Important Biotech Catalysts For September 15, 2022 - End Of The Day Summary - Kymera Therapeutics (NASDAQ:KYMR), Edwards Lifesciences (NYSE:EW), Alnylam Pharmaceuticals (NASDAQ:ALNY), Candel Therapeutics (NASDAQ:CADL)

Pfizer PFE announced positive top-line results from the pivotal Phase 3 trial assessing the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine (MenABCWY) in healthy individuals 10 through 25 years of age. The trial met all primary and secondary endpoints. Pfizer shares traded in a range of $45.7 to $46.29 on day volume of 15.14 million shares, closed regular trading session at $45.94.

Alnylam (NASDAQ: ALNY) and Regeneron (NASDAQ: REGN) announced preliminary Phase 1 data supporting the clinical advancement of ALN-HSD, an investigational RNAi therapeutic targeting HSD17B13 in development for the treatment of nonalcoholic steatohepatitis (NASH). Alnylam shares traded in a range of $202.6 to $210.86 on day volume of 771.5 thousand shares, closed regular trading session at $208.48.

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Kymera Therapeutics’ KYMR product candidate KT-333 for the treatment of Cutaneous T-cell Lymphoma (CTCL). Kymera shares traded as high as 6.33 percent, in a range of $27.41 to $29.57 on day volume of 581.28 thousand shares, closed regular trading session at $28.76.

Jasper Therapeutics JSPR announced that its lead asset JSP191 has received fast track designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with severe combined immunodeficiency (SCID) undergoing allogeneic hematopoietic stem cell transplant. Jasper shares traded as high as 22.56 percent, in a range of $1.27 to $1.63 on day volume of 395.73 thousand shares versus three months average volume of 47.29 thousand shares, closed regular trading session at $1.30.

The European Medicines Agency (EMA) Committee for Orphan Medical Products (COMP) has issued a positive opinion on Candel Therapeutics’ CADL application for orphan drug designation for CAN-2409 for the treatment of glioma. Candel shares traded as high as 3.99 percent, in a range of $3.34 to $3.65 on day volume of 12.56 thousand shares, closed regular trading session at $3.43.

The U.S. Food and Drug Administration (FDA) has agreed with Lipocine's LPCN proposal for establishing the efficacy of LPCN 1154 through a single pivotal pharmacokinetic (PK) bridge to an approved IV infusion brexanolone via a 505(b)(2) NDA filing. A pilot PK bridge study is planned with results expected in the first quarter of 2023. Lipocine shares traded as high as 7.27 percent, in a range of $0.54 to $0.59 on day volume of 221.28 thousand shares, closed regular trading session at $0.58.

Celsion CLSN announced that its Phase I/II OVATION 2 Study with GEN-1 in advanced ovarian cancer has completed enrollment with 110 patients. Topline results are expected in the second half of 2023. Celsion shares traded as high as 10.63 percent, in a range of $2.02 to $2.29 on day volume of 33.24 thousand shares, closed regular trading session at $2.08.

Tenax Therapeutics TENX is evaluating alternative strategic paths focused on maximizing shareholder value. To optimize its financial resources through this strategic review process, Tenax is shifting the anticipated launch of the imatinib Phase 3 trial in PAH, previously anticipated to begin in 2H 2022, into 2023. Tenax shares traded as high as 21.74 percent, in a range of $0.21 to $0.28 on day volume of 3 million shares versus three months average volume of 417.02 thousand shares, closed regular trading session at $0.26.

Edwards Lifesciences’ EW lead product PASCAL Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER) has received FDA approval for the treatment of patients with degenerative mitral regurgitation (DMR). Edwards Lifesciences shares traded as high as 4.49 percent, in a range of $94.4 to $98.35 on day volume of 2.57 million shares, closed regular trading session at $94.88.

Omeros OMER reported results from the narsoplimab arm of the I-SPY COVID Trial, analysis from the randomized patient population shows that the addition of narsoplimab to treatment of critically ill patients with COVID-19 reduces the mortality risk. Omeros shares traded as low as 3.53 percent, in a range of $3.86 to $5.2 on day volume of 2.1 million shares versus three months average volume of 1.26 million shares, closed regular trading session at $3.99.

Incyte’s INCY lead candidate PEMAZYRE (pemigatinib) has been provisionally approved by the Therapeutic Goods Administration (TGA) for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 FGFR2) fusion. Incyte shares traded as high as 1.43 percent, in a range of $68 to $69.4 on day volume of 1.11 million shares, closed regular trading session at $68.98.

Important Biotech Catalysts For September 15, 2022 - End Of The Day Summary