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

• The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Merck's (NYSE:MRK) lead asset MK-2060 for the reduction in risk of major thrombotic cardiovascular events in patients with end-stage renal disease (ESRD). Merck shares traded in a range of $89.72 to $90.97 on day volume of 5.2 million shares, closed regular trading session at $90.20.

• Synlogic (NASDAQ:SYBX) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its drug candidate SYNB1353 for the potential treatment of homocystinuria (HCU). Synlogic shares traded as high as 6.06 percent, in a range of $0.93 to $1.05 on day volume of 871.25 thousand shares versus three months average volume of 141.7 thousand shares, closed regular trading session at $1.01.

• Health Canada announced approval for Bristol Myers Squibb’s (NASDAQ:BMY) OPDIVO (nivolumab) 360 mg (injection for intravenous use) in combination with platinum-doublet chemotherapy every three weeks for three cycles in adult patients with resectable non-small cell lung cancer (NSCLC) in the neoadjuvant setting. Bristol-Myers shares traded in a range of $72.6 to $74.49 on day volume of 8.97 million shares, closed regular trading session at $72.77.

• KalVista Pharmaceuticals (NASDAQ:KALV) has initiated the KONFIDENT-S open label extension (OLE) study for its ongoing Phase 3 study of sebetralstat for the on-demand treatment of hereditary angioedema (HAE) attacks. KalVista shares traded as high as 2 percent, in a range of $16.13 to $16.81 on day volume of 185.23 thousand shares, closed regular trading session at $16.47.

• Arcutis Biotherapeutics (NASDAQ:ARQT) has completed the enrollment of subject in its INTEGUMENT-2 pivotal Phase 3 trial of roflumilast cream 0.15% in adults and children with Atopic dermatitis (AD). Arcutis shares traded as high as 2.69 percent, in a range of $24.52 to $25.95 on day volume of 342.03 thousand shares, closed regular trading session at $25.48.

• BeiGene (NASDAQ:BGNE) announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted a supplemental biologics license application (sBLA) for tislelizumab in combination with chemotherapy as first-line treatment in patients with unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC). BeiGene shares traded as high as 1.31 percent, in a range of $171.18 to $175.25 on day volume of 194.44 thousand shares, closed regular trading session at $173.02.

• Immatics (NASDAQ:IMTX) announced the treatment of the first patient in its Phase 1b expansion cohort C (NCT03686124) evaluating IMA203CD8, its 2^nd generation TCR-T monotherapy approach where a proprietary CD8αβ co-receptor is added to PRAME-specific IMA203 T cells. Immatics shares traded as high as 4.82 percent, in a range of $11.38 to $11.95 on day volume of 173.09 thousand shares, closed regular trading session at $11.84.

• Jaguar Health (NASDAQ:JAGX) announced that its Orphan Drug Designation (ODD) application for crofelemer submitted to the U.S. Food and Drug Administration for a rare congenital diarrheal disorder called microvillus inclusion disease (MVID) has been accepted by the FDA for review. A response from the FDA on the application is expected by the end of September 2022. Jaguar Health shares traded as high as 8.33 percent, in a range of $0.24 to $0.26 on day volume of 6.84 million shares, closed regular trading session at $0.24.

• Amgen (NASDAQ:AMGN) announced positive top-line results from the DAHLIA study, a Phase 3 study evaluating the efficacy and safety of ABP 959, a biosimilar candidate to SOLIRIS (eculizumab), compared with SOLIRIS in adult patients with paroxysmal nocturnal hemoglobinuria (PNH). Amgen shares traded in a range of $242.85 to $246.69 on day volume of 2.2 million shares, closed regular trading session at $244.47.

• Sorrento Therapeutics (NASDAQ:SRNE) announced positive results from a pivotal study of Abivertinib on 209 response evaluable, heavily pretreated NSCLC patients by an IRC assessment with matured long-term follow up data. Sorrento shares traded as high as 7.34 percent, in a range of $1.78 to $1.90 on day volume of 13.24 million shares, closed regular trading session at $1.88. The company shares traded at $1.92, up 2.13 percent in the after-hours trading session.