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SVRA

Savara

$12.88

0.07 (0.55%)

16:14
07/25/18
07/25
16:14
07/25/18
16:14

Savara announces update on Molgradex, new CF study

Savara provided an update on the clinical development and commercial preparatory efforts for its lead product candidate Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor, or GM-CSF. In addition, Savara is expanding its Molgradex nontuberculous mycobacteria, or NTM program with a new study in the U.S. in cystic fibrosis, or CF affected individuals with chronic NTM lung infection. The company also announced its acquisition of the assets of Cardeas Pharma Corporation as part of its launch of an exploratory product pipeline comprising pre-proof-of-concept, high-potential programs focused on difficult-to-treat lung diseases. Savara's pivotal Phase 3 IMPALA study is evaluating Molgradex for the treatment of autoimmune pulmonary alveolar proteinosis, or aPAP. Completion of patient enrollment remains on track for the third quarter of 2018 and topline data are anticipated in Q2 of 2019. The IMPALA study includes a six-month placebo-controlled period with 2:1 randomization on Molgradex or placebo, followed by a six-month open-label period with all subjects receiving Molgradex. Earlier this year, the company launched the IMPALA-X study, an open-label, multicenter study designed to evaluate the long-term use of Molgradex in patients with aPAP. The IMPALA-X study offers patients completing the IMPALA study the opportunity to continue treatment with Molgradex for up to three additional years. Driven by its confidence in the outcome of the IMPALA study, the company will expedite its preparation for potential commercial launch by starting investments into core commercial staff and external activities required for timely launch, subject to product approval by the FDA. The company believes that robust results in the IMPALA study would make Molgradex eligible for designation as a breakthrough therapy and facilitate the submission of the Molgradex Biologic License Application, or BLA, in the first half of 2020, with an anticipated commercial launch in late 2020 or early 2021. The company is now preparing to initiate a new study in the U.S. in CF affected individuals with chronic NTM infection. This Phase 2a open-label study will enroll 30 subjects with CF and chronic NTM lung infection, and is planned to begin in Q1 of 2019. The study will enroll subjects with chronic Mycobacterium abscessus or Mycobacterium avium complex infection. The study will comprise a 48-week treatment period and a 24-week follow-up period, and three subgroups of subjects will be recruited into the study. Group 1 will consist of subjects who have been on antimycobacterial treatment for at least six months prior to the baseline visit. Group 2 will consist of subjects who have stopped antimycobacterial treatment due to intolerance or lack of effect prior to the baseline visit. Group 3 will consist of subjects who have not been treated with antimycobacterial treatment but are clinically stable prior to the baseline visit. The primary endpoint in the study will be NTM sputum culture conversion to negative. As part of its growth strategy, Savara has launched an exploratory product pipeline comprising pre-proof-of-concept, high-potential programs focused on difficult-to-treat lung diseases. As the first new product in the exploratory pipeline, Savara acquired the rights to amikacin/fosfomycin inhalation solution, a Phase 2 ready product candidate that had been in development by Cardeas Pharma Corporation for the treatment of ventilator associated pneumonia.

SVRA Savara
$12.88

0.07 (0.55%)

04/09/18
ADAM
04/09/18
NO CHANGE
Target $25
ADAM
Buy
Savara risk/reward compelling, says Canaccord
Canaccord analyst Dewey Steadman met with Savara management and came away impressed with the execution of its three main programs. The analyst sees several important catalysts that could start flowing through the end of 2018 and into 2019. He sees the catalysts providing a compelling risk/reward opportunity for investors. Steadman reiterated his Buy rating and $25 price target on Savara shares.
05/25/18
HCWC
05/25/18
INITIATION
Target $22
HCWC
Buy
Savara initiated with a Buy at H.C. Wainwright
H.C. Wainwright analyst Andrew Fein started Savara with a Buy rating and $22 price target. The company's two compounds, Molgradex and AeroVanc, are largely de-risked with well known pharmacokinetic, safety and toxicological profiles, Fein tells investors in a research note. He believes upside from current share levels is "more than substantiated" by the company's programs in pulmonary alveolar proteinosis and cystic fibrosis.
06/08/18
EVER
06/08/18
INITIATION
Target $40
EVER
Outperform
Savara initiated with an Outperform, sees 300% upside, says Evercore ISI
Evercore ISI analyst Johsua Shimmer initiated Savara with an Outperform and $40 price target, representing 300% upside from current levels. Shimmer said lead program, Molgradex, has shown compelling clinical results in a rare Orphan pulmonary disease know as autoimmune Pulmonary Alveolar Proteinosis, and might have strong utility in treating chronic lung infections. Additionally, Aerovanc, inhaled vancomycin for MRSA in CF, is in Phase 3 trial and follows on the heels of anti-Pseudomonas therapies for this patient population, the analyst said. Shimmer said Savara's most direct comp in the NTM space is Insmed (INSM) with a $2B market cap, and his $40 price target could potentially be quite conservative.
06/08/18
06/08/18
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Pfizer (PFE) and Eli Lilly (LLY) were initiated with an Overweight at Cantor Fitzgerald. 2. LivaNova (LIVN) initiated with a Buy at Stifel. 3. Occidental Petroleum (OXY) and Chevron (CVX) were initiated with a Buy at Mizuho while ConocoPhillips (COP) and Exxon Mobil (XOM) were initiated with a Neutral. 4. LeMaitre (LMAT) resumed with a Buy at Roth Capital. 5. Savara (SVRA) initiated with an Outperform, sees 300% upside, says Evercore ISI. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.

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