Friday, October 5, 2018
Audentes Therapeutics presents new ‘positive’ interim data from ASPIRO
Audentes Therapeutics announced new positive interim data from ASPIRO, the Phase 1/2 clinical trial of AT132 for the treatment of X-linked Myotubular Myopathy. The data will be presented at the 23rd International Annual Congress of the World Muscle Society by Nancy Kuntz, MD, Principal Investigator at Ann & Robert H. Lurie Children’s Hospital of Chicago, Medical Director of Mazza Foundation Neuromuscular Program and Professor of Pediatrics and Neurology at Northwestern University Feinberg School of Medicine. The oral presentation by Dr. Kuntz will be held during a session on new therapeutic modalities scheduled to begin at 9:30 a.m. ET on October 5, 2018. The newly reported data include follow-up assessments ranging from 4 to 48 weeks for the eight patients enrolled in ASPIRO to date, including the seven patients enrolled in Cohort 1 (1×1014 vg/kg; six treated and one untreated control) and one patient enrolled to date in Cohort 2 (3×1014 vg/kg). Key assessments include neuromuscular function as measured by CHOP INTEND; respiratory function as measured by maximal inspiratory pressure and ventilator dependence; and vector transduction, transgene expression and histological improvement as assessed via muscle biopsy. All treated patients continue to show meaningful improvements in neuromuscular and respiratory function, with no new treatment-related SAEs reported since the last scientific update in May 2018.
https://thefly.com/landingPageNews.php?id=2800285
XBiotech completes enrollment of phase 2 bermekimab study
XBiotech announced that it has completed enrollment in its Phase 2, open label clinical study evaluating subcutaneous administration of bermekimab in patients with moderate to severe Atopic Dermatitis, or AD. XBiotech has now completed and exceeded enrollment in the final cohort of patients who are receiving 400mg weekly doses of bermekimab over an 8 week treatment period. Enrollment for the study is now closed. XBiotech recently announced it completed the first cohort of patients in the study who received a low dose of bermekimab over a four week treatment regimen. The company reported that patients in the first cohort had significant improvement in multiple efficacy endpoints and that the treatment was well-tolerated.
Acorda target cut to $19 to account for Ampyra generics, Inbrija delay at Stifel
Stifel analyst Paul Matteis lowered his price target on Acorda Therapeutics shares to account for the arrival of Ampyra generics and the FDA’s extension of Inbrija’s PDUFA to early next year, which leads him to move his Inbrija launch expectation back by a quarter to the first quarter of 2019. The analyst, who cut his target to $19 from $25, keeps a Hold rating on Acorda shares.
https://thefly.com/landingPageNews.php?id=2800293
Abbott price target raised to $86 from $72 at Cowen
Cowen analyst Joshua Jennings raised his price target on Abbott to $86 from $72 and said it remains a top pick. The analyst cited increased visibility from Libre and MitraClip reinforcing confidence in top tier revenue and earnings growth, which he sees supporting a peer average multiple. Jennings reiterated his Outperform rating on Abbott shares.
https://thefly.com/landingPageNews.php?id=2800317
Evolent Health resumed with an Outperform at Leerink
Leerink analyst David Larsen resumed coverage of Evolent Health with an Outperform rating and $35 price target, telling investors in a research note that he remains positive on shares following the close of the New Century Health acquisition. Larsen says he is “more confident” in Evolent’s growth prospects given the company’s greater presence in Medicare Advantage, Oncology and Cardiology, and says the deal makes strategic sense and will help enable Evolent to serve as a “conduit” between providers and payors to drive lower costs and improved outcomes.
https://thefly.com/landingPageNews.php?id=2800329
Thursday, October 4, 2018
ANI Launches Authorized Generic of Atacand HCT® Tablets
ANI Pharmaceuticals, Inc. (“ANI”) (Nasdaq: ANIP) today announced the launch of Candesartan Hydrochlorothiazide Tablets, 16mg/12.5mg, 32mg/12.5mg, and 32mg/25mg, an authorized generic of Atacand HCT®. The current annual U.S. market for this product is approximately $20 million, according to Iqvia/IMS Health.
Arthur S. Przybyl, ANI’s President and CEO stated, “We are pleased to announce the launch of the authorized generic of our brand product Atacand HCT®. This launch represents ANI’s sixth generic new product introduction in 2018.”
About Atacand HCT® Tablets
Atacand HCT® is indicated for the treatment of hypertension.
ARYA Sciences Acquisition Corp. Prices $125 Million IPO
ARYA Sciences Acquisition Corp. (“ARYA” or the “Company”), announced today that it priced its initial public offering of 12,500,000 units at $10.00 per unit for aggregate gross proceeds of $125,000,000. The sponsor of ARYA is ARYA Sciences Holdings, which is controlled by principals of Perceptive Advisors, LLC. The Company has granted the underwriters a 45-day option to purchase up to an additional 1,875,000 units to cover over-allotments, if any. The units are expected to begin trading on The Nasdaq Capital Market on October 5, 2018 under the symbol “ARYAU”. Each unit consists of one Class A ordinary share and one-half of one redeemable warrant, each whole warrant entitling the holder thereof to purchase one Class A ordinary share. No fractional warrants will be issued upon separation of the units and only whole warrants will trade.
The offering is expected to close on October 10, 2018, subject to customary closing conditions.
Jefferies LLC is acting as the sole book-running manager and Chardan is acting as the lead manager for the offering.
A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on October 4, 2018. The offering will be made only by means of a prospectus. Copies of the prospectus related to the offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, or by telephone at 877-547-6340, or by email at Prospectus_Department@Jefferies.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About ARYA
We are a newly organized blank check company newly incorporated as a Cayman Islands exempted company for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. We have not selected any business combination target and we have not, nor has anyone on our behalf, initiated any substantive discussions, directly or indirectly, with respect to identifying any business combination target.
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