Axcella Health names Alison Schecter as President of R&D » 16:2203/0303/03/21
Axcella announced the…
Axcella announced the appointment of Alison D. Schecter, M.D., as the company's President of Research and Development. In this role, Dr. Schecter will oversee all of the company's research, product candidate design, clinical and regulatory efforts. Additionally, Manu Chakravarthy, M.D., Ph.D., has decided to step down as the company's Chief Medical Officer to pursue another opportunity.
Fly Intel: Top five analyst initiations » 09:5303/0303/03/21
COIN, CURI, EQ, ONEW, BCO
Catch up on today's…
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Coinbase (COIN) initiated with a Buy at DA Davidson. 2. CuriosityStream (CURI) initiated with a Buy at Needham. 3. Equillium (EQ) initiated with a Buy at JonesTrading. 4. OneWater Marine (ONEW) initiated with an Overweight at KeyBanc. 5. Brink's (BCO) reinstated with a Buy at Goldman Sachs. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
Protagonist Therapeutics price target raised to $41 from $30 at SVB Leerink » 08:4803/0303/03/21
SVB Leerink analyst…
SVB Leerink analyst Joseph Schwartz raised the firm's price target on Protagonist Therapeutics (PTGX) to $41 from $30 and keeps an Outperform rating on the shares. Up about 25% over the past two days likely on positive read-through from Morphic's (MORF) oral anti-integrin Phase 1 results, the analyst believes there is still more value to be created for Protagonist's "underappreciated" Inflammatory Bowel Disease/IBD assets including PN-943, a potentially first-in-class oral anti-integrin for IBD.
Equillium initiated with a Buy at JonesTrading » 07:2003/0303/03/21
JonesTrading analyst Prakhar Agrawal initiated coverage of Equillium with a Buy rating and $14 price target. Lead asset Itolizumab, which is in Phase 1 trials in acute graft-versus-host disease, or GVHD, as well as for lupus/lupus nephritis and asthma, has shown high response rates in a very sick acute GVHD population, which "bodes well for success," said Agrawal. The analyst assigns 65% odds of success to Itolizumabin in aGVHD and forecasts unadjusted peak sales in that indication of $415M.
Eli Lilly, Incyte announce BRAVE-AA2 study met primary endpoint » 06:5103/0303/03/21
Eli Lilly (LLY) and…
Eli Lilly (LLY) and Incyte (INCY) announced top-line results from BRAVE-AA2, a Phase 3 study evaluating the efficacy and safety of once-daily baricitinib 2-mg and 4-mg in adults with severe alopecia areata, or AA. Both doses of baricitinib met the primary efficacy endpoint at Week 36, demonstrating a statistically significant improvement in scalp hair regrowth compared to those randomized to placebo. AA is an autoimmune disease that causes patchy hair loss on the scalp, face and sometimes on other areas of the body that can progress. Baricitinib has received breakthrough therapy designation from the FDA for the treatment of AA. This classification aims to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over already available therapies on a clinically significant endpoint. There are currently no FDA-approved treatments for AA. This multicenter, randomized, double-blind, placebo-controlled study included 546 adults with a Severity of Alopecia Tool, or SALT, score of 50 and a current episode of severe AA lasting at least six months but no more than eight years. The study included a diverse patient population from Argentina, Australia, Brazil, China, Israel, Japan, South Korea, Taiwan and the U.S. Safety outcomes of baricitinib in BRAVE-AA2 were consistent with its established safety profile in patients with rheumatoid arthritis, or RA, and atopic dermatitis, or AD. No deaths, major adverse cardiovascular events, or MACE, or venous thromboembolic events, or VTEs, were reported in the study. BRAVE-AA2 is the first Phase 3 study with "positive" results in patients with AA. Data from an additional Phase 3 study of baricitinib in AA will be available in the first half of this year. Detailed results from the BRAVE program will be presented at an upcoming medical conference and published in a peer-reviewed journal later this year. AA is the second potential treatment indication in dermatology for baricitinib after AD. Baricitinib is an oral JAK inhibitor discovered by Incyte and licensed to Lilly. It is approved and commercially available as Olumiant in the U.S. and more than 70 countries as a treatment for adults with moderate to severe active RA and in the European Union and Japan for the treatment of adult patients with moderate to severe AD who are candidates for systemic therapy. Baricitinib is also being investigated in systematic lupus erythematosus, juvenile idiopathic arthritis and COVID-19.
Some Catholic bishops advise against certain Covid-19 vaccines, WSJ reports » 06:1403/0303/03/21
JNJ, MRNA, PFE
At least two Catholic…
At least two Catholic bishops in the U.S. are advising their parishioners to avoid certain Covid-19 vaccines, The Wall Street Journal's Ian Lovett reports. The Archdiocese of New Orleans last week released a statement advising Catholics that the Johnson & Johnson (JNJ) vaccine is "morally compromised as it uses the abortion-derived cell line in development and production of the vaccine as well as the testing," and advises them to opt for a vaccine made by Moderna (MRNA) or Pfizer (PFE), if possible. A spokesman for J&J said it manufactures vaccine doses using "our engineered cell-line system" and didn't comment on the archdiocese's statement. In December, the Vatican issued a statement deeming it "morally acceptable to receive Covid-19 vaccines that have used cell lines from aborted fetuses in their research and production process" when no "ethically irreproachable" vaccines were available. Reference Link
Raymond James to hold a virtual conference » 04:5503/0303/03/21
JLL, PODD, SMG, IDXX, APLS, AVT, SBAC, LPTX, RJF, WY, LZB, DXCM, ADMA, CTT, CACI, BR, CWST, FLXN, HOLX, VSAT
42nd Annual Institutional…
42nd Annual Institutional Investors Virtual Conference will be held on March 1-3.
Piper 'increasingly bullish' on Axonics after closer look at deal » 04:4603/0303/03/21
Piper Sandler analyst…
Piper Sandler analyst Adam Maeder is "increasingly bullish" on Axonics after taking a closer look at its acquisition of Contura. Maeder says that while the deal came as a bit of a surprise, he sees a "strong strategic fit and potentially disruptive technology in a large, underpenetrated market." The analyst's initial physician diligence came back "very positive," leaving Maeder believing that Contura's Bulkamid has the potential to be a "disruptive product" in the stress urinary incontinence market. The analyst keeps an Overweight rating on Axonics with a $64 price target.
Helios Technologies price target raised to $82 from $72 at Baird » 17:0503/0203/02/21
Baird analyst Mircea…
Baird analyst Mircea Dobre raised the firm's price target on Helios Technologies to $82 from $72 and keeps an Outperform rating on the shares. The analyst notes that the company's early days of Balboa Water Group ownership are proving fruitful, providing meaningful upside to estimates and contributing to operating beat. Dobre adds that the guidance for 2021 introduced by Helios management is above consensus, and he sees further upside to high-single-digit core growth estimate given "broad end-market improvements" and pricing potential.
Mizuho healthcare analysts to hold an analyst/industry conference call » 13:0103/0203/02/21
Analysts discuss Eli…
Analysts discuss Eli Lilly's Alzheimer's Disease Drug, Donanemab and the real-world clnical implications with Paul R. Solomon, PhD on an Analyst/Industry conference call to be held on March 5.