BPC February 12 update

TEVA shares rise on earnings; Deciphera DCPH issued priority review for ripretinib - PDUFA date August

Price and Volume Movers

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) shares closed up 9% to $13.44 following the release of fourth quarter earnings for 2019. Revenues in the fourth quarter were $4.468m, an increase of 1%, compared with the fourth quarter of 2018. The company continued to see decreased revenue from its multiple sclerosis drug, Copaxone, as it continues to battle with generic competition, with revenue falling 26% during the period. However, this was offset by higher revenues from its tardive dyskinesia treatment Austedo.

Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) announced the FDA has accepted for priority review its New Drug Application (NDA) seeking approval for ripretinib, for the treatment of patients with advanced gastrointestinal stromal tumors (GIST). The PDUFA date is August 13, 2020. The company also announced after hours a registered underwritten public offering of $250m in shares of its common stock. Shares are trading flat after hours at $69.39.

AVROBIO, Inc. (NASDAQ:AVRO) shares are trading down 8% to $24.66 after hours following news it intends to raise $100m from an underwritten public offering of its common stock.

Catalyst Biosciences, Inc. (NASDAQ:CBIO) also announced that it is offering shares of its common stock in an underwritten public offering. Shares are trading down 14% to $6.90 after hours.

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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:

NeuroBo Pharmaceuticals, Inc. (NRBO): $30.00; +104%.

AIM ImmunoTech Inc. (AIM): $1.25; +18%.

Evelo Biosciences, Inc. (EVLO): $4.93; 15%.

LogicBio Therapeutics, Inc. (LOGC): $8.15; +15%.

Beam Therapeutics Inc. (BEAM): $27.60; +15%.

DECLINERS:

PDS Biotechnology Corporation (PDSB): $1.32; -26%.

BioXcel Therapeutics, Inc. (BTAI): $18.90; -12%.

Theravance Biopharma, Inc. (TBPH): $24.67; -12%.

Morphic Holding, Inc. (MORF): $17.50; -11%.

Moderna, Inc. (MRNA): $19.01; -11%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALNA – Allena Pharmaceuticals Inc.
Reloxaliase ALLN-177 (URIROX-2)
Enteric Hyperoxaluria

Phase 3 Phase 3 interim analysis due 3Q 2021 with top-line data due 1Q 2022.
$48.8 million

CRSP – CRISPR Therapeutics AG
CTX120
Relapsed or refractory multiple myeloma

Phase 1 Phase 1 enrolment has commenced - noted February 12, 2020.
$3.2 billion

DCPH – Deciphera Pharmaceuticals Inc.
Ripretinib DCC-2618
Gastrointestinal Stromal Tumors (GIST) - fourth-line

PDUFA priority review PDUFA date under priority review August 13, 2020.
$2.7 billion

HEPA – Hepion Pharmaceuticals Inc.
CRV431
Non-alcoholic steatohepatitis

Phase 2 Phase 2 trial to be initiated 2H 2020.
$17.4 million

KALA – Kala Pharmaceuticals Inc.
KPI‑121 0.25% STRIDE 3
Dry eye disease

Phase 3 Phase 3 data due 1Q 2020.
$233.3 million

KMDA – Kamada Ltd.
Alpha-1 antitrypsin (AAT)
Prevention of lung transplant rejection

Phase 1/2 Phase 2 top-line data due 2020.
$262.4 million

MRK – Merck & Company Inc. (new)
Keytruda KN-355
Triple negative breast cancer (TNBC)

Phase 3 Phase 3 PFS data met primary endpoint. Trial to continue to evaluate overall survival endpoint.
$207.1 billion

PRTA – Prothena Corporation plc
PRX002 (PASADENA)
Parkinson's disease

Phase 2 Phase 2 data due 2020.
$486.3 million

TEVA – Teva Pharmaceutical Industries Limited American Depositary Shares
AUSTEDO (deutetrabenazine)
Tourette Syndrome

Phase 2/3 Phase 2/3 trial did not meet primary endpoint - February 19, 2020.
$13.9 billion

TEVA – Teva Pharmaceutical Industries Limited American Depositary Shares
AUSTEDO (deutetrabenazine)
Dyskinetic cerebral palsy (DCP)

Phase 3 Phase 3 data due in 2021.
$13.9 billion

TEVA – Teva Pharmaceutical Industries Limited American Depositary Shares
Fremanezumab
Fibromyalgia

Phase 2 Phase 2 data due 2021.
$13.9 billion

TLC – Taiwan Liposome Company Ltd.
TLC590
Postsurgical pain

Phase 2 Phase 2 completion of enrolment announced February 12, 2020 with data due mid-2020.
$193.7 million

VERU – Veru Inc.
Zuclomiphene citrate
Hot flashes

Phase 2 Phase 3 trial to commence by early summer 2020.
$281 million

VERU – Veru Inc.
Tadalafil and Finasteride combo
Benign prostatic hyperplasia (BPH)

NDA Filing NDA filing due 2H 2020.
$281 million