BPC March 05 update

Clinical and regulatory catalysts to watch for the remaining weeks of 1Q 2021 - updated

Weekly watchlist

The latest week saw a number of price-moving regulatory decisions, clinical trial readouts and corporate events. We review the major movers for the week while also refreshing our list of key events to watch to round out the first quarter of 2021.

CORPORATE RELATED:

Five Prime Therapeutics (NASDAQ:FPRX) announced that it will be acquired by Amgen (NASDAQ:AMGN) for $38.00 per share in cash, representing an equity value of approximately $1.9 billion. Shares of Five Prime closed Thursday up 79% to $38.00.

REGULATORY DECISIONS:

KemPharm, Inc. (NASDAQ:KMPH) announced that the FDA approved the New Drug Application for (NDA) Azstarys (KP415), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older. Shares closed the week up 37% to $10.05.

Athenex, Inc., (NASDAQ: ATNX) shares slid to close Monday down 55% to $5.46 on news the FDA issued a complete response letter (CRL) for its New Drug Application (NDA) for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer. The FDA recommended that Athenex conduct a new trial.

CorMedix Inc. (NASDAQ:CRMD) also announced Monday that the FDA issued a CRL for its New Drug Application (NDA) for DefenCath, noting concerns at the third-party manufacturing facility. The FDA is also requested a further trial to demonstrate that the labeled volume can be consistently withdrawn from the vials. Shares fell 40% to $9.02.

FibroGen, Inc. (Nasdaq: FGEN) shares closed Tuesday down 25% to $38.07 on news that the FDA Cardiovascular and Renal Drugs Advisory Committee will hold a meeting to review the new drug application for Roxadustat. A date for the meeting has yet to be set. While not officially announced, it is expected that the PDUFA date slated for later this month will be extended.

CLINICAL DATA:

Morphic Therapeutic (Nasdaq: MORF) shares closed the week up 93% to $70.05. The company announced initial data from its Phase 1 trial of MORF-057 in healthy volunteers. The data showed greater than 95% mean receptor occupancy of α4β7 at the three highest dose levels. MORF-057 is in clinical development for inflammatory bowel disease.

Neurocrine Biosciences (NASDAQ:NBIX) announced that its Phase 2 trial of luvadaxistat (NBI-1065844/TAK-831) did not meet its primary endpoint in adults with negative symptoms of schizophrenia. Shares closed the week down 15% to $93.23.

Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) announced that an independent Data and Safety Monitoring Board (DSMB) has recommended that the VIR-7831 arm of their Phase 3 ACTIV-3 trial antibody trial in hospitalized patients with COVID-19 to be closed to enrolment. The DSMB noted that the data raised concerns about the magnitude of potential benefit. Shares of Vir fell 28% for the week to close down at $45.18. Data from a separate Phase 3 trial (COMET-ICE) in newly-diagnosed COVID-19 patients at high risk of hospitalization are due this month.


Clinical and regulatory catalysts to watch for the remaining weeks of 1Q 2021:

Drug Stage Catalyst Market Cap

ALT – Altimmune Inc.
NASOSHIELD
Anthrax

Phase 1b Phase 1b data released April 1, 2021.
$479.2 million

ANAB – AnaptysBio Inc.
ANB019 - POPLAR
Palmo-plantar pustular psoriasis

Phase 2 Phase 2 trial did not meet primary endpoint - March 8, 2021.
$571.1 million

ANVS – Annovis Bio Inc.
ANVS401
Alzheimer’s disease (AD) and Parkinson’s disease (PD)

Phase 2 Phase 2 initial data released March 16, 2021. PD interim data (reversal of the toxic cascade) due April; AD data in May. Full data June / July 2021.
$184.4 million

AZN – AstraZeneca PLC
AZD1222
COVID-19 vaccine

Phase 3 Phase 3 data exhibited 70% efficacy (90% and 60% across two dosing regimens) - UK and Brazil trial. Data from U.S. trial noted 76% efficacy rate - March 24, 2021.
$131.1 billion

AZRX – AzurRx BioPharma Inc.
MS1819 - OPTION 2
Cystic fibrosis

Phase 2b Phase 2b top line data did not meet primary endpoint - March 31, 2021.
$69.2 million

BCLI – Brainstorm Cell Therapeutics Inc.
NurOwn
Progressive Multiple Sclerosis

Phase 2 Phase 2 top-line data released March 24, 2021 - safety primary endpoint met.
$130.4 million

DCTH – Delcath Systems Inc.
Melphalan/HDS - FOCUS
Liver-dominant ocular melanoma

Phase 3 Phase 3 top-line data released March 31, 2021. Overall Response Rate (ORR) of 29.2%.
$86.2 million

GSK – GlaxoSmithKline PLC
VIR-7831 / GSK4182136 (COMET-ICE)
COVID-19 antibody

Phase 3 Phase 3 data released March 10, 2021. 85% reduction in hospitalization or death. Trial to be stopped. FDA Emergency Use Authorization filing announced March 26, 2021.
$92.2 billion

HGEN – Humanigen Inc.
Lenzilumab
COVID-19

Phase 3 Phase 3 trial met primary endpoint - March 29, 2021.
$1 billion

IDRA – Idera Pharmaceuticals Inc.
Tilsotolimod (IMO-2125) + ipilimumab - ILLUMINATE 301
Melanoma

Phase 3 Phase 3 trial did not meet primary endpoint - March 18, 2021.
$56.6 million

IMTX – Immatics N.V.
IMA201 (ACTengine)
Solid tumors

Phase 1 Phase 1 initial data released March 17, 2021. Tumor shrinkage observed in 8 out of 10 patients including one partial response across three trials. Further data due 2H 2021.
$734.8 million

SAGE – Sage Therapeutics Inc.
SAGE-324 KINETIC (324-ETD-201)
Essential tremor

Phase 2 Phase 2 data due early-2021.
$4.5 billion

WVE – Wave Life Sciences Ltd.
WVE-120101 (PRECISION-HD1)
Huntington’s disease

Phase 1/2 Development to be stopped - March 29, 2021.
$305.3 million