BPC May 30 update

​Zafgen ZFGN shares close lower on unresolved clinical hold

Price and Volume Movers

Zafgen, Inc.(Nasdaq:ZFGN) announced an brief update following its Type A meeting held with the FDA regarding the clinical hold placed on ZGN-1061, in patients with diabetes. The company noted that it is working with the FDA on an in vivo animal model as a next step toward resolving the clinical hold. Investors had expected a more positive update, with shares closing the session down 20% to $1.91.

BioCryst Pharmaceuticals (NASDAQ: BCRX) closed the session up 15% to $3.36. The rise follows news released last week of data from its trial for the prevention of hereditary angioedema (HAE) attacks, that shed 55% of its price. In a Schedule 13G SEC filing late-yesterday, it was noted that Millennium Management has purchased a 5.6% position in the company.

Tocagen Inc. (NASDAQ:TOCA) shares closed up 21% to $5.12. The stock reaction appears to be in reaction to a combination of a buy rating issued by Citi, with a price target of $24 and potential short-covering following last week’s 48% slide on negative news that an Independent Data Monitoring Committee (IDMC) recommended that its Phase 3 Toca 5 trial continue through to final analysis.

XBiotech Inc. (NASDAQ: XBIT) shares are trading down 9% to $8.26 on news that it has commenced an underwritten public offering of common shares.

Myovant Sciences (NYSE: MYOV) and Aptose Biosciences Inc. (NASDAQ: APTO) shares closed down 25% to $8.99 and 11% to $2.00, respectively, following their announcements of public offerings late-Wednesday.

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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:

Novan, Inc. (NOVN): $2.23; +16%.

Provention Bio, Inc. (PRVB): $4.50; +13%.

Veru Inc. (VERU): $1.98; +12%.

Cerecor Inc. (CERC): $4.97; +11%.

Moleculin Biotech, Inc. (MBRX): $1.21; +10%.

DECLINERS:

Armata Pharmaceuticals, Inc. (ARMP): $3.57; -10%.

Constellation Pharmaceuticals, Inc. (CNST): $8.50; -10%.

Aduro BioTech, Inc. (ADRO): $3.10; -10%.

Titan Pharmaceuticals, Inc. (TTNP): $1.16; -10%.

Nymox Pharmaceutical Corporation (NYMX): $1.64; -10%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ASND – Ascendis Pharma A/S
TransCon CNP
Achondroplasia

Phase 1 Phase 2 trial to be initiated 3Q 2019.
$5.7 billion

EPZM – Epizyme Inc.
Tazemetostat
Epithelioid Sarcoma

NDA Filing NDA filing announced May 30, 2019.
$1.2 billion

MRUS – Merus N.V.
MCLA-128
Gastric cancer, non-small cell lung cancer

Phase 1/2 Phase 1/2 NSCLC cohort update due 2H 2019.
$324.7 million

MRUS – Merus N.V.
MCLA-128
Breast cancer - HER2-positive MBC and ER+/HER2-low MBC

Phase 2 Phase 2 update due 2H 2019.
$324.7 million

MRUS – Merus N.V.
MCLA-117
Acute Myeloid Leukemia

Phase 1 Phase 1 initial data due 2H 2019.
$324.7 million

MRUS – Merus N.V.
MCLA-158
Colorectal cancer

Phase 1 Phase 1 emerging data due YE 2019.
$324.7 million

NVS – Novartis AG
QMF149
Asthma

Phase 3 Phase 3 trial met primary endpoint.
$211.9 billion

RETA – Reata Pharmaceuticals Inc.
Bardoxolone - FALCON
Chronic Kidney Disease

Phase 3 Phase 3 enrolment has commenced - May 30, 2019.
$2.6 billion

RGNX – REGENXBIO Inc.
RGX-314
Wet age-related macular degeneration (wet AMD)

Phase 1/2 Phase 1/2a data due by end of 2019. Phase 2b trial to be initiated late 2019.
$1.8 billion

VRTX – Vertex Pharmaceuticals Incorporated
VX-445 in combination with tezacaftor and ivacaftor
Cystic fibrosis (CF) who have two copies of the F508del mutation

NDA Filing NDA filing due 3Q 2019.
$46.1 billion

VRTX – Vertex Pharmaceuticals Incorporated
VX-445 in combination with tezacaftor and ivacaftor
Cystic fibrosis (CF) who have one copy of the F508del mutation and one minimal function mutation

NDA Filing NDA filing due 3Q 2019.
$46.1 billion

ZFGN – Zafgen Inc.
ZGN-1061
Diabetes

Phase 2 Noted May 30, 2019 that clinical hold has yet to be resolved.
$47.8 million