BPC November 19 update

Key Phase 3 catalysts left for the quarter; Biotech week in review

Weekly watchlist

This week we revisit our list of fourth-quarter Phase 3 catalysts and focus on the readouts we are still waiting for. Next week we will highlight the remaining Phase 1 and 2 catalysts from our fourth quarter list before updating our regulatory events watchlist.

First, however, let’s review the week that was with price-moving events.

REGULATORY UPDATES:

Longeveron Inc. (NASDAQ: LGVN) received Rare Pediatric Disease (RPD) designation from the FDA for its drug Lomecel-B to treat Hypoplastic Left Heart Syndrome (HLHS). Shares closed the week up 195% at $10.03.

CLINICAL UPDATES:

Kezar Life Sciences, Inc. (NASDAQ: KZR) released interim results from its Phase 2 MISSION trial of KZR-616 to treat lupus nephritis (LN). 4 of the 5 patients reported a partial or complete renal response at the end of treatment, with 3 of 5 patients reporting a 50% or greater reduction in UPCR. Shares closed the week up 69% at $13.97.

OTHER:

Odonate Therapeutics, Inc. (NASDAQ: ODT) will undergo a share repurchase plan of 20 million shares in connection to its discontinuation of tesetaxel. As of September 30, 2021, Odonate had total stockholders' equity of $71.4 million, or $1.85 per share, based on 38.5 million shares outstanding. Shares closed the week down 43% at $1.83.

Tricida, Inc. (NASDAQ: TCDA) announced a direct equity financing deal with certain investors for the purchase and sale of common stock, pre-funded warrants, and common warrants. Total proceeds are $42 million. Shares closed the week up 43% at $7.67.

Dicerna Pharmaceuticals, Inc. (NASDAQ: DRNA) will be acquired by Novo Nordisk (NYSE: NVO) following a definitive agreement announced on Thursday. Dicerna shares closed the week up 70% at $37.92.

RedHill Biopharma Ltd. (NASDAQ: RDHL) announced a public offering of 4.7 million American Depositary Shares for gross proceeds of $15.5 million. Shares closed the week down 42% at $2.83.

Drug Price Stage Catalyst Market Cap

AGLE – Aeglea BioTherapeutics Inc.
Pegzilarginase (AEB1102) - PEACE
Arginase I deficiency

$6.45
-0.15  -2%
Phase 3 Phase 3 data due December 2021.
$318.1 million

ALDX – Aldeyra Therapeutics Inc.
Reproxalap (ADX-102) - (TRANQUILITY)
Dry eye syndrome

$7.68
-0.24  -3%
Phase 3 Phase 3 enrollment completed November 9, 2021 with data due 4Q 2021. NDA submission expected early 2022.
$446.1 million

ALLK – Allakos Inc.
Lirentelimab - (ENIGMA 2)
Eosinophilic Gastritis and/or eosinophilic duodenitis (EoD)

$80.09
-1.13  -1%
Phase 3 Phase 3 top-line data due 4Q 2021 or 1Q 2022. Phase 3 study showed 45% (181/405) of patients with moderate-to-severe unexplained gastrointestinal symptoms who underwent upper endoscopy with biopsy met the histologic criteria for eosinophilic gastritis and/or eosinophilic duodenitis (EG/EoD) noted October 25, 2021.
$4.3 billion

BBIO – BridgeBio Pharma Inc.
Acoramidis (AG10) - ATTRibute-CM
ATTR-CM

$39.55
-1.19  -3%
Phase 3 Phase 3 top-line Part A data due late-2021. Part B data due 2023. NDA filing expected in 2022.
$5.8 billion

IMGN – ImmunoGen Inc.
Mirvetuximab - SORAYA
Ovarian cancer

$4.81
-0.11  -2%
Phase 3 Phase 3 trial top-line data due 4Q 2021. BLA filing expected in 1Q 2022.
$974.6 million

SWTX – SpringWorks Therapeutics Inc.
Nirogacestat (DeFi)
Desmoid tumors

$68.48
-1.82  -3%
Phase 3 Phase 3 top-line data due 4Q 2021 or early 2022.
$3.4 billion