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 IMMU breast cancer drug snagging an FDA nod and Sanofi SA's 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 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 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 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. PFE awaits the FDA decision on its sNDA for Braftovi in combination with Bristol-Myers Squibb Co's 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 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. 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 SNDX: updated Phase 1 data for SNDX-5613 in relapsed/refractory acute leukemia.
• Verastem Inc 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. CGEN: Phase 1 data for COM701 and Bristol-Myers Squibb's Opdivo in solid tumors.
• IMMUTEP LTD/S ADR IMMP: Initial Phase 1 results for eftilagimod alpha and Merck & Co., Inc.'s MRK Keytruda in non-small cell lung cancer and head and neck cancer.
• Idera Pharmaceuticals Inc IDRA: updated Phase 2 data for tilsotolimod along with Opdivo and Yervoy in squamous cell carcinoma of the head and neck.
• Moderna Inc MRNA: Phase 1/2 data for mRNA-2416 and durvalumab in advanced malignancies.
• GlaxoSmithKline plc GSK: Phase 1 data for GSK3174998 in solid tumors.
• Sutro Biopharma Inc STRO: updated Phase 1 data for STRO-002 in ovarian and endometrial cancer.

Tuesday

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

The Other Readouts

• Regeneron Pharmaceuticals Inc REGN and Sanofi: initial Phase 2/3 Kevzara data (April).
• Gilead Sciences, Inc. GILD: Phase 3 data for remdesivir in COVID-19 severe patients (late-April).
• Ovid Therapeutics Inc OVID: Phase 2 top-line data for OV101 in Fragile X syndrome (Early Q2).
• Iterum Therapeutics PLC ITRM: Phase 3 data for Sulopenem in uncomplicated and complicated urinary tract infections (Early Q2).
• Atossa Therapeutics Inc 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. LXRX (before the market open)

Tuesday

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

Wednesday

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

Thursday

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

Friday

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

IPO Quiet Period Expiry

• Zentalis Pharmaceuticals Inc ZNTL

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