BPC February 01 update

Evolus EOLS issued FDA Approval; Alkermes ALKS receives expected CRL

Price and Volume Movers

Evolus, Inc. (NASDAQ: EOLS) announced the FDA has approved Jeuveau for the temporary improvement in the appearance of moderate to severe glabellar lines. Launch of the treatment is slated for spring of this year, with pricing expected at a discount to Botox. Shares spiked up following the release of news during intra-day trading, closing the session up 12% to $18.33. Shares have made further gains after hours, currently trading up 6% to $19.50. 

Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) shares closed Friday up 34% to $1.65 following Thursday’s update of its commercial relaunch of Probuphine (buprenorphine) implant, for the treatment for Opioid Use Disorder (OUD). The company noted that since taking on responsibility for Probuphine from Braeburn Pharmaceuticals in mid-June 2018, total shipments during the rest of the year increased by over 20%.Titan expects to provide more details in its 4Q and full-year 2018 financial results, which it expects to release in late March 2019. 

CTI BioPharma Corp. (NASDAQ:CTIC) shares closed down 16% to $1.00 following news it will withdraw its European Marketing Authorization Application (MAA) for pacritinib as a treatment for myelofibrosis. The company received notice from the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) that it was likely to formally adopt a negative opinion in its evaluation of the application. The CHMP indicated that the risk-benefit profile for pacritinib for the intended indication has not been sufficiently established with the clinical data available to date.  

Alkermes plc (Nasdaq: ALKS) announced that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD). The news was expected with an earlier FDA Advisory Committee voting 2-21 against recommending approval. However, shares are still trading down 3% to $32.00 after hours despite the expected news.

OncoSec Medical Incorporated (NASDAQ:ONCS) shares closed down 25% to $0.66 following a further update regarding KEYNOTE-695, its trial in patients with melanoma. With 20% of patients in the study now evaluated, the observed preliminary response rate is approximately 24% (5/21), of which four were partial responses and one was a complete response.

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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:

Aileron Therapeutics, Inc. (ALRN): $1.42; +29%.

Adial Pharmaceuticals, Inc. (ADIL): $6.88; +26%.

Fortress Biotech, Inc. (FBIO): $2.47; +19%.

Marinus Pharmaceuticals, Inc. (MRNS): $3.73; +12%.

CytomX Therapeutics, Inc. (CTMX): $19.04; +12%.

DECLINERS:

Leap Therapeutics, Inc. (LPTX): $1.50; -23%.

Corcept Therapeutics Incorporated (CORT): $10.03; -10%.

GTx, Inc. (GTXI): $1.01; -7%.

Kitov Pharma Ltd (KTOV): $1.18; -7%.

Tyme Technologies, Inc. (TYME): $2.50; -7%.

 

Pipeline updates below:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALKS – Alkermes plc
ALKS 5461
Major depressive disorder

CRL CRL announced February 1, 2019.
$5.2 billion

EOLS – Evolus Inc.
DWP-450
Glabellar lines

Approved FDA Approval announced February 1, 2019.
$672.3 million

MRK – Merck & Company Inc. (new)
KEYTRUDA and Inlyta - KEYNOTE-426
Renal cell carcinoma

PDUFA priority review PDUFA date under priority review June 20, 2019.
$210 billion

MRK – Merck & Company Inc. (new)
Keytruda KN-122
Nasopharyngeal Carcinoma

Phase 3 Phase 3 data due 2020.
$210 billion

NVO – Novo Nordisk A/S
Anti-IL 21 GLP-1 T1D (NNc)
Type 1 diabetes

Phase 2 Phase 2 data due 2Q 2019.
$119.1 billion

NVO – Novo Nordisk A/S
Somapacitan
Growth Hormone Deficiency (GHD)

Phase 3 Phase 3 trial to be initiated 2Q 2019.
$119.1 billion

NVO – Novo Nordisk A/S
Semaglutide - oral - PIONEER
Type 2 diabetes

NDA Filing Regulatory filing due 1Q 2019.
$119.1 billion

NVO – Novo Nordisk A/S
LAI287
Type 2 diabetes

Phase 2 Phase 2 data due 4Q 2019.
$119.1 billion

NVO – Novo Nordisk A/S
AM833
Obesity

Phase 2 Phase 2 trial to commence 1Q 2019.
$119.1 billion

ONCS – OncoSec Medical Incorporated
ImmunoPulse IL-12 - KEYNOTE-695
Melanoma - cancer

Phase 2b Phase 2b data noted ORR 24% (5/21) - including 1CR.
$38.7 million

ONCS – OncoSec Medical Incorporated
TAVO + KEYTRUDA KEYNOTE-890
Triple negative breast cancer (TNBC)

Phase 2 Phase 2 enrolment to be completed in 2019 with preliminary top-line data due 2H 2019.
$38.7 million

OPK – Opko Health Inc.
OPK88004
Benign Prostatic Hyperplasia (BPH)

Phase 2b Phase 2b trial suspension announced January 31, 2019.
$1.7 billion