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May 15 2017

Biohaven's Trigriluzole Receives Fast Track Designation From U.S. FDA

May 15 2017
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.
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May 15 2017

Syros Announces First Patient Dosed in Phase 1 Clinical Trial of SY-1365, its First-in-Class Selective CDK7 Inhibitor, in Patients with Advanced Solid Tumors

May 15 2017

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.

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May 10 2017

Loxo Oncology Announces Enrollment of First Patient in Phase 1 Clinical Trial for Highly Selective RET Inhibitor, LOXO-292

May 10 2017

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.

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May 9 2017

FDA Accepts Aclaris Therapeutics’ New Drug Application for Topical Treatment of Seborrheic Keratosis, a Common Skin Condition

May 9 2017

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.

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May 8 2017

Paratek Announces Completion of Enrollment for Oral-only Omadacycline Phase 3 Skin Study, Top-line Data Expected in Mid-July

May 8 2017

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.

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May 5 2017

Aclaris Therapeutics Completes Phase 1 Clinical Trial of ATI-50001 for the Treatment of Alopecia Universalis and Alopecia Totalis

May 5 2017

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.

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May 4 2017

Biohaven Announces Pricing of Initial Public Offering of Common Shares

May 4 2017

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.

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May 2 2017

Ajax Health Formed to Help Address Unmet Needs in the Medical Device Field

May 2 2017

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.

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Apr 28 2017

Allergan Successfully Completes ZELTIQ® Aesthetics Acquisition

Apr 28 2017

DUBLIN, April 28, 2017 /PRNewswire/ — Allergan plc (NYSE: AGN), a leading global biopharmaceutical company, today announced it has successfully completed the acquisition of ZELTIQ® Aesthetics, Inc., a medical technology company behind a proprietary controlled-cooling fat reducing treatment, CoolSculpting®. Allergan acquired ZELTIQ® Aesthetics for approximately $2.4 billion in cash. ZELTIQ® stockholders approved the transaction during its stockholder meeting held on April 27, 2017. With the acquisition, Allergan adds ZELTIQ’s flagship CoolSculpting® System, the sales leader in the fast-growing cash-pay body contouring segment of medical aesthetics. The combination is expected to be immediately accretive and makes body contouring the third pillar in Allergan’s global aesthetics portfolio, joining its leading facial aesthetics and plastic surgery & regenerative medicine businesses.

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Apr 27 2017

Verona Pharma Announces Pricing of Global Offering and Approval to List on the NASDAQ Global Market

Apr 27 2017

April 27, 2017, LONDON – Verona Pharma plc (AIM: VRP) (“Verona Pharma”), a clinical-stage biopharmaceutical company focused on developing and commercialising innovative therapeutics for the treatment of respiratory diseases with significant unmet medical needs, announces today the pricing of its global offering of an aggregate of 47,399,001 new ordinary shares, comprising 5,768,000 American Depositary Shares (“ADSs”) at a price of $13.50 per ADS and 1,255,001 ordinary shares at a price of £1.32 per ordinary share, for aggregate proceeds of approximately $80.0 million before deducting underwriting discounts and commissions. Each ADS offered represents eight ordinary shares of Verona Pharma. The ADSs are being offered in a registered public offering in the United States and the ordinary shares are being offered in a concurrent private placement in Europe and other countries outside of the United States and Canada (together, the “Global Offering”).

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