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 IBB gained about 6% for the week.

Large-cap pharma names AstraZeneca plc AZN and Novartis AG 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 GILD remdesivir obtained full regulatory approval in Japan.

Moderna Inc 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 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 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 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 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. PFE will present Phase 1b data for PF-06939926 in Duchenne muscular dystrophy on Friday.

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

Tuesday

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

Wednesday

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

Thursday

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

Friday

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

IPO Quiet Period Expiry

ORIC Pharmaceuticals Inc ORIC