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Bellerophon Therapeutics ($BLPH) reported receiving the FDA approval for all its proposed modifications to the Phase 3 program for lead product candidate INOpulse for the treatment of pulmonary arterial hypertension.
Under the amended conditions, the program will now involve the ongoing INOvation-1 study and a second confirmatory withdrawal study involving 40 subjects from INOvation-1 who will cross over. These two trials will provide the data supporting a New Drug Application (NDA) seeking approval for INOpulse in PAH patients on long-term oxygen treatment.
INOpulse is a drug-device combination system that delivers pulsed doses of nitric oxide.

IntelGenx Technologies Corp ($IGXT) stock jumped nearly 5% in its Wednesday trading session. The stock responded to the announcement of the company signing a global agreement with Chemo Group to co-develop and commercialize a generic tablet used in the central nervous system area.
Under the terms of the deal, both the companies will share the profits generated from the commercialization of the treatment. IntelGenx will also be eligible to receive upfront payments and other funds for paying development costs. The company will also receive milestone payments.
The company had recently entered into another agreement with Endo Ventures Ltd. for developing and commercializing a new product using VersaFilm.


• Interpace Diagnostics Group ($IDXG) signed a securities purchase agreement with institutional investors for the direct sale of 375K common shares at $6.75 and 255K pre-funded warrants to purchase common shares at $6.74. the closing date for the deal is January 6.
• Bruker ($BRKR) announced acquiring two German firms. One firm is Bremen-based SCiLS GmbH, a developer of of software tools for the collaborative interpretation of complex mass spectrometry imaging data while the second one is Hennigsdorf-based InVivo Biotech Services GmbH, a provider of monoclonal antibodies and recombinant proteins.

• Aeterna Zentaris ($AEZS) reported that the confirmatory Phase 3 clinical trial of Macrilen failed to achieve its objective of validating a single oral dose of macimorelin for the evaluation of growth hormone deficiency in adults.
• Trevena ($TRVN) announced completing enrollment in the Phase 3 studies, APOLLO-1 and APOLLO-2, evaluating lead product candidate oliceridine (TRV130) for the treatment of moderate-to-severe acute pain following bunionectomy and abdominoplasty, respectively.

• U.S. Physical Therapy ($USPH) announced acquiring a 70% interest in an unnamed physical therapy practice that owns and operates 17 clinics and manages an additional eight facilities. The deal is reported to be worth $11.4 million.
• CymaBay Therapeutics ($CBAY) announced that it has signed an exclusive license agreement with Kowa Pharmaceuticals America for the development and commercialization of gout candidate arhalofenate in the US.

• Novartis ($NVS) receives rating downgrade from J.P. Morgan. The stock is now rated ‘Hold.’
• Catabasis Pharmaceuticals ($CATB) received Buy rating from Oppenheimer. The price target for the stock has been set at $18 apiece.

Gainers (% price change) Last Trade Change Mkt Cap
ImmunoGen, Inc.
2.49 +0.41 (19.71%) 221.64M
Sangamo Biosciences, Inc.
3.50 +0.40 (12.90%) 251.24M
EXACT Sciences Corp.
14.95 +1.54 (11.48%) 1.63B
ACADIA Pharmaceuticals
31.94 +3.17 (11.02%) 3.86B
Amicus Therapeutics, Inc.
5.63 +0.50 (9.75%) 827.09M
Losers (% price change)
The Ensign Group, Inc.
20.95 -1.43 (-6.39%) 1.07B
Omnicell, Inc.
33.30 -1.10 (-3.20%) 1.23B
Cerner Corporation
47.93 -1.47 (-2.98%) 16.97B
Atrion Corporation
492.60 -9.80 (-1.95%) 890.14M
Intuitive Surgical, Inc.
629.49 -12.30 (-1.92%) 24.68B
Most Actives (dollar volume)
IDEXX Laboratories, Inc.
115.95 -1.65 (-1.40%) 10.43B
St. Jude Medical, Inc.
80.82 +0.13 (0.16%) 23.24B
Gilead Sciences, Inc.
76.38 +2.22 (2.99%) 104.21B
Abbott Laboratories
39.36 +0.31 (0.79%) 58.92B
Pfizer Inc.
33.29 +0.29 (0.88%) 205.25B