Sanofi price target raised to EUR 100 from EUR 93 at JPMorgan » 14:3807/3007/30/21
JPMorgan analyst Richard…
JPMorgan analyst Richard Vosser raised the firm's price target on Sanofi to EUR 100 from EUR 93 and keeps an Overweight rating on the shares.
Regeneron price target raised to $729 from $703 at H.C. Wainwright » 12:5807/2907/29/21
H.C. Wainwright analyst…
H.C. Wainwright analyst Michael King raised the firm's price target on Regeneron Pharmaceuticals (REGN) to $729 from $703 and keeps a Buy rating on the shares after the company and Sanofi (SNY) announced Dupixent met all key primary and secondary endpoints in the Phase 3 trial for chronic spontaneous urticaria. The data continues to support Dupixent's "well-established" safety profile, King tells investors in a research note. The analyst updated his model to reflect the increased probability of success for Dupixent.
Sanofi now sees FY21 business EPS up around 12% at CER » 06:3507/2907/29/21
Sanofi now expects 2021…
Sanofi now expects 2021 business EPS to grow around 12% at CER, barring unforeseen major adverse events. Applying average July 2021 exchange rates, the currency impact on 2021 business EPS is estimated to be between -4% to -5%.
Sanofi reports Q2 business EPS EUR1.38, up 16.4% at CER » 06:3507/2907/29/21
Q2 sales grew double…
Q2 sales grew double digit to EUR 8.7 billion, up 12.4% at CER, mainly driven by Dupixent and Vaccines. CEO Paul Hudson commented: "The Sanofi business momentum has accelerated in the second quarter, delivering strong financial results driven by our core growth drivers Dupixent and Vaccines. We continue to deliver on our Play to Win strategy, and our second quarter performance gives us confidence in Sanofi's growth trajectory for this year. Consequently, we are raising our full-year EPS guidance to around 12%. Significant progress was made across several clinical and regulatory milestones and in June, we formed the Sanofi mRNA vaccines Center of Excellence with the aim to lead the field in this next chapter of vaccine innovation. We are well on our way making Sanofi more representative of communities we serve, executing on our Diversity and Inclusion strategy and creating a work environment where our people can bring their best selves to transform the practice of medicine."
Regeneron, Sanofi announce Dupixent trial met primary and secondary endpoints » 05:5307/2907/29/21
Regeneron (REGN) and…
Regeneron (REGN) and Sanofi (SNY) announced a pivotal Phase 3 trial evaluating Dupixent in patients with moderate-to-severe chronic spontaneous urticaria, or CSU, met its primary and all key secondary endpoints at 24 weeks. Adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-naive patients, compared to antihistamines alone in Study A, the first of two trials of the LIBERTY-CUPID clinical program. In the trial, adding Dupixent to standard-of-care antihistamines nearly doubled the reduction in itch and urticaria activity compared to standard-of-care alone (placebo) with continuous improvement out to 24 weeks. Patients experienced a 63% reduction in itch severity with Dupixent versus 35% with placebo, as measured by a 0-21 point itch severity scale, the primary endpoint in the U.S.; 65% reduction in urticaria activity severity with Dupixent versus 37% with placebo, as measured by a 0-42 point urticaria activity scale, the secondary endpoint in the U.S. The trial demonstrated safety results similar to the known safety profile of Dupixent in its approved indications. For the 24-week treatment period, the occurrence of treatment emergent adverse events were generally similar between the Dupixent and placebo groups. The most common adverse events were injection site reactions. The potential use of Dupixent in CSU and EoE is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.
Sanofi says CHMP adopts positive opinion for avalglucosidase alfa in Pompe » 13:3007/2707/27/21
The European Medicines…
The European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, has adopted a positive opinion for avalglucosidase alfa, a long-term enzyme replacement therapy for the treatment of people with Pompe disease, Sanofi announced. "The CHMP positive opinion and recommended indication reflect the robust data from avalglucosidase alfa's clinical development program. While Sanofi is pleased with the CHMP's recognition of the clinically meaningful improvements demonstrated in the avalglucosidase alfa development program, the CHMP considered that avalglucosidase alfa does not qualify as a New Active Substance, or NAS. As a result, Sanofi will be requesting a re-examination of the CHMP opinion in relation to the NAS conclusion. The positive opinion is based on data from the Phase 3 COMET study, which found that avalglucosidase alfa showed clinically meaningful improvements in respiratory function and movement endurance measures in people with late-onset Pompe disease," the company stated. Reference Link
Translate Bio price target raised to $45 from $28 at Roth Capital » 07:3907/2607/26/21
Roth Capital analyst Tony…
Roth Capital analyst Tony Butler raised the firm's price target on Translate Bio (TBIO) to $45 from $28 and keeps a Buy rating on the shares. The analyst believes Translate Bio is "not being adroitly rewarded" especially if considering the transition of recombinant and/or egg-based flu vaccine currently at Sanofi (SNY) to an mRNA-based business. That said, he expects Phase I data from the COVID-19 vaccine program in Q3.
|Over a week ago|
Sanofi granted orphan status for polyneuropathy treatment » 11:5707/2307/23/21
The FDA granted Sanofi…
The FDA granted Sanofi orphan status for its monoclonal antibody for its treatment of chronic inflammatory demyelinating polyneuropathy.
GeoVax Labs announces presentation on Sudan Ebolavirus vaccine data » 09:1007/2207/22/21
GeoVax Labs announced the…
GeoVax Labs announced the presentation of data from a study of its preventive vaccine against Sudan Ebolavirus. The presentation was titled "A single immunization of guinea pigs with a modified vaccinia Ankara virus producing Sudan virus-like particles protects from Sudan virus lethal challenge." In her talk, Dr. Malherbe discussed the preclinical efficacy studies of GeoVax's vaccine, a novel vaccine candidate for SUDV constructed on an MVA vector expressing two immunogens derived from the Sudan virus. Upon vaccination, these immunogens form Virus Like Particles in the host, which in turn induce immunity against subsequent infections with SUDV. Immunogenicity and efficacy of MVA-SUDV-VLP were tested in a guinea pig lethal challenge model, in which a single intramuscular dose of the GeoVax vaccine protected 100% of animals challenged with a lethal dose of SUDV. A comparison between prime and prime-boost vaccinations of guinea pigs with MVA-SUDV-VLP showed that both regimens elicited SUDV-specific binding and neutralizing antibody responses, and that the second immunization enhanced these responses. Challenge of vaccinated animals with guinea pig-adapted SUDV demonstrated a complete protection against death and disease by the prime and the prime-boost regimens. Importantly, there was no difference in outcomes between the prime and the prime-boost vaccine regimens thus demonstrating the efficacy of a single dose of MVA-SUDV-VLP. This is the first report that a replication-deficient MVA vector may confer full protection against SUDV after a single dose.
Piper Sandler biotech analysts hold an analyst/industry conference call » 09:5107/1507/15/21
RGNX, ROG, ADVM, SNY, JNJ, BIIB, AGTC, ISEE, GSGTF
Biotechnology Analysts Rahimi & Raymond, along with Roger A. Goldberg, MD, MBA, Ophthalmologist at Bay Area Retina Associates discuss gene therapy for ocular disease on an Analyst/Industry conference call to be held on July 15 at 10 am. Webcast Link