BPC March 18 update

Key regulatory catalysts remaining for the first quarter; Biotech week in review

Weekly watchlist

This week we revisit our list of regulatory catalysts and focus on the PDUFA dates we are still waiting for this quarter. Next week we will begin the countdown to the end of the quarter, and make note of catalysts left before diving into Phase 3 catalysts in the second quarter.

First, let’s review the week that was with notable price-moving events in the healthcare sector.

REGULATORY

The FDA approved Marinus Pharmaceuticals, Inc’s (NASDAQ: MRNS) ZTALMY (ganaxolone) to treat seizures associated with CDKL5 deficiency disorder.

CLINICAL

Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR) released data from its Phase 3 TOGETHER trial of Peginterferon Lambda (Lambda) to treat COVID-19, noting that the trial met its primary endpoint. Shares closed the week up 49% at $7.92.

Revelation Biosciences Inc. (NASDAQ: REVB) shares closed the week up 47% at $1.59 after it announced that it completed enrollment for its Phase 2b RVL-VRL01 study of intranasal REVTx-99 to treat H3N2 influenza (influenza A) infection.

OTHER

AVEO Oncology (NASDAQ: AVEO) released financials for the fourth quarter of 2021. It reported a loss of $0.21 per share, and revenue of $16.8 million, up 17% from the same period last year. Shares closed the week up 38% at $5.66.

Ikena Oncology, Inc. (NASDAQ: IKNA) reported earnings with quarterly earnings per share (EPS) of $0.07 and $20.22 million in sales for the fourth quarter 2021. Shares closed the week up 30% at $7.99.

China’s top financial policy body spoke out this week, vowing to ensure stability in capital markets, support overseas stock listings, resolve risks around property developers and complete the crackdown on Big Tech. China biotechs traded higher off the news; HUTCHMED Limited (NASDAQ: HCM) shares closed the week up 29% at $20.1, BeiGene (NASDAQ: BGNE) shares closed the week up 29% at $192.97, I-Mab (NASDAQ: IMAB) shares closed the week up 31% at $19.59 and, Zai Lab Limited (NASDAQ: ZLAB) shares closed the week up 38% at $38.73.

RedHill Biopharma Ltd. (NASDAQ: RDHL) reported fourth quarter and full year earnings for 2021. Net revenues were $85.8 million for 2021, up 33.2% from 2020. Shares closed the week up 44% at $2.55.

Nymox Pharmaceutical Corporation (NASDAQ: NYMX) announced a direct registered offering of 3,030,304 shares at $1.65 per share. Total proceeds are to be $5 million. Shares closed the week down 32% at $1.35.

EARNINGS:

Selection of top revenue-earning companies scheduled to report earnings week of March 21st- March 25th (PREMIUM members see BioPharmCatalyst earnings calendar for full list and details).

MONDAY: URGN MRNS

TUESDAY: CLBS APTO ERYP CINC

WEDNESDAY: NAVB PDSB CELC RLMD EXAI APTX

THURSDAY: VALN TFFP

FRIDAY:

Drug Price Stage Catalyst Market Cap

AKBA – Akebia Therapeutics Inc.
Vadadustat
Anemia due to chronic kidney disease (CKD)

$0.33
-0.02  -5%
CRL CRL announced March 30, 2022.
$60.6 million

AMLX – Amylyx Pharmaceuticals Inc.
AMX0035 - (CENTAUR)
Amyotrophic lateral sclerosis

$8.70
-0.32  -4%
PDUFA priority review Adcom Meeting resulted in a 4-6 against vote regarding if the submitted trials establish a conclusion of efficacy, noted March 30, 2022. PDUFA priority review date June 29, 2022.
$509.2 million

ATRS – Antares Pharma Inc.
TLANDO (testosterone undecanoate)
Testosterone replacement therapy (TRT)

$5.59
+0.01  +0%
Approved Approved March 29, 2022.
$955.1 million

ERYP – Erytech Pharma S.A.
GRASPA (Eryaspase)
Acute lymphoblastic leukemia (ALL)

$1.18
+0.03  +3%
BLA Filing BLA filing due 2Q 2022.
$36.6 million

IBRX – ImmunityBio Inc.
IL-15 Superagonist N-803 - (QUILT 3.032)
BCG-Unresponsive Bladder Cancer Carcinoma

$3.91
+0.17  +5%
Phase 2/3 Phase 2/3 data results confirm prolonged sustained complete response, with 71% of patients in situ (CIS) having a complete remission with a median duration of response of 24.1 months, noted February 14, 2022. Data will be presented by principal investigator at ASCO, June 2-7, 2022. BLA filing expected in 2Q 2022.
$1.6 billion

IMAB – I-MAB
Felzartamab (TJ202/MOR202)
Third-line multiple myeloma

$10.74
-1.46  -12%
BLA Filing BLA submission expected in 2022.
$887.6 million

IMGN – ImmunoGen Inc.
Mirvetuximab - (SORAYA)
Ovarian cancer

$3.58
+0.05  +1%
BLA Filing BLA filing submitted March 29, 2022.
$789.5 million

RETA – Reata Pharmaceuticals Inc.
Omaveloxolone
Friedreich’s ataxia (FA)

$28.78
+1.10  +4%
NDA Filing Rolling NDA filing completed March 31, 2022.
$1 billion

SAGE – Sage Therapeutics Inc.
Zuranolone (SAGE-217) - (WATERFALL)
Major depressive disorder (MDD)

$32.53
+0.70  +2%
NDA Filing NDA filing due in 2H 2022.
$1.9 billion

SCPH – scPharmaceuticals Inc.
FUROSCIX (furosemide)
Heart failure

$5.02
+0.14  +3%
PDUFA PDUFA date October 8, 2022.
$137.4 million

YMAB – Y-mAbs Therapeutics Inc.
Omburtamab
CNS/Leptomeningeal Metastases from Neuroblastoma

$10.02
+0.14  +1%
BLA Filing Refusal to file letter issued October 5, 2020. Type B pre-BLA meeting in January 2022. BLA resubmission completed, noted April 1, 2022.
$438.1 million

ZGNX – Zogenix Inc.
FINTEPLA (fenfluramine)
Lennox-Gastaut syndrome

$0.00
0.00  0%
PDUFA priority review PDUFA priority review date March 25, 2022. Acquired by UCB March 7, 2022.
$