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.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Although there were promising updates from some coronavirus vaccine makers, negative headlines plagued Novavax, Inc. (NASDAQ: NVAX) and Moderna Inc (NASDAQ: MRNA), sending their stocks lower by 4.7% and 23%, respectively, for the week.” data-reactid=”20″>Although there were promising updates from some coronavirus vaccine makers, negative headlines plagued Novavax, Inc. (NASDAQ: NVAX) and Moderna Inc (NASDAQ: 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

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="The FDA is set to rule on Ultragenyx Pharmaceutical Inc’s (NASDAQ: RARE) NDA for UX007, its investigational drug for long-chain fatty acid oxidation disorders. (Friday)” data-reactid=”26″>The FDA is set to rule on Ultragenyx Pharmaceutical Inc’s (NASDAQ: RARE) NDA for UX007, its investigational drug for long-chain fatty acid oxidation disorders. (Friday)

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="GW Pharmaceuticals PLC- ADR (NASDAQ: 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)” data-reactid=”27″>GW Pharmaceuticals PLC- ADR (NASDAQ: 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:

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Alector Inc (NASDAQ: ALEC): preliminary data from a Phase 2 open-label study evaluating AL001 in individuals with frontotemporal dementia (Tuesday)” data-reactid=”29″>Alector Inc (NASDAQ: ALEC): preliminary data from a Phase 2 open-label study evaluating AL001 in individuals with frontotemporal dementia (Tuesday)

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Eisai Co., Ltd (OTC: ESALY) and Biogen Inc (NASDAQ: 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” data-reactid=”30″>Eisai Co., Ltd (OTC: ESALY) and Biogen Inc (NASDAQ: 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

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="AC Immune SA (NASDAQ: 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” data-reactid=”31″>AC Immune SA (NASDAQ: 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

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="See Also: How Moderna’s Patent Challenge Loss Could Impact Coronavirus Vaccine Program” data-reactid=”32″>See Also: How Moderna’s Patent Challenge Loss Could Impact Coronavirus Vaccine Program

Standalone releases:

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Tcr2 Therapeutics Inc (NASDAQ: 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)” data-reactid=”34″>Tcr2 Therapeutics Inc (NASDAQ: 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)

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Genocea Biosciences Inc (NASDAQ: 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)” data-reactid=”35″>Genocea Biosciences Inc (NASDAQ: 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:

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI): top-line results from Cohort 2 of the ZENITH20 trial evaluating poziotinib in previously treated HER2 non-small cell lung cancer patients” data-reactid=”37″>Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI): top-line results from Cohort 2 of the ZENITH20 trial evaluating poziotinib in previously treated HER2 non-small cell lung cancer patients

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Intra-Cellular Therapies Inc (NASDAQ: ITCI): top-line results from a Phase 3 study evaluating lumateperone as adjunctive therapy in bipolar depression.” data-reactid=”38″>Intra-Cellular Therapies Inc (NASDAQ: ITCI): top-line results from a Phase 3 study evaluating lumateperone as adjunctive therapy in bipolar depression.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="BioXcel Therapeutics Inc (NASDAQ: BTAI): top-line results from a Phase 1/2b trial of BXCL501 for the acute treatment of agitation associated with geriatric dementia.” data-reactid=”39″>BioXcel Therapeutics Inc (NASDAQ: BTAI): top-line results from a Phase 1/2b trial of BXCL501 for the acute treatment of agitation associated with geriatric dementia.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Alnylam Pharmaceuticals, Inc. (NASDAQ: 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.” data-reactid=”40″>Alnylam Pharmaceuticals, Inc. (NASDAQ: 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.

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Karuna Therapeutics Inc (NASDAQ: KRTX): data from Phase 1b clinical trial of KarXT in experimentally induced pain” data-reactid=”41″>Karuna Therapeutics Inc (NASDAQ: KRTX): data from Phase 1b clinical trial of KarXT in experimentally induced pain

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Akari Therapeutics PLC (NASDAQ: AKTX): interim update on the Part B placebo-controlled efficacy arm of the study of nomacopan eye drops in atopic keratoconjunctivitis” data-reactid=”42″>Akari Therapeutics PLC (NASDAQ: AKTX): interim update on the Part B placebo-controlled efficacy arm of the study of nomacopan eye drops in atopic keratoconjunctivitis

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Seres Therapeutics Inc (NASDAQ: MCRB): Data from SER-109 Phase 3 study in recurrent C. difficile infection” data-reactid=”43″>Seres Therapeutics Inc (NASDAQ: MCRB): Data from SER-109 Phase 3 study in recurrent C. difficile infection

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Mesoblast&nbsp;(NASDAQ: MESO): data from a Phase 3 randomized controlled trial of Revascor for advanced heart failure” data-reactid=”44″>Mesoblast (NASDAQ: MESO): data from a Phase 3 randomized controlled trial of Revascor for advanced heart failure

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Akebia Therapeutics Inc (NASDAQ: 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” data-reactid=”45″>Akebia Therapeutics Inc (NASDAQ: 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

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="View more earnings on IBB” data-reactid=”46″>View more earnings on IBB

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Anavex Life Sciences Corp (NASDAQ: AVXL): top-line results from the Phase 2 study of ANAVEX 2-73 in Parkinson’s disease dementia Phase 2 trial” data-reactid=”47″>Anavex Life Sciences Corp (NASDAQ: AVXL): top-line results from the Phase 2 study of ANAVEX 2-73 in Parkinson’s disease dementia Phase 2 trial

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="BIOLINERX LTD/S ADR (NASDAQ: 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 &amp; Co., Inc.’s (NYSE: MRK) Keytruda in advanced second-line pancreatic cancer” data-reactid=”48″>BIOLINERX LTD/S ADR (NASDAQ: 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 (NYSE: MRK) Keytruda in advanced second-line pancreatic cancer

<p class="canvas-atom canvas-text Mb(1.0em) Mb(0)–sm Mt(0.8em)–sm" type="text" content="Arcus Biosciences Inc (NYSE: RCUS): preliminary data from Phase 1b expansion trials involving combinations with AB928 in multiple tumor types and settings” data-reactid=”49″>Arcus Biosciences Inc (NYSE: RCUS): preliminary data from Phase 1b expansion trials involving combinations with AB928 in multiple tumor types and settings