BPC January 05 update

​Marker MRKR clinical hold lifted +18%; Millendo MLND discontinues lead candidate -18%

Price and Volume Movers

Marker Therapeutics, Inc. (Nasdaq:MRKR) announced that the FDA lifted the partial clinical hold on its Phase 2 trial investigating MT-401 for the treatment of post-transplant acute myeloid leukemia (AML). Shares closed up 18% to $1.73.

Rhythm Pharmaceuticals, Inc. (NASDAQ:RYTM) announced that it has sold its Rare Pediatric Disease Priority Review Voucher (PRV) for $100m. Shares closed up 4% to $31.52.

Hoth Therapeutics, Inc. (NASDAQ:HOTH) shares closed down 8% to $2.30 following news of a private placement of 2,475,248 shares and accompanying warrants to purchase up to 1,237,624 shares, at a purchase price of $2.02 per share and accompanying warrant to purchase 0.5 of a share, for gross proceeds of approximately $5m.

Millendo Therapeutics, Inc. (Nasdaq: MLND) shares fell 18% to $1.69 following its announcement it will discontinue development of its lead pipeline candidate, MLE-301, following data from the ongoing single ascending dose portion of its Phase 1 trial being conducted in healthy male volunteers.

Mersana Therapeutics, Inc. (NASDAQ:MRSN) shares closed down 29% to $18.70 following an update from its Phase 1 trial of XMT-1536 in patients with ovarian cancer. Among all 47 patients evaluable for response, the company noted an overall response rate (ORR) of 28% (13/47), compared with an ORR of 34% recorded in September.

Aerpio Pharmaceuticals, Inc. (Nasdaq: ARPO) shares are trading up 11% to $1.19 after hours on news it will be reviewing a range of strategic alternatives, which might include options such as partnerships, sale of assets, merger of the company or license agreements.

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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:

Synthetic Biologics, Inc. (SYN): $1.00; +100%.

Brickell Biotech, Inc. (BBI): $1.22; +49%.

Gritstone Oncology, Inc. (GRTS): $5.55; +36%.

9 Meters Biopharma, Inc. (NMTR): $1.07; +28%.

Aileron Therapeutics, Inc. (ALRN): $1.30; +24%.

DECLINERS:

Lumos Pharma, Inc. (LUMO): $23.50; -24%.

Generation Bio Co. (GBIO): $24.90; -17%.

Precigen, Inc. (PGEN): $9.57; -13%.

Prelude Therapeutics Incorporated (PRLD): $59.81; -11%.

Celldex Therapeutics, Inc. (CLDX): $17.06; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ABBV – AbbVie Inc.
Risankizumab KEEPSAKE2
Psoriatic Arthritis

Phase 3 Phase 3 trial met primary endpoint - January 5, 2021.
$196.4 billion

BTAI – BioXcel Therapeutics Inc.
BXCL501 (TRANQUILITY)
Agitation associated with dementia

Phase 1b Phase 1b/2 trial met primary and secondary endpoints - January 5, 2021.
$1.2 billion

CERC – Cerecor Inc.
CERC-002
COVID-19 induced Acute Respiratory Distress Syndrome (ARDS)

Phase 2 Phase 2 data released January 5, 2021.
$273.4 million

IDYA – IDEAYA Biosciences Inc.
IDE196 and crizotinib
Metastatic uveal melanoma (MUM)

Phase 1 Phase 1 trial initiation announced January 5, 2021.
$509.9 million

IFRX – InflaRx N.V.
IFX-1 (IXPLORE)
ANCA-associated vasculitis (AAV)

Phase 2 Phase 2 final data due mid-2021.
$158.6 million

IVA – Inventiva S.A.
Lanifibranor
Nonalcoholic steatohepatitis (NASH)

Phase 3 Phase 3 trial to be initiated 1H 2021.
$717.7 million

MLND – Millendo Therapeutics Inc.
MLE-301
Vasomotor symptoms (VMS)

Phase 1 Announced January 5, 2021 that development will be discontinued.
$35.7 million

MRKR – Marker Therapeutics Inc.
MT-401
Acute Myeloid Leukemia

Phase 2 Phase 2 partial clinical lifted - January 5, 2021.
$97.5 million

MRSN – Mersana Therapeutics Inc.
XMT-1536
Ovarian Cancer, Non Small Cell Lung Cancer

Phase 1 Phase 1 update January 5, 2021 noted 28% objective response rate and 68% disease control rate.
$1.4 billion

MTCR – Metacrine Inc.
MET409 with Empagliflozin
Type 2 Diabetes and Nonalcoholic steatohepatitis (NASH)

Phase 2a Phase 2 initiation announced January 5, 2020. Top-line data due 1H 2022.
$243.2 million

PGEN – Precigen Inc.
PRGN-2012
Recurrent Respiratory Papillomatosis (RRP)

Phase 1 Phase 1 trial to be initiated.
$1.7 billion

REPL – Replimune Group Inc.
RP3
Solid tumors

Phase 1 Phase 1 initiation of dosing announced January 5, 2021. Initial data due 2H 2021.
$2 billion

RGNX – REGENXBIO Inc.
RGX-314 (ATMOSPHERE)
Wet AMD

Phase 3 Pivotal trial dosing to commence 1Q 2021.
$1.8 billion

RGNX – REGENXBIO Inc.
RGX-314 (AAVIATE)
Wet AMD using suprachoroidal delivery

Phase 2 Phase 2 initial data due 3Q 2021.
$1.8 billion