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 - ACcomplisH
Achondroplasia

Phase 2 Phase 2 trial has been initiated.
$4.7 billion

EPZM – Epizyme Inc.
Tazemetostat
Epithelioid Sarcoma

PDUFA priority review PDUFA date priority review January 23, 2020.
$941.3 million

MRUS – Merus N.V.
MCLA-128
Solid tumors

Phase 1/2 Phase 1/2 trial amended to focus on solid tumors harboring Neuregulin 1 (NRG1) gene fusions.
$383.9 million

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

Phase 2 Phase 2 update due 4Q 2019.
$383.9 million

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

Phase 1 Phase 1 readouts due 1H 2020.
$383.9 million

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

Phase 1 Phase 1 emerging data due YE 2019.
$383.9 million

NVS – Novartis AG
QMF149
Asthma

Phase 3 Phase 3 trial met primary endpoint.
$199.1 billion

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

Phase 3 Phase 3 enrolment has commenced - May 30, 2019.
$5.6 billion

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

Phase 1/2 Phase 2b trial to be initiated late 2019.
$1.4 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 and patients with two copies of the F508del mutation

PDUFA priority review PDUFA date under priority review March 19, 2020.
$45.3 billion

ZFGN – Zafgen Inc.
ZGN-1061
Diabetes

Phase 1 Data from in vivo animal model unlikely to resolve current clinical hold - September 5, 2019.
$27.5 million