BPC January 04 update

Biotech stock catalysts slated for January; Biotech Week in Review

Weekly watchlist

Happy New Year to all readers of BioPharmCatalyst.

The first week of 2019 saw much noteworthy news flow for a shortened week, dominated by news that Bristol-Myers has sought to acquire Celgene. More of that news below.

The upcoming week will see most attention focused on the J.P. Morgan Healthcare Conference featuring around 450 public and private companies. The full agenda can be viewed on the conference website (need to sign in).

While most eyes will be on the conference next week there are a number of other catalysts slated for January. We note some of the key events below after reviewing the week that was.

Bristol-Myers Squibb Company (NYSE:BMY) and Celgene Corporation (NASDAQ:CELG) announced a merger agreement under which Bristol-Myers Squibb intends to acquire Celgene for $74b. Celgene shareholders will receive one Bristol-Myers Squibb share and $50 in cash for each share of Celgene. Celgene shareholders will also receive one tradeable Contingent Value Right (CVR) for each share of Celgene, which will entitle the holder to receive a payment for the achievement of future regulatory milestones. Shares of CELG closed Thursday up 21% to $80.43 on the news while BMY shares shed 13% to $45.12.

Epizyme, Inc. (Nasdaq: EPZM) announced Friday that following discussions with the FDA, it intends to seek accelerated approval of tazemetostat for patients with relapsed and/or refractory follicular lymphoma (FL). The company anticipates submitting a New Drug Application (NDA) in 4Q 2019. Shares closed up 33% to $7.94.

Verrica Pharmaceuticals Inc.  (Nasdaq: VRCA) shares saw a two-day gain of 25%, closing the week at $9.92 following news its two Phase 3 trials, CAMP-1 and CAMP-2, of VP-102 for the treatment of molluscum contagiosum, met the primary endpoint. The company intends to file a New Drug Application (NDA) in 2H 2019.

Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) announced that the FDA has approved its Prior Approval Supplement (PAS) for Andexxaallowing for broad commercial launch in the United States. Andexxa was initially approved in May 2018. Shares closed the week up 13% to $19.38.

Sesen Bio, Inc. (Nasdaq: SESN) shares closed the week down 39% to $0.86 following the release of preliminary efficacy data of its ongoing Phase 3 VISTA trial, of Vicinium for the treatment of patients with high-grade non-muscle invasive bladder cancer (NMIBC). The stock saw significant upward buying pressure prior to the catalyst, rising over 50% in the six trading days leading up to data release. Such stock behaviour is not uncommon when a defined date for release of data is provided by a small-cap company, with the stock price rising in anticipation of exceptional data only to sell off on the news.

Aevi Genomic Medicine, Inc. (NASDAQ: GNMX) announced that its Phase 2 ASCEND trial of orally-administered AEVI-001 in children aged 6-17 with Attention Deficit Hyperactivity Disorder (ADHD), did not achieve statistical significance on the primary endpoint of reduction of ADHD-RS (rating scale). Shares closed Thursday down 75% to $0.19.

Biopharm catalysts slated for January:

Drug Stage Catalyst Market Cap

ALDX – Aldeyra Therapeutics Inc.
Reproxalap (ADX-102)
Allergic conjunctivitis

Phase 3 Phase 3 data March 25, 2019 - primary endpoint met.
$200.1 million

ASLN – ASLAN Pharmaceuticals Limited
Gastric cancer

Phase 2/3 Phase 2 trial did not meet primary endpoint - January 13, 2019.
$109 million

AUPH – Aurinia Pharmaceuticals Inc
Voclosporin Ophthalmic Solution (VOS)
Dry eye syndrome

Phase 2 Phase 2 data released January 22, 2019. Primary endpoint not met, secondary met.
$594.8 million

AXSM – Axsome Therapeutics Inc.
Major Depressive Disorder

Phase 2 Phase 2 data met primary endpoint - January 7, 2019.
$835.6 million

IMMU – Immunomedics Inc.
Cancer - metastatic triple-negative breast cancer

NDA Filing CRL issued January 17, 2019. NDA to be refiled early 4Q 2019.
$2.8 billion

LXRX – Lexicon Pharmaceuticals Inc.
Type 1 Diabetes

CRL CRL issued March 22, 2019.
$624.9 million

MDWD – MediWound Ltd.
Severe burns

Phase 3 BLA filing due 4Q 2019.
$112 million

SAGE – Sage Therapeutics Inc.
Postpartum depression (PPD)

Phase 3 Phase 3 data met primary endpoint - January 7, 2019.
$9 billion

SNNA – Sienna Biopharmaceuticals Inc.
Reduction of light-pigmented hair

Phase 3 Phase 3 data met non-inferiority primary endpoint - February 8, 2019. Seeking partner for further advancement.
$40.6 million

TYME – Tyme Technologies Inc.
Pancreatic cancer

Phase 2 Phase 3 trials to be initiated mid-2019.
$162.3 million

URGN – UroGen Pharma Ltd.
MitoGel - UGN-101
Urothelial Carcinoma

Phase 3 Initiation of rolling NDA announced December 17, 2018. Phase 3 data May 5, 2019 noted 59% CR. 6-month CR durability 89%. Full Phase 3 data due 2H 2019.
$784.7 million