Recap of Tuesday's Biotech Catalysts - End of the Day Summary

Ionis IONS announced that Eplontersen met co-primary and secondary endpoints in interim analysis of the Phase 3 NEURO-TTRansform study for hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN)

Ionis shares are trading low 4 percent at $35.10 in the after-hours session

Merck MRK presented positive results from Phase 1/2 study evaluating V116, the investigational pneumococcal conjugate caccine for adults at the International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12) taking place in Toronto from June 19-23, 2022.

Merck shares are trading down 3.5 percent at $85 in the after-hours session

EyePoint Pharmaceuticals EYPT and OcuMension Therapeutics announced approval of New Drug Application by China's NMPA for YUTIQ for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

EyePoint closed Tuesday’s trading at $8.04

Xenon Pharmaceuticals Inc. XENE announced next steps in its clinical program evaluating XEN1101 for the treatment of patients with focal onset seizures (FOS) following the completion of an End-of-Phase 2 (EOP2) meeting with the U.S. Food & Drug Administration (FDA). The outcome of the EOP2 meeting supports the advancement of XEN1101 into Phase 3 clinical development, and Xenon remains on track to initiate the Phase 3 program in the second half of 2022.

Xenon shares are trading higher at $33.20 in the after-hours session

Novocure NVCR enrolled first patient in KEYNOTE-B36, a pilot study of Tumor Treating Fields Together with KEYTRUDA (pembrolizumab) for patients with first-line stage III Non-Small Cell Lung Cancer.

Novocure closed Tuesday’s trading at $58.76.

Celldex CLDX dosed first patient in Phase 2 Study of Barzolvolimab in Patients with Chronic Spontaneous Urticaria.

Celldex shares are trading at $24 in the after-hours session.

Exelixis EXEL initiated the STELLAR-303 Phase 3 pivotal trial evaluating XL092 in patients with Metastatic Colorectal Cancer.

Exelixis shares closed Tuesday’s trading at $19.35.

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Regulus Therapeutics’ RGLS RGLS8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

Regulus shares closed Tuesday’s trading at $0.28.

The U.S. Food and Drug Administration (FDA) schedules a meeting of the Cardiovascular and Renal Drugs Advisory Committee (Advisory Committee) with Ardelyx ARDX tentatively for November 16, 2022, to discuss the New Drug Application (NDA) for XPHOZAH for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

Ardelyx shares are trading down at $0.57 in the after-hours session.

Abbvie ABBV submitted a supplemental New Drug Application (sNDA) for Atogepant (QULIPTATM) to the U.S. Food and Drug Administration (FDA) to support the preventive treatment of chronic migraine in adults, supported by the pivotal Phase 3 PROGRESS chronic migraine study evaluating Atogepant (QULIPTATM) in adult patients that met primary endpoint.

Abbvie shares closed Tuesday’s trading at $143.47.

The U.S. Food and Drug Administration (FDA) cleared Nuvectis Pharma’s NVCT Investigational New Drug Application (IND) for NXP800, which includes the Phase 1 clinical trial protocol. The Company plans to initiate the Phase 1b in early 2023.

Nuvectis shares closed Tuesday’s trading at $12.22

The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to  Acer Therapeutics’ ACER  New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders (UCDs). FDA indicated that its field investigator could not complete inspection the facility was not ready. Planning to resubmit NDA in early-to-mid Q3 2022.

Acer Therapeutics’ shares are trading down at $1.38 in the after-hours session

Celsion CLSN announces the Data Safety Monitoring Board’s unanimous recommendation to continue dosing patients in the Phase II portion of the OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer.

Celsion shares are trading higher 5 percent at $2.02 in the after-hours session.

MyMD Pharmaceuticals MYMD announced further advancement in the Phase 2 Multi-Center Clinical Trial of MYMD-1 as a Therapy for Delaying Aging and Extending Healthy Lifespan.

MyMD shares closed Tuesday’s trading at $2.30

Hoth Therapeutics HOTH has received approval from the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate the next phase of its BioLexa trial for patients suffering with Atopic Dermatitis.

Hoth Therapeutics shares are trading down at $0.38 in the after-hours session.

Paratek Pharmaceuticals, Inc. PRTK received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its lead drug NUZYRA (omadacycline) for the treatment of pulmonary Nontuberculous Mycobacterial (NTM) disease caused by both Mycobacterium avium complex (MAC) and Mycobacterium abscessus (MAB).

Paratek shares are trading higher 14 percent at $2.16 in the after-hours session.