BPC October 13 update

Biotech stock catalysts for the October; Biotech week in Review

Weekly watchlist

Almost halfway through October, this week we highlight a number of likely catalysts to occur by the end of this month, aside from those appearing at ESMO later this month. Key ESMO events were noted last week.

First, let’s review the week that was with a selection of price moving events.

AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) announced Friday that a FDA Advisory Committee voted 10-3 in favor of recommending the approval of Dsuvia for the management of moderate-to-severe acute pain in medically supervised settings for adult patients. The PDUFA date for a final decision by the FDA is November 3, 2018. Shares closed after hours at $4.92, compared with Tuesday’s close of $2.65 prior to Wednesday’s release of FDA briefing documents, a gain of 86%. Briefing documents are released by the FDA two days prior to an advisory committee meeting.

Trevena, Inc. (NASDAQ: TRVN) on the contrary closed the week down 72% to $0.88 following news its appearance before an FDA Advisory Committee resulted in a narrow recommendation against approval (7-8) of oliceridine for the management of moderate to severe acute pain in adult patients for whom an intravenous (IV) opioid is warranted. The PDUFA date for a final decision by the FDA is November 2, 2018.

Corium International, Inc. (Nasdaq: CORI) shares closed Friday up 53% to $12.70 following news that it will be acquired by Gurnet Point Capital (GPC), a private investment firm focused on the healthcare and life sciences sectors. GPC will pay $12.50 per share, while a Contingent Value Right (CVR) of $0.50 per share is also payable based on the FDA approval of Corium’s lead product candidate, Corplex Donepezil prior to March 31, 2020. Including the CVR payment, the transaction is valued at up to $504m. 

Immune Design (Nasdaq: IMDZ) closed Friday down 34% to $1.85 on news that its Phase 2 trial of CMB305 and Tecentriq (atezolizumab) showed there is not likely to be a survival benefit in relapsed synovial sarcoma patients. As a result, the company has decided to discontinue the Phase 3 Synovate trial.

Menlo Therapeutics Inc. (NASDAQ: MNLO) shares slid Monday 40% to $6.14 following news its Phase 2 trial of serlopitant for the treatment of refractory chronic cough failed to demonstrate benefit versus placebo on the primary and key secondary endpoints.

Affimed N.V. (Nasdaq: AFMD) shares closed Tuesday down 27% to $3.50 after its announcement that its Phase 1 trials of AFM11 in patients with non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL) have been placed on clinical hold due to the occurrence of Serious Adverse Events (SAEs) in three patients.

Likely October Biotech Stock Catalysts:

Drug Stage Catalyst Market Cap

BIIB – Biogen Inc.
BAN2401 (Aβ mAb)
Alzheimer’s disease

Phase 2 Phase 2 mixed data released July 25, 2018. High dose exhibited statistical improvement. Low doses missed.
$63.4 billion

EARS – Auris Medical Holding AG
AM-125
Vertigo

Phase 1 Phase 1 data released October 17, 2018 with Phase 2 trials to commence 1Q 2019.
$13 million

ESPR – Esperion Therapeutics Inc.
Bempedoic acid - CLEAR LDL-C Lowering Program 1002-047
Hypercholesterolemia

Phase 3 Phase 3 data released October 28, 2018. 18% LDL-C Lowering, no difference in adverse events vs placebo. NDA filings due 1Q 2019.
$1.3 billion

FOMX – Foamix Pharmaceuticals Ltd.
FMX103
Papulopustular rosacea

Phase 3 Phase 3 top-line data released November 7, 2018. Primary endpoints met. Safety data due 1H 2019.
$216 million

GLPG – Galapagos NV
GLPG 2451+2222+2737 - FALCON open label
Cystic fibrosis - homozygous F508del patients

Phase 1/2 Phase 1b data released October 24, 2018 noted drug was well tolerated. Safety data due 1Q 2019.
$5.7 billion

HSGX – Histogenics Corporation
NeoCart
Cartilage defects in the knee

Phase 3 Phase 3 data released September 5, 2018. Primary endpoint not met. Update regarding possibility of filing BLA expected by end 2018 or early 2019.
$34 million

SELB – Selecta Biosciences Inc.
SEL-212
Tophaceous gout

Phase 3 Phase 3 trial to be initiated 1Q 2019 with with interim data likely 3Q and 4Q 2019 and full data 1Q 2020.
$105.9 million

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

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