Merck announced that the U.S. FDA has accepted for review regulatory filings for two antibacterial agents. These filings are: (1) a NDA accepted for Priority Review for the combination of relebactam, the company’s investigational beta-lactamase inhibitor, with imipenem/cilastatin, for the treatment of complicated urinary tract infections and complicated intra-abdominal infections caused by certain susceptible Gram-negative bacteria, in adults with limited or no alternative therapies available; and (2) a sNDA accepted for Priority Review for ZERBAXA to treat adult patients with nosocomial pneumonia, including ventilator-associated pneumonia caused by certain susceptible Gram-negative microorganisms. The Prescription Drug User Fee Act target action date for IMI/REL is July 16, 2019, while the PDUFA target action date for ZERBAXA is June 3, 2019.
Tuesday, February 5, 2019
InflaRx price target raised to $65 from $42 at JPMorgan
JPMorgan analyst Anupam Rama raised his price target for InflaRx to $65 from $42 ahead of the Phase 2b Shine study of IFX-1 In hidradenitis suppurativa. The data readout, expected in Q2, “largely remains an under the radar catalyst,” Rama tells investors in a research note. The analyst continues to believe the Shine study has a high probability of success and the potential to be a “transformational catalyst” for InflaRx shares. Rama sees share upside potential from the readout ranging from 60% to 150%-plus versus downside in the 40%-55% range. He reiterates InflaRx as a top pick for the first half of 2019 and keeps an Overweight rating on the name.
Mallinckrodt completed open-label phase of Phase 4 H.P. Acthar Gel trial
Mallinckrodt has completed the open-label phase of the ongoing Phase 4, multicenter study assessing the efficacy and safety of H.P. Acthar Gel in patients with persistently active rheumatoid arthritis, or RA, who were previously treated with disease-modifying anti-rheumatic drugs, or DMARDs, and corticosteroids. Primary end point results observed from the 100% patient enrollment point in the study’s open-label phase are consistent with those observed at the 25% and 50% milestone assessments. As most recently reported relative to 50% patient enrollment data – where primary end point results showed 61% of the 100 patients with persistently active RA who completed the open-label period achieved low disease activity at 12 weeks – H.P. Acthar Gel continued to produce reduction in joint disease activity in patients whose disease was uncontrolled on prednisone and DMARDs. The company intends to present full open-label phase findings by mid-2019. “We are pleased with the insights gleaned thus far into the clinical utility of H.P. Acthar Gel in patients with persistently active rheumatoid arthritis who were previously treated with disease-modifying drugs and corticosteroids,” said Steven Romano, M.D., Executive Vice President and Chief Scientific Officer at Mallinckrodt.
Zimmer Biomet price target raised to $135 from $126 at SunTrust
SunTrust analyst Bruce Nudell raised his price target on Zimmer Biomet to $135 and kept his Buy rating after its Q4 results and FY19 guidance, saying the quarter also showed improving supply issues and abating FDA worries. The analyst further expects the company’s new products to improve its outlook, with the “flagship” knee franchise set to “rebound with the full launch of the Persona revision,cement-less and partial offerings as well as the introduction of the ROSA robotic solution.”
AstraZeneca says EMA grants PRIME eligibility for MEDI8897
AstraZeneca and its global biologics research and development arm, MedImmune, announced that the European Medicines Agency has granted access to its PRIME, or PRIority MEdicines, scheme for MEDI8897, an extended half-life respiratory syncytial virus F monoclonal antibody being developed for the prevention of lower respiratory tract infection caused by RSV. Mene Pangalos, Executive Vice-President, R&D BioPharmaceuticals, said: “We are excited to receive PRIME eligibility for MEDI8897, our next-generation monoclonal antibody targeting respiratory syncytial virus in infants. We will work closely with the European Medicines Agency to optimise our development plan and help us bring MEDI8897 to patients as quickly as possible.”
Catalent reaffirms FY19 revenue view $2.5B-$2.59B, consensus $2.51B
Management is reaffirming its previously issued financial guidance. For fiscal year 2019, Catalent expects revenue in the range of $2.5B to $2.59B, Adjusted EBITDA in the range of $597M to $622M, and Adjusted Net Income in the range of $260M to $285M. The Company expects self-funded capital expenditures in the range of $175M to $185M and fully diluted share count in the range of 146 million to 147 million shares on a weighted-average basis, taking into account the issuance of 11.4 million shares in the July 2018 equity offering.
Rexahn price target lowered to $10 from $17 at H.C. Wainwright
H.C. Wainwright analyst Joseph Pantginis lowered his price target for Rexahn Pharmaceuticals to $10 following the company’s equity raise and keeps a Buy rating on the shares.
Subscribe to:
Comments (Atom)