BPC October 29 update

Merck MRK and Pfizer PFE up on earnings; AMAG negative Advisory Committee vote

Price and Volume Movers

Pfizer Inc (NYSE:PFE) announced better than expected third-quarter earnings following increased revenue from its oncology treatment Ibrance, coupled with initial strong revenue from its recently approved heart treatment, Vyndaqel. Accordingly, forecast earnings for 2019 were increased to a range of $2.94 to $3.00 from $2.76 to $2.86 per share. Shares closed up 2.5% to $38.21.

Merck (NYSE: MRK) shares closed up 4% to $85.10 as it also reported better than expected third quarter earnings. Non-GAAP EPS was $1.51, an increase of 27%, with Keytruda revenue surging 62% to $3.1b. Earnings for 2019 are forecast to be in the range of $5.12 to $5.17 per share.

AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) received a negative vote from an Advisory Committee reviewing its marketed treatment for pre-term births. The panel voted 9-7 in favor of recommending the withdrawal of Makena from the market, following a post-approval trial that showed the treatment not to be effective. Makena was originally approved in 2011. The FDA generally follows an advisory committee's recommendation but is not bound to do so.

Mirati Therapeutics, Inc. (NASDAQ: MRTX) shares closed up 17% to $95.10 following data released after hours Monday from its Phase 1/2 trial evaluating its KRAS inhibitor, MRTX849, in patients with solid tumors expressing KRAS G12C mutations. Across all dose levels, three of six patients with non-small cell lung cancer (NSCLC) and one of four patients with colorectal cancer (CRC) achieved a partial response.

Exact Sciences Corp. (Nasdaq: EXAS) announced third quarter earnings of $218.8m, an increase of 85% over the same period in 2018. The company anticipates revenue of $802-$810 million during 2019, lower than analyst estimates. Shares are trading down 8% after hours to $82.99.

Sesen Bio, Inc. (NASDAQ: SESN) shares are trading down 12% to $1.25 after hours on news that it has modified its 2017 and 2018 common stock warrants, allowing for future at-the-market (ATM) programs.

Roche (OTCQX:RHHBY) and Spark Therapeutics, Inc. (NASDAQ:ONCE) announced that Roche has extended the offering period of its previously announced tender offer to acquire all shares of Spark. The offer, which was previously scheduled to expire on October 30, 2019, has been extended until November 25, 2019,

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) shares closed up 40% to $1.09. The company announced that enrolment will continue as planned following results from the first interim analysis of its Phase 2b NAV3-31 trial in patients with active rheumatoid arthritis.

Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) announced the commencement of a registered underwritten public offering of up to $125m in shares of its common stock.

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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:

Iveric bio Inc (ISEE): $2.15; +26%.

Cyclerion Therapeutics Inc (CYCN): $13.43; +22%.

Tiziana Life Sciences (TLSA): $3.59; +18%.

Stoke Therapeutics Inc (STOK): $29.80; +15%.

Aclaris Therapeutics Inc (ACRS): $1.90; +14%.

DECLINERS:

Tetraphase Pharmaceuticals Inc (TTPH): $3.62; -15%.

Kala Pharmaceuticals Inc (KALA): $3.48; -12%.

Ocugen Inc (OCGN): $1.50; -10%.

Acorda Therapeutics Inc (ACOR): $1.79; -10%.

Tcr2 Therapeutics Inc (TCRR): $12.17; -8%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

CLLS – Cellectis S.A.
UCARTCS1A - MELANI01
Multiple Myeloma

Phase 1 Phase 1 trial initiation announced October 29, 2019. Update due by end of 2020.
$817 million

CTMX – CytomX Therapeutics Inc.
PROCLAIM-CX-072-002
Solid tumors

Phase 2 Phase 2 trial has been terminated - March 30, 2020.
$377.5 million

EYEN – Eyenovia Inc.
MicroProst
Chronic angle closure glaucoma (CACG)

Phase 2 Development to be deferred - noted October 29, 2019.
$56 million

EYEN – Eyenovia Inc.
MicroLine
Presbyopia

Phase 3 Phase 3 trial to be initiated in 2020.
$56 million

GSK – GlaxoSmithKline PLC
M72/AS01E
Pulmonary tuberculosis

Phase 2b Phase 2b data significantly reduced incidence of pulmonary tuberculosis disease - October 29, 2019.
$103.2 billion

INCY – Incyte Corporation
Itacitinib - GRAVITAS-301
Treatment-naïve acute GVHD

Phase 3 Phase 3 trial did not meet primary endpoint - January 2, 2020.
$23.4 billion

INCY – Incyte Corporation
Tafasitamab (MOR208/XmAb5574)
Relapsed or refractory diffuse large B cell lymphoma

PDUFA priority review PDUFA date under priority review August 30, 2020.
$23.4 billion

KURA – Kura Oncology Inc.
Tipifarnib
Head and neck squamous cell carcinomas (HNSCC) with HRAS Mutations

Phase 2 Phase 2 mature data presented at ASCO May 29, 2020 - Median OS of 15.4 months, median PFS of 5.9 months and ORR of 50% observed in recurrent/metastatic HRAS mutant HNSCC
$943.1 million

MNLO – Menlo Therapeutics Inc.
Serlopitant
Pruritus associated with prurigo nodularis

Phase 3 Phase 3 data did not meet primary endpoint - April 6, 2020.
$277.4 million

NAVB – Navidea Biopharmaceuticals Inc.
NAV3-31 (TC99m-tilmanocept)
Rheumatoid arthritis

Phase 2b Phase 2b full enrolment announced June 15, 2020. Final patients to be screened and evaluated by end of 2020.
$92.9 million

PFE – Pfizer Inc.
Marstacimab (PF-06741086)
Hemophilia A or B

Phase 3 Phase 3 trial to commence in 2020.
$192.1 billion

PTCT – PTC Therapeutics Inc.
PTC-AADC
AADC deficiency

BLA Filing BLA filing due 2H 2020.
$3.6 billion

SGEN – Seattle Genetics Inc.
Tisotumab Vedotin (innovaTV 204 )
Cervical Cancer

Phase 2 Phase 2 data noted 24% ORR with a median duration of response of 8.3 months.
$29.8 billion