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Biotech stocks rebounded along with the broader market in the week ended June 19. The week was a busy one from the perspective of PDUFA dates, with the FDA issuing approvals for Merck & Co., Inc. (NYSE: MRK) and Novartis AG (NYSE: NVS), among others. The week also witnessed a flurry of activity on the IPO front.
The following are key biotech catalysts for the unfolding week.
Conferences
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American Association of Cancer Research, or AACR, Virtual Annual Meeting II: June 22-24
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BMO 2020 Prescriptions for Success Healthcare Conference: June 23
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American Thoracic Society, or ATS 2020 Virtual: Clinical Trials Session: June 24
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BofA Securities Napa Biopharma Conference: June 24
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Cowen FutureHealth Conference: June 24-25
PDUFA Dates
The FDA is scheduled to rule on Karyopharm Therapeutics Inc's (NASDAQ: KPTI) sNDA for Selinexor, which could expand the drug's label to include adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, who have received at least two prior therapies. (Tuesday)
Zogenix, Inc.'s (NASDAQ: ZGNX) NDA for Fintepla as a potential treatment candidate for seizures associated with Dravet syndrome is pending before the FDA, with the regulatory agency expected to rule on the drug by the June 25 PDUFA date.
Heron Therapeutics Inc (NASDAQ: HRTX) awaits an FDA nod for its HTX-011 as a treatment option for post-operative pain. (Friday)
The FDA is also expected to rule on Chiasma Inc's (NASDAQ: CHMA) NDA for Mycapssa, which is being evaluated as a maintenance therapy for acromegaly. (Friday)
Intercept Pharmaceuticals Inc (NASDAQ: ICPT) has a PDUFA date of June 26 for its NDA for NASH drug candidate obeticholic acid.
An Adcom meeting scheduled for June 9 has been postponed, making it less likely an approval comes through by the PDUFA date.
Clinical Readouts AACR Presentations
VBI Vaccines Inc (NASDAQ: VBIV) is due to present expanded immunologic and tumor response data from the ongoing Phase 1/2a study of VBI-1901, its cancer vaccine immunotherapeutic candidate, in recurrent glioblastoma patients. (Monday)
BioNTech SE – ADR (NASDAQ: BNTX) will present data from the Phase 1 trial of BNT122 in multiple solid tumors.
DelMar Pharmaceuticals Inc (NASDAQ: DMPI) is due to present data from separate Phase 2 trials of dianhydrogalactitol (VAL-083) in patients with newly diagnosed MGMT-unmethylated glioblastoma as well as in patients with MGMT-unmethylated, bevacizumab-naïve glioblastoma in the recurrent or adjuvant setting.