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The Week Ahead In Biotech: Virtual Conference Presentations, Clovis PDUFA Date In The Spotlight

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The Week Ahead In Biotech: Virtual Conference Presentations, Clovis PDUFA Date In The Spotlight

The smid-cap biotech earnings deluge hit Wall Street in the week ended May 9, positively impacting the stocks in the sector. The iShares NASDAQ Biotechnology Index (NASDAQ: IBB) gained about 6% for the week.

Large-cap pharma names AstraZeneca plc (NYSE: AZN) and Novartis AG (NYSE: NVS) received FDA nods for their heart failure and lung cancer therapies, respectively. After receiving emergency use authorization from the FDA in the U.S., Gilead Sciences, Inc.'s (NASDAQ: GILD) remdesivir obtained full regulatory approval in Japan.

Moderna Inc (NASDAQ: MRNA) received the OK to proceed with the Phase 2 trial of its mRNA coronavirus vaccine candidate mRNA-1273.

The following are the key events and catalysts that biotech investors need to watch in the coming week.  

Conferences

  • Bank of America Securities 2020 HealthCare Virtual Conference: May 12-14
  • American Society of Gene and Cell Therapy, or ASGCT, 23rd Virtual Annual Meeting: May 12-15
  • 2020 Society for Investigative Dermatology, or SID, Annual Meeting Virtual Conference: May 13-16
  • Society for Cardiovascular Angiography and Interventions, or SCAI, 2020 Virtual Conference, Scientific Sessions: May 14-16

PDUFA Dates

Clovis Oncology Inc (NASDAQ: CLVS) awaits the FDA nod for an expanded indication for its cancer therapy Rubraca. The sNDA seeks approval of Rubraca as a monotherapy treatment for patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer.

Clinical Readouts

ASGCT Conference Presentations

Abeona Therapeutics Inc (NASDAQ: ABEO) is due to present updated interim results from the Transpher A and Transpher B studies, Phase 1/2 trials of ABO-102 and ABO-101, respectively, in mucopolysaccharidosis type IIIA, aka as Sanfilippo syndrome type.

Rocket Pharmaceuticals Inc (NASDAQ: RCKT will present updated data from Phase 1/2 FANCOLEN-I study, which is evaluating the safety and efficacy of infusion of autologous CD34 + cells transduced with a lentiviral vector carrying the FANCA gene in patients with Fanconi anemia subtype A, and updates from the Phase 1 LAD-I study that is evaluating its investigational gene therapy RP-L201 to treat severe Leukocyte Adhesion Deficiency-I.

Avrobio Inc (NASDAQ: AVRO) is scheduled to make an oral presentation on new data from the Phase 2 trial of AVR-RD-01 for Fabry (Wednesday). The company will also make an oral presentation of new data from the collaborator-sponsored Phase 1/2 clinical trial of AVR-RD-04 in cystinosis. Another oral presentation on new data from a preclinical research program for a gene therapy for Pompe disease is also scheduled for Wednesday.

Ultragenyx Pharmaceutical Inc (NASDAQ: RARE) is due to present updated data from the first three cohorts of a Phase 1/2 study of DTX301 in treating ornithine transcarbamylase deficiency (Wednesday). The company will also present updated data from the confirmatory cohort from a Phase 1/2 study of DTX401 in glycogen storage disease Type 1a (Friday).

Pfizer Inc. (NYSE: PFE) will present Phase 1b data for PF-06939926 in Duchenne muscular dystrophy on Friday.

Krystal Biotech Inc (NASDAQ: KRYS) will present a poster on KB407, an HSV-1 based gene therapy vector, for the treatment of cystic fibrosis.

See Also: Gilead Works To 'Maximize Global Supply' Of Coronavirus Candidate Remdesivir Amid Threat Of Patent Loss

Other Readouts

Genocea Biosciences Inc (NASDAQ: GNCA) will host a KOL symposium with a live Q&A for analysts and investors to reflect on the progress of the T cell therapy landscape and provide an in-depth profile of GEN-011 – Genocea's neoantigen cell therapy. (Tuesday)

Krystal Biotech is due to present at the SID meeting with results from a Phase 1/2 study of in vivo gene therapy KB105 for treating autosomal recessive congenital ichthyosis as well as results of a Phase 1/2 trial that is evaluating in vivo correction of dystrophic epidermolysis bullosa by direct cutaneous COL7A1 gene replacement.

Caladrius Biosciences Inc (NASDAQ: CLBS) will present at the SCAI meeting Thursday with full data from the ESCaPE-CMD study of CLBS16 for the treatment of coronary microvascular dysfunction.

Constellation Pharmaceuticals Inc (NASDAQ: CNST) said abstracts of a presentation due at the June 11-14 European Hematology Association meeting will be made available Thursday. The abstract pertains to an interim update from the MANIFEST Phase 2 study that is evaluating CPI-0610 in myelofibrosis.

Auris Medical Holding Ltd (NASDAQ: EARS) is due to release top-line data in early May from the Phase 1b trial that is evaluating AM-201 in healthy volunteers. AM-201 is the company's investigational drug for the prevention of antipsychotic-induced weight gain and somnolence.

Earnings

Monday

  • Amneal Pharmaceuticals Inc (NYSE: AMRX) (before the market open)
  • Arbutus Biopharma Corp (NASDAQ: ABUS) (before the market open)
  • Apyx Medical Corp (NASDAQ: APYX) (before the market open)
  • Evelo Biosciences Inc (NASDAQ: EVLO) (before the market open)
  • bluebird bio Inc (NASDAQ: BLUE) (before the market open)
  • Sesen Bio Inc (NASDAQ: SESN) (before the market open)
  • Mylan NV (NASDAQ: MYL) (before the market open)
  • Zimmer Biomet Holdings Inc (NYSE: ZBH) (before the market open)
  • Wave Life Sciences Ltd (NASDAQ: WVE) (before the market open)
  • Passage Bio Inc (NASDAQ: PASG) (before the market open)
  • Pieris Pharmaceuticals Inc (NASDAQ: PIRS) (before the market open)
  • Oyster Point Pharma Inc (NASDAQ: OYST) (before the market open)
  • Recro Pharma Inc (NASDAQ: REPH) (before the market open)
  • Intercept Pharmaceuticals Inc (NASDAQ: ICPT) (before the market open)
  • Corbus Pharmaceuticals Holdings Inc (NASDAQ: CRBP) (before the market open)
  • Assertio Therapeutics Inc (NASDAQ: ASRT) (before the market open)
  • Eagle Pharmaceuticals Inc (NASDAQ: EGRX) (before the market open)
  • Catalyst Pharmaceuticals Inc (NASDAQ: CPRX) (after the close)
  • AcelRx Pharmaceuticals Inc (NASDAQ: ACRX) (after the close)
  • 10X Genomics Inc (NASDAQ: TXG) (after the close)
  • Aimmune Therapeutics Inc (NASDAQ: AIMT) (after the close)
  • Acceleron Pharma Inc (NASDAQ: XLRN) (after the close)
  • Avadel Pharmaceuticals PLC (NASDAQ: AVDL) (after the close)
  • Pulse Biosciences Inc (NASDAQ: PLSE) (after the close)
  • Matinas BioPharma Holdings Inc (NYSE: MTNB) (after the close)
  • CorMedix Inc. (NYSE: CRMD) (after the close)
  • Castle Biosciences Inc (NASDAQ: CSTL) (after the close)
  • Omeros Corporation (NASDAQ: OMER) (after the close)
  • Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV) (after the close)
  • GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) (after the close)
  • Halozyme Therapeutics, Inc. (NASDAQ: HALO) (after the close)
  • Organogenesis Holdings Inc (NASDAQ: ORGO) (after the close)
  • Neos Therapeutics Inc (NASDAQ: NEOS) (after the close)
  • Retrophin In (NASDAQ: RTRX) (after the close)
  • Sangamo Therapeutics Inc (NASDAQ: SGMO) (after the close)
  • Rockwell Medical Inc (NASDAQ: RMTI) (after the close)
  • Inovio Pharmaceuticals Inc (NASDAQ: INO) (after the close)
  • Infinity Pharmaceuticals Inc. (NASDAQ: INFI) (after the close)
  • Misonix Inc (NASDAQ: MSON) (after the close)
  • Liquidia Technologies Inc (NASDAQ: LQDA) (after the close)
  • Cara Therapeutics Inc (NASDAQ: CARA) (after the close)
  • CymaBay Therapeutics Inc (NASDAQ: CBAY) (after the close)
  • ChemoCentryx Inc (NASDAQ: CCXI) (after the close)
  • DURECT Corporation (NASDAQ: DRRX) (after the close)
  • Endologix, Inc. (NASDAQ: ELGX) (after the close)
  • Exagen Inc (NASDAQ: XGN) (after the close)
  • Evolus Inc (NASDAQ: EOLS) (after the close)
  • Intersect ENT Inc (NASDAQ: XENT) (after the close)
  • Fate Therapeutics Inc (NASDAQ: FATE) (after the close)

Tuesday

  • BioXcel Therapeutics Inc (NASDAQ: BTAI) (before the market open)
  • DarioHealth Corp (NASDAQ: DRIO) (before the market open)
  • Palatin Technologies, Inc. (NYSE: PT) (before the market open)
  • InspireMD Inc (NYSE: NSPR) (before the market open)
  • STRATA Skin Sciences Inc (NASDAQ: SSKN) (before the market open)
  • BioNTech SE – ADR (NASDAQ: BNTX) (before the market open)
  • aTyr Pharma Inc (NASDAQ: LIFE) (after the close)
  • Adaptive Biotechnologies Corp (NASDAQ: ADPT) (after the close)
  • Gossamer Bio Inc (NASDAQ: GOSS) (after the close)
  • Catabasis Pharmaceuticals Inc (NASDAQ: CATB) (after the close)
  • Curis, Inc. (NASDAQ: CRIS) (after the close)
  • Clearpoint Neuro Inc (NASDAQ: CLPT) (after the close)
  • OncoCyte Corp (NYSE: OCX) (after the close)
  • Shockwave Medical Inc (NASDAQ: SWAV) (after the close)
  • Turning Point Therapeutics Inc (NASDAQ: TPTX) (after the close)
  • Opiant Pharmaceuticals Inc (NASDAQ: OPNT) (after the close)
  • TapImmune Inc. common stock (NASDAQ: MRKR) (after the close)

Wednesday

  • PDS Biotechnology Corp (NASDAQ: PDSB) (before the market open)
  • Veru Inc (NASDAQ: VERU) (before the market open)
  • Fulcrum Therapeutics Inc (NASDAQ: FULC) (before the market open)
  • Applied Genetic Technologies Corp (NASDAQ: AGTC) (before the market open)
  • BioLife Solutions Inc (NASDAQ: BLFS) (after the close)
  • DiaMedica Therapeutics Inc (NASDAQ: DMAC) (after the close)
  • Viela Bio Inc (NASDAQ: VIE) (after the close)
  • Biocept Inc (NASDAQ: BIOC) (after the close)
  • Eyenovia Inc (NASDAQ: EYEN) (after the close)
  • Edap Tms SA (NASDAQ: EDAP) (after the close)
  • RA Medical Systems Inc (NYSE: RMED) (after the close)
  • TRACON Pharmaceuticals Inc (NASDAQ: TCON) (after the close)

Thursday

  • Vascular Biogenics Ltd (NASDAQ: VBLT) (before the market open)
  • ImmuCell Corporation (NASDAQ: ICCC) (before the market open)
  • Galmed Pharmaceuticals Ltd (NASDAQ: GLMD) (before the market open)
  • Transenterix Inc (NYSE: TRXC) (before the market open)
  • Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP) (before the market open)
  • Aptinyx Inc (NASDAQ: APTX) (after the close)
  • Aytu Bioscience Inc (NASDAQ: AYTU) (after the close)
  • Applied DNA Sciences Inc (NASDAQ: APDN) (after the close)
  • INmune Bio Inc (NASDAQ: INMB) (after the close)
  • Dare Bioscience Inc (NASDAQ: DARE) (after the close)
  • Navidea Biopharmaceuticals Inc (NYSE: NAVB) (after the close)
  • Thermogenesis Holdings Inc (NASDAQ: THMO) (after the close)
  • Eton Pharmaceuticals Inc (NASDAQ: ETON) (after the close)
  • Onconova Therapeutics Inc (NASDAQ: ONTX) (after the close)
  • TFF Pharmaceuticals Inc (NASDAQ: TFFP) (after the close)
  • Viveve Medical Inc (NASDAQ: VIVE) (after the close)
  • Salarius Pharmaceuticals Inc (NASDAQ: SLRX) (after the close)
  • Vermillion, Inc. (NASDAQ: VRML) (after the close)

Friday

  • Digirad Corporation (NASDAQ: DRAD) (before the market open)
  • Zyla Life Sciences (OTC: ZCOR) (before the market open)
  • PLx Pharma Inc (NASDAQ: PLXP) (before the market open)

IPO Quiet Period Expiry

ORIC Pharmaceuticals Inc (NASDAQ: ORIC)

 

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