BPC January 10 update

Sorrento SRNE receives buyout offer +40%; Verona VRNA data coming Monday

Price and Volume Movers

EDIT: RVNC agreement added following initial post (see below):

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Sorrento Therapeutics, Inc. (NASDAQ: SRNE) shares closed up 40% to $4.76 following its announcement it has received a non-binding proposal from a private equity fund to acquire a majority or all of the issued and outstanding shares for up to $7 per share.

Verona Pharma plc (NASDAQ:VRNA) announced it will release data from its Phase 2b dose-ranging study evaluating nebulized ensifentrine as an add-on to treatment with a long acting bronchodilator in patients with moderate-to-severe COPD, pre-market on Monday, January 13, 2020.

Eli Lilly and Company (NYSE:LLY) announced it will acquire Dermira, Inc. (NASDAQ:DERM) for $18.75 per share, or approximately $1.1b. Shares of Dermira closed up 4% to $19.16. Prior to the announcement, shares had already risen by 25% for the week.

Nektar Therapeutics (Nasdaq:NKTR) shares closed up 27% to $26.92. The company announced a revision to its agreement with Bristol-Myers Squibb Company (NYSE:BMY) regarding the development of bempegaldesleukin (bempeg) plus Opdivo (nivolumab). Development will be expanded from three ongoing trials in first-line metastatic melanoma, urothelial cancer and renal cell carcinoma (RCC) to include two additional trials in adjuvant melanoma and in muscle-invasive bladder cancer. The FDA also posted Friday briefing documents for Tuesday’s Advisory Committee meeting which will discuss oxycodegol, its opioid for back pain.

Akari Therapeutics, Plc (Nasdaq: AKTX) shares closed up 25% to $2.16. The company announced interim data from its Phase 3 Capstone trial in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) showed that of the first eight patients who were all transfusion dependent at entry to the trial, all four patients randomized to nomacopan were transfusion independent for the first six months while all four patients on standard of care (SOC) remained transfusion dependent.

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) shares closed Friday up 23% to $53.96 following the release of positive data on Thursday from its Phase 1/2 trial of DTX301, for the treatment of ornithine transcarbamylase (OTC) deficiency. The company noted up to six responders were evident across all nine patients dosed in the trial.

Portola Pharmaceuticals, Inc. (NASDAQ:PTLA) shares closed down 40% to $14.76 following its report after hours Thursday of Andexxa net revenues of $28m, well down on expectations.

Kadmon Holdings, Inc. (NYSE: KDMN) announced that expanded data from the interim analysis of ROCKstar (KD025-213), its pivotal trial in chronic graft-versus-host disease (cGVHD), will be presented in a late-breaking oral presentation at the 2020 Transplantation & Cellular Therapy (TCT) Meetings on February 23, 2020, 12:00 p.m. ET.

Revance Therapeutics, Inc. (NASDAQ:RVNC) shares closed up 18% to $19.50. The company announced a U.S. distribution agreement with Teoxane for its Resilient Hyaluronic Acid line of fillers for correction of dynamic wrinkles. The agreement covers three FDA approved products, with approval of a fourth anticipated for 2021.

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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:

Monopar Therapeutics Inc. (MNPR): $22.00; +24%.

AzurRx BioPharma, Inc. (AZRX): $1.72; +21%.

ContraFect Corporation (CFRX): $1.05; +21%.

PhaseBio Pharmaceuticals, Inc. (PHAS): $6.79; +20%.

Revance Therapeutics, Inc. (RVNC): $19.50; +18%.

DECLINERS:

Matinas BioPharma Holdings, Inc. (MTNB): $1.46; -24%.

Applied Genetic Technologies Corporation (AGTC): $7.84; -15%.

Kezar Life Sciences, Inc. (KZR): $3.29; -14%.

Turning Point Therapeutics, Inc. (TPTX): $56.82; -13%.

EyeGate Pharmaceuticals, Inc. (EYEG): $7.51; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AKTX – Akari Therapeutics Plc
Nomacopan - CAPSTONE
Paroxysmal nocturnal hemoglobinuria (PNH)

Phase 3 Phase 3 interim data January 10, 2020 noted all patients achieved the primary endpoint of transfusion independence.
$63.6 million

ALNY – Alnylam Pharmaceuticals Inc.
Lumasiran (ALN-GO1)
Primary Hyperoxaluria Type 1 (PH1)

PDUFA priority review PDUFA date under priority review December 3, 2020.
$15.8 billion

AQST – Aquestive Therapeutics Inc.
APL-130277
Parkinson’s Disease with motor fluctuations

Approved FDA approval announced May 21, 2020.
$239.7 million

CFRX – ContraFect Corporation
CF-301 exebacase
Serious infections caused byStaph aureus including MRSA

Phase 3 Phase 3 initiation of dosing announced January 10, 2020. Continues to enroll as of August 2020.
$146.8 million

CHMA – Chiasma Inc.
Mycapssa - OPTIMAL
Acromegaly

Approved FDA approval announced June 26, 2020.
$264.2 million

EVLO – Evelo Biosciences Inc.
EDP1815
Mild to moderate psoriasis

Phase 2 Phase 2 trial to be initiated 3Q 2020 with data due mid-2021.
$233 million

IONS – Ionis Pharmaceuticals Inc.
AKCEA-TTR-LRx - CARDIO-TTRansform
ATTR cardiomyopathy

Phase 3 Phase 3 trial initiation announced January 10, 2020. Data due 2023.
$7.4 billion

KDMN – Kadmon Holdings Inc.
KD025 - ROCKstar (KD025-213)
Chronic graft-versus-host disease (cGVHD)

NDA Filing NDA filing 4Q 2020.
$706.8 million

SEEL – Seelos Therapeutics Inc.
SLS-002-101
Healthy volunteers

Phase 1 Phase 1 DDI initial data released January 10, 2020 - generally safe and well-tolerated.
$46.3 million

SRRK – Scholar Rock Holding Corporation
SRK-181
Solid Tumors

Phase 1 Phase 1 initiation of dosing announced May 5, 2020. Update on dose escalation 4Q 2020; clinical response and safety data anticipated in 2021.
$397.9 million

VRNA – Verona Pharma plc
Ensifentrine (RPL554) and tiotropium
Chronic obstructive pulmonary disease (COPD)

Phase 2b Phase 3 trial to be initiated 2H 2020.
$427.5 million