BPC September 30 update

DOVA acquired - shares rise 38%; ESMO movers - SGEN +12%; GTHX -33%; MRTX -8%

Price and Volume Movers

Dova Pharmaceuticals, Inc. (NASDAQ:DOVA) announced it will be acquired by Swedish Orphan Biovitrum AB. Dova stockholders will be offered an upfront payment for $27.50 per share in cash, along with one non-tradeable Contingent Value Right (CVR) that entitles them to an additional $1.50 per share in cash upon regulatory approval of Doptelet for the treatment of chemotherapy-induced thrombocytopenia (CIT), representing a total potential consideration of up to $915m. Shares closed up 38% to $27.95.

Amgen Inc. (NASDAQ: AMGN) released further data from its Phase 1 trial of AMG 510 in patients with colorectal cancer. The data showed just one of 29 patients exhibited a partial response. The lower than expected data saw shares of Mirati Therapeutics, Inc. (NASDAQ: MRTX) fall 8% to $77.91. Mirati is developing its own KRAS G12C inhibitor, MRTX849, with data due later this year.

Seattle Genetics, Inc. (NASDAQ: SGEN) shares closed up 12% to $85.40 following its appearance at ESMO over the weekend. In a Phase 1 trial combining Enfortumab vedotin and Keytruda an overall response rate of 71% (32/45) was noted, with a complete response rate of 13% and partial response rate of 58%. The promising data followed up on impressive data released from its trial of tucatinib, also presented at ESMO.

G1 Therapeutics, Inc. (NASDAQ: GTHX), conversely saw its shares slide to close down 33% to $22.78 following its presentations at ESMO.

Geron Corporation (NASDAQ:GERN) shares are trading up 20% to $1.59 after hours on news its has been granted Fast Track designation by the FDA for imetelstat for the treatment of relapsed/refractory myelofibrosis (MF), the same patient population that was studied in its IMbark Phase 2 clinical trial. Geron plans to conduct an End of Phase 2 meeting with the FDA by the end of the first quarter of 2020 to determine if there is a path forward for imetelstat in relapsed/refractory MF. Its partner, Janssen, noted in 2018 that it would not be continuing its collaboration with Geron.

NewLink Genetics Corporation (NASDAQ:NLNK) shares are trading up 10% to $1.75 after hours following its announcement of a merger with privately-held Lumos Pharma, Inc. Lumos stockholders will own approximately 50% of NewLink and the merged company will be renamed "Lumos Pharma, Inc." and will trade on Nasdaq under the symbol "LUMO."

Johnson & Johnson (NYSE: JNJ) announced the FDA approved a new indication for Invokana to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular (CV) death, and hospitalization for heart failure in adults with type 2 diabetes and diabetic kidney disease.

Benitec Biopharma Limited (NASDAQ:BNTC) shares closed down 15% to $0.71 on news of a registered direct offering where it will issue 2.8m American Depositary Shares ("ADSs"), at a purchase price of US$0.70 per ADS. Warrants were also attached to the offering. Total gross proceeds are expected to be $2.25m.

Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) shares closed down 12% to $3.01, in what seems to be a reaction to a negative article published on Seeking Alpha.

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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:

Capricor Therapeutics, Inc. (CAPR): $3.70; +20%.

Verrica Pharmaceuticals Inc. (VRCA): $14.76; +18%.

Summit Therapeutics plc (SMMT): $1.79; +17%.

Akero Therapeutics, Inc. (AKRO): $22.75; +15%.

NantKwest, Inc. (NK): $1.22; +13%.

DECLINERS:

Adamas Pharmaceuticals, Inc. (ADMS): $5.12; -23%.

Tyme Technologies, Inc. (TYME): $1.19; -20%.

Provention Bio, Inc. (PRVB): $6.83; -16%.

Aravive, Inc. (ARAV): $7.50; -14%.

Fulcrum Therapeutics, Inc. (FULC): $6.64; -13%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ACST – Acasti Pharma Inc.
CaPre (TRILOGY 1 and 2)
Hypertriglyceridemia

Phase 3 Phase 3 top-line data due in December 2019 (1) and January 2020 (2).
$183.2 million

ANAB – AnaptysBio Inc.
ANB019
Generalized pustular psoriasis

Phase 2 Phase 2 interim data on first TWO patients announced September 30, 2019 with patients reaching primary endpoint. Further data due 2020.
$973.2 million

AVEO – AVEO Pharmaceuticals Inc.
FOTIVDA (Tivozanib) and IMFINZI (Durvalumab)
Hepatocellular carcinoma (HCC)

Phase 1/2 Phase 1/2 trial initiation announced September 30, 2019.
$131.5 million

BOLD – Audentes Therapeutics Inc.
AT132 - ASPIRO
X-Linked Myotubular Myopathy

Phase 1/2 Phase 1/2 data presented at WMS October 5, 2019. BLA filing due mid-2020.
$1.3 billion

CATB – Catabasis Pharmaceuticals Inc.
Edasalonexent (CAT-1004)
Duchenne muscular dystrophy (DMD)

Phase 3 Phase 3 data due 4Q 2020.
$55.8 million

EIDX – Eidos Therapeutics Inc.
AG10 / BBP-265 - open label
ATTR-CM

Phase 2 Phase 2 data to be presented at AHA November 16, 2019, 5:30 PM ET.
$1.4 billion

ETTX – Entasis Therapeutics Holdings Inc.
Zoliflodacin
Uncomplicated gonorrhea

Phase 3 Phase 3 trial initiation announced September 30, 2019. Data due 2021.
$75.9 million

IDRA – Idera Pharmaceuticals Inc.
Tilsotolimod + nivolumab and ipilimumab - ILLUMINATE 206
Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Phase 2 Phase 2 trial initiation announced September 30, 2019.
$75 million

IMMU – Immunomedics Inc.
SACTUZUMAB GOVITECAN (IMMU-132)
Cancer - metastatic triple-negative breast cancer

NDA Filing NDA to be refiled late-November / early December, 2019.
$2.8 billion

JNJ – Johnson & Johnson
INVOKANA - CREDENCE
Diabetic Kidney Disease

Approved FDA Approval announced September 30, 2019.
$350.6 billion

LCTX – BioTime Inc.
OpRegen
Dry age-related macular degeneration (AMD)

Phase 1/2 Phase 1/2 data presented at AAO October 14, 2019.
$142 million
OCU 300
Graft Versus Host Disease

Phase 3 Phase 3 top-line data due 2H 2019.