Important Biotech Catalysts For September 12, 2022 - End Of The Day Summary - Mersana Therapeutics (NASDAQ:MRSN), Dynavax Technologies (NASDAQ:DVAX), Pfizer (NYSE:PFE), BioNTech (NASDAQ:BNTX)

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Mersana Therapeutics’ MRSN lead candidate XMT-1660 for the treatment of adult patients with advanced or metastatic triple-negative breast cancer (TNBC). Mersana shares traded as high as 1.79 percent, in a range of $7.48 to $7.94 on day volume of 1.34 million shares, closed regular trading session at $7.48. The company shares traded at $7.40, down 1.07 percent in the after-hours trading session.

The U.S. Food and Drug Administration (FDA) has accepted for filing Acadia Pharmaceuticals’ ACAD New Drug Application (NDA) of trofinetide for the treatment of Rett syndrome.The regulatory agency has granted a priority review and assigned a PDUFA action date of March 12, 2023. ACADIA shares traded as high as 4.95 percent, in a range of $17.33 to $18.24 on day volume of 1.35 million shares, closed regular trading session at $17.91.

BioLineRx BLRX has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate Motixafortide in stem cell mobilization (SCM) for autologous bone marrow transplantation for multiple myeloma patients. BioLineRx shares traded as low as 1.65 percent, in a range of $1.63 to $1.79 on day volume of 387.02 thousand shares, closed regular trading session at $1.64.

AVITA Medical RCEL reveals positive top-line results from a pivotal trial evaluating the safety and effectiveness of the RECELL System for repigmentation of stable vitiligo lesions. Avita shares traded in a range of $6.20 to $6.43 on day volume of 73.73 thousand shares, closed regular trading session at $6.20. The company shares traded at $6.50, up 4.84 percent in the after-hours trading session.

The European Commission (EC) has approved the expanded conditional marketing authorization (CMA) of Novavax’s NVAX lead drug Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in the European Union as a homologous and heterologous booster for active immunization to prevent COVID-19 caused by SARS-CoV-2 for adults aged 18 and older. Novavax shares traded as high as 4.22 percent, in a range of $31.4 to $33.06 on day volume of 3.35 million shares versus, closed regular trading session at $33.

Pfizer PFE and BioNTech BNTX announced a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals ages 12 years and older. BioNTech SE shares traded in a range of $148.06 to $152.2 on day volume of 472.57 thousand shares, closed regular trading session at $148.27.

Haemonetics HAE has earned CE mark certification for its VASCADE vascular closure and VASCADE MVP venous vascular closure systems. The CE marking will allow Haemonetics to engage in the next steps of country-specific entrance of both products into the European Union (EU) and forms the basis for entry into other geographies that recognize CE marking. Haemonetics shares traded as high as 3.04 percent, in a range of $77.29 to $79.21 on day volume of 403.62 thousand shares, closed regular trading session at $78.66.

Agenus AGEN has initiated Phase 2 ACTIVATE trials of botensilimab to advance globally in metastatic patients who have progressed on available therapies. This global Phase 2 program include clinical trials of ACTIVATE-Colorectal and ACTIVATE-Melanoma studies. Agenus shares traded in a range of $2.62 to $2.71 on day volume of 2.29 million shares versus, closed regular trading session at $2.70.

Adamis Pharmaceuticals ADMP announced that it has reached the initial planned enrollment target in the ongoing U.S. Phase 2/3 clinical trial investigating Tempol as a treatment for COVID-19. Adamis shares traded as high as 12.12 percent, in a range of $0.33 to $0.37 on day volume of 801.33 thousand shares, closed regular trading session at $0.36.

Alector ALEC announced the initiation of the first-in-human Phase 1 trial of AL044, investigating the safety profile, pharmacokinetics (PK), pharmacodynamics (PD) and target engagement of AL044 in healthy adults. Alector shares traded as high as 5.71 percent, in a range of $9.12 to $10.18 on day volume of 993.71 thousand shares, closed regular trading session at $10.17. The company shares traded at $9.76, down 4.03 percent in the after-hours trading session.

Regulus Therapeutics RGLS announced positive topline safety and PK data from its Phase 1 SAD clinical trial of RGLS8429 and announced the initiation of its Phase 1b MAD clinical trial of RGLS8429. Regulus shares traded as high as 44.58 percent, in a range of $1.84 to $2.4 on day volume of 45.29 million shares versus three months average volume of 103.52 thousand shares, closed regular trading session at $1.94. The company shares traded at $1.98, up 2.06 percent in the after-hours trading session.

Hepion Pharmaceuticals HEPA has dosed the first NASH stage 3 subject with rencofilstat in a Phase 2 clinical trial designed to measure hepatic function. ALTITUDE-NASH is a Phase 2 study to evaluate the safety and efficacy of rencofilstat in 60 adult subjects. Hepion shares traded as high as 5.08 percent, in a range of $0.60 to $0.62 on day volume of 71.09 thousand shares, closed regular trading session at $0.61.

Dynavax DVAX announced that the first participant has been dosed in a Phase 2 clinical trial evaluating the immunogenicity, safety, and tolerability of the JPEO-CBRND's Recombinant Plague (rF1V) vaccine combined with Dynavax's CpG 1018adjuvant, in adults 18 to 55 years of age. Dynavax shares traded as high as 4.46 percent, in a range of $11.68 to $12.17 on day volume of 1.52 million shares, closed regular trading session at $11.78.

Horizon Therapeutics HZNP announced that its Phase 2 trial evaluating dazodalibep for the treatment of Sjögren's syndrome met the primary endpoint in patients with moderate-to-high systemic disease activity. Horizon shares traded as high as 3.01 percent, in a range of $65.92 to $68.08 on day volume of 2.93 million shares, closed regular trading session at $66.68.