BPC July 09 update

​Altimmune ALT to acquire Spitfire Pharma +7%

Price and Volume Movers

Altimmune, Inc. (NASDAQ: ALT) announced that it will acquire Spitfire Pharma, Inc, currently developing its product candidate SP-1373 (ALT-801), for the treatment of non-alcoholic steatohepatitis (NASH). Development is still in the pre-clinical phase, with clinical trials set to commence in 2020. The transaction is expected to close during July 2019. Spitfire shareholders will receive an upfront payment of $5m in Altimmune common stock. Shares of Altimmune closed up 7% to $2.66.

Merck (NYSE: MRK) announced that the FDA has accepted for review six supplemental Biologics License Applications (sBLAs) to update the dosing frequency for Keytruda to include an every-six-weeks (Q6W) dosing schedule option. Merck is seeking approval for indications in melanoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma and Merkel cell carcinoma. The PDUFA date is February 18, 2020.

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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:

Neos Therapeutics, Inc. (NEOS): $1.67; +21%.

Oasmia Pharmaceutical (OASM): $2.60; +14%.

Atreca, Inc. (BCEL): $19.05; +14%.

Nymox Pharmaceutical Corporation (NYMX): $1.67; +14%.

Kiniksa Pharmaceuticals, Ltd. (KNSA): $15.88; +14%.

DECLINERS:

OncoSec Medical Incorporated (ONCS): $2.11; -14%.

Diffusion Pharmaceuticals Inc. (DFFN): $2.17; -13%.

Immutep Limited (IMMP): $1.56; -11%.

Melinta Therapeutics, Inc. (MLNT): $5.62; -11%.

Armata Pharmaceuticals, Inc. (ARMP): $3.40; -8%.

Pipeline updates:

Pipeline Database Updates

Drug Stage Catalyst Market Cap

ALBO – Albireo Pharma Inc.
Odevixibat (A4250) - PEDFIC- 1
Progressive familial intrahepatic cholestasis (PFIC)

Phase 3 Phase 3 top-line data due mid-2020.
$223.4 million

ALBO – Albireo Pharma Inc.
Elobixibat
Nonalcoholic steatohepatitis (NASH)

Phase 2 Phase 2 data due mid-2020.
$223.4 million

ALBO – Albireo Pharma Inc.
Odevixibat (A4250)
Biliary atresia

Phase 3 Phase 3 trial planned for 2020.
$223.4 million

CARA – Cara Therapeutics Inc.
KORSUVA (CR845/difelikefalin) oral
Atopic dermatitis patients with moderate-to-severe pruritus

Phase 2 Phase 2 trial initiation announced July 9, 2019.
$891.2 million

CRMD – CorMedix Inc.
Neutrolin - LOCK-IT 100
Hemodialysis patients with central venous catheters

NDA Filing NDA filing likely 1H 2020 (estimate only).
$183.1 million

HTBX – Heat Biologics Inc.
HS-110 and nivolumab (Opdivo)
Non-small cell lung cancer (NSCLC)

Phase 2 Phase 2 data due 4Q 2019.
$12.7 million

KDMN – Kadmon Holdings Inc.
KD025
Systemic sclerosis (scleroderma)

Phase 2 Phase 2 trial initiation announced July 9, 2019.
$377.2 million

MRK – Merck & Company Inc. (new)
Keytruda
6-week dosing for melanoma and other indications

PDUFA PDUFA date February 18, 2020.
$216.8 billion

PULM – Pulmatrix Inc.
Pulmazole (PUR1900)
Allergic bronchopulmonary aspergillosis in patients with asthma.

Phase 2 Phase 2 dosing has commenced with top-line data due mid-2020.
$13.9 million

TROV – TrovaGene Inc.
Onvansertib, Folfiri and Avastin (bevacizumab)
KRAS-Mutated Colorectal Cancer

Phase 1/2 Phase 1b/2 trial initiation announced July 9, 2019.
$6.5 million