BPC September 29 update

11 small cap regulatory catalysts for 4Q 2018

Weekly watchlist

The last week of the third quarter saw significant clinical readouts producing monumental price gains and losses, with Amarin leading the way with a 444% gain. 

We highlight five such readouts and also look ahead to key regulatory events (PDUFA dates and Advisory Committee meetings) for small-cap biotech stocks in 4Q 2018.

Amarin Corporation plc (NASDAQ:AMRN) shares surged to close the week up 444% to $16.27 following the release of top-line results from its Vascepa cardiovascular (CV) outcomes trial, REDUCE-IT. The trial met its primary endpoint demonstrating an approximately 25% relative risk reduction in major adverse CV events (MACE) in the intent-to-treat patient population with use of Vascepa as compared to placebo.   

Geron Corporation (NASDAQ: GERN) shares posted a two-day loss of 72%, closing the week at $1.76 following news Janssen Biotech will not continue its collaboration and license agreement of imetelstat and will return rights of back to Geron.

TG Therapeutics (NASDAQ: TGTX) shares slid Tuesday 44% to $5.15 following news that its Phase 3 UNITY-CLL interim analysis of Overall Response Rate (ORR) could not be conducted as the data were not sufficiently mature to conduct the analysis and will now instead focus on the primary endpoint of Progression Free Survival (PFS) to support approval of the ublituximab plus umbralisib combination. 

Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) shares closed the week up 52% to $13.80 with the company noting positive data from its Phase 2b clinical trial of topical ocular reproxalap in patients with dry eye disease.

AnaptysBio, Inc. (Nasdaq: ANAB) shares closed Monday up 10% to $101.95 following the release of top-line data from its Phase 2a trial of etokimab in adult patients with severe eosinophilic asthma. The company noted lung function improvement of etokimab, with an 8% increase in FEV1 (Forced Exhaled Volume In One Second) over placebo at Day 2, rising to 11% by Day 64. The improvement at Day 64 was aided to some degree by a decline in placebo.

 

11 small cap Advisory Committee and PDUFA date catalysts for 4Q 2018:

Drug Stage Catalyst Market Cap

ACRX – AcelRx Pharmaceuticals Inc.
DSUVIA (ARX-04)
Moderate-to-severe acute pain following a surgical procedure

Approved FDA Approval announced November 2, 2018.
$172.1 million

ADMA – ADMA Biologics Inc
BIVIGAM
Primary humoral immunodeficiency

PDUFA PDUFA date delayed two months to December 18, 2018.
$210 million

CHRS – Coherus BioSciences Inc.
CHS-1701
Pegfilgrastim biosimilar

Approved FDA approval announced November 2, 2018.
$661.9 million

CPRX – Catalyst Pharmaceuticals Inc.
Firdapse
Lambert-Easton Myasthenic Syndrome (LEMS)

Approved FDA approval announced November 28, 2018.
$240.4 million

EYPT – EyePoint Pharmaceuticals Inc.
YUTIQ
Non-infectious uveitis

Approved FDA approval announced October 15, 2018.
$214.4 million

OCUL – Ocular Therapeutix Inc.
DEXTENZA
Ocular inflammation and pain following cataract surgery

Approved FDA approval announced December 3, 2018.
$219 million

PRTK – Paratek Pharmaceuticals Inc.
Omadacycline
Acute bacterial skin and skin structure infections (ABSSSI)

Approved FDA Approval announced October 2, 2018.
$193.2 million

TBPH – Theravance Biopharma Inc.
Revefenacin
COPD

Approved FDA Approval announced November 9, 2018.
$1.5 billion

THERF – Theratechnologie Inc
Single vial formulation of EGRIFTA
Reduction of abdominal fat in HIV- patients

Approved FDA approval announced November 5, 2018.
$499.1 million

TRVN – Trevena Inc.
Oliceridine (TRV130)
Moderate to severe acute pain

CRL CRL issued November 2, 2018.
$47.8 million

TXMD – TherapeuticsMD Inc.
TX-001HR: BIJUVA
Moderate to severe vasomotor symptoms (VMS)

PDUFA FDA approval announced October 29, 2018.
$920.6 million