News

NEWARK, Calif., May 30, 2017 /PRNewswire/ -- Protagonist Therapeutics, Inc. (Nasdaq: PTGX) today announced that the company has entered into a worldwide license and collaboration agreement with Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the co-development and commercialization of PTG-200, Protagonist's first-in-class, oral peptide IL-23 receptor antagonist for all indications including inflammatory bowel disease (IBD). PTG-200 is expected to enter Phase 1 clinical testing in normal healthy volunteers in the second half of 2017. The agreement builds upon a Johnson & Johnson Innovation – JJDC, Inc. Series B venture financing from 2013 in support of the discovery and development of Protagonist's pipeline of oral peptide therapeutics.

NEW HAVEN, Conn., May 30, 2017 /PRNewswire/ -- (NYSE: BHVN) -- Biohaven Pharmaceutical Holding Company Ltd. (Biohaven) announced today that the company has completed enrollment in its clinical study of trigriluzole (BHV-4157) in patients with spinocerebellar ataxia (SCA). Trigriluzole, a novel drug candidate being developed by Biohaven, has received both Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA) as a potential treatment for SCA.  SCA is a rare, debilitating neurodegenerative disorder that is estimated to affect approximately 22,000 people in the United States. No medications are currently approved for this often severe condition.

NEW HAVEN, Conn., May 15, 2017 /PRNewswire/ -- (NYSE: BHVN) -- Biohaven Pharmaceutical Holding Company Ltd. (Biohaven) announced today that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track Designation for Biohaven's product candidate trigriluzole (BHV-4157) for the potential treatment of Spinocerebellar Ataxia (SCA).  Trigriluzole previously received Orphan Drug Designation from the FDA for the treatment of SCA in 2016. Biohaven is currently conducting a Phase 2/3 clinical trial in patients with SCA, with topline results expected in 2018.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 15, 2017-- Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of disease-driving genes, announced today that the first patient has been dosed in the Phase 1 clinical trial of SY-1365, its first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, in patients with advanced solid tumors, including transcriptionally dependent cancers such as triple negative breast, small cell lung and ovarian cancers.

STAMFORD, Conn., May 10, 2017 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that the first patient has been enrolled in the Phase 1 clinical trial of LOXO-292, an investigational, highly potent and selective RET inhibitor. RET gene alterations are thought to play a key role in the development of certain cases of lung, thyroid, colon and other cancers.

MALVERN, Pa., May 09, 2017 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biotechnology company, today announced that the U.S. Food and Drug Administration has accepted its New Drug Application (NDA) A-101 40% topical solution (A-101 40%), an investigational drug, for the potential treatment of seborrheic keratosis (SK), a common skin condition. The NDA acceptance by the FDA in its 74-day letter indicates that the application is sufficiently complete to permit a substantive review. The PDUFA target action date for the completion of the FDA’s review of the NDA is December 24, 2017. If approved, A-101 40% would be the first FDA-approved topical medication for the treatment of SK.

BOSTON, May 08, 2017 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK), a biopharmaceutical company focused on the development and commercialization of innovative therapies based upon tetracycline chemistry, announced today that it has completed enrollment in its pivotal Phase 3 clinical study evaluating oral-only omadacycline for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). The Company expects to report top-line data from this study in mid-July. This study is designed to assess the efficacy and safety of once-daily oral-only omadacycline compared with twice-daily oral-only linezolid in subjects with ABSSSI.

MALVERN, Pa., May 05, 2017 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biotechnology company focused on identifying, developing and commercializing innovative and differentiated therapies to address significant unmet needs in medical and aesthetic dermatology, today announced it has completed a Phase 1 clinical trial of ATI-50001, an investigational oral Janus Kinase (JAK) 1/3 inhibitor.

NEW HAVEN, Conn. May 4, 2017 – Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced the pricing of its initial public offering of 9,900,000 of its common shares at an initial public offering price of $17.00 per share. In addition, Biohaven has granted the underwriters a 30-day option to purchase up to an additional 1,485,000 common shares at the initial public offering price, less underwriting discounts and commissions. The shares are expected to begin trading on the New York Stock Exchange on May 4, 2017 under the ticker symbol “BHVN.” The offering is expected to close on May 9, 2017, subject to customary closing conditions.

MENLO PARK, Calif.--(BUSINESS WIRE)--KKR, along with Aisling Capital, today announced the creation of a new platform, Ajax Health (“Ajax”), which will source and provide operational and financial capabilities to a diversified portfolio of emerging medical device companies under the leadership of Duke Rohlen. Mr. Rohlen is a 15-year medical device veteran who has served as President of FoxHollow Technologies and Founder and CEO of CV Ingenuity. Mr. Rohlen successfully sold these businesses to strategic acquirers for aggregate consideration in excess of $1 billion.