BPC February 06 update

Biotech earnings week ahead; February events to watch; Biotech week in review

Weekly watchlist

This week we list key earnings dates to look out for over the next week, while looking at biotech catalysts slated specifically for February. Similar to recent lists, catalysts that are not definitively listed as occurring in February are not listed. For general first quarter regulatory and clinical catalysts, we suggest you refer to the Phase 1/2, Phase 3, and PDUFA lists highlighted last month. Completed catalysts from the original lists remain in the links above. However, most are still in play and remain the focus for the quarter.

First, let’s review the week that was.

Insmed Incorporated (NASDAQ:INSM) shares closed the week up 60% to $32.92. The company announced Monday its Phase 2 Willow trial evaluating INS1007 administered once daily in adults with non-cystic fibrosis bronchiectasis (NCFBE), met its primary endpoint.

Moderna, Inc. (NASDAQ: MRNA) shares closed Friday up 17% to $23.24 following an update at a White House news conference that no glitches have been seen in the development of Moderna's coronavirus vaccine and a human Phase 1 clinical trial will commence by the end of April assuming current progress continues.

Assertio Therapeutics,Inc (NASDAQ:ASRT) shares closed Friday up 46% to $1.52 following news released after hours Thursday that Collegium Pharmaceutical, Inc. (NASDAQ: COLL) will acquire its Nucynta franchise of products for $375m in cash. Collegium shares closed Friday up 25% to $25.45.

Zogenix, Inc. (NASDAQ: ZGNX) shares closed Friday down 39% to $32.12 following the release of data from its Phase 3 trial of Fintepla (ZX008) for the treatment of Lennox-Gastaut Syndrome (LGS), with investors interpreting the data as inferior to GW Pharma’s (NASDAQ: GWPH) approved treatment, Epidiolex. Zogenix noted that the trial met its primary endpoint in reducing the frequency of drop seizures at a dose of 0.7 mg/kg/day compared with placebo by 26.5% (p=0.0012), yielding a placebo-adjusted decrease of 18.7%. The decrease with the lower dose (0.2 mg/kg/day), a secondary endpoint, did not reach statistical significance (p=0.0915). Shares of GW Pharma closed Friday up 7% to $126.65. Epidiolex is also marketed for the treatment Dravet syndrome and Fintepla has an upcoming PDUFA date also for Dravet syndrome of March 25, 2020.

Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) announced its Phase 3 trial of Tonmya, for the treatment of posttraumatic stress disorder (PTSD), has been stopped due to futility. An Independent Data Monitoring Committee (IDMC) determined Tonmya is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall change from baseline in the severity of PTSD symptoms. The company followed the news up with an offering of shares and warrants, closing the week down 62% to $0.53.

Biogen Inc. (NYSE: BIIB) announced the U.S Patent Trial and Appeal Board ruled in favor of Biogen following a patent challenge by generic company Mylan (NYSE: MYL) of its patent on its top revenue-earning multiple sclerosis drug Tecfidera. Shares closed the week up 26% to $338.70.

Key earnings dates for the week ahead:

M: AGN

T: EXAS

W: TEVA

Th: ACOR AGIO INCY IRWD

Fr: AZN IMGN

Drug Stage Catalyst Market Cap

ACST – Acasti Pharma Inc.
CaPre (TRILOGY 1 and 2)
Hypertriglyceridemia

Phase 3 Phase 3 TRILOGY 1 data did not meet primary endpoint - January 13, 2020. TRILOGY 2 data due 3Q 2020.
$65.5 million

ADXS – Advaxis Inc.
ADXS-PSA and Keytruda - KEYNOTE-046
Castrate-resistant prostate cancer

Phase 1/2 Phase 1 presentation at ASCO Genitourinary Cancers Symposium February 13, 2020 noted median overall survival (95% CI) of 33.7 months.
$35.1 million

AGRX – Agile Therapeutics Inc.
Twirla
Contraceptive patch

Approved FDA Approval announced February 14, 2020.
$218 million

AVRO – AVROBIO Inc.
AVR-RD-04 (ASGCT)
Cystinosis

Phase 1/2 Phase 1/2 updated data presented at American Society of Gene & Cell Therapy (ASGCT) May 13, 2020.
$627.4 million

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

Phase 3 Phase 3 top-line data met primary endpoint - March 30, 2020.
$4.3 billion

BXRX – Baudax Bio Inc.
Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery

Approved FDA Approval announced February 20, 2020.
$62 million

CRDF – Cardiff Oncology Inc.
Onvansertib (PCM-075) and Zytiga
Prostate cancer

Phase 2 Phase 2 biomarker data were to be presented at AACR April 24-29, 2020. Postponed due to COVID-19.
$94.2 million

CRVS – Corvus Pharmaceuticals Inc.
CPI-444
Solid tumors - cancer

Phase 1b Phase 1b/2 initial data from the RCC cohort at ASCO May 29, 2020. AdenoSig positive group -ORR of 17%. AdenoSig negative group - no partial responses.
$123 million

ESPR – Esperion Therapeutics Inc.
Bempedoic acid
Hypercholesterolemia

Approved FDA Approval announced February 21, 2020.
$1.4 billion

EXEL – Exelixis Inc.
Cabozantinib + atezolizumab (TECENTRIQ) CONTACT-01
Solid tumors

Phase 3 Phase 3 trial initiation announced June 11, 2020.
$7.6 billion

IMMP – Immutep Limited
Eftilagimod alpha and Keytruda - TACTI-002
Non-small cell lung cancer; Head and neck cancer

Phase 2 Phase 2 completion of enrolment announced June 29, 2020. Further interim data due 2H 2020.
$42.8 million

KDMN – Kadmon Holdings Inc.
KD025 - ROCKstar (KD025-213)
Chronic graft-versus-host disease (cGVHD)

NDA Filing Phase 2 top-line data noted statistically significant Overall Response Rates (ORRs) of 73% with 200 mg once daily. NDA filing 4Q 2020.
$673.7 million

MNLO – Menlo Therapeutics Inc.
Serlopitant
Chronic pruritus of unknown origin

Phase 2 Phase 2 trial did not meet primary endpoint - February 26, 2020.
$279.9 million