Vistagen (NASDAQ: VTGN) a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression and other central nervous system (CNS) disorders, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of PH10, one of the Company’s investigational nasal sprays, for the treatment of major depressive disorder (MDD). The FDA’s Fast Track program facilitates the expedited development and review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs, with the intention to bring promising new medicines to patients sooner.
Early proof-of-concept data support durable clinical benefit including confirmed partial response and stable disease in heavily pre-treated patients with advanced NSCLC -
- Safety and tolerability profile potentially expands opportunity to include patients ineligible for high dose lymphodepletion or high dose IL-2 -
- Mechanism of action informed by translational science platform’s capability to correlate cNeT with anti-tumor activity -
- Additional monotherapy data and initial anti-PD-1 combination data expected in 2023 -
- Conference call and webcast today at 8:00am ET / 1:00pm UK -
Webcast and Conference Call Details
The company will host a live webcast and conference call today, Tuesday, December 6, 2022 at 8:00am ET / 1:00pm UK to review the interim update presented at ESMO IO. The live conference call will be webcast in listen-only mode and a slide presentation will be made available in the Events & Presentations section of the Company website at https://ir.achillestx.com/events-and-presentations. For listeners who wish to participate in the question-and-answer session via telephone, please pre-register here.
MEI Pharma Inc (NASDAQ: MEIP) and Kyowa Kirin Co Ltd are discontinuing global development of zandelisib outside of Japan for B-cell malignancies.
Kyowa Kirin continues the ongoing clinical trials, including the Phase 2 MIRAGE study evaluating Japanese patients with relapsed or refractory indolent B-cell non-Hodgkin lymphomas.
Recently, the companies reported topline data from a MIRAGE study demonstrating a 75.4% objective response rate, and 24.6% of patients achieved a complete response.
The move follows the most recent guidance from a late November meeting with the FDA that provided further guidance regarding the design and statistical analysis for the Phase 3 COASTAL trial.
The company believes the clinical development cannot be completed within a time supporting further investment.
In March, the FDA informed that a randomized clinical trial is "needed to adequately assess drug efficacy and safety of PI3K inhibitor drug candidates, including zandelisib."
Following the zandelisib update, MEI Pharma will focus on developing two earlier clinical-stage assets, voruciclib (B-cell malignancies) and ME-344 (solid tumors).
It plans to initiate a staggered workforce reduction, initially representing approximately 30% of the current workforce.
Following workforce reductions, MEI expects its existing cash, cash equivalents, and marketable securities will be sufficient to fund operations through clinical data milestones for voruciclib and ME-344.
The company further announced that it had engaged Torreya Partners as a financial advisor to help explore additional strategic opportunities.
Shares of Gossamer Bio Inc. plunged 64.5% in premarket trading on Tuesday after Wall Street analysts questioned the performance of the company's experimental hypertension drug in a Phase 2 clinical trial. Though Gossamer said the drug, seralutinib, met the primary endpoint in a Phase 2 clinical trial, SVB Securities analyst Joseph Schwartz told investors that the therapy didn't outperform Merck & Co. Inc.'s sotatercept. "We expect the street to be disappointed in these topline results given both endpoints fell below the [Phase 2] placebo-adjusted data from sotatercept," he wrote in a note. "We note that the topline data also fell below our base case expectation for seralutinib vs. placebo to show a 20% to 30%" reduction in pulmonary vascular resistance. Gossamer's stock is down 17.8% this year, while the S&P 500 has declined 16.1%.
The third supercharged growth stock with truly jaw-dropping upside potential, based on the price target of one analyst, is biotech stock Novavax (NVAX 6.60%). According to H.C. Wainwright analyst Vernon Bernardino, who last updated his firm's price target in March 2022, Novavax is poised to hit (drum roll) $207 per share. That represents a whopping 1,153% upside from where shares ended this past week.
Bernardino's price target, which sits as the high-water mark among covering analysts, was based on the idea that Novavax would receive authorization to sell its protein-based COVID-19 vaccine, NVX-CoV2373, worldwide. Whereas the Moderna and Pfizer/BioNTech vaccines rely on messenger-RNA (mRNA) technology, the Novavax vaccine is differentiated in that it relies on an older and more traditional application of introducing harmless pieces of spike protein to teach a person's immune system how to fight and/or prevent infection. The thinking here is that folks who were leery of getting an mRNA vaccine might be more willing to receive an initial series or booster shots from Novavax's protein-based COVID-19 vaccine.
Something else that's working in Novavax's favor is the efficacy of NVX-CoV2373. Only three COVID-19 vaccines have reached the highly coveted 90% vaccine efficacy (VE) level. Those being Moderna (94.1%), Pfizer/BioNTech (95%), and Novavax (90.4%) with its U.S./Mexico trial in 2021. Even though VE is just one measure of efficacy, it's a strong enough headline number to keep Novavax in the global rotation as a major initial series and booster vaccine player.
Similar to Bionano, Novavax is swimming with cash. The company ended the third quarter with $1.28 billion in cash and cash equivalents, which is more than enough to cover the future repayment of its convertible notes and fuel ongoing research. In particular, Novavax could be one of the first drug developers to bring a combination vaccine targeting COVID-19 and influenza to market.
But even being a shareholder, I don't in any way foresee $207 as a viable price target for Novavax in 2023. With the company enduring numerous emergency-use filing delays and production snafus, it missed out on most of the low-hanging fruit in developed markets in 2022. Moving forward, it'll primarily be focusing its attention on recurring booster shots in developed countries and initial series vaccinations in emerging markets.
While I believe Novavax is an amazing value at its current share price, it could take a couple of quarters before Wall Street realizes that as well. If sales growth continues, losses shrink, and the company advances its combination vaccines, it could certainly end 2023 on a much higher note than it'll finish 2022.
https://www.fool.com/investing/2022/12/06/3-growth-stocks-with-393-to-1153-upside-in-2023/
A second supercharged growth stock with monumental upside, at least according to one Wall Street analyst, is small-cap genome analysis company Bionano Genomics (BNGO -4.31%). If Oppenheimer analyst Francois Brisebois is correct, Bionano shares will hit $12 in 2023, which would represent upside of a cool 474%.
Although Brisebois is the current analyst covering Bionano for Oppenheimer, it was his predecessor, Kevin DeGeeter, who primarily laid out the case for Bionano Genomics running to $12. In DeGeeter's view, Bionano's optical genome mapping (OGM) system, known as Saphyr, has demonstrated that it's faster, less expensive, and in many ways more effective at identifying structural genome variations than other OGM systems.
One thing investors don't have to worry about with Bionano Genomics is a lack of data demonstrating Saphyr's efficacy. Over the past two years, the company has released numerous studies and data points extolling Saphyr's ability to recognize structural variations in everything from various types of cancer to genetic disorders and recurrent pregnancy loss. In theory, Saphyr can play a key role in helping researchers and drug developers fight hard-to-treat diseases.
Another positive for Bionano Genomics is its healthy cash position. After its share price went parabolic to begin 2021, management wisely chose to issue stock to raise plenty of capital. The company ended September with approximately $180 million in cash, cash equivalents, and available-for-sale securities. That's more than enough to offset quarterly losses as the company continues to innovate and look for ways to expand Saphyr's utility.
So, why is Bionano Genomics at $2.09 per share and not $12? The answer to that question largely has to do with Saphyr not being an approved diagnostic system by the U.S. Food and Drug Administration (FDA). Without this approval, Saphyr's utility is limited within the United States. It's not exactly clear if and when Saphyr might get the green light from the FDA, either.
Although Bionano's cash does provide a somewhat safe floor, the ceiling proposed by Brisebois and DeGeeter doesn't seem achievable without FDA support.
https://www.fool.com/investing/2022/12/06/3-growth-stocks-with-393-to-1153-upside-in-2023/
