BPC October 24 update

3Q earnings and other biotech stock catalysts slated for next week; Biotech week in Review

Weekly watchlist

Third quarter earnings season gets into full stride next week as mid-cap companies start reporting earnings. We note a summary of key earnings dates together with other catalysts for the upcoming week below. First, let’s review price moving events from the week that was.

Anika Therapeutics, Inc. (NASDAQ: ANIK) was a notable earnings mover, with shares closing Friday’s session up 35% to $73.36. The rally comes off the back of better than expected 3Q earnings. Total revenue for the quarter increased 11% year-over-year to $29.7m.

Biogen (Nasdaq: BIIB) announced that its Phase 3 Emerge trial, which it noted in March 2019 would be discontinued due to futility, met its primary endpoint showing a significant reduction in clinical decline in patients with Alzheimer’s disease following new analysis. As a result, the company intends to file a Biologics License Application (BLA) with the FDA in early 2020. Shares closed the week up 31% to $288.04.

MacroGenics, Inc. (NASDAQ: MGNX) shares closed the week down 21% to $8.71 following the release of data from the second interim overall survival (OS) analysis for its Phase 3 Sophia trial of margetuximab in patients with HER2-positive metastatic breast cancer. Median OS of patients treated with margetuximab and chemotherapy was 21.6 months compared to 19.8 months in patients who received trastuzumab and chemotherapy (hazard ratio 0.885; p=0.326).

Spark Therapeutics Inc (NASDAQ: ONCE) shares closed Thursday up 8% to $108.64. Capitol Forum reported that Federal Trade Commission staff have recommended the acquisition by Roche of Spark. The report has not been confirmed by the respective companies.

Seattle Genetics, Inc. (Nasdaq:SGEN) announced positive data from its pivotal HER2CLIMB trial evaluating tucatinib in combination with trastuzumab and capecitabine compared with trastuzumab and capecitabine alone in patients with locally advanced unresectable or metastatic HER2-positive breast cancer. The trial met the primary endpoint of progression-free survival (PFS), with a 46% reduction in the risk of disease progression or death (hazard ratio =0.54). The tucatinib arm also demonstrated an improvement in overall survival, with a 34% reduction in the risk of death (HR=0.66). Shares closed the week up 13% to $102.62.

Assertio Therapeutics, Inc. (NASDAQ:ASRT) announced that its partner West Therapeutic Development received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for its injectable formulation of long-acting cosyntropin for the screening of patients presumed to have adrenocortical insufficiency. Shares closed the week down 21% to $0.92.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) closed the week up 10% to $194.49 following two positive news releases. Early in the week it announced the FDA approved Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis (CF) in people ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, well ahead of the assigned PDUFA date of March 19, 2020. Mid-week it also announced an access agreement with NHS England to supply its cystic fibrosis medicines.

Selection of 15 top revenue earning companies reporting 3Q earnings week of October 28:

Tue: AMGN EXAS INCY MRK PFE SGEN

Wed: ACAD EXEL VRTX

Thur: BMY CELG LNTH SNY

Fri: ABBV NVO

Other biotech stock events slated for the upcoming week:

Drug Stage Catalyst Market Cap

ADMP – Adamis Pharmaceuticals Corporation
Higher Dose Naloxone Injection
Opioid overdose

PDUFA PDUFA date October 31, 2019. Company noted as of November 4, 2019 no communication has been received from the FDA.
$65.7 million

AGRX – Agile Therapeutics Inc.
Twirla
Contraceptive patch

PDUFA CRLs issued 2013 and 2017. New PDUFA extended by three months to February 16, 2020. Advisory Committee Meeting October 30, 2019 voted 14 to 1 in favor.
$103.2 million

AMAG – AMAG Pharmaceuticals Inc.
Makena
Preterm birth

Phase 3 Advisory Committee voted 9-7 recommending withdrawal from market - October 29, 2019.
$334.4 million

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

Phase 3 Phase 3 data due at ASH December 7, 2019 at 5:30pm ET.
$35.3 million

DCPH – Deciphera Pharmaceuticals Inc.
Rebastinib and paclitaxel
Solid tumors

Phase 1/2 Phase 1b/2 preliminary data noted 8/43 partial responses - October 28, 2019.
$2.5 billion

DCPH – Deciphera Pharmaceuticals Inc.
Ripretinib DCC-2618
Gastrointestinal Stromal Tumors (GIST) - second-fourth line

Phase 1 Phase 1 updated data presented at AACR-NCI-EORTC October 29, 2019.
$2.5 billion

FLXN – Flexion Therapeutics Inc.
Zilretta - FX006 repeat
Osteoarthritis of the knee

PDUFA PDUFA date for sNDA filing delayed. Decision due in the coming weeks - noted November 11, 2019.
$642.9 million

KURA – Kura Oncology Inc.
Tipifarnib
Head and neck squamous cell carcinomas (HNSCC) with HRAS Mutations

Phase 2 Phase 2 data presented at AACR-NCI-EORTC October 29, 2019 noted PFS 6.1 months. 10/18 partial responses.
$675.2 million

MRTX – Mirati Therapeutics Inc.
MRTX849
Solid tumors

Phase 1/2 Phase 1/2 data presented at AACR-NCI-EORTC October 28, 2019. 3/6 partial responses in NSCLC, 1/4 responses in CRC patients.
$3.5 billion

RDHL – Redhill Biopharma Ltd.
Talicia RHB-105
H. pylori

Approved FDA Approval announced November 4, 2019.
$203.2 million