The Week Ahead In Biotech: Conferences, PDUFA Dates, Clinical Trials, Earnings And IPOs

Biotech stocks have managed to end the quarter in the green, supported in part by the broader market sentiment and some company-specific catalytic events.

Curis, Inc. CRIS and PhaseBio Pharmaceuticals Inc PHAS were among the biggest gainers of the week, with the former reacting to the sale of rights to part of the royalty stream from its basal cell carcinoma drug Erivedge.

While the FDA greenlighted Novartis AG NVS's new multiple sclerosis drug, it issued a complete response letter for Recro Pharma Inc REPH's NDA for its investigational pain medication meloxicam – the second time the asset is facing rejection.

Here are the catalytic events a biotech investor needs to focus on in the unfolding week.

Conferences

  • American Association For Cancer Research annual meeting – March 29-April 3, in Atlanta, Georgia
  • International Symposium On Targeted Alpha Therapy – April 1-4, in Ottawa, Canada
  • 41st annual meeting of the Society For Inherited Metabolic Disorders – April 6-9, in Bellevue, Washington

See Also: Attention Biotech Investors: Mark Your Calendar For These April PDUFA Dates

PDUFA Dates

The FDA is set to rule on Evoke Pharma Inc EVOK's NDA for Gimoti, which is being evaluated for treating symptoms in adult women with acute and recurrent diabetic gastroparesis. The PDUFA date has been set for Monday, April 1.

ADMA Biologics Inc ADMA awaits FDA nod for its BLA for RI-002, which is being evaluated as a treatment option for Primary Immune Deficiency Disease, or PIDD. The PDUFA date is scheduled for April 2.

Clinical Trial Results

Proteon Therapeutics Inc PRTO is due to release Phase 3 data of Vonapanitase in chronic kidney disease patients undergoing surgical placement of an arteriovenous fistula.

Actinium Pharmaceuticals Inc ATNM will present Phase 2 data for Actimab-A in acute myeloid leukemia at the international symposium on TAT.

Aeglea Bio Therapeutics Inc AGLE is scheduled to present Phase 1/2 data of Pegzilarginase in treating arginase 1 deficiency at the SMID conference.

See Also: 6 Gene Therapy M&A Targets On The Radar

AACR Presentations On Sunday, March 31

Advaxis, Inc. ADXS - Phase 1 safety and immunogenicity data for ADXS-NEO (non-small cell lung cancer)
Atara Biotherapeutics Inc ATRA – Phase 1 data for autologous T-cells (malignant pleural disease)

AACR Presentations On Monday, April 1

Advaxis – Phase 1 safety and immunogenicity data for ADXS-PSA and Keytruda (castration-resistant prostate cancer)
Incyte Corporation INCY – poster presentation of Phase 1 data for INCMGA0012 (solid tumors)
Neon Therapeutics Inc NTGN - Phase 1b correlative data of NEO-PV-01 + nivolumab (melanoma, lung Cancer or bladder Cancer)
TrovaGene Inc TROV - Phase 1/2 safety and preliminary anti-leukemic activity data of Onvansertib (acute myeloid leukemia)
Autolus Therapeutics Ltd – ADR AUTL - Phase 1 data of AUT-01 (acute lymphoblastic leukemia)
Constellation Pharmaceuticals Inc CNST – Phase 1b data for CPI-1205 (castration-resistant prostate cancer)
Celldex Therapeutics, Inc. CLDX – updated Phase 1 data for CDX-1140 (solid tumors)
Aduro BioTech Inc ADRO – Poster presentation of Phase 1/2 data for BION-1301 (multiple myeloma)
TG Therapeutics Inc TGTX – Presentation of Phase 2/3 MZL cohort data for TG-1101 and TGR-1202 (non-Hodgkin lymphoma)
Cyclacel Pharmaceuticals Inc CYCC – Phase 1 data for Sapacitabine and seliciclib (BRCA mutant resistant breast cancer)

AACR Presentations oOn Tuesday, April 2

Dynavax Technologies Corporation DVAX - Phase 1/2 safety data of DV281 (non-small cell lung cancer)
TrovaGene - Phase 1/2 safety and initial efficacy data of Onvansertib (PCM-075) and Zytiga (prostate cancer)
Clovis Oncology Inc CLVS & Bristol-Myers Squibb Co BMY – Poster presentation of Phase 3 data of Opdivo and Rubraca (first-line maintenance treatment of ovarian cancer)
NewLink Genetics Corp NLNK – Phase 2 data for NLG207 (CRLX101) and paclitaxel (platinum-resistant ovarian cancer)
Jounce Therapeutics Inc JNCE - Phase 1/2 data for JTX-2011 (solid tumors)

AACR Presentations On  Wednesday, April 3

Tocagen Inc TOCA – updated Phase 1 data of Toca 511 & Toca FC (glioma)
TRACON Pharmaceuticals Inc TCON – Poster presentation of Phase 2 data for TRC102 and Temodar (colorectal cancer)

Earnings

Monday

  • Edap Tms SA EDAP (before the market open)
  • OncoCyte Corp OCX (after the market close)
  • Precision Therapeutics Inc AIPT (after the market close)
  • Reshape Lifesciences Inc RSLS (after the market close)
  • Titan Pharmaceuticals, Inc.  TTNP (after the market close)

Tuesday

  • Altimmune Inc ALT (before the market open)
  • Matinas BioPharma Holdings Inc MTNB (before the market open)

Wednesday

  • Ascendis Pharma A/S ASND (after the market close)

IPOs

Medical device maker Silk Road Medical is set to offer 4.688 million shares in an IPO, with the price estimated in the range of $15-$17. The shares are to be listed on the Nasdaq under the ticker symbol SILK.

NGM Biopharmaceuticals, a clinical-stage biotech company that develops therapies for cardio-metabolic, liver, oncologic and ophthalmic diseases, is due to offer 6.667 million shares in an IPO, to be priced between $14 and $16. The company seeks to list the shares on the Nasdaq under the ticker symbol NGM.

IPO Quiet Period Expiry

Shockwave Medical Inc SWAV

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