BPC October 09 update

Mallinckrodt MNK shares fall as reported bankruptcy approaches -31%; Alkermes ALKS positive Advisory Committee vote

Price and Volume Movers

Precigen, Inc. (NASDAQ:PGEN) shares closed up 29% to $5.69 with investors reacting ot news that Ares Trading S.A. a subsidiary of shareholder Merck KGaA, Darmstadt, Germany, will convert convertible note with an outstanding principal balance of $25m to increase its stake in Precigen from approximately 11.6% to 14.8%.

Alkermes plc (NASDAQ:ALKS) appeared before a joint meeting of the FDA Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committees, to review its New Drug Application (NDA) of ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and the treatment of adults with bipolar I disorder. The committee voted 16-1 in favor that adequate evidence was presented that samidorphan meaningfully mitigates olanzapine-associated weight gain; 13-3 in favor that the safety profile of ALKS 3831 has been adequately characterized; and 11-6 in favor that labeling is sufficient to mitigate risks of opioid antagonist action. The PDUFA date for a final decision by the FDA is November, 15, 2020. Shares were halted during the meeting.

Mallinckrodt Plc (NASDAQ:MNK) shares closed down 31% to $0.75 on news reported by Bloomberg that the company is nearing a deal to hand majority ownership to its unsecured bondholders as part of a bankruptcy filing.

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Major price movers (stocks priced > $1.00, volume > 50k listed on NASDAQ/NYSE):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume:

ADVANCERS:

Vaccinex, Inc. (VCNX): $2.22; +31%.

AcelRx Pharmaceuticals, Inc. (ACRX): $1.88; +18%.

Intellia Therapeutics, Inc. (NTLA): $26.31; +15%.

Aclaris Therapeutics, Inc. (ACRS): $4.75; +14%.

RAPT Therapeutics, Inc. (RAPT): $38.57; +14%.

DECLINERS:

Nkarta, Inc. (NKTX): $29.20; -13%.

SCYNEXIS, Inc. (SCYX): $5.54; -10%.

Syndax Pharmaceuticals, Inc. (SNDX): $15.83; -7%.

Annovis Bio, Inc. (ANVS): $5.38; -7%.

Altimmune, Inc. (ALT): $12.37; -7%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AXGT – Axovant Gene Therapies Ltd.
AXO-AAV-GM1
GM1 gangliosidosis

Phase 1 Phase 1 six-month data from low dose cohort due 4Q 2020.
$170.1 million

CDAK – Codiak BioSciences Inc.
exoSTING
Solid tumors

Phase 1/2 Phase 1/2 clinical trial began in September 2020. Safety, biomarker and preliminary efficacy data by mid-2021.
$167.7 million

CDAK – Codiak BioSciences Inc.
exoIL-12
Cutaneous T cell lymphoma

Phase 1 Phase 1 clinical trial began in September 2020. Single ascending dose data due year end 2020. Biomarker and preliminary efficacy results in CTCL patients of due mid-2021.
$167.7 million

KRON – Kronos Bio Inc.
Entospletinib
Acute myeloid leukemia (AML)

Phase 2/3 Phase 2/3 trial to be initiated 2021.
$1.7 billion

KRON – Kronos Bio Inc.
KB-0742
Solid tumors

Phase 1/2 Phase 1/2 trial to be initiated in 2021.
$1.7 billion

NAVB – Navidea Biopharmaceuticals Inc.
NAV3-31 (TC99m-tilmanocept)
Rheumatoid arthritis

Phase 2b Phase 2b second interim analysis to be presented at ACR meeting November 9, 2020 from 9:00 am ET.
$65.5 million

PFE – Pfizer Inc.
IBRANCE (palbociclib) - PENELOPE-B
Early stage breast cancer

Phase 3 Phase 3 trial did not meet primary endpoint - October 9, 2020.
$197 billion

PRAX – Praxis Precision Medicines Inc.
PRAX-114
Major depressive disorder

Phase 2a Phase 2a top-line data (Part B) due 2H 2021. Part C data due 4Q 2021.
$1.2 billion

PRAX – Praxis Precision Medicines Inc.
PRAX-944
Essential Tremor

Phase 2a Phase 2a top-line data due 1H 2021.
$1.2 billion

PRAX – Praxis Precision Medicines Inc.
PRAX-562
Healthy volunteers

Phase 1 Phase 1 safety data due 4Q 2020.
$1.2 billion

RIGL – Rigel Pharmaceuticals Inc.
Fostamatinib
COVID-19

Phase 2 Phase 2 initiation of dosing announced October 9, 2020.
$413.9 million

RTRX – Retrophin Inc.
Sparsentan
Focal segmental glomerulosclerosis (FSGS)

Phase 2 Phase 3 top-line data due 1Q 2021.
$1.1 billion

SPRB – Spruce Biosciences Inc.
Tildacerfont - CAHmelia-203
Congenital Adrenal Hyperplasia (poor disease control)

Phase 2b Phase 2b trial ongoing. Data due 4Q 2021 or 1Q 2022.
$501.9 million

SPRB – Spruce Biosciences Inc.
Tildacerfont - CAHmelia-204
Congenital Adrenal Hyperplasia (good disease control)

Phase 2b Phase 2b data due 1H 2022.
$501.9 million

SYRS – Syros Pharmaceuticals Inc.
SY-5609
Solid tumors

Phase 1 Phase 1 dose escalation data due mid-2021.
$304.5 million