The Week Ahead In Biotech (Nov. 28-Dec. 4): FDA Decisions For VBI Vaccines, & More

The Week Ahead In Biotech Nov. 28-Dec. 4: FDA Decisions For VBI Vaccines, BeyondSpring, CTI Biopharma And Merck Take The Spotlight In A Light Calendar Week

Biotech stocks advanced in the week ending Nov. 26, as a late-week surge on the back of news about a new COVID-19 variant named Omicron helped mitigate the losses notched earlier in the holiday-shortened week. Shares of companies with a COVID-19 portfolio, including a vaccine, a treatment, or both, reacted with strong moves to the upside in the truncated session on Friday.

Takeda Pharmaceutical Company Limited (TAK) and Aadi Bioscience, Inc. (AADI) received a Food and Drug Administration nod for their Livtencity and Fyarro, respectively.

Here are the catalysts that could impact trading in the upcoming week.

Conferences

  • The Evercore ISI 4th Annual HealthCONx Virtual Conference: Nov. 30-Dec. 2.
  • Piper Sandler 33rd Annual Virtual Healthcare Conference: Nov. 29-Dec. 2.
  • American Epilepsy Society, or AES, 2021 Annual Meeting: Dec. 3-7, in Illinois, Chicago.

PDUFA Dates

The FDA is scheduled to rule on VBI Vaccines Inc.'s (VBIV) biologic license application for its Sci-B-Vac meant to treat hepatitis B virus infection. The PDUFA date is scheduled for Tuesday, Nov. 30.

BeyondSpring Inc.'s (BYSI) NDA for plinabulin + G-CSF Combination has a PDUFA date of Tuesday, Nov. 30. Plinabulin, in combination with granulocyte colony-stimulating factor, is being studied for the prevention of chemotherapy-induced neutropenia.

CTI BioPharma Corp.'s (CTIC) NDA for pacritinib also has a PDUFA date of Tuesday, Nov. 30. Pacrotinib, if approved, is expected to address the unmet medical need of myelofibrosis patients with severe thrombocytopenia.

The regulator will also announce its verdict on Merck & Co.'s, Inc. (MRK) supplemental BLA for Keytruda for the adjuvant treatment of adult and pediatric patients with stage IIB or IIC melanoma following complete resection. The PDUFA date is set for Saturday, Dec. 4.

Clinical Readouts/Presentations

  • 180 Life Sciences Corp. (ATNF) is scheduled to present at the 2021 International Dupuytren Symposium phase 2a clinical trial data to identify the optimal dose and top line data for the recently completed phase 2b clinical trial on efficacy for patients with early-stage disease. This is scheduled for Wednesday, Dec. 1, at 3 p.m.
  • Xenon Pharmaceuticals Inc. (XENE) will present at the AES meeting additional data from the Phase 2b X-TOLE study of XEN1101 in ‘difficult-to-treat' adult patients with focal epilepsy.
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