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

Abbvie ABBV has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for atogepant for the prophylaxis of migraine in adult patients who have at least four migraine days per month. The company shares traded in a range of $148.89 to $154.47 on a day volume of 6.84 million shares, closed regular trading session at $149.57.

The National Institute for Health and Care Excellence (NICE) has issued guidance that recommends Rhythm Pharmaceuticals' RYTM IMCIVREE (setmelanotide) as an option for treating obesity and controlling hunger caused by pro-opiomelanocortin (POMC) deficiency. The company shares traded in a range of $10.09 to $11.59 on a day volume of 7.29 million shares, closed regular trading session at $11.38. The company shares are currently trading at $11.21, down 1.49 percent in the after-hours trading session

The U.S. Food and Drug Administration (FDA) has granted Entera Bio’s ENTX request for a Type C Meeting based on the revised phase 3 registrational study for lead clinical asset, EB613 (oral formulation of PTH (1-34, teriparatide), as the first oral anabolic drug to treat post-menopausal women with osteoporosis. The meeting is expected in second half of 2022. The company shares traded in a range of $1.39 to $1.53 on a day volume of 117.98 thousand shares, closed regular trading session at $1.40. The company shares are currently trading at $1.42, higher 1.43 percent in the after-hours trading session.

The U.S. Food and Drug Administration (FDA) has approved Eton Pharmaceuticals’ ETON ZONISADE (zonisamide oral suspension). The company shares traded in a range of $2.91 to $3.25 on a day volume of 6.16 million shares, closed regular trading session at $3.03. The company shares are currently trading at $2.94, down 2.97 percent in the after-hours trading session.

Eliem Pharma ELYM has updated development plans and the advancement of ETX-155 for the treatment of Major Depressive Disorder, Planning to Initiate a Phase 1 pharmacokinetics trial of ETX-155 to enable a Phase 2a trial in MDD planned to commence in first quarter of 2023. The company shares traded in a range of $3.36 to $3.89 on a day volume of 68.86 thousand shares, closed regular trading session at $3.56.

EyePoint Pharmaceuticals EYPT hosted an investor day event to highlight EYP-1901 and Durasert technology tevelopments and provided  financial update. The company shares traded in a range of $9.3 to $10.19 on a day volume of 298.52 thousand shares, closed regular trading session at $9.79. The company shares are currently trading at $9.31, down 4.9 percent in the after-hours trading session.

Apyx Medical APYX has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the use of the Renuvion APR Handpiece for certain skin contraction procedures. The company shares traded in a range of $7.77 to $8.49 on a day volume of 405.37 thousand shares, closed regular trading session at $8.04.

MEI Pharma MEIP announced the publication in the Lancet Oncology of data from Phase 1b Clinical Study of Zandelisib in patients with Relapsed or Refractory B-cell Malignancy. The company shares traded in a range of $0.56 to $0.59 on a day volume of 1.01 million shares, closed regular trading session at $0.57.

Prometheus Biosciences RXDX completes patient enrollment of the ARTEMIS-UC Cohort 1 Phase 2 study in Ulcerative Colitis. The ttopline results from from the study are expected in the fourth quarter of this year. The company shares traded in a range of $29.26 to $31.15 on a day volume of 227.62 thousand shares, closed regular trading session at $29.29.

Eledon Pharmaceuticals ELDN dosed the first patient in Phase 1b trial evaluating Tegoprubart in Kidney Transplantation. The company shares traded in a range of $3.01 to $3.14 on a day volume of 3.24 thousand shares, closed regular trading session at $3.01. The company shares are currently trading at $3.06, up 1.66 percent in the after-hours trading session.

Acer Therapeutics ACER has resubmitted New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with urea cycle disorders (UCDs). The company shares traded in a range of $1.55 to $1.63 on a day volume of 110.83 thousand shares, closed regular trading session at $1.60.

Acadia Pharmaceuticals ACAD has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for trofinetide for the treatment of Rett syndrome. The company shares traded in a range of $14.96 to $15.72 on a day volume of 1.85 million shares, closed regular trading session at $15.01.

Ultragenyx Pharmaceutical RARE provided program update on GTX-102 for Angelman Syndrome including promising interim data from Phase 1/2 Study. The company shares traded in a range of $60.93 to $66.17 on a day volume of 499.9 thousand shares, closed regular trading session at $61.02.