BPC May 15 update

​Deciphera DCPH and Clovis CLVS receive FDA approval decisions; Cassava SAVA Alzheimer's trial fails

Price and Volume Movers

Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) announced the FDA approved QINLOCK (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. The approval decision was granted well before the original PDUFA date of August 15. Shares closed up 7% to $51.69 before being halted. Following the resumption of trading, shares are trading up a further 2% after hours.

Blueprint Medicines Corporation (NASDAQ: BPMC), on the contrary, announced that the FDA issued a complete response letter (CRL) for the new drug application of avapritinib for the treatment of adults with unresectable or metastatic fourth-line gastrointestinal stromal tumor (GIST).

Clovis Oncology, Inc. (NASDAQ: CLVS) announced the FDA approved Rubraca (rucaparib) tablets for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Shares closed up 2% to $9.69.

Cassava Sciences, Inc. (NASDAQ:SAVA) shares slumped 74% to $2.12 on news its Phase 2b trial of PTI-125, in patients with Alzheimer's disease, study did not meet its primary endpoint.

Sarepta Therapeutics, Inc. (NASDAQ:SRPT) shares closed up 11% to $141.25 following the release of data from a potential competitor, Pfizer Inc. (NYSE:PFE) in patients with Duchenne muscular dystrophy (DMD), with investors and analysts suggesting that Sarepta’s SRP-9001 remains ahead of Pfizer. Baird’s Brain Skorney noted,"we continue to believe Sarepta holds every advantage: time to approval, safety and expression levels."

Sorrento Therapeutics, Inc. (Nasdaq: SRNE) shares soared to close up 158% to $6.76 following an appearance on Fox News and a press release which noted its anti-SARS-CoV-2 antibody, STI-1499, demonstrated 100% inhibition of SARS-CoV-2 virus infection in an in vitro testing. It should be noted, however, that the tests were only from petri dish testing. No clinical trials, nor even pre-clinical animal tests have yet to be conducted.

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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:

Tetraphase Pharmaceuticals, Inc. (TTPH): $2.19; +34%.

Cardiff Oncology, Inc. (CRDF): $1.90; +33%.

Diffusion Pharmaceuticals Inc. (DFFN): $1.35; +32%.

Baudax Bio, Inc. (BXRX): $4.34; +25%.

iBio, Inc. (IBIO): $1.48; +24%.

DECLINERS:

Plus Therapeutics, Inc. (PSTV): $1.79; -16%.

NantKwest, Inc. (NK): $4.36; -15%.

Genfit SA (GNFT): $5.78; -13%.

AIM ImmunoTech Inc. (AIM): $2.56; -13%.

Chimerix, Inc. (CMRX): $3.18; -12%.


Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

BMY – Bristol-Myers Squibb Company
CM-227 – Opdivo + Yervoy
First-line Non-small cell lung cancer (NSCLC)

Approved FDA Approval announced May 15, 2020.
$135.1 billion

BMY – Bristol-Myers Squibb Company
POMALYST (pomalidomide)
Kaposi’s sarcoma

Approved FDA Approval announced May 15, 2020.
$135.1 billion

BPMC – Blueprint Medicines Corporation
Avapritinib
Fourth-line GIST

CRL CRL issued May 15, 2020.
$3.5 billion

CLVS – Clovis Oncology Inc.
Rubraca (rucaparib)
Castrate-resistant prostate cancer (mCRPC)

Approved FDA Approval announced May 15, 2020.
$608.9 million

DCPH – Deciphera Pharmaceuticals Inc.
Ripretinib
Gastrointestinal Stromal Tumors (GIST) - fourth-line

Approved FDA Approval announced May 15, 2020.
$3.3 billion

IMV – IMV Inc.
DPX-Survivac and KEYTRUDA (pembrolizumab) - basket trial
Solid tumors

Phase 2 Phase 2 top-line data due 2H 2020.
$178.3 million

NVUS – Novus Therapeutics Inc.
OP0201 - C-006
Acute Otitis Media - children

Phase 2a Phase 2a data due June 2020.
$20.4 million

OTLK – Outlook Therapeutics Inc.
NORSE 1 (ONS-5010-001)
Wet age-related macular degeneration (wet AMD)

Phase 3 Phase 3 data due August 2020.
$93.2 million

PFE – Pfizer Inc.
PF-06939926
Duchenne muscular dystrophy (DMD)

Phase 3 Phase 3 trial to be initiated 2H 2020.
$212.1 billion

PLXP – PLx Pharma Inc.
VAZALORE
Aspirin - cardiovascular and stroke patients patients

sNDA Filing sNDA filing due by end of 2020 following bioequivalence study.
$33.7 million

SAVA – Cassava Sciences Inc.
PTI-125
Alzheimer’s disease

Phase 2b Phase 2b trial did not meet primary endpoint - May 15, 2020.
$53 million

SNCA – Seneca Biopharma Inc.
NSI-566
Amyotrophic lateral sclerosis (Lou Gehrig's)

Phase 2 Phase 2 data due 2H 2020.
$11.3 million

SNGX – Soligenix Inc.
SGX942 (dusquetide)
Oral Mucositis in Patients with Head & Neck Cancer

Phase 3 Phase 3 top-line data due 4Q 2020.
$50.8 million

STOK – Stoke Therapeutics Inc.
STK-001
Dravet syndrome

Phase 1/2 Phase 1/2 trial to be initiated 2H 2020 with data due 2021.
$912 million