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

Shanthi Rexaline

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. (NASDAQ: CRIS) and PhaseBio Pharmaceuticals Inc (NASDAQ: 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 (NYSE: NVS)'s new multiple sclerosis drug, it issued a complete response letter for Recro Pharma Inc (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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 (NASDAQ: 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 (NYSE: ATNM) will present Phase 2 data for Actimab-A in acute myeloid leukemia at the international symposium on TAT.

Aeglea Bio Therapeutics Inc (NASDAQ: 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

View more earnings on IBB

AACR Presentations On Sunday, March 31

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

AACR Presentations oOn Tuesday, April 2

Dynavax Technologies Corporation (NASDAQ: 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 (NASDAQ: CLVS) & Bristol-Myers Squibb Co (NYSE: BMY) – Poster presentation of Phase 3 data of Opdivo and Rubraca (first-line maintenance treatment of ovarian cancer)
NewLink Genetics Corp (NASDAQ: NLNK) – Phase 2 data for NLG207 (CRLX101) and paclitaxel (platinum-resistant ovarian cancer)
Jounce Therapeutics Inc (NASDAQ: JNCE) - Phase 1/2 data for JTX-2011 (solid tumors)

AACR Presentations On Wednesday, April 3

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

Earnings

Monday

  • Edap Tms SA (NASDAQ: EDAP) (before the market open)

  • OncoCyte Corp (NYSE: OCX) (after the market close)

  • Precision Therapeutics Inc (NASDAQ: AIPT) (after the market close)

  • Reshape Lifesciences Inc (OTC: RSLS) (after the market close)

  • Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) (after the market close)

Tuesday

  • Altimmune Inc (NASDAQ: ALT) (before the market open)

  • Matinas BioPharma Holdings Inc (NYSE: MTNB) (before the market open)

Wednesday

  • Ascendis Pharma A/S (NASDAQ: 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 (NASDAQ: SWAV)

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