The Week Ahead In Biotech: Spotlight On GW Pharma, Ultragenyx FDA Decisions, Pfizer Earnings

Biotech stocks moved lower in the week ended July 26, as the broader market weakness and sector-specific developments pressured stocks.

Although there were promising updates from some coronavirus vaccine makers, negative headlines plagued Novavax, Inc. NVAX and Moderna Inc MRNA, sending their stocks lower by 4.7% and 23%, respectively, for the week.

The week saw the listing of 4 biopharma companies on the Nasdaq, which raised a combined $772.9 million.

Here are the key catalysts for the unfolding week.

Conferences:

Alzheimer's Association International Conference, or AAIC, to be held virtually: July 27-31

PDUFA Dates

The FDA is set to rule on Ultragenyx Pharmaceutical Inc's RARE NDA for UX007, its investigational drug for long-chain fatty acid oxidation disorders. (Friday)

GW Pharmaceuticals PLC- ADR GWPH has a PDUFA action date, with the FDA due to announce its verdict on the company's sNDA for Epidiolex for the treatment of seizures associated with tuberous sclerosis complex. (Friday)

Clinical Readouts

AAIC Presentations:

Alector Inc ALEC: preliminary data from a Phase 2 open-label study evaluating AL001 in individuals with frontotemporal dementia (Tuesday)

Eisai Co., Ltd ESALY and Biogen Inc BIIB: latest data of the investigational anti-amyloid beta protofibril antibody BAN2401; Biogen will also make an oral presentation of the previously publicized topline results of Phase III studies EMERGE and ENGAGE

AC Immune SA ACIU: Key data on its alpha-synuclein-positron emission tomography tracer program along with a second oral presentation of the Phase 1b trial of the anti-Abeta vaccine ACI-24 in Down syndrome

See Also: How Moderna's Patent Challenge Loss Could Impact Coronavirus Vaccine Program

Standalone releases:

Tcr2 Therapeutics Inc TCRR said it plans to discuss initial data from the Phase 1 portion of the TC-210 Phase 1/2 clinical trial for patients with mesothelin-expressing solid tumors. (before the market open, Monday)

Genocea Biosciences Inc GNCA is scheduled to present initial clinical data on the first 5 patients from Part B of the Phase 1/2 study, which is exploring the combination of GEN-009 and immune checkpoint inhibitor-based regimens in advanced solid tumors. (Friday)

Pending mid-2020 Releases:

Spectrum Pharmaceuticals, Inc. SPPI: top-line results from Cohort 2 of the ZENITH20 trial evaluating poziotinib in previously treated HER2 non-small cell lung cancer patients

Intra-Cellular Therapies Inc ITCI: top-line results from a Phase 3 study evaluating lumateperone as adjunctive therapy in bipolar depression.

BioXcel Therapeutics Inc BTAI: top-line results from a Phase 1/2b trial of BXCL501 for the acute treatment of agitation associated with geriatric dementia.

Alnylam Pharmaceuticals, Inc. ALNY: top-line results from the ILLUMINATE-B Phase 3 study of lumasiran in primary hyperoxaluria type 1 patients less than six years of age with preserved renal function.

Karuna Therapeutics Inc KRTX: data from Phase 1b clinical trial of KarXT in experimentally induced pain

Akari Therapeutics PLC AKTX: interim update on the Part B placebo-controlled efficacy arm of the study of nomacopan eye drops in atopic keratoconjunctivitis

Seres Therapeutics Inc MCRB: Data from SER-109 Phase 3 study in recurrent C. difficile infection

Mesoblast MESO: data from a Phase 3 randomized controlled trial of Revascor for advanced heart failure

Akebia Therapeutics Inc AKBA top-line data from the global Phase 3 studies evaluating the safety and efficacy of vadadustat in adult patients not on dialysis with anemia due to chronic kidney disease

Anavex Life Sciences Corp AVXL: top-line results from the Phase 2 study of ANAVEX 2-73 in Parkinson's disease dementia Phase 2 trial

BIOLINERX LTD/S ADR BLRX: Progression-free survival and overall survival data from the triple combination arm of the COMBAT/KEYNOTE-202 Phase 2a study of BL-8040 in combination with Merck & Co., Inc.'s MRK Keytruda in advanced second-line pancreatic cancer

Arcus Biosciences Inc RCUS: preliminary data from Phase 1b expansion trials involving combinations with AB928 in multiple tumor types and settings

Homology Medicines Inc FIXX: additional data from Phase 1/2 pheNIX gene therapy trial for phenylketonuria

Vaxart Inc VXRT: data from universal Influenza vaccine collaboration with Johnson & Johnson's JNJ Janssen unit

Albireo Pharma Inc ALBO: top-line results from the Phase 3 PEDFIC 1 trial that is evaluating Odevixibat in progressive familial intrahepatic cholestasis; top-line data from the Phase 3 trial of elobixibat in non-alcoholic steatohepatitis and non-alcoholic fatty liver disease

resTORbio, Inc. TORC: data from the four completed cohorts of the Phase 1b/2a trial of RTB101 in combination with sirolimus in Parkinson's disease

Earnings

Monday

Medpace Holdings Inc MEDP (after the close)

Tuesday

Exagen Inc XGN (before the market open)
Pfizer Inc. PFE (before the market open)
Ironwood Pharmaceuticals, Inc. IRWD (before the market open)
Masimo Corporation MASI (after the close)
AtriCure Inc. ATRC (after the close)
Amgen, Inc. AMGN (after the close)
NeoGenomics, Inc. NEO (after the close)
DexCom, Inc. DXCM (after the close)
Infinity Pharmaceuticals Inc. INFI (after the close)

Wednesday

Boston Scientific Corporation BSX (before the market open)
United Therapeutics Corporation UTHR (before the market open)
Hologic, Inc. HOLX (after the close)
Alimera Sciences Inc ALIM (after the close)
Merit Medical Systems, Inc. MMSI (after the close)

Thursday

Lexicon Pharmaceuticals, Inc. LXRX (before the market open)
Blueprint Medicines Corp BPMC (before the market open)
Iradimed Corp IRMD (before the market open)
Alexion Pharmaceuticals, Inc. ALXN before the market open)
Agios Pharmaceuticals Inc AGIO (before the market open)
Eli Lilly And Co LLY (before the market open)
Elanco Animal Health Inc ELAN (before the market open)
Evelo Biosciences Inc EVLO (before the market open)
BioTelemetry Inc BEAT (after the close)
MacroGenics Inc MGNX (after the close)
Vertex Pharmaceuticals Incorporated VRTX (after the close)
Emergent Biosolutions Inc EBS (after the close)
Bio-Rad Laboratories, Inc. Class A Common Stock BIO (after the close)
Anika Therapeutics Inc ANIK (after the close)
Gilead Sciences, Inc. GILD (after the close)
Natus Medical Inc NTUS (after the close)
Retrophin Inc RTRX (after the close)
Veracyte Inc VCYT (after the close)
Ultragenyx Pharmaceutical Inc RARE (after the close)
Globus Medical Inc GMED (after the close)
Quidel Corporation QDEL (after the close)
EXACT Sciences Corporation EXAS (after the close)
Tandem Diabetes Care Inc TNDM (after the close)

Friday

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

IPOs

Cambridge, Massachusetts-based AlloVir, which develops allogenic off-the-shelf virus-specific T cell therapy candidates targeting 12 devastating viruses, proposes to offer 14.75 million shares in an IPO, with the price range estimated between $16 and $18. The company has applied for listing its shares on the Nasdaq under the ticker symbol ALVR.

Woodcliff Lake, New Jersey-based PaxMedica, Inc. has filed with the SEC to offer 2.5 million shares to be priced between $5.50 and $6.50. The company is an early clinical-stage biopharma focusing on the development of anti-purinergic therapies for the treatment of neurodevelopmental disorders, including autism spectrum disorder, and Fragile X syndrome tremor-ataxia. It has applied for listing its shares on the Nasdaq under the ticker symbol PXMD.

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