BPC November 13 update

Biotech week in Review; Biotech catalysts to watch to round out November

Weekly watchlist

The last week saw a number of price-moving catalysts hit the wires, led by upbeat initial COVID-19 vaccine data and complemented by a series of other positive clinical readouts, a distinct welcome from the recent run of largely negative clinical trial news. We highlight the main movers of the week and continue our look ahead to catalysts slated over the next two weeks.

COVID-19 VACCINE:

Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) announced their Phase 3 trial of the COVID-19 vaccine candidate, BNT162b2, demonstrated evidence of efficacy against COVID-19. After receiving two doses, the vaccine was found to be more than 90% effective in preventing COVID-19. Submission for Emergency Use Authorization (EUA) to the FDA is planned soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November. The companies expect that they will be able to produce up to 50m vaccine doses in 2020 for 25m people and up to 1.3b doses (650m people) in 2021. Shares of BioNTech closed the week 15% higher at $106.00 while Pfizer closed marginally higher by 1% to $38.62.

Moderna, Inc., (Nasdaq: MRNA) announced that it has completed case accrual for the first interim analysis of the Phase 3 COVE trial of mRNA-1273, its COVID-19 vaccine candidate and that the last data on these cases is being prepared for submission to the independent Data Safety Monitoring Board (DSMB) for analysis and recommendation, which likely puts the release of the analysis sometime over the next week. Shares of Moderna closed the week up 23% to $89.39.

REGULATORY:

Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN) announced that the FDA issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for SPN-812 for the treatment of ADHD in pediatric patients. It also announced the receipt of a Refusal to File (RTF) letter from the FDA regarding its NDA for SPN-830 for the treatment of motor fluctuations in Parkinson's disease (PD). After closing Tuesday down 16% following the news, shares pared back losses to close the week largely flat at $23.01.

CLINICAL DATA:

Five Prime Therapeutics, Inc. (NASDAQ: FPRX) shares surged to close the week up 328% to $21.41 following the release of top-line results from its Phase 2 FIGHT trial comparing mFOLFOX6 chemotherapy in combination with bemarituzumab (FPA144), in patients with front-line advanced gastric or gastroesophageal junction (GEJ) cancer. The trial met all three primary endpoints (improvements in overall survival, progression-free survival and overall response rate (ORR)).

Calliditas Therapeutics AB (NASDAQ:CALT) shares closed Monday up 35% to $33.95 on news top-line data from Part A of its Phase 3 clinical trial of Nefecon versus placebo in patients with primary IgA nephropathy (IgAN) met its primary endpoint, demonstrating a statistically significant reduction in urine protein creatinine ratio compared to placebo.

BUYOUTS:

Urovant Sciences (NASDAQ:UROV) shares closed Friday up 93% to $16.02 on news that Sumitovant Biopharma will acquire the outstanding shares of Urovant not already owned by Sumitovant at a price of $16.25 per share in cash. Sumitovant currently owns 72% of Urovant common stock.

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

KZIA – Kazia Therapeutics Limited
GDC-0084
Glioblastoma multiforme

Phase 2 Phase 2 data to be presented at SNO meeting November 2020. Median PFS 8.4 months vs 5.3 months for temozolomide; OS 17.5 months vs 12.7 months for temozolomide.
$94.5 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