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The Week Ahead In Biotech: Baudax Bio, Merck, Esperion Await FDA Decisions

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The Week Ahead In Biotech: Baudax Bio, Merck, Esperion Await FDA Decisions

Editor's note: This story has been updated to reflect the FDA's approval Friday of Agile Therapeutics' hormonal contraceptive patch Twirla. 

Biotech stocks were quiet in the week ending Feb. 14 amid some data readouts at a couple of conferences and earnings news flow from smid-cap companies.

The following are key biotech catalysts to look forward to for the unfolding week:

Conferences

34th German Cancer Conference: Feb 19-22 in Berlin, Germany
International Association For The Study of Lung Cancer, or IASLC, 2020 Targeted Therapies of Lung Cancer Meeting: Feb. 19-22 in Santa Monica, California

Related Link: 13 Key NASH Drug Candidates To Watch For In A Potential $30-Billion Market

PDUFA Dates

The FDA approved Agile Therapeutics Inc's (NASDAQ: AGR) hormonal contraceptive patch Twirla Friday. After two rejections in the past, Twirla managed to snag a positive Adcom verdict in October 2019. The company said last week that it has negotiated a $35-million loan facility.

The FDA is scheduled to issue its verdict on Merck & Co., Inc.'s (NYSE: MRK) sBLAs for Keytruda dosing schedule updates. The verdict is expected Tuesday.

Baudax Bio Inc (NASDAQ: BXRX), which has faced two prior rejections for its meloxicam intravenous formulation, is awaiting an FDA decision on its investigational pain drug on Thursday.

The FDA will also rule on Esperion Therapeutics Inc's (NASDAQ: ESPR) bempedoic acid as a treatment option for elevated LDL cholesterol. The decision is expected Friday.

Clinical Readouts

IMMUTEP LTD/S ADR (NASDAQ: IMMP) is due to present at the German Cancer Congress Phase 2 mature data for its eftilagimod alpha in combination with Merck's Keytruda in non-small cell lung cancer and head & neck cancer (Wednesday).

Cellectar Biosciences Inc (NASDAQ: CLRB) will release updated Phase 2 data on CLR 131, which is being evaluated for various lymphomas (Wednesday). The company will also issue an update on the Phase 1 data for the same asset in multiple myeloma.

Agenus Inc (NASDAQ: AGEN) is scheduled to present on its Investor Day interim analysis of Phase 1 data for balstilimab, or AGEN2034, in cervical cancer (Thursday). The company will also present Phase 1 data for AGEN1181 in advanced cancer.

Advaxis, Inc. (NASDAQ: ADXS) will present at the IASLC Congress Phase 1 data for ADXS-503 monotherapy as well as combo therapy along with Keytruda in metastatic non-small cell lung cancer (Saturday).

Earnings

Tuesday

  • Medtronic PLC (NYSE: MDT) (before the market open)
  • 10X Genomics Inc (NASDAQ: TXG) (after the market close)
  • AtriCure Inc. (NASDAQ: ATRC) (after the market close)
  • ImmuCell Corporation (NASDAQ: ICCC) (after the market close)

Wednesday

  • Elanco Animal Health Inc (NYSE: ELAN) (before the market open)
  • Integra Lifesciences Holdings Corp (NASDAQ: IART) (before the market open)
  • Endologix, Inc. (NASDAQ: ELGX) (after the market close)
  • Anika Therapeutics Inc (NASDAQ: ANIK (after the market close)
  • Masimo Corporation (NASDAQ: MASI) (after the market close)
  • InVitae Corp NYSE: (NVTA (after the market close)
  • OraSure Technologies, Inc. (NASDAQ: OSUR) (after the market close)

Thursday

  • Repligen Corporation (NASDAQ: RGEN) (before the market open)
  • Syneos Health Inc (NASDAQ: SYNH) (before the market open)
  • TherapeuticsMD Inc (NASDAQ: TXMD) (before the market open)
  • Puma Biotechnology Inc (NASDAQ: PBYI) (after the market close)
  • Emergent Biosolutions Inc (NYSE: EBS) (after the market close)
  • Cerus Corporation (NASDAQ: CERS) (after the market close)
  • Globus Medical Inc (NYSE: GMED) (after the market close)
  • PRA Health Sciences Inc (NASDAQ: PRAH) (after the market close)
  • NuVasive, Inc. (NASDAQ: NUVA) (after the market close)
 

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