BPC March 31 update

Delcath DCTH and AzurRx AZRX shares fall on respective data readouts

Price and Volume Movers

Delcath Systems, Inc. (NASDAQ:DCTH) announced top-line preliminary data from its Phase 3 FOCUS trial of HEPZATO KIT (melphalan hydrochloride for injection/hepatic delivery system) in patients with liver dominant metastatic ocular melanoma (mOM). An Overall Response Rate (ORR) of 29.2% in the Intent to Treat (ITT) population was recorded compared with the predefined success criteria (21.0%) for the primary ORR endpoint [95% CI: 20.1, 39.8]. Shares, however, fell 24% to $12.42.

AzurRx BioPharma, Inc. (NASDAQ: AZRX) shares are trading down 30% to $0.93 after hours following the release of top-line data from its Phase 2b OPTION 2 clinical trial investigating MS1819 in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). The primary efficacy endpoint of the coefficient of fat absorption (CFA) was not met.

CTI BioPharma Corp. (NASDAQ:CTIC) announced that it intends to sell shares of its common stock and preferred stock in an underwritten registered public offering. Shares are trading down 10% to $2.62 after hours.

Celsion Corporation (NASDAQ:CLSN) shares fell 15% to $1.38 on news of a registered direct offering of 11,538,462 shares at a purchase price of $1.30 per share for gross proceeds of $15 million.

Sanofi (NASDAQ:SNY) announced the early approval of Sarclisa (isatuximab) in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. The original PDUFA date was set for July 2021.

BioXcel Therapeutics, Inc. (NASDAQ: BTAI) announced that its Phase 1b/2 proof-of-concept RELEASE study of BXCL501, for the treatment of opioid withdrawal symptoms met its primary safety endpoint. However, with respect to retention, a secondary endpoint, the study showed while patients had numerical improvements in retention rates, the improvements in the 120 mcg and 180 mcg dose groups were not statistically significant. Shares are trading down 8% to $39.85 after hours.

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Major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):

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

ADVANCERS:

AbCellera Biologics Inc. (ABCL): $33.96; +27%.

CASI Pharmaceuticals, Inc. (CASI): $2.40; +21%.

Benitec Biopharma Inc. (BNTC): $5.17; +20%.

Sigilon Therapeutics, Inc. (SGTX): $22.35; +19%.

Inhibrx, Inc. (INBX): $20.07; +19%.

DECLINERS:

9 Meters Biopharma, Inc. (NMTR): $1.17; -14%.

EDAP TMS S.A. (EDAP): $8.40; -13%.

Humanigen, Inc. (HGEN): $19.10; -12%.

Orphazyme A/S (ORPH): $8.38; -10%.

Gemini Therapeutics, Inc. (GMTX): $13.55; -9%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AZRX – AzurRx BioPharma Inc.
MS1819 - OPTION 2
Cystic fibrosis

Phase 2b Phase 2b top line data did not meet primary endpoint - March 31, 2021.
$69.2 million

BTAI – BioXcel Therapeutics Inc.
BXCL501 - RELEASE
Opioid Withdrawal Symptoms

Phase 1/2 Phase 1b/2 top-line data released March 31, 2021. Primary endpoint met. Retention secondary endpoint not met.
$881.4 million

CTIC – CTI BioPharma Corp.
Pacritinib
Myelofibrosis

NDA Filing Completion of rolling NDA filing announced Match 31, 2021.
$234.6 million

DCTH – Delcath Systems Inc.
Melphalan/HDS - FOCUS
Liver-dominant ocular melanoma

Phase 3 Phase 3 top-line data released March 31, 2021. Overall Response Rate (ORR) of 29.2%.
$86.2 million

EARS – Auris Medical Holding Ltd.
AM-125
Vertigo

Phase 2 Phase 2 data due 3Q 2021.
$30.6 million

FBIO – Fortress Biotech Inc.
CUTX-101
Menkes disease

NDA Filing Rolling NDA submission expected to start in 2H 2021.
$516.3 million

FRLN – Freeline Therapeutics Holdings plc
FLT180a
Hemophilia B

Phase 1/2 Phase 1/2 four-year durability data from the dose-finding trial due by end of 2021. Dose confirmation data due by end of 2022.
$474.3 million

GALT – Galectin Therapeutics Inc.
GR-MD-02
Non-alcoholic steatohepatitis (NASH) with cirrhosis

Phase 2/3 Phase 2b/3 interim analysis due late-2023
$149.7 million

MREO – Mereo BioPharma Group plc
ETIGILIMAB (OMP-313M32)
Solid tumors

Phase 1/2 Phase 1b/2 initial data due 2H 2021.
$441.2 million

NEXI – NexImmune Inc.
NEXI-002
Multiple Myeloma

Phase 1/2 Phase 1/2 preliminary data from the initial safety cohorts due 2Q 2021 with more complete results in 4Q 2021.
$406.2 million

OTLK – Outlook Therapeutics Inc.
NORSE 2 (ONS-5010-002)
Wet age-related macular degeneration (wet AMD)

Phase 3 Phase 3 data due 3Q 2021.
$380.2 million

SNY – Sanofi
Isatuximab
Refractory Multiple Myeloma

Approved FDA approval announced March 31, 2021.
$126.8 billion

YMTX – Yumanity Therapeutics Inc.
YTX-7739
Parkinson’s Disease

Phase 1b Phase 1b preliminary results expected by mid-year 2021.
$182.8 million

YMTX – Yumanity Therapeutics Inc.
YTX-7739
Healthy volunteers

Phase 1 Phase 1 data due early-2Q 2021.
$182.8 million