BPC May 15 update

Agios AGIO shares +19% - hits late stage endpoint; Iovance IOVA +20% on ASCO abstract

Price and Volume Movers

Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) shares are trading up 20% to $13.45 after hours following the release of abstracts for the upcoming ASCO conference. Its Phase 2 trial of LN-145 in patients with recurrent cervical cancer noted an overall response rate (ORR) of 44%, which included one complete response and nine partial responses. Data will be presented on June 1.

Agios Pharmaceuticals, Inc. (NASDAQ:AGIO) announced that its Phase 3 ClarIDHy trial of Tibsovo (ivosidenib) in previously treated cholangiocarcinoma patients with an IDH1 mutation met its primary endpoint, demonstrating a statistically significant improvement in progression-free survival (PFS) compared with patients who received placebo. Shares are trading up 19% to $56.25 after hours.

Cellectar Biosciences, Inc. (NASDAQ: CLRB) shares closed up 24% to $2.82 on news that 50% of patients from its sixth cohort in a Phase 1 open-label trial of CLR 131 in relapsed or refractory multiple myeloma patients, showed a partial response. Data from the seventh cohort are due 4Q 2019.

ImmunoGen, Inc., (Nasdaq: IMGN) shares closed down 32% to $2.14 following news the FDA has requested the company conduct a new Phase 3 trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with ovarian cancer. Its previous FORWARD I trial did not meet the primary endpoint.

ADMA Biologics, Inc. (Nasdaq: ADMA) shares are trading down 9% to $4.05 after hours following its announcement that it has commenced a $45m public offering of its common stock.

AbbVie (NYSE: ABBV) announced the FDA approved Venclexta (venetoclax) in combination with obinutuzumab (Gazyva) for previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

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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:

PDS Biotechnology Corporation (PDSB): $8.68; +41%.

Catalyst Pharmaceuticals, Inc. (CPRX): $2.82; +24%.

Acer Therapeutics Inc. (ACER): $22.51; +13%.

BioTime, Inc. (BTX): $1.18; +10%.

Anavex Life Sciences Corp. (AVXL): $3.45; +10%.

DECLINERS:

Evofem Biosciences, Inc. (EVFM): $5.12; -24%.

Navidea Biopharmaceuticals, Inc (NAVB): $1.35; -18%.

DelMar Pharmaceuticals, Inc. (DMPI): $2.21; -18%.

PhaseBio Pharmaceuticals, Inc. (PHAS): $11.67; -11%.

Regulus Therapeutics Inc. (RGLS): $1.33; -8%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ACHV – Achieve Life Sciences Inc.
Cytisine - ORCA-2
Smoking cessation

Phase 3 Phase 3 trial to be initiated 2H 2020.
$15.8 million

ADXS – Advaxis Inc.
Axalimogene filolisbac - AIM2CERV Trial
High-risk, locally advanced cervical cancer

Phase 3 Phase 3 trial closed - noted June 27, 2019.
$47.1 million

AGIO – Agios Pharmaceuticals Inc.
AG-120 Ivosidenib (ClarIDHy)
IDH1 mutant positive cholangiocarcinoma - cancer

Phase 3 sNDA filing due to be filed following final overall survival analysis between the end of 2020 and mid-2021. Mature data due mid-2020, but anticipates delays in collecting the data due to COVID-19.
$3.5 billion

CLRB – Cellectar Biosciences Inc.
CLR 131
Multiple myeloma

Phase 1 Phase 1 trial has been completed - February 19, 2020.
$9.7 million

DMPI – DelMar Pharmaceuticals Inc.
VAL-083 (AACR)
MGMT-unmethylated newly diagnosed Glioblastoma Multiforme (GBM)

Phase 2 Phase 2 data to be presented at AACR June 22-24, 2020.
$9.4 million

MLND – Millendo Therapeutics Inc.
Livoletide
Prader-Willi syndrome (PWS)

Phase 2b Phase 2b data did not meet primary endpoint - April 6, 2020.
$41.4 million

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

Phase 3 Phase 3 data due 1H 2021.
$106.3 million

PFE – Pfizer Inc.
PF-04965842 - abrocitinib
Moderate-to-severe atopic dermatitis (AD)

Phase 3 Phase 3 data released May 15, 2019 met primary endpoints.
$200.9 billion

QLGN – Qualigen Therapeutics Inc.
RP-G28
Lactose intolerance

Phase 3 Phase 3 data failed to meet primary endpoint - September 12, 2019.
$9.4 million

STRO – Sutro Biopharma Inc.
STRO-001
Non-Hodgkin lymphoma (NHL)

Phase 1 Phase 1 additional data due 2H 2020.
$365.2 million

TORC – resTORbio Inc.
RTB101 and sirolimus
Parkinson's disease

Phase 1/2 Phase 1/2 data from first four cohorts due mid-2020.
$81.3 million

VBLT – Vascular Biogenics Ltd.
VB-111
Recurrent platinum resistant ovarian cancer

Phase 3 Phase 3 next interim analysis due 3Q 2020.
$60.8 million

VERU – Veru Inc.
Zuclomiphene citrate
Hot flashes

Phase 2 Phase 3 trial to commence late-2020.
$227.4 million