BPC October 29 update

Biotech earnings calendar; Biotech week in Review; Events locked in for November

Weekly watchlist

With just two months left in 2020, this week we narrow down our focus to catalysts specifically slated for November. Next week, all eyes will be on the major Advisory Committee meeting of the year where the FDA will discuss Biogen’s regulatory application for Alzheimer’s disease. Expect briefing notes to be released by the FDA on Wednesday November 4, two days prior to Friday's meeting. Phase 3 interim data from at least one COVID-19 vaccine trial will also be eagerly awaited.

First, let’s review the week that was with notable news in the healthcare sector.

COVID-19:

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) started the week with positive data from its ongoing trial in the COVID-19 outpatient setting, with its antibody cocktail REGN-COV2 meeting the primary and key secondary endpoints, significantly reducing COVID-19 patient medical visits. However, on Friday it announced that an independent data monitoring committee (IDMC) recommended that enrolment for a separate trial in hospitalised patients, be halted in those requiring high-flow oxygen or mechanical ventilation, due to an unfavorable risk/benefit profile. Enrolment will continue in patients requiring either no or low-flow oxygen as the risk/benefit remains acceptable. Shares closed down 2% to $543.56.

CLINICAL DATA:

Scholar Rock Holding Corporation (NASDAQ:SRRK) shares surged to close the week up 175% to $38.90 following the release of promising interim data from its Phase 2 trial evaluating SRK-015 in patients with Type 2 and 3 spinal muscular atrophy (SMA). The data showed 67% of total patients achieved at least a 1 point improvement in Hammersmith scale scores, designed to measure physical abilities in patients with SMA. Top-line data are due in 2Q 2021.

Mirati Therapeutics, Inc. (NASDAQ:MRTX) shares closed the week up 20% to $217.14 following the release of initial data from its trial of MRTX849 (adagrasib) in non-small cell lung cancer (NSCLC), which delivered an objective response rate of 45% (23/51). Of the 23 responders, 70% (16/23) had a best tumor response greater than 40%. The company plans to file a regulatory application with the FDA during 2H 2021. The company also closed a public offering raising $926m in gross proceeds.

BioLineRx Ltd. (NASDAQ: BLRX) shares closed Friday up 36% to $2.20 on news that its Phase 3 Genesis trial of motixafortide for stem cell mobilization (SCM) in multiple myeloma patients, will stop enrolment following an interim analysis from the trial’s independent Data Monitoring Committee (DMC). Based on the statistically significant evidence favoring treatment with motixafortide, the DMC issued a recommendation that patient enrollment may be ceased immediately, without the need to recruit all 177 patients originally planned for the study. Top-line data are due 1H 2021.

Axovant Gene Therapies Ltd. (Nasdaq: AXGT) announced in an update that due to manufacturing delays, it is unlikely that its planned randomized, sham-controlled trial of its AXO-Lenti-PD gene therapy for Parkinson's disease, will commence enrolment by the end of 2021. Shares closed Friday down 43% to $2.10.

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Biotech Earnings (selection of 15 top revenue earning companies. Full calendar available to premium members):

M: HZNP JAZZ

T: BHC

W: IONS

Th: AMRX AZN BMRN BNY EBS ENDP EXEL GLPG INCY REGN TEVA

Drug Stage Catalyst Market Cap

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

CRL CRL announced November 16, 2020.
$40.6 million

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

BIIB – Biogen Inc.
Aducanumab
Alzheimer’s disease

PDUFA priority review PDUFA date under priority review March 7, 2021. Advisory Committee meeting November 6, 2020 voted that treatment was not effective.
$37 billion

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

EIGR – Eiger BioPharmaceuticals Inc.
Lonafarnib
Hutchinson-Gilford Progeria Syndrome (HGPS)

Approved FDA approval announced November 20, 2020.
$297.3 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

RVNC – Revance Therapeutics Inc.
DAXI (RT002)
Moderate to severe glabellar (frown) lines

PDUFA PDUFA date November 25, 2020. Decision has been deferred by the the FDA as it was unable to conduct a required inspection of a manufacturing facility due to travel restrictions associated with the COVID-19 pandemic.
$1.6 billion

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

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