The biotech analysts at Cantor Fitzgerald have a packed calendar: here are some of the dates they’re tracking and why they’re important.
- Mallinckrodt PLC (NYSE: MNK) is expected to release Phase 4 interim Acthar data for multiple sclerosis at the end of May, rheumatoid arthritis in June and systemic lupus erythematosus at some point in the second quarter.
- Mylan NV (NASDAQ: MYL)’s Neulasta and Advair biosimilars have June 4 and June 27 Target Action Dates, respectively. Cantor forecast June oral arguments for challenged Restasis patents and a second-quarter launch of Cimduo.
- Teva Pharmaceutical Industries Ltd (ADR) ADR (NYSE: TEVA)’s injectable CGRP fremanezumab has a June 16 PDUFA date, and Cantor anticipates approval and launch before the end of the year.
- Valeant Pharmaceuticals Intl Inc (NYSE: VRX) is expected to secure approval for Duobrii June 18 and release Phase 3 data for IPD-123 in the second quarter.
- Arsanis Inc (NASDAQ: ASNS) will report Phase 2 interim results for ASN100 in late June.
- Dermira Inc (NASDAQ: DERM)’s DRM04 has a June 30 PDUFA date, and management will host an investor day May 24.
- Nabriva Therapeutics PLC - ADR (NASDAQ: NBRV) is expected to report Phase 3 Lefamulin data in late spring.
- Amneal Pharmaceuticals Inc (NYSE: AMRX) plans to launch generic Welchol and begin its Rytary trial with Teva sometime in the second quarter.
- Aclaris Therapeutics Inc (NASDAQ: ACRS) is expected to release Phase 2 data for ATI-502 in the second quarter.
- Shire PLC (ADR) (NASDAQ: SHPG) anticipates approval for its Covington manufacturing facility in June or July.
- Heron Therapeutics Inc (NASDAQ: HRTX) expects top-line results for its HTX-011 studies toward the end of the second quarter.
- Cidara Therapeutics Inc (NASDAQ: CDTX) plans to announce a development candidate midyear.
- Spero Therapeutics Inc (NASDAQ: SPRO) will report Phase 1 data for SPR994 by mid-2018 with the second quarter bringing results for a Phase 1b study of SPR741 and preclinical study of SPR206. SPR994 will begin a Phase 3 trial at the end of the year.
- Theravance Biopharma Inc (NASDAQ: TBPH) will report Phase 2a data for TD-9855 by the end of July, has a Nov. 13 PDUFA date for TD-4208 and will begin reporting Phase 1b data for its JAK inhibitor in the back half of 2018.
- Allergan plc (NYSE: AGN) has a PDUFA date for Esmya in August; anticipates Sarecycline approval and the release of Abicipar Phase 3 data in the second half of 2018; and will report Rapastinel Phase 3 data in 2019. Cantor Fitzgerald expects Phase 2b data for oral CGRP atogepant and Phase 2 data for pilocarpine/oxymetazoline in the second half of 2018.
- Endo International PLC (NASDAQ: ENDP) will report Phase 3 data for Xiaflex by the first quarter of 2019.
- Paratek Pharmaceuticals Inc (NASDAQ: PRTK) will report Phase 2 data for Omadacycline cUTI in the second half of 2019.
- Opko Health Inc. (NASDAQ: OPK) is expected to release interim Phase 2b data for OPK88004.
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