BPC December 13 update

Biotech stock events slated for the final two weeks of 2018; Biotech week in review

Weekly watchlist

The last week saw a number of companies releasing price-moving news, predominantly to the negative, with stocks reacting accordingly. As we approach the festive season one would normally expect a slow down in news flow. However, a number of key events are still slated for this month. Some of which are noted below.

Let’s first review the week that was with six market moving biotech stock events.

Johnson & Johnson (NYSE: JNJ) shares plunged Friday to close down 10% to $133.00, equivalent to a loss of $40b from its market cap, following a Reuters report that alleged that the company knew that some of its previous baby powder products contained small amounts of asbestos. 

Neurocrine Biosciences, Inc. (NASDAQ: NBIX) announced Wednesday that top-line data from its Phase 2b T-Force GOLD trial of valbenazine did not meet the primary endpoint in children and adolescents with moderate to severe Tourette syndrome. Shares closed Thursday down 14% to $73.83.

Synergy Pharmaceuticals Inc. (NASDAQ: SGYP) shares slid Wednesday down 53% to $0.16 on news it has initiated proceedings for Chapter 11 Bankruptcy.  Bausch Health Companies Inc., (NYSE: BHC) has agreed to acquire all of its assets for approximately $200m.

Axovant Sciences (NASDAQ: AXON) announced Monday that its Phase 2 trial of nelotanserin for the treatment of REM sleep behavior disorder (RBD) in patients with Lewy body dementia (LBD), did not meet the primary efficacy endpoint of reduction in frequency of RBD events. Shares closed the week down 41% to $1.01 with the company also announcing a secondary offering of its stock.

Corcept Therapeutics (NASDAQ: CORT) shares surged Tuesday closing up 32% to $17.17 following the issuance of a patent to the company related to Cushing’s disease. The company derives most of its revenue from Korlym, its FDA approved product for Cushing’s.  Shares ended the week trading at $16.11.

Applied Genetic Technologies Corporation (NASDAQ: AGTC) shares closed Thursday down 47% to $3.47 following Wednesday’s news that interim data from its Phase 1/2 for X-linked retinoschisis (XLRS) showed no signs of clinical activity, which saw Biogen terminate its collaboration agreement.

Biotech stock events slated for the last two weeks of 2018:

Drug Stage Catalyst Market Cap

ACHN – Achillion Pharmaceuticals Inc.
C3 glomerulopathy (C3G)

Phase 2 End of Phase 2 meeting 4Q 2019.
$414.8 million

ADMA – ADMA Biologics Inc
Primary humoral immunodeficiency

CRL Response to Complete Response Letter submitted January 7, 2019.
$215.3 million

CELG – Celgene Corporation
First-line ABC Diffuse large B-cell lymphoma (DLBCL)

Phase 3 Phase 3 data released April 25, 2019 did not meet primary endpoint.
$69 billion

CFRX – ContraFect Corporation
Serious infections caused byStaph aureus including MRSA

Phase 2 Phase 2 trial noted clinically meaningful data but not statistically significant. Phase 3 trial planned.
$37.5 million

EVFM – Evofem Biosciences Inc.
Amphora - AMPOWER
contraceptive vaginal gel

NDA Filing Phase 3 data released December 17, 2018. Primary endpoint met. NDA to be refiled 2H 2019.
$306.8 million

FGEN – FibroGen Inc
Anaemia in Chronic Kidney Disease

NDA Filing Phase 3 MACE safety data released May 9, 2019. Non-inferior in non-dialysis, no worse risk than placebo. NDA filing due September/October 2019.
$3.8 billion

HTBX – Heat Biologics Inc.
HS-110 and nivolumab (Opdivo)
Non-small cell lung cancer (NSCLC)

Phase 2 Phase 2 additional data due 4Q 2019.
$25.6 million

MRNS – Marinus Pharmaceuticals Inc.
Refractory status epilepticus (RSE)

Phase 2 Data due by the end of 3Q 2019.
$215.5 million

SESN – Sesen Bio Inc.
Non-muscle invasive bladder cancer (NMIBC)

BLA Filing Rolling BLA filing to commence 4Q 2019.
$119.5 million