BPC April 12 update

Biohaven BHVN rise 20% on buyout chatter; Tracon TCON shares slide 49% following trial termination

Price and Volume Movers

Tracon Pharmaceuticals (NASDAQ:TCON) shares closed down 49% to $0.66 following news that its Phase 3 TAPPAS trial evaluating TRC105 in combination with Votrient (pazopanib) in patients with advanced or metastatic angiosarcoma was terminated for futility based on the recommendation of the Independent Data Monitoring Committee (IDMC) following its review of interim unblinded safety and efficacy data. The company also noted that it will terminate further enrolment in all other company sponsored trials of TRC105 in oncology.

Biohaven Pharmaceutical (NASDAQ: BHVN) shares spiked in late-morning trading following a report from Bloomberg that the company is exploring a sale of the company. Shares closed up 20% to $58.24.

“The drugmaker, which is working with a financial adviser, is in the early stages of considering a sale or partnerships and the talks may not lead to a deal, said the people, who asked not to be identified as the details aren’t public.”

Clovis Oncology, Inc. (NASDAQ: CLVS) shares are currently trading down 13% after hours to $20.49 after it announced in a SEC filing that it is discontinuing its ATLAS Phase 2 open label trial of rucaparib in recurrent, metastatic bladder cancer. The decision follows a review by an independent data monitoring committee which noted the objective response rate does not meet the to protocol continuance criteria, and is unlikely to provide clinical benefit to patients.

Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), as noted earlier in the week, announced that its previously announced 1-for-12 reverse stock split became effective today.

Bristol-Myers Squibb Company (NYSE: BMY) and Celgene Corporation (NASDAQ: CELG) announced their respective stockholders have voted to approve their proposed merger. The transaction is on track to close in 3Q 2019.

Johnson & Johnson (NYSE: JNJ) announced that the FDA approved Balversa (erdafitinib) for the treatment of adults with locally advanced or metastatic urothelial carcinoma.

Vital Therapies, Inc. (Nasdaq: VTL) announced that following its reverse merger, the company has been renamed Immunic, Inc. and will commence trading on The Nasdaq Capital Market under the ticker symbol “IMUX” on April 15, 2019. Drug pipeline information can be viewed in the table of pipeline updates below.

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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:

Kitov Pharma Ltd (KTOV): $1.30; +18%.

Immuron Limited (IMRN): $7.00; +17%.

PhaseBio Pharmaceuticals, Inc. (PHAS): $14.66; +9%.

Merus N.V. (MRUS): $14.72; +8%.

Alector, Inc. (ALEC): $26.42; +8%.

DECLINERS:

X4 Pharmaceuticals, Inc. (XFOR): $12.57; -17%.

Lipocine Inc. (LPCN): $1.87; -12%.

Nymox Pharmaceutical Corporation (NYMX): $1.81; -10%.

Intercept Pharmaceuticals, Inc. (ICPT): $95.21; -9%.

FibroGen, Inc. (FGEN): $48.03; -9%.


Pipeline Database Updates

Drug Stage Catalyst Market Cap

CLVS – Clovis Oncology Inc.
Rucaparib - ATLAS
Urothelial carcinoma

Phase 2 Phase 2 trial to be discontinued due to lack of efficacy - April 12, 2019.
$1.1 billion

GLYC – GlycoMimetics Inc.
GMI-1359
Hormone receptor positive metastatic breast cancer

Phase 2 Proof of concept trial to be initiated 2H 2019.
$532.7 million

HZNP – Horizon Pharma plc
Teprotumumab
Thyroid Eye Disease (TED)

Phase 3 Phase 3 data released February 28, 2019 - endpoints met. Data to be presented at AACE April 26, 2019, 11am PT.
$4.5 billion

IMUX – Immunic Inc.
IMU-838
Ulcerative colitis

Phase 2 Phase 2 interim dosing analysis expected mid-2019 and full data readout expected 2Q 2020.
$142.6 million

IMUX – Immunic Inc.
IMU-838
Relapsing-remitting multiple sclerosis

Phase 2 Phase 2 data due 2021.
$142.6 million

IMUX – Immunic Inc.
IMU-838
Crohn’s disease

Phase 2 Phase 2 trial to commence April 12, 2019.
$142.6 million

JNJ – Johnson & Johnson
Erdafitinib
Urothelial cancer

Approved FDA Approval announced April 12, 2019.
$366.1 billion

MNK – Mallinckrodt plc
StrataGraft skin tissue
Deep partial thickness severe burns - skin defects

Phase 3 Phase 3 completion of enrolment announced April 12, 2019 with top-line data due by the end of 2019.
$1.5 billion

TCON – TRACON Pharmaceuticals Inc.
TRC105 (TAPPAS)
Angiosarcoma cancer

Phase 3 Phase 3 interim analysis April 12, 2019 noted trial to be terminated due to futility.
$20.3 million

TCON – TRACON Pharmaceuticals Inc.
TRC105 + Opdivo
Non-small cell lung cancer (NSCLC)

Phase 1/2 Enrolment to be terminated - April 12, 2019.
$20.3 million

WVE – Wave Life Sciences Ltd.
Suvodirsen (WVE-210201)
Duchenne muscular dystrophy - Exon 51

Phase 1 Phase 1 interim efficacy data from open-label trial due 2H 2019. Phase 2/3 trial to be initiated July 2019.
$870.5 million