The Week Ahead In Biotech: Karyopharm, Zogenix, Heron, Chiasma On The Radar Ahead Of FDA Decisions

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. MRK and Novartis AG 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

American Association of Cancer Research, or AACR, Virtual Annual Meeting II: June 22-24
BMO 2020 Prescriptions for Success Healthcare Conference: June 23
American Thoracic Society, or ATS 2020 Virtual: Clinical Trials Session: June 24
BofA Securities Napa Biopharma Conference: June 24
Cowen FutureHealth Conference: June 24-25

PDUFA Dates

The FDA is scheduled to rule on Karyopharm Therapeutics Inc's 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 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 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 CHMA NDA for Mycapssa, which is being evaluated as a maintenance therapy for acromegaly. (Friday)

Intercept Pharmaceuticals Inc 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 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 BNTX will present data from the Phase 1 trial of BNT122 in multiple solid tumors.

DelMar Pharmaceuticals Inc 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.

Affimed NV AFMD is scheduled to present two posters, one on AFM24, a bispecific EGFR/CD16A Innate Cell Engager with the potential to overcome resistance to current targeted treatments for EGFR-positive malignancies, and another on preclinical pharmacology and safety of RO7297089, a novel anti-BCMA/CD16a bispecific antibody for the treatment of multiple myeloma.

Presentations At ATS 2020 Virtual: Clinical Trials Session

AstraZeneca plc AZN: Phase 3 ETHOS trial for triple-combination therapy Breztri Aerosphere, formerly PT010, in patients with moderate to very severe chronic obstructive pulmonary disease.

Insmed Incorporated INSM: Phase 2 WILLOW study evaluating the efficacy, safety and pharmacokinetics of INS1007 administered once daily in adults with non-cystic fibrosis bronchiectasis.

United Therapeutics Corporation UTHR: key data from the INCREASE study of Tyvaso inhalation solution in patients suffering from WHO Group 3 pulmonary hypertension associated with interstitial lung disease.

Earnings

Affimed (Tuesday, before the market open)
Aethlon Medical, Inc. AEMD (Thursday, after the close)

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