the-week-ahead-in-biotech-(aug.-24-29):-lipocine-binary-event,-liver-congress-in-the-spotlight

The Week Ahead In Biotech (Aug. 24-29): Lipocine Binary Event, Liver Congress In The Spotlight

M&A announcements and a couple of adverse rulings handed down by the FDA.” data-reactid=”19″ type=”text”>After seeing some strength earlier on, biotech stocks came under pressure in the week ended Aug. 21. With the earnings season tapering and not much of noise on the coronavirus front, the sector reacted to some clinical readouts, two M&A announcements and a couple of adverse rulings handed down by the FDA.

NNOX) raised $165.2 million.” data-reactid=”20″ type=”text”>Three biotech issues IPOed this week, collecting a cumulative $404.1 in gross proceeds. This apart, Israeli medical imaging startup Nano-X Imaging Ltd (NASDAQ: NNOX) raised $165.2 million.

Here’re the key catalysts for the unfolding week:

European Association for the Study of the Liver, or EASL, Digital International Liver Congress 2020: Aug. 27-29
European Society of Cardiology, ESC, Congress 2020: Aug. 29 – Sept. 1
46th Annual Meeting of the European Society for Blood and Marrow Transplantation: Aug. 29 – Sept. 1″ data-reactid=”27″ type=”text”>Virtual World Orphan Drug Congress USA 2020: Aug. 24-27

European Association for the Study of the Liver, or EASL, Digital International Liver Congress 2020: Aug. 27-29

European Society of Cardiology, ESC, Congress 2020: Aug. 29 – Sept. 1

46th Annual Meeting of the European Society for Blood and Marrow Transplantation: Aug. 29 – Sept. 1

Lipocine Inc (NASDAQ: LPCN) is knocking at FDA’s doors for the fourth time with respect to its Tlando, an oral prodrug of testosterone containing testosterone undecanoate that is designed to help restore normal testosterone levels in hypogonadal men. The FDA has set a PDUFA action date of Jan. 28 (Friday).” data-reactid=”29″ type=”text”>Lipocine Inc (NASDAQ: LPCN) is knocking at FDA’s doors for the fourth time with respect to its Tlando, an oral prodrug of testosterone containing testosterone undecanoate that is designed to help restore normal testosterone levels in hypogonadal men. The FDA has set a PDUFA action date of Jan. 28 (Friday).

Odonate Therapeutics Inc (NASDAQ: ODT) announced it will hold a conference call on Monday at 8: 30 a.m. ET. Although the company has not given details, it is scheduled to report top-line results from the CONTESSA Phase 3 study investigating tesetaxel as a potential treatment for patients with metastatic breast cancer in the third quarter.” data-reactid=”31″ type=”text”>Odonate Therapeutics Inc (NASDAQ: ODT) announced it will hold a conference call on Monday at 8: 30 a.m. ET. Although the company has not given details, it is scheduled to report top-line results from the CONTESSA Phase 3 study investigating tesetaxel as a potential treatment for patients with metastatic breast cancer in the third quarter.

Why This 9 Meters Biopharma Analyst Sees 800% Upside Ahead ” data-reactid=”32″ type=”text”>See also: Why This 9 Meters Biopharma Analyst Sees 800% Upside Ahead

Assembly Biosciences Inc (NASDAQ: ASMB): additional interim analyses from Study 211, a Phase 2 open-label extension study of ABI-H0731 in combination with standard of care therapy for hepatitis B virus, and data from multiple dose cohorts in the Phase 1b clinical of ABI-H2158-containing regimens for chronic hepatic B virus infection” data-reactid=”34″ type=”text”>Assembly Biosciences Inc (NASDAQ: ASMB): additional interim analyses from Study 211, a Phase 2 open-label extension study of ABI-H0731 in combination with standard of care therapy for hepatitis B virus, and data from multiple dose cohorts in the Phase 1b clinical of ABI-H2158-containing regimens for chronic hepatic B virus infection

MIRM): Phase 2 open-label data on five-year transplant-free survival for pediatric patients with progressive familial intrahepatic cholestasis type 2″ data-reactid=”35″ type=”text”>Mirum Pharmaceuticals Inc (NASDAQ: MIRM): Phase 2 open-label data on five-year transplant-free survival for pediatric patients with progressive familial intrahepatic cholestasis type 2

CBAY): final results on durability of treatment response after 1 year of therapy from an international phase 2 study of seladelpar in patients with primary biliary cholangitis, or PBC” data-reactid=”36″ type=”text”>CymaBay Therapeutics Inc (NASDAQ: CBAY): final results on durability of treatment response after 1 year of therapy from an international phase 2 study of seladelpar in patients with primary biliary cholangitis, or PBC

ADAP): Updated data from the third dose cohort of an ongoing Phase 1 study of ADP A2AFP SPEAR T-cells in hepatocellular carcinoma” data-reactid=”37″ type=”text”>Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP): Updated data from the third dose cohort of an ongoing Phase 1 study of ADP A2AFP SPEAR T-cells in hepatocellular carcinoma

EIGR): Phase 2 LIFT study end-of-treatment data for peginterferon Lambda in hepatitis delta virus” data-reactid=”38″ type=”text”>Eiger Biopharmaceuticals Inc (NASDAQ: EIGR): Phase 2 LIFT study end-of-treatment data for peginterferon Lambda in hepatitis delta virus

ARWR): an oral presentation showing short-term treatment with RNA interference therapy, JNJ-3989 (Friday)” data-reactid=”39″ type=”text”>Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR): an oral presentation showing short-term treatment with RNA interference therapy, JNJ-3989 (Friday)

View more earnings on IBB” data-reactid=”40″ type=”text”>View more earnings on IBB

VKTX): new data from the Phase 2 study of VK2809 in patients with non-alcoholic fatty liver disease, or NAFLD, and elevated LDL-cholesterol” data-reactid=”41″ type=”text”>Viking Therapeutics Inc (NASDAQ: VKTX): new data from the Phase 2 study of VK2809 in patients with non-alcoholic fatty liver disease, or NAFLD, and elevated LDL-cholesterol

AXLA): key data from AXA1125-003, assessing the impact of AXA1125 and AXA1957 in NAFLD” data-reactid=”42″ type=”text”>Axcella Health Inc (NASDAQ: AXLA): key data from AXA1125-003, assessing the impact of AXA1125 and AXA1957 in NAFLD

ICPT): new interim analysis of data from the Phase 3 REGENERATE study of obeticholic acid in non-alcoholic steatohepatitis, or NASH, and additional long-term data of OCA through six years of open-label treatment in PBC” data-reactid=”43″ type=”text”>Intercept Pharmaceuticals Inc (NASDAQ: ICPT): new interim analysis of data from the Phase 3 REGENERATE study of obeticholic acid in non-alcoholic steatohepatitis, or NASH, and additional long-term data of OCA through six years of open-label treatment in PBC

ALNY) and Vir Biotechnology Inc (NASDAQ: VIR): results from an ongoing Phase 2 study of VIR-2218 in patients with chronic hepatitis B virus” data-reactid=”44″ type=”text”>Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) and Vir Biotechnology Inc (NASDAQ: VIR): results from an ongoing Phase 2 study of VIR-2218 in patients with chronic hepatitis B virus

NGM): Positive topline results from a 24-week, Phase 2 paired liver biopsy study of the FGF19 analogue aldafermin, codenamed NGM282, in patients with NASH” data-reactid=”45″ type=”text”>NGM Biopharmaceuticals Inc (NASDAQ: NGM): Positive topline results from a 24-week, Phase 2 paired liver biopsy study of the FGF19 analogue aldafermin, codenamed NGM282, in patients with NASH

ENTA): oral presentation of data from the Phase 2a ARGON-1 study of DP-305 in NASH (Friday), and final results of a Phase 1 study of EDP-514 in hepatitis B virus infection (Saturday)” data-reactid=”46″ type=”text”>Enanta Pharmaceuticals Inc (NASDAQ: ENTA): oral presentation of data from the Phase 2a ARGON-1 study of DP-305 in NASH (Friday), and final results of a Phase 1 study of EDP-514 in hepatitis B virus infection (Saturday)

Akcea Therapeutics Inc (NASDAQ: AKCA) and Ionis Pharmaceuticals Inc (NASDAQ: IONS) will present data from the Phase 2 study of AKCEA-APOCIII-LRx in a late-breaking clinical trial session. AKCEA-APOCIII-LRx is an antisense drug developed using Ionis’ proprietary ligand conjugated antisense technology platform and is designed to reduce the production of apolipoprotein C-III, a protein produced in the liver that plays a central role in the regulation of serum triglycerides.” data-reactid=”48″ type=”text”>Akcea Therapeutics Inc (NASDAQ: AKCA) and Ionis Pharmaceuticals Inc (NASDAQ: IONS) will present data from the Phase 2 study of AKCEA-APOCIII-LRx in a late-breaking clinical trial session. AKCEA-APOCIII-LRx is an antisense drug developed using Ionis’ proprietary ligand conjugated antisense technology platform and is designed to reduce the production of apolipoprotein C-III, a protein produced in the liver that plays a central role in the regulation of serum triglycerides.

MYOK) will present 38-week data from its pivotal Phase 3 EXPLORER-HCM study that is evaluating the efficacy and safety of mavacamten in adults with symptomatic obstructive hypertrophic cardiomyopathyclinical during a late-breaker session.” data-reactid=”53″ type=”text”>Myokardia Inc (NASDAQ: MYOK) will present 38-week data from its pivotal Phase 3 EXPLORER-HCM study that is evaluating the efficacy and safety of mavacamten in adults with symptomatic obstructive hypertrophic cardiomyopathyclinical during a late-breaker session.

EBMT Presentations” data-reactid=”55″ type=”text”>EBMT Presentations

BLUE) is scheduled to do multiple presentations at the conference; new Phase 3 study of its investigational elivaldogene autotemcel – eli-cel, Lenti-D gene therapy – in patients with cerebral adrenoleukodystrophy and encore presentations from its cerebral adrenoleukodystrophy, sickle cell disease, transfusion-dependent β-thalassemia and multiple myeloma programs” data-reactid=”56″ type=”text”>bluebird bio Inc (NASDAQ: BLUE) is scheduled to do multiple presentations at the conference; new Phase 3 study of its investigational elivaldogene autotemcel – eli-cel, Lenti-D gene therapy – in patients with cerebral adrenoleukodystrophy and encore presentations from its cerebral adrenoleukodystrophy, sickle cell disease, transfusion-dependent β-thalassemia and multiple myeloma programs

Medtronic PLC (NYSE: MDT) (Tuesday, after the close)
Edap Tms SA (NASDAQ: EDAP) (Wednesday, after the close)
Ascendis Pharma A/S (NASDAQ: ASND) (Thursday, after the close)” data-reactid=”58″ type=”text”>Medtronic PLC (NYSE: MDT) (Tuesday, after the close)

Edap Tms SA (NASDAQ: EDAP) (Wednesday, after the close)

Ascendis Pharma A/S (NASDAQ: ASND) (Thursday, after the close)

Allovir Inc (NASDAQ: ALVR)” data-reactid=”60″ type=”text”>Allovir Inc (NASDAQ: ALVR)

Novavax’s Coronavirus Vaccine Candidate Protects Against Viral Replication In Animal Studies ” data-reactid=”61″ type=”text”>Related Link: Novavax’s Coronavirus Vaccine Candidate Protects Against Viral Replication In Animal Studies

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