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The Week Ahead In Biotech (April 26-May 2): Cancer Conference, Earnings News Flow In The Spotlight

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The Week Ahead In Biotech April 26-May 2: Cancer Conference, Earnings News Flow In The Spotlight

The week ended April 24 turned out to be an up-and-down one for biotech stocks, as the sector swayed along with the broader market. Two FDA approvals came through this week, with Immunomedics, Inc.'s (NASDAQ: IMMU) breast cancer drug snagging an FDA nod and Sanofi SA's (NASDAQ: SNY) meningococcal vaccine greenlighted by the regulatory agency.

First-quarter earnings were healthy, although the same cannot be said of the forward outlook given the uncertainty associated with the COVID-19 pandemic. Biogen Inc (NASDAQ: BIIB) came under pressure on a delay in the regulatory filing for its Alzheimer's drug.

The following are key catalysts that could sway biotech stocks in the unfolding week:

Conferences

  • American Association for Cancer Research, or AACR, 2020 Virtual Annual Meeting: April 27-28

PDUFA Dates

  • The FDA is set to rule on Neurocrine Biosciences, Inc.'s (NASDAQ: NBIX) NDA for Opicapone, a once-daily, oral, selective catechol-O-methyltransferase inhibitor that is being evaluated as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes. (Sunday)
  • The FDA will also decide on United Therapeutics Corporation's (NASDAQ: UTHR) NDA for Trevyent. Trevyent is a drug-device combination product that combines two-day, single use, disposable PatchPump technology with treprostinil, for the subcutaneous treatment of pulmonary arterial hypertension. (Monday)
  • Pfizer Inc. (NYSE: PFE) awaits the FDA decision on its sNDA for Braftovi in combination with Bristol-Myers Squibb Co's (NYSE: BMY) Erbitux. The Braftovi-Erbitux combo is being evaluated as a treatment option for patients with advanced BRAFV600E-mutant metastatic colorectal cancer, following one or two lines of therapy. (April schedule)
  • Amgen, Inc.'s (NASDAQ: AMGN) sNDA for Otezla to expand the prescribing information to include data from the Phase 3 scalp psoriasis study is under review by the FDA. The PDUFA action date is in April.

See also: Some Biogen Analysts Unimpressed By Explanation For Aducanumab Filing Delay

Clinical Readouts

AACR Virtual Conference Presentations

Monday

  • Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI): Data from Cohort 1 of a Phase 2 study that evaluated poziotinib in non-small cell lung cancer with exon 20 insertion mutation in EGFR or HER2
  • Syndax Pharmaceuticals Inc (NASDAQ: SNDX): updated Phase 1 data for SNDX-5613 in relapsed/refractory acute leukemia.
  • Verastem Inc (NASDAQ: VSTM): Phase 1 data for VS-6766, its RAF/MEK inhibitor, in combination with defactinib, its FAK inhibitor, in patients with KRAS mutant advanced solid tumors.
  • Compugen Ltd. (NASDAQ: CGEN): Phase 1 data for COM701 and Bristol-Myers Squibb's Opdivo in solid tumors.
  • IMMUTEP LTD/S ADR (NASDAQ: IMMP): Initial Phase 1 results for eftilagimod alpha and Merck & Co., Inc.'s (NYSE: MRK) Keytruda in non-small cell lung cancer and head and neck cancer.
  • Idera Pharmaceuticals Inc (NASDAQ: IDRA): updated Phase 2 data for tilsotolimod along with Opdivo and Yervoy in squamous cell carcinoma of the head and neck.
  • Moderna Inc (NASDAQ: MRNA): Phase 1/2 data for mRNA-2416 and durvalumab in advanced malignancies.
  • GlaxoSmithKline plc (NYSE: GSK): Phase 1 data for GSK3174998 in solid tumors.
  • Sutro Biopharma Inc (NASDAQ: STRO): updated Phase 1 data for STRO-002 in ovarian and endometrial cancer.

Tuesday

  • Iovance Biotherapeutics Inc (NASDAQ: IOVA): Phase 1 data for tumor-infiltrating lymphocytes in non-small cell lung cancer.

The Other Readouts

  • Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and Sanofi: initial Phase 2/3 Kevzara data (April).
  • Gilead Sciences, Inc. (NASDAQ: GILD): Phase 3 data for remdesivir in COVID-19 severe patients (late-April).
  • Ovid Therapeutics Inc (NASDAQ: OVID): Phase 2 top-line data for OV101 in Fragile X syndrome (Early Q2).
  • Iterum Therapeutics PLC (NASDAQ: ITRM): Phase 3 data for Sulopenem in uncomplicated and complicated urinary tract infections (Early Q2).
  • Atossa Therapeutics Inc (NASDAQ: ATOS) will meet with the FDA Thursday to discuss the clinical development of oral Endoxifen to reduce mammographic breast density.

Earnings

Monday

  • Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) (before the market open)

Tuesday

  • Merck & Co., Inc. (NYSE: MRK) (before the market open)
  • Pfizer Inc. (NYSE: PFE) (before the market open)
  • NeoGenomics, Inc. (NASDAQ: NEO) (before the market open)
  • Masimo Corporation (NASDAQ: MASI) (after the close)
  • Medpace Holdings Inc (NASDAQ: MEDP) (after the close)
  • DexCom, Inc. (NASDAQ: DXCM) (after the close)

Wednesday

  • Alkermes Plc (NASDAQ: ALKS) (before the market open)
  • Boston Scientific Corporation (NYSE: BSX) (before the market open)
  • United Therapeutics Corporation (NASDAQ: UTHR) (before the market open)
  • Alimera Sciences Inc (NASDAQ: ALIM) (after the close)
  • AtriCure Inc. (NASDAQ: ATRC) (after the close)
  • BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (after the close)
  • Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) (after the close)
  • SurModics, Inc. (NASDAQ: SRDX) (after the close)
  • Hologic, Inc. (NASDAQ: HOLX) (after the close)

Thursday

  • Agios Pharmaceuticals Inc (NASDAQ: AGIO) (before the market open)
  • ABIOMED, Inc. (NASDAQ: ABMD) (before the market open)
  • BIO-TECHNE Corp (NASDAQ: TECH) (before the market open)
  • Syneos Health Inc (NASDAQ: SYNH) (before the market open)
  • PRA Health Sciences Inc (NASDAQ: PRAH) (before the market open)
  • Lantheus Holdings Inc (NASDAQ: LNTH) (before the market open)
  • Iradimed Corp (NASDAQ: IRMD) (before the market open)
  • Concert Pharmaceuticals Inc (NASDAQ: CNCE) (before the market open)
  • Amgen, Inc. (NASDAQ: AMGN) (after the close)
  • Emergent Biosolutions Inc (NYSE: EBS) (after the close)
  • Insmed Incorporated (NASDAQ: INSM) (after the close)
  • Gilead Sciences, Inc. (NASDAQ: GILD) (after the close)
  • Seattle Genetics, Inc. (NASDAQ: SGEN) (after the close)
  • Natus Medical Inc (NASDAQ: NTUS) (after the close)
  • Illumina, Inc. (NASDAQ: ILMN) (after the close)
  • PTC Therapeutics, Inc. (NASDAQ: PTCT) (after the close)
  • LeMaitre Vascular Inc (NASDAQ: LMAT) (after the close)
  • ResMed Inc. (NYSE: RMD) (after the close)
  • Viking Therapeutics Inc (NASDAQ: VKTX) (after the close)
  • Silk Road Medical Inc (NASDAQ: SILK) (after the close)
  • Corvus Pharmaceuticals Inc (NASDAQ: CRVS) (after the close)
  • CareDx Inc (NASDAQ: CDNA) (after the close)
  • Tandem Diabetes Care Inc (NASDAQ: TNDM) (after the close)

Friday

  • AbbVie Inc (NYSE: ABBV) (before the market open)
  • GlycoMimetics Inc (NASDAQ: GLYC) (before the market open)
  • ImmunoGen, Inc. (NASDAQ: IMGN) (before the market open)

IPO Quiet Period Expiry

  • Zentalis Pharmaceuticals Inc (NASDAQ: ZNTL)

Related Link: BioNTech, Immunic Soar On COVID-19 Developmental Updates

 

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