVS: Phase 3 data for LEE011 from MONALEESA-3 study that evaluated for breast cancer in post-menopausal women.
- TESARO Inc TSRO: Phase 1 data for niraparib-keytruda combo for treating triple-negative breast cancer or ovarian cancer.
- Calithera Biosciences Inc CALA: Phase 1/2 data for CB-839 and panitumumab for treating colorectal cancer.
- MacroGenics Inc MGNX: Phase 2 data for margetuximab in combination with Keytruda to treat gastric cancer.
- Incyte Corporation INCY: Phase 1 data for DPX-survivac vaccine therapy and epacadostat for recurrent ovarian cancer.
- ARMO Biosciences Inc ARMO: Phase 1b data for AM0010 in solid tumors
- Roche Holdings AG Basel ADR Common Stock RHHBY is presenting the following:
- Phase 3 data for venclexta for treating relapsed or refractory chronic lymphocytic leukemia.
- Updated Phase 3 data for alecensa for treating ALK-positive metastatic NSCLC.
- Pfizer is presenting the following:
- Phase 3 data for ibrance from the PALOMA-3 study in breast cancer patients.
- Phase 2 data for ibrance in treating head and neck squamous cell carcinoma.
- Other companies due to present data June 3 include:
- Immunomedics, Inc. IMMU
- Epizyme Inc EPZM
- Exelixis, Inc. EXEL
- NewLink Genetics Corp NLNK
- AbbVie Inc ABBV
- Syndax Pharmaceuticals Inc SNDX
- Spectrum Pharmaceuticals, Inc. SPPI
- Seattle Genetics, Inc. SGEN
- FibroGen Inc FGEN
- Tyme Technologies Inc TYME
- Five Prime Therapeutics Inc FPRX
- Zai Lab Ltd ZLAB
Monday, June 4
- Roche is presenting:
- Phase 3 data for tecentriq and cb and pac/nab-pac from the Impower 131 study that evaluated for squamous NSCLC.
- Phase 3 data for tecentriq from the Impower 150 study in patients with non-squamous NSCLC.
- Infinera Corp. INFN: Phase 1 study of IPI-549 and opdivo for treating solid tumors.
- Agenus Inc AGEN: A Phase 1/2 study of AGEN2034 in cervical cancer and Phase 1 data for AGEN1884 in solid cancers.
- Acceleron Pharma Inc XLRN: Phase 2 study of luspatercept for myelodysplastic syndromes.
- Nektar Therapeutics NKTR: Phase 1/2 data for NKTR-214 and tecentriq in solid tumors.
- Eli Lilly And Co LLY: Phase 3 data from the REACH-2 study that evaluated its ramucirumab for hepatocellular carcinoma.
- ImmunoGen, Inc. IMGN: Phase 1/2 data for mirvetuximab soravtansine in the FORWARD II study that evaluated it in ovarian cancer and relapsed endometrial cancer.
- Bristol-Myers Squibb Co BMY is presenting:
- Phase 3 data of CM-227 (opdivo-yervoy combo) for first-line NSCLC.
- Phase 2 data for opdivo and rubraca in castration-resistant prostate cancer, along with Clovis Oncology Inc CLVS.
- AstraZeneca plc (ADR) AZN – Phase 2 data for lyparza and Keytruda for castration-resistant prostate cancer.
- Regeneron Pharmaceuticals Inc REGN & Sanofi SA (ADR) SNY: Phase 1 data for cemiplimab in NSCLC
- Celgene and Acceleron: Phase 2 data for luspatercept in myelofibrosis.
- Pfizer: Phase 3 data on dacomitinib for treating NSCLC.
Other companies due to present data on June 4 include:
- Stemline Therapeutics Inc STML
- Verastem Inc VSTM
- CytomX Therapeutics Inc CTMX
- OncoSec Medical Inc ONCS
- Corcept Therapeutics Incorporated CORT
- Protalix Biotherapeutics Inc PLX
- MEI Pharma Inc MEIP
- Portola Pharmaceuticals Inc PTLA
- Agios Pharmaceuticals Inc AGIO
- Molecular Templates Inc MTEM
- Mersana Therapeutics Inc MRSN
- Adaptimmune Therapeutics PLC – ADR ADAP
- Calithera Biosciences
- Miragen Therapeutics Inc MGEN
- AbbVie Inc
- Dynavax Technologies Corporation DVAX
- ZIOPHARM Oncology Inc. ZIOP
- Tesaro
- TG Therapeutics Inc common stock TGTX
- Sellas Life Sciences Group Inc SLS
- Merrimack Pharmaceuticals Inc MACK
- Idera Pharmaceuticals Inc IDRA
Earnings
Thursday, June 7
- Advaxis, Inc. ADXS
IPO Calendar
MeiraGTx Holdings, a gene therapy company that focuses on disorders of the eye and salivary gland, is set offer 5 million shares at an estimated price range of $14-$16.
The company seeks to list its shares on the Nasdaq under the ticker symbol MGTX.
Quiet Period Expirations
Evelo Biosciences Inc EVLO listed its shares on the Nasdaq on May 8, with the stock closing its debut session at its offer price of $16. The stock is currently trading at a discount to the offer price.
Related Link:
'Right To Try' Law Signed By Trump Increases Patient Access To Experimental Drugs
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