BPC April 01 update

ADMA FDA Approval; ​Sangamo SGMO clinical update pre-market tomorrow

Price and Volume Movers

ADMA Biologics, Inc. (NASDAQ: ADMA) announced following the close of the after-hours session the FDA approved Asceniv (RI-002) for the treatment of Primary Humoral Immunodeficiency Disease

Sangamo Therapeutics, Inc. (Nasdaq: SGMO) announced that management will host a conference call on Tuesday, April 2nd at 8a.m. Eastern Time to provide a clinical development update. No details were provided of the nature of the call.

Evoke Pharma, Inc. (NASDAQ: EVOK) shares closed up 13% to $1.70. The company is expecting a decision from the FDA today regarding its New Drug Application for Gimoti (EVK-001) in females with diabetic gastroparesis. It noted earlier this month the FDA had listed various clinical and chemistry concerns regarding the NDA.

Pulmatrix, Inc. (NASDAQ: PULM) shares closed up 82% to $2.31 on news of a co-development and commercialization agreement with Cipla Technologies for Pulmazole (PUR1900), for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. Cip Tec will make an upfront payment of $22m to Pulmatrix in exchange for an assignment of all rights to Pulmazole. Following this assigning, Pulmatrix will retain the right to receive 50% of the free cash flow from future sales of Pulmazole.

EyePoint Pharmaceuticals, Inc. (Nasdaq: EYPT) announced that it intends to offer and sell shares of its common stock in an underwritten public offering.

Tricida, Inc. (Nasdaq: TCDA) also announced that it has commenced an offering of 5m shares of its common stock. Shares are trading down 4% after hours to $35.34, adding to the 9% loss during normal trading hours.

Advaxis, Inc. (NASDAQ: ADXS) announced updated data from the Phase 1/2 KEYNOTE-046 study in metastatic, castration-resistant prostate cancer (mCRPC), evaluating ADXS-PSA, alone and in combination with Keytruda. In patients initially dosed with ADXS-PSA, overall survival was 8.5 months, which increased to 23 months following the addition of doses of Keytruda. Shares closed up 10% to $6.51.

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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:

AVEO Pharmaceuticals, Inc. (AVEO): $1.11; +35%.

PhaseBio Pharmaceuticals, Inc. (PHAS): $12.38; +30%.

TrovaGene, Inc. (TROV): $4.75; +27%.

Translate Bio, Inc. (TBIO): $12.77; +25%.

Melinta Therapeutics, Inc. (MLNT): $4.24; +19%.

DECLINERS:

Akari Therapeutics, Plc (AKTX): $3.18; -11%.

Sorrento Therapeutics, Inc. (SRNE): $4.25; -11%.

MannKind Corporation (MNKD): $1.80; -9%.

Tricida, Inc. (TCDA): $35.33; -9%.

Immunomedics, Inc. (IMMU): $17.59; -8%.


Pipeline Database Updates

Drug Stage Catalyst Market Cap

ADMA – ADMA Biologics Inc
RI-002
Primary Immune Deficiency Diseases

Approved FDA Approval announced April 1, 2019.
$245 million

ADXS – Advaxis Inc.
ADXS-PSA and Keytruda - KEYNOTE-046
Castrate-resistant prostate cancer

Phase 1/2 Phase 1 monotherapy, overall survival was 8.5 months, combo with Keytruda 23 months.
$11.5 million

AGLE – Aeglea BioTherapeutics Inc.
Pegzilarginase (AEB1102)
Arginase I deficiency

Phase 1/2 Phase 3 trial initiation announced June 3, 2019 with data due 1Q 2021. Phase 1/2 further data due September 2019.
$195.3 million

ALEC – Alector Inc.
AL003
Alzheimer’s disease

Phase 1 Phase 1 trial initiation announced April 3, 2019.
$1.3 billion

ALKS – Alkermes plc
ALKS 3831 - ENLIGHTEN-2
Schizophrenia, bipolar

NDA Filing Noted July 15, 2019 that NDA filing due 4Q 2019 will include Bipolar I indication
$3.7 billion

ALT – Altimmune Inc.
HepTCell
Hepatitis B

Phase 1 Phase 2 trial planned for 2020.
$33.2 million

AUTL – Autolus Therapeutics plc
AUTO1
Acute lymphoblastic leukemia (ALL)

Phase 2 Phase 2 trial to be initiated 2H 2019.
$751.1 million

AVEO – AVEO Pharmaceuticals Inc.
Ficlatuzumab and cytarabine
Acute myeloid leukemia (AML)

Phase 1b Phase 1b poster presented at AACR April 1, 2019. 9/17 CRs.
$116.7 million

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
BHV-3500
Acute treatment of migraine

Phase 2/3 Phase 2/3 top-line data due 4Q 2019.
$2.3 billion

CNST – Constellation Pharmaceuticals Inc.
CPI-1205 - ProSTAR
Castration-resistant prostate cancer

Phase 1/2 Phase 2 interim data due 2H 2019.
$257.6 million

COCP – Cocrystal Pharma Inc.
CC-42344
Influenza

Phase 1 Phase 1 trial to be initiated in 2019.
$66.4 million

INO – Inovio Pharmaceuticals Inc.
INO-5401 + cemiplimab
Glioblastoma (GBM)

Phase 1/2 Phase 1/2 interim readout due 2019.
$293.1 million

JAGX – Jaguar Health Inc.
Mytesi (crofelemer) HALT-D
Cancer related diarrhea (CRD)

Phase 2 Phase 2 interim data due 1H 2019. Timeline missed. Assume 3Q 2019 release.
$7.1 million

LOGC – LogicBio Therapeutics Inc.
LB-001
Methylmalonic Acidemia (MMA)

Phase 1/2 Phase 1/2 trial to be initiated in 2020.
$290.2 million

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

Phase 3 Phase 3 dosing to commence June 2019.
$45.3 million

PIRS – Pieris Pharmaceuticals Inc.
PRS-060
Asthma

Phase 1 Phase 1 initial data presented May 22, 2019 - well tolerated, supports further development.
$212.3 million

PULM – Pulmatrix Inc.
Pulmazole (PUR1900)
Allergic bronchopulmonary aspergillosis in patients with asthma.

Phase 2a Phase 2 trial initiation announced July 9, 2019 with data due mid-2020.
$17.1 million

RARX – Ra Pharmaceuticals Inc.
RA101495 zilucoplan
Myasthenia Gravis (MG)

Phase 3 Phase 3 trial to commence 2H 2019.
$1.4 billion

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

Phase 1 Phase 1 initial safety data at EHA June 15, 2019 - generally well-tolerated
$261.8 million

SVRA – Savara Inc.
Molgradex - ENCORE
Nontuberculous mycobacterial (NTM) lung infection with cystic fibrosis (CF)

Phase 2a Phase 2a initiation announced April 1, 2019.
$98.5 million

TCRR – TCR2 Therapeutics Inc.
TC-210
Mesothelin-positive solid tumors

Phase 1/2 Phase 1/2 update due 2H 2019.
$308.1 million

TGTX – TG Therapeutics Inc.
TG-1101 and TGR-1202 - UNITY-NHL study
Non-Hodgkin Lymphoma (NHL)

NDA Filing NDA filing to be submitted by the end of 2019.
$714.9 million

TROV – TrovaGene Inc.
Onvansertib (PCM-075)
Acute Myeloid Leukemia (AML)

Phase 1/2 Phase 1/2 presentation at ESMO September 27, 2019.
$11.5 million

VTGN – VistaGen Therapeutics Inc.
PH94B nasal spray
Social Anxiety Disorder (SAD)

Phase 3 Phase 3 pivotal program to be initiated 1H 2020.
$28 million

XBIO – Xenetic Biosciences Inc.
XBIO-101
Endometrial cancer

Phase 2 Phase 2 enrolment closed in March 2019 due to slow enrolment.
$9.8 million

XFOR – X4 Pharmaceuticals Inc.
X4P-001
WHIM syndrome

Phase 3 Phase 3 trial initiation announced June 26, 2019 with data due 2021.
$182.3 million

XFOR – X4 Pharmaceuticals Inc.
Mavorixafor and axitinib
Renal Cell Carcinoma (RCC) - cancer

Phase 2a Phase 2a data due 2H 2019.
$182.3 million

ZIOP – ZIOPHARM Oncology Inc
Ad-RTS-hIL-12 plus veledimex in combination with OPDIVO (nivolumab)
Refractory glioblastoma multiforme (GBM)

Phase 1 Phase 1 completion of enrolment of third cohort announced June 26, 2019. Further data due in 2019.
$914.3 million