Why Cassava Sciences and Ocugen Stock Fell

 The stock market got choppy on Wednesday morning, and the Nasdaq Composite (NASDAQINDEX:^IXIC) wasn't able to sustain its recent push higher to all-time records. As of 11:15 a.m. EST, the Nasdaq was down about 0.5%, having given up an early gain.

Big-name companies have helped power the Nasdaq higher, yet investors have also benefited from some smaller companies that have a lot more long-term growth potential. On Wednesday, two of the most popular stocks on the Nasdaq recently -- Cassava Sciences (NASDAQ:SAVA) and Ocugen (NASDAQ:OCGN) -- posted sharp losses that showed that biotech stocks could remain volatile for quite some time despite their favorable prospects.

Cassava raises cash

Shares of Cassava Sciences were down 15% Wednesday morning. Investors weren't happy about the terms that the biotech company settled for in raising capital.

Cassava announced a registered direct offering of common stock on Wednesday morning, with the intent of raising $200 million in cash. Several institutional investors focusing on the healthcare field negotiated directly with Cassava to buy nearly 4.1 million shares of stock at $49 per share. That price was far below the $57.56 per share Cassava stock fetched at the close on Tuesday, and current shareholders were disappointed that the company offered such a massive discount on a hot stock.

The capital raise came after Cassava reported its plans for developing its candidate Alzheimer's disease treatment, simulfilam, in the coming year. With costly phase 3 clinical trials upcoming, bringing in cash was an inevitable move.

If simulfilam is successful in offering a permanent solution to Alzheimer's, then Cassava shareholders are likely to see huge long-term stock gains that will make them forget about today's one-day drop. Nevertheless, it's always tough to accept when new investors aren't willing to pay the same price the market is putting on the stock.

Getting cautious on Ocugen

Elsewhere, shares of Ocugen fell 16% on Wednesday morning. That left shares of the clinical stage biotech at a price double where it began the day, but it continued a decline from nearly $19 per share to its current price below $11.

The push higher for Ocugen began when the company announced a strategic partnership with Indian biopharmaceutical company Bharat Biotech to commercialize the Covaxin coronavirus vaccine in the U.S. market. In the aftermath of that announcement, Ocugen was able to raise $23 million in capital at a premium to its previous share price, an almost unheard-of accomplishment for a biotech.

Yet there's a chance that Ocugen might not receive an immediate Emergency Use Authorization from the U.S. Food and Drug Administration, at least without further study. The delay could cost Ocugen and Bharat significant revenue, and that brought the stock down from recent highs.

There's no doubt that coronavirus vaccines will be a big moneymaker for those allowed to sell them. Ocugen has a good chance, but the stock's movements reflect changing ideas about the odds of success. Shareholders can expect a bumpy ride as long as the uncertainty lasts.

https://www.fool.com/investing/2021/02/10/why-cassava-sciences-and-ocugen-stock-fell-nasdaq/

Pulmatrix started at Buy by Wainwright

 Target $5

https://finviz.com/quote.ashx?t=PULM

10 Things to Know About Anchiano Therapeutics

 Anchiano Therapeutics (NASDAQ:ANCN) stock has skyrocketed as much as 150% at the time of writing today on the announcement that its first patient has been enrolled in a clinical trial for a treatment aimed at “liver, skin, and lung fibrosis-related diseases such as PSC and systemic sclerosis (SSc).”

This announcement signals the company’s on the right track with gaining approval with the U.S. Food and Drug Administration for this treatment. Currently, no disease-modifying drugs have been approved by the FDA for these disorders.

Here are ten things investors need to know about Anchiano therapeutics:

• ANCN stock has been on a tear since a merger with Chemomab was announced in mid-December. Accordingly, the stock has moved from below the $2 level toward the $6 level in a span of a couple months.
• This merger shifted the focus of Anchiano to Chemomab’s key products aimed at liver, lung and skin ailments.
• Initial results from phase-one data has been positive, with safety, tolerability, and biomarker readouts showing positive signs.
• The clinical study underway is taking place in the U.K and Israel. Up to 45 randomized patients are expected to be included in the trial.
• This clinical trial enrollment is significant as it starts the timeline for getting these therapies approved. Accordingly, the company expects clinical readouts over the next 12-18 months to drive value inflection with this stock.
• The fact that there are no current therapies that exist for these disorders puts the Anchiano-Chemomab entity in a strong market position.
• Additionally, the potential market for these drugs is enticing. According to the company’s financial presentation, the combined market for PSC and SSc is worth more than $2 billion. More than 200,000 patients are inflicted with these diseases.
• It appears the market is rewarding execution with this company right now. Expectations were that these clinical trials could be delayed due to the global pandemic. Indeed, the fact that trials have started on time is good news for long-term investors interested in these therapies.
• A confirmation of the positive results seen in animals has the potential to drive this stock much higher as the company gets closer to capturing this specific niche drug market.
• This is an early-stage clinical stock. Accordingly, there is a tremendous amount of speculation built into ANCN’s stock price right now. This company is executing its strategy well, but investors need to understand the intricacies of this company’s operations before investing.

https://investorplace.com/2021/02/ancn-stock-10-things-to-know-as-anchiano-therapeutics-rockets-higher/

Clinical trial in hospitalized COVID-19 patients evaluates long-acting antibody therapy

 An international randomized, controlled Phase 3 clinical trial has begun evaluating the safety and efficacy of an investigational long-acting antibody combination for treating people hospitalized with COVID-19. The trial, part of a master protocol known as ACTIV-3, has an adaptive design allowing investigators to add new sub-studies of additional investigational agents. ACTIV-3 is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.

The new sub-study is evaluating AZD7442, an investigational long-acting antibody combination developed by biopharmaceutical company AstraZeneca (Cambridge, United Kingdom). Antibodies are infection-fighting proteins naturally made by the immune system. Antibodies can prevent viruses from infecting cells, usually by binding to the surface of the virus. In 2020, researchers at Vanderbilt University Medical Center, Nashville, Tennessee, isolated antibodies from two patients who had recovered from COVID-19. These antibodies, which were licensed to AstraZeneca, formed the basis for the synthetic antibodies included in AZD7442. AZD7442 is engineered with AstraZeneca’s proprietary half-life extension technology which helps the therapeutic work for a longer period of time. This investigational long-acting antibody combination might function both as a treatment and as a means of preventing infection with SARS-CoV-2, the virus that causes COVID-19. However, the ACTIV-3 trial will only be testing its efficacy as a therapeutic.

ACTIV-3 is part of the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership to develop a coordinated research strategy for prioritizing and accelerating development of the most promising treatments and vaccines. The ACTIV-3 master trial is designed to conduct multiple different trials of experimental therapeutics simultaneously. The placebo group serves as a shared comparison group for two or more experimental therapeutics, increasing the chance that participants will receive a therapeutic in this randomized trial. The new sub-study of AZD7442 will be running concurrently with two other sub-studies. One sub-study is evaluating VIR-7831, a SARS-CoV-2 experimental monoclonal antibody developed through a partnership between GlaxoSmithKline (Brentford, United Kingdom) and Vir Biotechnology, Inc. (San Francisco). The other ongoing sub-study is evaluating the combination of BRII-196 and BRII-198, two investigational SARS-CoV-2 neutralizing monoclonal antibodies manufactured by Brii Biosciences (Durham, North Carolina, and Beijing).

Initial participants in the new ACTIV-3 sub-study will be hospitalized patients with mild-to-moderate COVID-19 and fewer than 13 days of symptoms. They will be randomized to receive either a saline placebo control or one of the three experimental therapeutics. After five days, the participants’ medical condition will be assessed on two seven-point ordinal scales, each ranging from being able to undertake usual activities with minimal or no symptoms to death.  

If the ordinal outcomes assessed at five days, after approximately 150 volunteers have received AZD7442, indicate that AZD7442 is likely to be both safe and effective, enrollment in the trial will be expanded. At that time, an additional 700 participants, some of whom may have more severe cases of COVID-19, will be enrolled and randomized in the trial. This expanded pool of participants will allow researchers to better evaluate whether the therapeutic fulfills the trial’s primary endpoint of sustained recovery. Participants will have met this endpoint when they have been discharged from the hospital and have lived at home for 14 consecutive days.

The principal investigator of ACTIV-3 is Jens Lundgren, M.D., of the University of Copenhagen and Rigshospitalet. Leaders of the participating networks include James Neaton, Ph.D., of the NIAID-sponsored INSIGHT network; Taylor Thompson, M.D., of the PETAL network, Annetine Gelijns, Ph.D., and Alan Moskowitz, M.D., of the CTSN, both NHLBI-sponsored networks; and Victoria Davey, Ph.D., M.P.H., of the U.S. Department of Veterans Affairs.

People interested in learning more about the trial can visit ClinicalTrials.gov and search identifier NCT04501978.

NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.  

https://www.nih.gov/news-events/news-releases/clinical-trial-hospitalized-covid-19-patients-evaluates-long-acting-antibody-therapy

Deciphera Pharmaceuticals (NASDAQ:DCPH) Price Target Cut to $70

 Deciphera Pharmaceuticals (NASDAQ:DCPH) had its price target reduced by investment analysts at Barclays from $85.00 to $70.00 in a research note issued to investors on Wednesday, Benzinga reports. 

https://www.marketbeat.com/instant-alerts/nasdaq-dcph-a-buy-or-sell-right-now-2021-02/

S. Africa will give the unapproved J&J vax to front-line health care workers

 starting next week.

https://finance.yahoo.com/news/south-africa-unapproved-johnson-johnson-072419001.html

Incyte cut to Underperform by Leerink

 Target $70

https://finviz.com/quote.ashx?t=INCY