BPC October 28 update

​Mirati MRTX shares rise 15% AH on early data; Agile AGRX negative briefing documents ahead of Adcom -59%

Price and Volume Movers

Mirati Therapeutics, Inc. (NASDAQ: MRTX) announced the first clinical data from its Phase 1/2 trial evaluating its KRAS inhibitor, MRTX849, in patients with solid tumors expressing KRAS G12C mutations. At the highest dose, three of five patients with non-small cell lung cancer (NSCLC) and one of two patients with colorectal cancer (CRC) achieved a partial response (PR). Across all dose levels, three of six patients with NSCLC and one of four patients with CRC achieved a PR. Shares are trading up 15% to $93.40 after hours.

MorphoSys AG (NASDAQ: MOR) and Galapagos NV (NASDAQ: GLPG) announced after hours that they will not continue with the development program of MOR106 in atopic dermatitis. The decision was based on an interim analysis for futility that was performed in the Phase 2 IGUANA trial, which determined a low probability to meet the primary endpoint of the trial.

Agile Therapeutics, Inc. (Nasdaq: AGRX) shares slumped to close down 59% to $0.45 following a press release regarding its Advisory Committee Meeting to be held on October 30, 2019 to review the New Drug Application (NDA) for Twirla. Briefing documents released by the FDA ahead of the meeting noted, “a number of concerns regarding Twirla’s approvability, including, but not limited to, concerns related to Twirla’s efficacy when balanced against its safety. The FDA also did not appear to agree with the Company’s proposal to include a limitation of use based on patient weight and BMI in the product label.”

AstraZeneca (NYSE: AZN) announced that its Phase 3 Poseidon trial of Imfinzi (durvalumab) and tremelimumab, added to chemotherapy, in previously-untreated non-small cell lung cancer (NSCLC) patients, met the progression free survival (PFS) endpoint. The triple combination exhibited a statistically significant and clinically meaningful improvement in PFS compared with chemotherapy alone. The trial will continue to assess the additional primary endpoint of overall survival (OS) with data anticipated in 2020.

IVERIC bio, Inc. (Nasdaq: ISEE) shares surged to close up 83% to $1.70 following news its Phase 2b trial of Zimura met the primary endpoint in reducing the rate of geographic atrophy (GA) growth in patients with dry age-related macular degeneration (AMD).

TG Therapeutics, Inc. (NASDAQ: TGTX) shares closed up 18% to $6.80 following news that the follicular lymphoma cohort of the UNITY-NHL Phase 2b pivotal trial evaluating umbralisib, met the primary endpoint of overall response rate (ORR), meeting its prespecified ORR target of 40-50%.

Blueprint Medicines Corp (NASDAQ: BPMC) shares closed down 14% to $67.05 following its announcement the FDA will require data from its Phase 3 Voyager trial of avapritinib in patients with third and fourth-line Gastrointestinal Stromal Tumors (GIST), before delivering a decision on the current New Drug Application for patients with fourth-line GIST. The current PDUFA date of February 14, 2020 will need to be extended given that data from the Voyager trial will not be available until 2Q 2020. Deciphera Pharmaceuticals Inc (NASDAQ: DCPH) shares rallied to close up 8% to $39.07 on news of the delay, with its pipeline candidate, Ripretinib, also in development for GIST.

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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:

Clovis Oncology, Inc. (CLVS): $3.95; +32%.

Aquestive Therapeutics, Inc. (AQST): $4.12; +24%.

Corvus Pharmaceuticals, Inc. (CRVS): $3.66; +18%.

CRISPR Therapeutics AG (CRSP): $6.79; +17%.

Strongbridge Biopharma plc (SBBP): $2.22; +11%.

DECLINERS:

TrovaGene, Inc. (TROV): $1.75; -18%.

Tetraphase Pharmaceuticals, Inc. (TTPH): $4.25; -17%.

Merus N.V. (MRUS): $15.51; -16%.

Diffusion Pharmaceuticals Inc. (DFFN): $1.09; -14%.

Melinta Therapeutics, Inc. (MLNT): $2.96; -12%.

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ARNA – Arena Pharmaceuticals Inc.
Etrasimod
Atopic dermatitis (AD)

Phase 2 Phase 2 completion of enrolment announced May 26, 2020. Data due 4Q 2020.
$3.6 billion

ATNM – Actinium Pharmaceuticals Inc. (Delaware)
Iomab-B
Acute myeloid leukemia (AML)

Phase 3 Phase 3 top-line data due 4Q 2020.
$141.5 million

AZN – Astrazeneca PLC
Imfinzi + tremelimumab (POSEIDON)
Non-small cell lung cancer (NSCLC)

Phase 3 Phase 3 PFS data met primary endpoint. OS data due 2021.
$142.2 billion

BCLI – Brainstorm Cell Therapeutics Inc.
NurOwn
Amytrophic lateral sclerosis (ALS)

Phase 3 Phase 3 top-line data due 4Q 2020.
$361.5 million

BPMC – Blueprint Medicines Corporation
Avapritinib BLU-285
PDGFRA exon 18 mutant Gastrointestinal stromal tumors (GIST)

Approved FDA Approval announced January 9, 2020.
$4.4 billion

DCPH – Deciphera Pharmaceuticals Inc.
Rebastinib and paclitaxel
Solid tumors

Phase 1/2 Phase 1b/2 data presented May 29, 2020 at ASCO. 7/18 partial responses.
$3.1 billion

GLPG – Galapagos NV
MOR106 IGUANA
Atopic dermatitis

Phase 2 Phase 2 trial halted due to futility - October 28, 2019.
$13.2 billion

GSK – GlaxoSmithKline PLC
Gepotidacin
Uncomplicated urinary tract infection (uUTI)

Phase 3 Phase 3 trial initiation announced October 28, 2019. Data due by the end of 2021.
$103.1 billion

HRTX – Heron Therapeutics Inc.
HTX-011
Post operative pain

CRL CRL announced June 29, 2020.
$1.4 billion

ISEE – IVERIC bio Inc.
Zimura - GATHER2
Geographic atrophy

Phase 3 Phase 3 trial met primary endpoint. Initiation of second trial announced June 30, 2020.
$444.2 million

MRTX – Mirati Therapeutics Inc.
MRTX849
Solid tumors

Phase 1/2 Phase 1/2 updated data due 2H 2020.
$5.1 billion

OMER – Omeros Corporation
OMS721
Hematopoietic stem cell-associated TMA (HSCT-TMA)

BLA Filing Rolling BLA filing to be completed 3Q 2020.
$848.7 million

TGTX – TG Therapeutics Inc.
Umbralisib
Marginal zone lymphoma (MZL) and follicular lymphoma (FL)

NDA Filing Rolling NDA has been completed - June 17, 2020.
$2.4 billion