BPC May 08 update

FDA issues drug approvals for applications from ​AstraZeneca AZN Merck MRK and Eli Lilly

Price and Volume Movers

AstraZeneca (NYSE: AZN) and Merck (NYSE:MRK) announced the FDA has approved LYNPARZA in combination with bevacizumab as a first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. The approval was based on data from the Phase 3 PAOLA-1 trial.

The FDA also announced the approval of Retevmo (selpercatinib) by Eli Lilly And Co (NYSE: LLY) to treat three types of tumors – non-small cell lung cancer, medullary thyroid cancer and other types of thyroid cancers – in patients whose tumors have an alteration (mutation or fusion) in a specific gene (RET or “rearranged during transfection”). Retevmo is the first therapy approved specifically for cancer patients with the RET gene alterations.

Protagonist Therapeutics (NASDAQ: PTGX) shares closed up 84% to $14.20 following an update that its pipeline candidate PTG-300 will be trialled in a pivotal trial for polycythemia vera, a type of blood cancer. The news followed an update where six polycythemia vera patients in its Phase 2 trial of PTG-300 showed control of hematocrit levels, the ratio of the volume of red cells to the volume of whole blood.

Cassava Sciences, Inc. (NASDAQ: SAVA) shares closed up 15% to $9.01 following an analyst note by H.C. Wainwright, which raised its price target from $6 to $16 and reiterated a Buy rating on the shares. Data from its Phase 2b trial of PTI-125 in patients with Alzheimer's are likely due later this quarter.

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Major price movers (stocks priced > $1.00, volume > 50k):

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

ADVANCERS:

Bellicum Pharmaceuticals, Inc. (BLCM): $7.36; +32%.

89bio, Inc. (ETNB): $31.20; +25%.

Aptevo Therapeutics Inc. (APVO): $6.29; +25%.

Adaptimmune Therapeutics plc (ADAP): $4.44; +24%.

BioCryst Pharmaceuticals, Inc. (BCRX): $4.70; +20%.

DECLINERS:

Tetraphase Pharmaceuticals, Inc. (TTPH): $2.02; -17%.

Adamas Pharmaceuticals, Inc. (ADMS): $3.00; -13%.

Flexion Therapeutics, Inc. (FLXN): $9.50; -13%.

Anika Therapeutics, Inc. (ANIK): $30.54; -12%.

Phathom Pharmaceuticals, Inc. (PHAT): $38.79; -11%.


Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

AXSM – Axsome Therapeutics Inc.
AXS-07 - MOMENTUM
Migraine

NDA Filing NDA filing due 4Q 2020.
$2.9 billion

AXSM – Axsome Therapeutics Inc.
AXS-12
Narcolepsy

Phase 3 Phase 3 trial to be initiated 2020.
$2.9 billion

AZN – Astrazeneca PLC
Lynparza + Avastin- PAOLA-1
First-line ovarian cancer

Approved FDA Approval announced May 8, 2020.
$143.3 billion

CRNX – Crinetics Pharmaceuticals Inc.
Paltusotine CRN00808 (ACROBAT EDGE)
Acromegaly

Phase 2 Phase 2 top-line data due 4Q 2020.
$536.7 million

EIDX – Eidos Therapeutics Inc.
AG10 / BBP-265 - ATTRibute-CM
ATTR-CM

Phase 3 Phase 3 enrolment to be completed 1H 2021.
$1.9 billion

EIDX – Eidos Therapeutics Inc.
AG10 / BBP-265
ATTR-PN

Phase 2 Phase 3 trial planned for 2H 2020.
$1.9 billion

IMUX – Immunic Inc.
IMU-838
Relapsing-remitting multiple sclerosis

Phase 2 Phase 2 data due 3Q 2020.
$153.4 million

IMUX – Immunic Inc.
IMU-838
Primary Sclerosing Cholangitis

Phase 2 Phase 2 data due early 2021.
$153.4 million

LLY – Eli Lilly and Company
Selpercatinib
Non-small cell lung cancer, medullary thyroid cancer and thyroid cancer.

Approved FDA Approval announced May 8, 2020.
$146.3 billion

MLND – Millendo Therapeutics Inc.
Nevanimibe
Congenital adrenal hyperplasia (CAH)

Phase 2b Phase 2b interim review due 3Q 2020.
$50.5 million

MRSN – Mersana Therapeutics Inc.
XMT-1592
Non-small cell lung cancer (NSCLC) adenocarcinoma and ovarian cancer

Phase 1 Phase 1 trial initiation announced May 14, 2020.
$1.3 billion

OCGN – Ocugen, Inc.
OCU 300
Graft Versus Host Disease

Phase 3 Phase 3 top-line data due 2H 2020.
$23.1 million

ONCY – Oncolytics Biotech Inc.
Pelareorep and Tecentriq - AWARE-1
Breast cancer

Phase 1b Phase 1b final data due 2H 2020.
$95.9 million

PSTI – Pluristem Therapeutics Inc.
PLX-PAD
COVID-19 / Acute Respiratory Distress Syndrome (ARDS)

Phase 2 Phase 2 trial planned.
$200 million