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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.

Benzinga · 05/10/2020 19:40

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.  


  • 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


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.



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IPO Quiet Period Expiry

ORIC Pharmaceuticals Inc (NASDAQ: ORIC)