BPC March 16 update

DBVT Advisory Committee Meeting cancelled - shares fall 58%; Moderna MRNA initiates dosing in coronavirus vaccine trial

Price and Volume Movers

BioNTech SE (Nasdaq: BNTX) announced a collaboration with Fosun Pharma to develop BioNTech’s mRNA vaccine candidate BNT162 in China for the prevention of COVID-19 infections. BioNTech intends to initiate clinical trials in late April 2020. Fosun Pharma will make an equity investment of $50m for 1,580,777 shares in BioNTech. Shares closed up 29% to $40.00.

Moderna, Inc., (NASDAQ:MRNA) announced that the first participant has been dosed in the Phase 1 trial of its mRNA vaccine (mRNA-1273) for the novel coronavirus (SARS-CoV-2). The company also expects to initiate a Phase 2 trial in a “few months”. Shares closed up 24% to $26.49.

DBV Technologies (Nasdaq: DBVT) shares are trading down 58% to $2.22 after hours on news the FDA has identified questions regarding efficacy, including the impact of patch-site adhesion of its Biologics License Application (BLA) for Viaskin Peanut on patients with peanut allergy. As a result, the Allergenic Products Advisory Committee (APAC) meeting to discuss the BLA will no longer take place as previously scheduled on May 15, 2020. The PDUFA date currently stands at August 5, 2020, however, this is likely to be extended following the submission of extra data.

Mallinckrodt plc (NYSE: MNK) shares closed down 41% to $1.80 following news the U.S. District Court for the District of Columbia in its suit against HHS and CMS regarding its calculation of Medicaid drug rebates for Acthar Gel, upheld CMS' decision to reverse its previous determination of the base date average manufacturer price (AMP) used to calculate Acthar Gel rebates.

AcelRx Pharmaceuticals, Inc. (NASDAQ:ACRX) announced it will acquire Tetraphase Pharmaceuticals, Inc. (NASDAQ: TTPH) in a stock for stock deal at an exchange ratio of 0.6303 shares of AcelRx for each share of Tetraphase, or approximately $14.4m as of the close of trading on March 13, 2020, plus a contingent value right (CVR). Shares of Tetraphase closed down 41% to $0.85.

Correvio Pharma Corp. (NASDAQ:CORV) announced it will be acquired by Advanz Pharma for $76m. Shares closed up 11% to $0.35.

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Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

Arcturus Therapeutics Ltd. (ARCT): $12.21; +31%.

Neon Therapeutics, Inc. (NTGN): $1.83; +25%.

Rubius Therapeutics, Inc. (RUBY): $4.44; +16%.

Enlivex Therapeutics Ltd. (ENLV): $5.42; +14%.

Phio Pharmaceuticals Corp. (PHIO): $2.20; +9%.

DECLINERS:

Intersect ENT, Inc. (XENT): $9.50; -40%.

Sutro Biopharma, Inc. (STRO): $6.19; -39%.

Aldeyra Therapeutics, Inc. (ALDX): $1.62; -35%.

Fulcrum Therapeutics, Inc. (FULC): $10.45; -35%.

Celyad SA (CYAD): $4.18; -35%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

CHMA – Chiasma Inc.
Mycapssa - MPOWERED
Maintenance treatment of adult acromegaly

Phase 3 Phase 3 data due 4Q 2020.
$148.7 million

CPRX – Catalyst Pharmaceuticals Inc.
Firdapse
MuSK-antibody positive myasthenia gravis (MuSK-MG)

Phase 3 Phase 3 data due 2Q 2020.
$389.9 million

DBVT – DBV Technologies S.A.
Viaskin Peanut
Peanut allergy - ages 4 to 11 years

PDUFA PDUFA date August 5, 2020 (likely to be extended). Advisory Committee meeting slated for May 15, 2020 has been cancelled.
$433.7 million

ERYP – Erytech Pharma S.A.
Eryaspase (GRASPA)
Acute lymphoblastic leukemia (ALL) - front line

Phase 2 Phase 2 interim update 2Q 2020 with full data 4Q 2020.
$85.9 million

FBIO – Fortress Biotech Inc.
CUTX-101
Menkes disease

NDA Filing Rolling NDA submission expected to start in 4Q 2020.
$134.2 million

FIXX – Homology Medicines Inc.
HMI-102
Phenylketonuria (PKU)

Phase 1/2 Phase 1/2 update due mid-2020.
$633.3 million

IMUX – Immunic Inc.
IMU-838
Relapsing-remitting multiple sclerosis

Phase 2 Phase 2 data due 3Q 2020.
$80 million

MRNA – Moderna Inc.
mRNA-1273
Coronavirus COVID-19 vaccine

Phase 1 Phase 1 initiation of dosing announced March 16, 2020. Estimated primary completion date June 1, 2021. Phase 2 trial to commence in a few months.
$9.9 billion

MRNS – Marinus Pharmaceuticals Inc.
Ganaxolone - Marigold
CDKL5 Deficiency Disorder (CDD)

Phase 3 Phase 3 top-line data due 3Q 2020.
$156.9 million

ONCT – Oncternal Therapeutics Inc.
TK216 and vincristine
Relapsed or refractory Ewing sarcoma

Phase 1b Phase 1b expansion cohort data due 2H 2020.
$42.9 million

REGN – Regeneron Pharmaceuticals Inc.
Sarilumab
Coronavirus COVID-19

Phase 2/3 Phase 2/3 initiation announced March 16, 2020. Estimated primary completion date March 2021.
$49.5 billion

SPRO – Spero Therapeutics Inc.
SPR994 (ADAPT-PO)
Complicated urinary tract infections (cUTI)

Phase 3 Phase 3 data due 3Q 2020.
$157.7 million

TPTX – Turning Point Therapeutics Inc.
Repotrectinib (TPX-0005) - TRIDENT-1
Non-small-cell lung cancer (NSCLC) and solid tumors

Phase 2 Phase 2 interim data due 2H 2020.
$1.5 billion

TRVI – Trevi Therapeutics Inc.
Nalbuphine ER - PRISM
Prurigo Nodularis

Phase 2/3 Phase 2b/3 top-line data due 2H 2020.
$41 million