BPC March 27 update

Likely biotech stock events for the upcoming week; Biotech week in Review

Weekly watchlist

Next week brings an end to the first quarter of 2020. As noted in last week’s newsletter, a number of key catalysts remain on the March calendar but given the events we have experienced recently, it still remains uncertain whether all companies will deliver on time, with a likelihood that some events will slip into April.

Key likely events for the upcoming week are listed below. First let’s review the week that was with major price-moving events.

A number of companies announced over the week suspensions of current and upcoming clinical trials due to COVID-19. One such notable delay was the announcement from Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), which informed investors that the FDA has rescheduled the previously announced Advisory Committee Meeting for their New Drug Application (NDA) for obeticholic acid (OCA) in liver fibrosis due to nonalcoholic steatohepatitis (NASH). The previous date of April 22, 2020 has now been moved to June 9, 2020. The PDUFA date remains at June 26, 2020.

Milestone Pharmaceuticals Inc. (Nasdaq: MIST) announced that its Phase 3 trial of NODE-301, in patients with paroxysmal supraventricular tachycardia (PSVT), did not achieve its primary endpoint of time to conversion of supraventricular tachycardia (SVT) to sinus rhythm (SR) compared to placebo. Shares closed the week down 84% to $1.98.

Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) shares spiked early in the week following news that it cancelled its conference call with Jefferies, originally scheduled for March 25. Shares closed the week up 41% to $32.16.

Bristol-Myers Squibb Company (NYSE: BMY) announced that the FDA approved Zeposia (ozanimod) for the treatment of adults with relapsing forms of multiple sclerosis (RMS). Shares closed up 6% to $52.25. The company also noted that it will delay commercialization of Zeposia due to the COVID-19 pandemic.

CytomX Therapeutics, Inc. (NASDAQ:CTMX) announced a collaboration with Astellas Pharma Inc for the development of antibodies targeting CD3 and tumor cell surface antigens for the treatment of cancer. CytomX will receive an upfront cash payment of $80m and is eligible to receive future preclinical, clinical and commercial milestones of around $1.6b. Shares closed the week up 28% to $6.35.

Novavax, Inc. (NASDAQ: NVAX) shares closed the week up 26% to $13.05 on news its Phase 3 trial of its NanoFlu seasonal influenza vaccine met the primary endpoints, demonstrating non-inferior immunogenicity compared to Fluzone Quadrivalent, a U.S.-licensed quadrivalent influenza vaccine.

IntelGenx Technologies Corp. (OTCQX:IGXT) received a Complete Response Letter (CRL) from the FDA regarding its resubmitted New Drug Application for Rizaport for the treatment of acute migraines. Shares closed Friday down 58% to $0.13.


Likely biotech catalysts for next week. Have a safe weekend.

Drug Stage Catalyst Market Cap

AKRO – Akero Therapeutics Inc.
AKR-001
Nonalcoholic steatohepatitis (NASH)

Phase 2a Phase 2a dose groups all met primary endpoint - March 31, 2020. Top-line safety/tolerability, laboratory measures and paired biopsy data due 2Q 2020.
$728.9 million

ASND – Ascendis Pharma A/S
TransCon
Hypoparathyroidism

Phase 2 Phase 2 six-month data from the open-label extension portion due 3Q 2020. Phase 3 trial to commence 4Q 2020.
$7 billion

AXSM – Axsome Therapeutics Inc.
AXS-05 STRIDE-1
Treatment resistant depression

Phase 3 Phase 3 data did not meet primary endpoint. Secondary endpoints met. Second Phase 3 trial to commence 3Q 2020.
$2.9 billion

AXSM – Axsome Therapeutics Inc.
AXS-07 - INTERCEPT
Migraine

Phase 3 Phase 3 data met primary endpoints - April 6, 2020.
$2.9 billion

BHVN – Biohaven Pharmaceutical Holding Company Ltd.
Rimegepant
Migraine - preventative

Phase 3 Phase 3 top-line data met primary endpoint - March 30, 2020.
$3.7 billion

IMVT – Immunovant Inc.
IMVT-1401
Graves Ophthalmopathy

Phase 2a Phase 2a initial data March 30, 2020 noted 65% mean reduction in total IgG.
$1.9 billion

ITRM – Iterum Therapeutics plc
Sulopenem
Uncomplicated urinary tract infections (uUTI)

Phase 3 Phase 3 data due May 2020.
$62.6 million

ITRM – Iterum Therapeutics plc
Sulopenem
Complicated urinary tract infections (cUTI)

Phase 3 Phase 3 data due 2Q 2020.
$62.6 million

MNLO – Menlo Therapeutics Inc.
Serlopitant
Pruritus associated with prurigo nodularis

Phase 3 Phase 3 data did not meet primary endpoint - April 6, 2020.
$325.7 million

MYOV – Myovant Sciences Ltd.
Relugolix - SPIRIT 2
Endometriosis-associated pain

Phase 3 Phase 3 data met co-primary endpoints - April 22, 2020.
$1.1 billion

PRQR – ProQR Therapeutics N.V.
QR-421a - STELLAR
Usher Syndrome Type 2

Phase 1/2 Phase 1/2 interim data March 31, 2020. 2/8 patients demonstrated benefit across multiple concordant outcome measures.
$277.8 million

XLRN – Acceleron Pharma Inc.
Luspatercept
Myelodysplastic syndromes (MDS) cancer

Approved FDA Approval announced April 3, 2020.
$5.3 billion