BPC August 13 update

​Mesoblast MESO receives positive vote from FDA Advisory Committee

Price and Volume Movers

Mesoblast Limited (NASDAQ:MESO) received a positive vote (8-2) from the FDA Oncologic Drugs Advisory Committee which convened to discuss the regulatory application of Ryoncil (remestemcel-L) for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients. The PDUFA date for a final decision is September 30, 2020. Shares were halted during the meeting and have yet to resume as of 6:15pm EST.

TG Therapeutics, Inc. (NASDAQ: TGTX) announced that the FDA has accepted the New Drug Application (NDA) for umbralisib, as a treatment for patients with previously treated marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen and follicular lymphoma (FL) who have received at least two prior systemic therapies. The MZL indication has been accepted for Priority Review and has a PDUFA date of February 15, 2021, while the PDUFA date for the FL indication is June 15, 2021.

Equillium, Inc. (NASDAQ:EQ) announced that it intends to offer and sell shares of its common stock in an underwritten registered public offering. Shares are trading down 16% to $7.41 after hours.

Optinose (NASDAQ:OPTN) also announced the commencement of a proposed underwritten public offering of shares of its common stock. Shares have fallen after hours 11% to $6.05.

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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:

Nurix Therapeutics, Inc. (NRIX): $24.97; +37%.

Tonix Pharmaceuticals Holding Corp. (TNXP): $1.14; +28%.

Seres Therapeutics, Inc. (MCRB): $28.58; +21%.

Aerpio Pharmaceuticals, Inc. (ARPO): $1.83; +20%.

Heat Biologics, Inc. (HTBX): $1.83; +17%.

DECLINERS:

Biofrontera AG (BFRA): $22.90; -25%.

Adverum Biotechnologies, Inc. (ADVM): $12.51; -16%.

Trevi Therapeutics, Inc. (TRVI): $5.66; -14%.

Monopar Therapeutics Inc. (MNPR): $6.05; -13%.

Veru Inc. (VERU): $2.73; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ACER – Acer Therapeutics Inc.
ACER-001
Urea cycle disorder (UCD)

NDA Filing NDA filing due 1H 2021.
$30.9 million

ATOS – Atossa Therapeutics Inc.
Endoxifen
Mammographic breast density (MBD)

Phase 2 Phase 2 initiation due in 2020 (Sweden).
$25.4 million

BPTH – Bio-Path Holdings Inc.
Prexigebersen - BP1001 + Decitabine + Venetoclax
Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)

Phase 2 Phase 2 commencement of Stage 2 dosing announced August 13, 2020.
$16.4 million

BVXV – BiondVax Pharmaceuticals Ltd.
M-001
Universal flu vaccine

Phase 3 Phase 3 data due late September to the end of October 2020.
$489.6 million

ETNB – 89bio Inc.
BIO89-100
Severe hypertriglyceridemia

Phase 2 Phase 2 trial initiation announced September 3, 2020.
$430.3 million

IMRA – IMARA Inc.
IMR-687
Sickle cell disease

Phase 2a Phase 2a top-line data due 4Q 2020.
$437.4 million

LUMO – Lumos Pharma Inc.
LUM-201
Pediatric Growth Hormone Deficiency (PGHD)

Phase 2b Phase 2b trial to be initiated by the end of 2020.
$121.2 million

MESO – Mesoblast Limited
Remestemcel-L (MSC-100-IV)
acute graft versus host disease (aGVHD) in children

PDUFA priority review PDUFA date under priority review September 30, 2020. FDA Oncologic Drugs Advisory Committee meeting August 13, 2020 voted 8-2 supporting approval.
$2.1 billion

SLS – SELLAS Life Sciences Group Inc.
Galinpepimut-S and Keytruda (pembrolizumab)
Solid tumors

Phase 1/2 Phase 1/2 interim data from basket trial due 1H 2021.
$25.5 million

TGTX – TG Therapeutics Inc.
Umbralisib
Follicular lymphoma (FL)

PDUFA PDUFA date June 15, 2021.
$3.3 billion

TGTX – TG Therapeutics Inc.
Umbralisib
Marginal zone lymphoma (MZL)

PDUFA priority review PDUFA date under priority review February 15, 2021.
$3.3 billion

VERU – Veru Inc.
Tadalafil and Finasteride combo
Benign prostatic hyperplasia (BPH)

NDA Filing NDA filing due 4Q 2020 or early 2021.
$200.9 million

ZEAL – Zealand Pharma A/S
Dasiglucagon
Congenital hyperinsulinism

Phase 3 Phase 3 data due 2020.
$1.4 billion

ZNTL – Zentalis Pharmaceuticals Inc.
ZN-e4
Non-small cell lung cancer

Phase 1 Phase 1 initial data due 2021.
$1.2 billion