Cantor Fitzgerald: 18 Drug Companies With Catalysts Worth Watching

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 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 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 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 VRX is expected to secure approval for Duobrii June 18 and release Phase 3 data for IPD-123 in the second quarter.
• Arsanis Inc ASNS will report Phase 2 interim results for ASN100 in late June.
• Dermira Inc DERM’s DRM04 has a June 30 PDUFA date, and management will host an investor day May 24.
• Nabriva Therapeutics PLC - ADR NBRV is expected to report Phase 3 Lefamulin data in late spring.
• Amneal Pharmaceuticals Inc AMRX plans to launch generic Welchol and begin its Rytary trial with Teva sometime in the second quarter.
• Aclaris Therapeutics Inc ACRS is expected to release Phase 2 data for ATI-502 in the second quarter.
• Shire PLC (ADR) SHPG anticipates approval for its Covington manufacturing facility in June or July.
• Heron Therapeutics Inc HRTX expects top-line results for its HTX-011 studies toward the end of the second quarter.
• Cidara Therapeutics Inc CDTX plans to announce a development candidate midyear.
• Spero Therapeutics Inc 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 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 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 ENDP will report Phase 3 data for Xiaflex by the first quarter of 2019.
• Paratek Pharmaceuticals Inc PRTK will report Phase 2 data for Omadacycline cUTI in the second half of 2019.
• Opko Health Inc. OPK is expected to release interim Phase 2b data for OPK88004.

Related Links:

Benzinga's Daily Biotech Pulse: ASCO Abstracts, Fibrocell, Ispen And More

The Week Ahead In Biotech: PDUFA Dates, Earnings, IPOs And More