BPC April 14 update

Key Regulatory catalysts for the second quarter; Biotech week in review

Weekly watchlist

This week we will follow our preview of the second quarter with regulatory events to watch such as application submissions, PDUFA dates and Advisory Committee meetings. As earnings season lies around the corner, next week we will highlight notable earnings releases and near term catalysts.

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

CLINICAL

Veru Inc. (NASDAQ: VERU) reported data from its Phase 3 trial of sabizabulin to treat coronavirus, noting that it met its primary endpoint with a 55% relative reduction in deaths. Shares closed the week up 150% at $14.95.

Hoth Therapeutics, Inc. (NASDAQ: HOTH) released preclinical data from its HT-KIT platform. Data reported a reduction of tumor growth and infiltration to other organs in a humanized mast cell leukemia mouse model. Shares closed the week down 53% at $0.69.

Turning Point Therapeutics, Inc. (NASDAQ: TPTX) shares closed the week up 32% at $32.90 after it reported data from the non-small cell lung cancer (NSCLC) cohorts of its Phase 1/2 TRIDENT-1 trial of repotrectinib. Data reported that 4 patients had a complete response, and 52 had a partial response.

Qualigen Therapeutics, Inc. (NASDAQ: QLGN) reported preclinical data of its QN-302 therapeutic program to treat cancer, noting antitumor activity against prostate cancer and pancreatic cancer. Shares closed the week up 26% at $0.73.

LIXTE Biotechnology Holdings, Inc. (NASDAQ: LIXT) also reported clinical data from its LB-100 program to treat cancer, noting evidence of DNA damage and mitotic stress. Later in the week LIXTE announced an offering of stock for the gross proceeds of $5.8 million. Shares closed the week up 27% at $1.57.

OTHER

Sierra Oncology, Inc (NASDAQ: SRRA) shares closed the week up 46% at $54.75 after GlaxoSmithKline plc (NYSE: GSK) announced that it would acquire the company for $1.9 billion, or $55 per share.

Antares Pharma, Inc. (NASDAQ: ATRS) also announced that it would be acquired by Halozyme Therapeutics, Inc. (NASDAQ: HALO) for a total transaction of $960 million or $5.60 per share. Shares closed the week up 41% at $5.56.

Drug Price Stage Catalyst Market Cap

ACER – Acer Therapeutics Inc.
ACER-001
Urea cycle disorder (UCD)

$2.19
+0.06  +3%
PDUFA PDUFA date June 5, 2022.
$33.5 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

AXSM – Axsome Therapeutics Inc.
MoSEIC meloxicam-rizatriptan (AXS-07)
Migraine

$31.65
+0.14  +0%
CRL CRL announced May 2, 2022.
$1.2 billion

BMY – Bristol-Myers Squibb Company
Camzyos (mavacamten)
Hypertrophic cardiomyopathy (HCM)

$76.19
+0.23  +0%
Approved Approved April 28, 2022.
$162.2 billion

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

INCY – Incyte Corporation
OLUMIANT (baricitinib)
COVID-19

$74.88
+0.54  +1%
Approved FDA approval on May 11, 2022.
$16.6 billion

PFE – Pfizer Inc.
MYFEMBREE (Relugolix)
Endometriosis-associated pain

$52.47
+1.82  +4%
PDUFA Deficiencies were noted by the FDA in the review of the application, final decision has yet to be made, noted April 12, 2022. PDUFA date extended to August 6, 2022.
$294.4 billion

PHAT – Phathom Pharmaceuticals Inc.
VOQUEZNA
H. pylori

$8.67
+0.16  +2%
Approved Approval announced May 3, 2022.
$338.8 million

RYTM – Rhythm Pharmaceuticals Inc.
IMCIVREE (setmelanotide)
Alstrom Syndrome and Bardet-Biedl Syndrome

$3.27
+0.15  +5%
PDUFA PDUFA date extended 3 months to June 16, 2022.
$164.8 million

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

TGTX – TG Therapeutics Inc.
UKONIQ (umbralisib) and ublituximab
Chronic Lymphocytic Leukemia (CLL) and small lymphocytic lymphoma (SLL)

$5.39
-0.65  -11%
BLA Filing Company voluntarily withdrew its pending Biologics License Application (BLA)/supplemental New Drug Application (sNDA), noted April 15, 2022. The planned Oncologic Drugs Advisory Committee (ODAC) Meeting has been canceled.
$778.5 million

VRCA – Verrica Pharmaceuticals Inc.
VP-102
Molluscum contagiosum

$5.94
+0.02  +0%
PDUFA CRL announced July 14, 2020. NDA resubmitted. CRL announced September 20, 2021. NDA resubmitted November 29, 2021. New PDUFA date of May 24, 2022.
$163.5 million