Recap Of Tuesday’s Biotech Catalysts - End of The Day Summary - Oramed Pharmaceuticals (NASDAQ:ORMP), Clearside Biomedical (NASDAQ:CLSD)

European Commission (EC) has approved AbbVie’s ABBV lead asset RINVOQ (upadacitinib 45 mg [induction dose] and 15 mg and 30 mg [maintenance doses]) for the treatment of adult patients with moderately to severely active ulcerative colitis. AbbVie shares traded in a range of $150.33 to $153.56 on a day volume of 4.85 million shares, closed regular trading session at $150.87.

Medicines and Healthcare products Regulatory Agency (MHRA) has granted UK marketing authorization for Global Blood Therapeutics’ GBT Oxbryta (voxelotor) for the treatment of hemolytic anemia due to sickle cell disease (SCD) in adult and pediatric patients 12 years of age and older. Global Blood Therapeutics shares traded in a range of $32.43 to $34.03 on a day volume of 808.38 thousand shares, closed regular trading session at $33.35.

Seagen SGEN and Astellas Pharma announced positive topline results from the phase 1b/2 EV-103 clinical trial (also known as KEYNOTE-869) Cohort K evaluating PADCEV® (enfortumab vedotin-ejfv) in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer. Seagen shares traded in a range of $174.14 to $181.67 on a day volume of 1.64 million shares, closed regular trading session at $177.51.

MediciNova MNOV announced the initiation of a Phase 2 clinical trial to evaluate MN-001 (tipelukast) for the treatment of patients with non-alcoholic fatty liver disease (NAFLD), type 2 diabetes mellitus (T2DM), and hypertriglyceridemia. MediciNova shares traded in a range of $2.39 to $2.5 on a day volume of 14.14 thousand shares, closed regular trading session at $2.39.

Clearside Biomedical CLSD completed dosing in Cohorts 3 and 4 of OASIS, its Phase 1/2a clinical trial of CLS-AX (axitinib injectable suspension) in patients with neovascular age-related macular degeneration (wet AMD). Clearside shares traded in a range of $1.55 to $1.67 on a day volume of 84.52 thousand shares, closed regular trading session at $1.62.

The U.S. Food and Drug Administration (FDA) has accepted Biogen’s BIIB New Drug Application (NDA) for its lead asset Tofersen for superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). The regulatory agency as granted priority review and assigned PDUFA action date of January 25, 2023. Biogen shares traded in a range of $206.7 to $214 on a day volume of 909.79 thousand shares, closed regular trading session at $210.85.

Reneo Pharmaceuticals RPHM positive results from the REN001 long-chain fatty acid oxidation disorders (LC-FAOD) study and provided additional development updates. Reneo shares traded in a range of $2.99 to $3.66 on a day volume of 401.39 thousand shares, closed regular trading session at $3.3. The company shares are currently trading at $3.21, down 2.73 percent in the after-hours trading session.

Brooklyn BTX reported results from the INSPIRE phase 2 trial of IRX-2, a multi-cytokine biologic immunotherapy, in patients with newly diagnosed stage II, III, or IVA squamous cell carcinoma of the oral cavity. Brooklyn shares traded in a range of $0.49 to $0.53 on a day volume of 451.46 thousand shares, closed regular trading session at $0.49.

MyMD MYMD announced further advancement of its fully funded Phase 2 clinical trial of lead drug candidate MYMD-1 as a therapy for delaying aging and expanding healthy lifespan. To date, the trial has completed dosing for the first patient cohort and dosing has been initiated in the next higher dose cohort. MyMD shares traded in a range of $3.48 to $4 on a day volume of 237.33 thousand shares, closed regular trading session at $3.49.

BridgeBio Pharma BBIO announced positive interim results from PROPEL 2, a Phase 2 trial of the investigational therapy Infigratinib in children with Achondroplasia (ACH). BridgeBio shares traded in a range of $9.22 to $11.95 on a day volume of 5.95 million shares, closed regular trading session at $9.29.

Oramed Pharmaceuticals ORMP has enrolled over 50 percent of the planned 450 patients for its international multicenter Phase 3 ORA-D-013-2 trial of oral insulin capsule, ORMD-0801, for the treatment of type 2 diabetes (T2D). Oramed shares traded in a range of $7.63 to $8.12 on a day volume of 381.33 thousand shares, closed regular trading session at $7.82. The company shares are currently trading at $8.11, up 3.71 percent in the after-hours trading session.

CinCor Pharma CINC has concluded patient enrolment in Phase 2 HALO trial of Baxdrostat (CIN-107), a highly selective aldosterone synthase inhibitor, in patients with uncontrolled hypertension. CinCor shares traded in a range of $21.11 to $24.64 on a day volume of 132.14 thousand shares, closed regular trading session at $23. The company shares are currently trading at $22.45, down 2.39 percent in the after-hours trading session.

The U.S. Food and Drug Administration (FDA) provided favorable feedback on the Current Good Manufacturing Practice (cGMP) design of Applied Genetic Technologies’ AGTC manufacturing facility. In its feedback from a recent Type C meeting, the FDA concurred the facility design and proposed operating procedures are appropriate to support the cGMP manufacture of recombinant AAV drug substance. Applied Genetic shares traded in a range of $0.37 to $0.38 on a day volume of 1.76 milion shares, closed regular trading session at $0.38.

The Japan Ministry of Health, Labour and Welfare (MHLW) granted expanded manufacturing and marketing approval from for Novavax’s NVAX Nuvaxovid (NVX-CoV2373) COVID-19 vaccine towards primary immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17 years. Novavax shares traded in a range of $54.14 to $58.73 on a day volume of 4.77 million shares, closed regular trading session at $56.55.

Synaptogenix SNPX announced changes to its Scientific Advisory Board (SAB) in preparation for Phase 2 data from its Phase 2b clinical trial of Bryostatin-1 for patients suffering from advanced and moderately severe Alzheimer's disease (AD). Synaptogenix shares traded in a range of $5.18 to $5.6 on a day volume of 144.75 thousand shares, closed regular trading session at $5.42.

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