BPC October 17 update

Biotech earnings next week; Events slated for October; Biotech Week in Review

Weekly watchlist

Third quarter earnings season gets well underway this coming week after a smattering of calls this latest week. Notable earnings dates of predominantly large cap companies are noted below, together with regulatory dates and data presentations slated for the rest of this month.

First, let’s review notable price-moving events from last week.

Reata Pharmaceuticals, Inc. (Nasdaq: RETA) shares closed the week up 93% to $184.91 following news its Phase 2 MOXIe trial of omaveloxolone in patients with Friedreich’s ataxia (FA) met its primary endpoint of the change in the modified Friedreich’s Ataxia Rating Scale (mFARS) relative to placebo after 48 weeks of treatment.

Achillion Pharmaceuticals, Inc. (NASDAQ:ACHN) announced that it will be acquired by Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) for approximately $930m or $6.30 per share with additional contingent value rights (CVRs) to be paid to Achillion shareholders if certain clinical and regulatory milestones are achieved. Shares closed the week up 68% to $6.09.

Syros Pharmaceuticals (NASDAQ:SYRS) shares closed Thursday week down 31% to $6.96.The company announced it will discontinue further development of SY-1365, its intravenous (IV) CDK7 inhibitor.

Assembly Biosciences, Inc. (NASDAQ: ASMB) shares closed the week up 73% to $15.05. Mizuho Securities initiated coverage of the stock earlier in the week with a Buy rating and a price target of $20.

Relmada Therapeutics, Inc. (NASDAQ: RLMD) announced Tuesday its Phase 2 trial of REL-1017 (dextromethadone), as an adjunctive treatment in patients with treatment resistant depression, exhibited statistically significant improvement in depression compared to patients on placebo. Shares closed the week up 76% to $19.81.

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Key earnings releases for the week of October 21:

Tue: BIIB NVS

Wed: ALKS ALXN BMRN LLY RIGL

Thur: ANIK ARGX AZN GILD GLPG

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Other notable events for October:

Drug Stage Catalyst Market Cap

AGRX – Agile Therapeutics Inc.
Twirla
Contraceptive patch

PDUFA CRLs issued 2013 and 2017. New PDUFA extended by three months to February 16, 2020. Advisory Committee Meeting October 30, 2019 voted 14 to 1 in favor.
$103.2 million

ARQL – ArQule Inc.
ARQ 751
Solid tumors

Phase 1 Phase 1b trial ongoing.
$1 billion

ARVN – Arvinas Inc.
ARV-110
Castration-resistant prostate cancer (CRPC)

Phase 1 Phase 1 initial data presented October 23, 2019. Further data due 1H 2020.
$1.2 billion

CLSN – Celsion Corporation
ThermoDox - OPTIMA
Hepatocellular carcinoma - liver cancer

Phase 3 Phase 3 interim efficacy November 4, 2019 - trial to continue as planned. Second analysis 2Q 2020.
$29.8 million

DCPH – Deciphera Pharmaceuticals Inc.
Rebastinib and paclitaxel
Solid tumors

Phase 1/2 Phase 1b/2 preliminary data noted 8/43 partial responses - October 28, 2019.
$2.5 billion

DCPH – Deciphera Pharmaceuticals Inc.
Ripretinib DCC-2618
Gastrointestinal Stromal Tumors (GIST) - second-fourth line

Phase 1 Phase 1 updated data presented at AACR-NCI-EORTC October 29, 2019.
$2.5 billion

ETON – Eton Pharmaceuticals Inc.
ET-202
Injectable hospital product

Approved FDA Approval announced October 22, 2019.
$107.5 million

MLNT – Melinta Therapeutics Inc.
Baxdela
Community-acquired bacterial pneumonia (CABP)

Approved FDA Approval announced October 24, 2019.
$18.7 million

MRTX – Mirati Therapeutics Inc.
MRTX849
Solid tumors

Phase 1/2 Phase 1/2 data presented at AACR-NCI-EORTC October 28, 2019. 3/6 partial responses in NSCLC, 1/4 responses in CRC patients.
$3.5 billion

SYRS – Syros Pharmaceuticals Inc.
SY-1425 and azaciditine
Acute Myeloid Leukemia / Myelodysplastic Syndrome

Phase 2 Phase 2 AML data due 2020.
$199 million