BPC November 06 update

Biotech week in Review; Earnings week ahead; Selection of catalysts left in November

Weekly watchlist

While the U.S. election was the main focus for the week, it will also be remembered for one of the most dramatic FDA Advisory Committee meetings held in recent history. We review the meeting and other events from the week that was.

REGULATORY:

Biogen Inc. (NASDAQ:BIIB) appeared before the FDA Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee on Friday, to discuss with the panel its regulatory application of aducanumab for the treatment of Alzheimer’s disease. The stock initially surged Wednesday 44% to $355.63 following the release of upbeat briefing documents prepared by the FDA. However, the committee unanimously disagreed with the findings in the documents with some panelists criticizing the FDA for its biased presentation of the documents. A total of four questions were voted on by the committee, with the key question being:

"In light of the understanding provided by the exploratory analyses of Study 301 and Study 302, along with the results of Study 103 and evidence of a pharmacodynamic effect on Alzheimer’s disease pathophysiology, is it reasonable to consider Study 302 as primary evidence of effectiveness of aducanumab for the treatment of Alzheimer’s disease?"

Ten panelists voted against with one abstention. No panelists voted in favor. The PDUFA date for a final decision by the FDA is March 7, 2021. Trading was halted during the meeting.

CLINICAL DATA:

Assembly Biosciences, Inc. (NASDAQ:ASMB) shares closed Friday down 69% to $4.87 following the release of data from its Phase 2 extension study (Study 211) of vebicorvir (ABI-H0731) in patients with chronic hepatitis B virus (HBV). The trial gauged whether meaningful sustained virologic response (SVR) rates could be achieved after discontinuing treatment with vebicorvir in virologically-suppressed patients. However, the trial did not achieve meaningful SVR rates with 39 of 41 patients relapsing.

Molecular Templates, Inc. (NASDAQ: MTEM) announced in its earnings report that trials of MT-3724, currently in Phase 2 development, have been placed on partial clinical hold following a treatment-related fatality in one subject in the Phase 2 monotherapy trial. Shares closed Friday down 21% to $8.56.

Aptevo Therapeutics Inc. (NASDAQ:APVO) shares closed the week up 267% to $23.70 on news that one patient in its Phase 1 trial of APVO436, for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), has shown complete remission. Shares closed the after hours session up an additional 124% to $53.00, compared with the previous week’s close of $6.46 for an effective weekly gain of 720%. The move follows a SEC filing showing Tang Capital Management, LLC increased its ownership share of the company to 54.4%.

EARNINGS (notable movers):

GW Pharmaceuticals plc (NASDAQ:GWPH): Closed Tuesday UP 21% to $108.21.

Global Blood Therapeutics, Inc. (NASDAQ: GBT): Closed Friday DOWN 37% to $38.21.

Clovis Oncology, Inc. (NASDAQ: CLVS): Closed Thursday DOWN 21% to $4.47.

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Biotech Earnings (selection of 15 companies scheduled to report. Full calendar available to premium members):

M: ARNA AVDL BHVN CCXI CPRX ICPT NBIX OMER PGEN REPH RMTI TXMD

T: BNTX

W: KMDA

Th: OPNT

Drug Stage Catalyst Market Cap

ADMP – Adamis Pharmaceuticals Corporation
ZIMHI (naloxone HCI Injection)
Opioid overdose

CRL CRL announced November 16, 2020.
$40.6 million

ALKS – Alkermes plc
ALKS 3831 (olanzapine/samidorphan)
Schizophrenia, bipolar

CRL CRL announced November 17, 2020
$2.9 billion

BCLI – Brainstorm Cell Therapeutics Inc.
NurOwn
Amytrophic lateral sclerosis (ALS)

Phase 3 Phase 3 trial did not meet primary endpoint - November 17, 2020.
$174.4 million

BMY – Bristol-Myers Squibb Company
liso-cel (JCAR017)
Relapsed or refractory (R/R) large B-cell lymphoma

PDUFA priority review PDUFA date under priority review scheduled for November 16, 2020 has been delayed as the FDA was unable to conduct an inspection of a manufacturing facility due to COVID-19. New date not supplied.
$141 billion

CHMA – Chiasma Inc.
Mycapssa - MPOWERED
Maintenance treatment of adult acromegaly

Phase 3 Phase 3 trial met primary non-inferiority endpoint - November 18, 2020.
$247.4 million

LPCN – Lipocine Inc.
TLANDO - LPCN 1021
Men with low testosterone (Low T)

PDUFA PDUFA date originally set for August 28, 2020 delayed. New date on or about the week of November 30, 2020.
$105.1 million

MRNA – Moderna Inc.
mRNA-1273
COVID-19 vaccine

Phase 3 Phase 3 data released November 30, 2020 with94.1% efficacy rate. EUA filed. FDA Advisory Committee meeting scheduled for December 17, 2020.
$60.4 billion

PFE – Pfizer Inc.
BNT162b2
COVID-19 vaccine

Phase 3 Phase 3 final efficacy analysis noted vaccine was 95% effective in preventing COVID-19. EUA filing announced November 20, 2020. Advisory Committee meeting December 10, 2020.
$212.9 billion

RYTM – Rhythm Pharmaceuticals Inc.
Setmelanotide
POMC deficiency obesity / Leptin Receptor Deficiency Obesity

Approved FDA approval announced November 27, 2020.
$1.4 billion